ISO/TS 22003:2007
(Main)Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems
Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems
ISO/TS 22003:2007 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements), and provides the necessary information and confidence to customers about the way certification of their suppliers has been granted. FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000:2005 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.
Systèmes de management de la sécurité des denrées alimentaires — Exigences pour les organismes procédant à l'audit et à la certification de systèmes de management de la sécurité des denrées alimentaires
L'ISO/TS 22003:2007 définit les règles applicables à l'audit et à la certification d'un système de management de la sécurité des denrées alimentaires (SMSDA) conforme aux exigences de l'ISO 22000:2005 (ou à d'autres ensembles d'exigences spécifiées en la matière) et fournit aux clients les informations nécessaires sur la manière de procéder à la certification de leurs fournisseurs et leur donne ainsi confiance dans cette certification. La certification d'un SMSDA n'atteste pas la sécurité ou l'aptitude à l'emploi des produits d'une organisation appartenant à la chaîne alimentaire. Cependant, l'ISO 22000:2005 exige qu'une organisation satisfasse à l'ensemble des exigences législatives et réglementaires en vigueur liées à la sécurité des denrées alimentaires par son système de management.
Sistemi vodenja varnosti živil - Zahteve za organe, ki izvajajo presoje in certificiranje sistemov vodenja varnosti živil
Ta tehnična specifikacija:
⎯ določa pravila, ki veljajo za presojo in certificiranje sistemov vodenja živil (FSMS), ki so v skladu z zahtevami, podanimi v ISO 22000 (ali drugih sklopih določenih zahtev FSMS), in
⎯ zagotavlja potrebne informacije in zaupanje strankam o tem, kako je bila certifikacija njihovih dobaviteljev podeljena.
Certifikacija FSMS (v tej tehnični specifikaciji imenovana »certifikacija«) je dejavnost ugotavljanja skladnosti, ki jo izvaja tretja oseba (glej ISO/IEC 17000:2004, točko 5.5). Organi, ki izvajajo to dejavnost, so potemtakem organi za ugotavljanje skladnosti tretje osebe (v tej tehnični specifikaciji imenovani »certifikacijski organi«).
OPOMBA 1: Certifikacija FSMS se včasih imenuje tudi »registracija«, certifikacijski organi pa se včasih imenujejo »registratorji«.
OPOMBA 2: Certifikacijski organ je lahko nevladni ali vladni (z regulativnim organom ali brez njega).
OPOMBA 3: Ta tehnična specifikacija je predvsem namenjena uporabi kot dokument s kriteriji za akreditacijo ali ovrednotenje certifikacijskih organov, ki si želijo biti prepoznani kot pristojni za certificikacijo, da je FSMS v skladu z ISO 22000. Prav tako je namenjen uporabi kot dokument s kriteriji regulativnih organov in industrijskih konzorcijev, ki neposredno priznavajo certifikacijskim organom certificiranje, da je FSMS v skladu z ISO 22000. Nekatere zahteve tehnične specifikacije so lahko uporabne tudi za druge stranke, udeležene pri ugotavljanju skladnosti takih certifikacijskih organov ter pri ugotavljanju skladnosti vseh organov, ki opravljajo certifikacijo skladnosti FSMS z dodatnimi kriteriji ali kriteriji, drugačnimi od tistih v ISO 22000.
Certifikacija FSMS ne potrjuje varnosti ali primernosti proizvodov organizacije v prehranski verigi. Vendar ISO 22000 zahteva, da organizacija izpolnjuje vse veljavne zakone, povezane z varnostjo hrane, in predpise z njenim nadzornim sistemom.
Pomembno je upoštevati, da je certifikacija FSMS, v skladu z ISO 22000, nadzorni certifikacijski sistem in ne specifikacija proizvoda.
Drugi uporabniki FSMS lahko uporabljajo koncepte in zahteve te tehnične specifikacije, če so zahteve po potrebi prilagojene.
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Buy Standard
Standards Content (Sample)
ТЕХНИЧЕСКИЕ ISO/TS
УСЛОВИЯ 22003
Первое издание
2007-02-15
Системы менеджмента безопасности
пищевых продуктов. Требования к
органам, проводящим аудит и
сертификацию систем менеджмента
безопасности пищевых продуктов
Food safety management systems — Requirements for bodies
providing audit and certification of food safety management systems
Ответственность за подготовку русской версии несёт GOST R
(Российская Федерация) в соответствии со статьёй 18.1 Устава ISO
Ссылочный номер
SO/TS 22003:2007(R)
©
ISO 2007
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ISO/TS 22003:2007(R)
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ISO/TS 22003:2007(R)
Содержание страница
Предисловие .iv
Введение .v
1 Область применения .1
2 Нормативные ссылки .2
3 Термины и определения .2
4 Принципы.2
5 Общие требования .3
5.1 Общие вопросы .3
5.2 Контроль беспристрастности .3
6 Структурные требования.3
7 Требования к ресурсам .3
7.1 Компетентность руководства и персонала.3
7.2 Персонал, участвующий в деятельности по сертификации .3
7.3 Использование индивидуальных внешних аудиторов и внешних технических
экспертов .9
7.4 Записи персонала.9
7.5 Аутсорсинг .9
8 Информационные требования .9
9 Требования к процессам.10
9.1 Общие требования .10
9.2 Первоначальный аудит и сертификация.12
9.3 Инспекционная деятельность.13
9.4 Повторная сертификация .13
9.5 Специальные аудиты .13
9.6 Временная отмена, исключение или сокращение области сертификации .13
9.7 Апелляции.13
9.8 Обжалования.14
9.9 Записи заявителей и клиентов .14
10 Требования к системе менеджмента для органов сертификации.14
Приложение А (нормативное) Классификация категорий в цепи производства и
потребления пищевых продуктов.15
Приложение В (информативное) Минимальное время для аудита .16
Библиография.18
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ISO/TS 22003:2007(R)
Предисловие
Международная организация по стандартизации (ISO) является всемирной федерацией
национальных организаций по стандартизации (комитетов-членов ISO). Разработка международных
стандартов обычно осуществляется техническими комитетами ISO. Каждый комитет-член,
заинтересованный в деятельности, для которой был создан технический комитет, имеет право быть
представленным в этом комитете. Международные правительственные и неправительственные
организации, имеющие связи с ISO, также принимают участие в работах. Что касается стандартизации
в области электротехники, ISO работает в тесном сотрудничестве с Международной
электротехнической комиссией (IEC).
Проекты международных стандартов разрабатываются по правилам, указанным в Директивах ISO/IEC,
Часть 2.
Главная задача технических комитетов состоит в разработке международных стандартов. Проекты
международных стандартов, принятые техническими комитетами, рассылаются комитетам-членам на
голосование. Их опубликование в качестве международных стандартов требует одобрения, по
меньшей мере, 75 % комитетов-членов, принимающих участие в голосовании
При других обстоятельствах, особенно когда существует срочная потребность рынка в таких
документах, технический комитет может принять решение о публикации других типов нормативного
документа:
общедоступные технические условия ISO (ISO/PAS) представляют собой соглашение между
техническими экспертами в рабочей группе ISO и принимаются к публикации после одобрения
более чем 50 % членов основного комитета, участвующих в голосовании;
технические условия ISO (ISO/TS) представляют собой соглашение между членами технического
комитета и принимаются к публикации после одобрения 2/3 членов комитета, участвующих в
голосовании.
Настоящий документ выходит в серии технических условий (согласно Директивам ISO/IEC, Часть 1,
3.1) как “проект стандарта для предварительного применения” в области безопасности пищевых
продуктов, потому что существует срочная необходимость в руководящих указаниях относительно
использования стандартов в этой области для удовлетворения идентифицируемой потребности.
Этот документ не должен рассматриваться как “Международный стандарт”. Он предлагается для
предварительного применения, чтобы можно было собрать информацию и опыт по его практическому
использованию. Комментарии по содержанию этого документа следует отправлять в Центральный
секретариат ISO.
Пересмотр этих технических условий будет проводиться не позднее чем через 3 года после их
публикации с целью продления их еще на 3 года, перевода в статус международного стандарта или
отмены.
Обращается внимание на возможность патентования некоторых элементов данного документа. ISO не
несет ответственности за идентификацию какого-либо или всех таких патентных прав.
ISO/TS 22003 были разработаны Техническим комитетом ISO/TC 34, Пищевые продукты, в
сотрудничестве с Комитетом ISO по оценке соответствия (ISO/CASCO).
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ISO/TS 22003:2007(R)
Введение
Сертификация системы менеджмента безопасности пищевых продуктов (FSMS) проводится в
заданной организации для получения гарантии, что эта организация реализовала систему для
менеджмента безопасности пищевых продуктов согласно своей политике.
Требования для FSMSs могут быть получены из нескольких источников, и настоящие технические
условия разработаны, чтобы помочь в сертификации FSMSs, которые выполняют требования
ISO 22000, Системы безопасности менеджмента пищевых продуктов. Требования ко всем
организациям в цепи производства и потребления пищевых продуктов. Содержание этих
технических условий можно также использовать для содействия сертификации FSMSs, которые
основаны на некоторых других установленных требованиях к FSMS.
Эти технические условия предназначены для использования органами, которые проводят аудит и
сертификацию FSMSs. Они дают общие требования для органов сертификации, выполняющих аудит и
сертификацию в области систем менеджмента безопасности пищевых продуктов. Такие органы
называют органами сертификации. Эта формулировка не должна быть препятствием к использованию
данных технических условий организациями, предназначенными для других целей, которые
занимаются деятельностью, относящейся к области применения этого документа. В действительности
эти технические условия годятся для всех органов, занимающихся оценкой FSMSs.
Деятельность по сертификации включает аудит FSMS в какой-либо организации. Форма аттестации
соответствия FSMS в организации конкретному стандарту на FSMS (например, ISO 22000) или другим
установленным требованиям обычно является сертификационным документом или сертификатом.
Организация, в которой проводится сертификация, разрабатывает свои собственные системы
менеджмента (включая FSMS по ISO 22000, ряд других установленных требований для FSMS, системы
менеджмента качества, системы менеджмента окружающей среды или системы менеджмента гигиены
труда и техники безопасности), и, кроме случаев, когда имеются противоположные законодательные
требования, именно организация должна решать, как будут устроены различные компоненты этих
систем. Степень интеграции различных компонентов систем менеджмента будет разной в разных
организациях. Поэтому уместно, чтобы органы сертификации, которые работают согласно настоящим
техническим условиям, учитывали культуру и практику работы своих клиентов относительно
интеграции их FSMSs внутри более широкой организации.
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ТЕХНИЧЕСКИЕ УСЛОВИЯ ISO/TS 22003:2007(R)
Системы менеджмента безопасности пищевых продуктов.
Требования к органам, проводящим аудит и сертификацию
систем менеджмента безопасности пищевых продуктов
1 Область применения
Настоящие технические условия
определяют правила, применяемые для аудита и сертификации системы менеджмента
безопасности продуктов питания (FSMS), соответствующие требованиям, данным в ISO 22000
(или ряду других установленных требований для FSMS), и
обеспечивают необходимую информацию и уверенность для заказчиков относительно
предоставленной сертификации поставщиков.
Сертификация FSMSs (называемая “сертификацией” в этих технических условиях) является
деятельностью третьей стороны по оценке соответствия (см. ISO/IEC 17000:2004, 5.5). Органы,
выполняющие эту деятельность, являются, следовательно, органами по оценке соответствия третьей
стороной (называемые “орган/органы сертификации” в этих технических условиях).
ПРИМЕЧАНИЕ 1 Сертификацию FSMS иногда также называют “регистрацией”, а органы сертификации иногда
называют “органами регистрации”.
ПРИМЕЧАНИЕ 2 Орган сертификации может быть неправительственным или правительственным (с
регулирующим официальным органом или без него).
ПРИМЕЧАНИЕ 3 Эти технические условия предназначены прежде всего для использования в качестве
документа, устанавливающего критерии для аккредитации или экспертной оценки органов сертификации, которые
хотят получить признание своей компетентности для сертификации соответствия FSMS стандарту ISO 22000. Эти
технические условия также предназначены для использования в качестве критериев органами технического
регулирования и промышленными консорциумами, которые занимаются непосредственным признанием органов
сертификации, устанавливающих соответствие FSMS стандарту ISO 22000. Некоторые из указанных требований
могли бы также быть полезными и другим сторонам, участвующим в оценке соответствия таких органов
сертификации и в оценке соответствия всех органов, которые проводят сертификацию соответствия FSMSs
критериям, дополнительным или не указанным в ISO 22000.
Сертификация FSMS не удостоверяет безопасность или пригодность продуктов организации в цепи
производства и потребления пищевых продуктов. Однако ISO 22000 требует, чтобы организация
удовлетворяла всем применяемым законодательным и нормативным требованиям, связанным с
безопасностью пищевых продуктов, посредством своей системы менеджмента.
Важно отметить, что сертификация FSMS согласно ISO 22000 является сертификацией системы
менеджмента, а не сертификацией продукта.
Другие пользователи FSMS могут применять концепции и требования этих технических условий, при
условии адаптации требований, когда необходимо.
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ISO/TS 22003:2007(R)
2 Нормативные ссылки
Следующие ссылочные нормативные документы являются обязательными при применении данного
документа. Для жестких ссылок применяется только цитированное издание документа. Для плавающих
ссылок необходимо использовать самое последнее издание нормативного ссылочного документа
(включая любые изменения).
ISO 19011:2002, Руководящие указания по аудиту систем менеджмента качества и/или систем
менеджмента качества
ISO 22000:2005, Системы менеджмента безопасности пищевых продуктов. Требования ко всем
организациям цепи производства и потребления пищевых продуктов
ISO/IEC 17000:2004, Оценка соответствия. Словарь и общие принципы
ISO/IEC 17021:2006, Оценка соответствия. Требования к органам, обеспечивающим аудит и
сертификацию систем менеджмента
3 Термины и определения
Применительно к этому документу используются термины и определения, данные в ISO/IEC 17000,
ISO/IEC 17021, ISO 22000, и следующие.
ПРИМЕЧАНИЕ В этих технических условиях термины “продукт” и “услуга” используются отдельно, что не
соответствует определению продукта, данному в ISO/IEC 17000.
3.1
анализ опасностей (рисков) и критическая контрольная точка
hazard analysis and critical control point
HACCP
система, которая идентифицирует, оценивает и контролирует опасности, являющиеся значительными
для пищевой промышленности
ПРИМЕЧАНИЕ Адаптировано из ссылки [8].
3.2
система менеджмента безопасности пищевых продуктов
food safety management system
FSMS
совокупность взаимосвязанных или взаимодействующих элементов для установления политики и
целей и для достижения этих целей, используемых для руководства и управления организацией в
области безопасности пищевых продуктов
ПРИМЕЧАНИЕ См. 3.2.1, 3.2.2 и 3.2.3 в ISO 9000:2005.
4 Принципы
Принципы, данные в Разделе 4 в ISO/IEC 17021:2006, являются основой для последующих конкретных
эксплуатационных и описательных требований в этих технических условиях. Настоящие технические
условия не дают конкретных требований для всех ситуаций, которые могут случиться. Эти принципы
следует применять как руководство для принятия нужных решений в непредвиденных ситуациях.
Принципы не являются требованиями.
Термин “система менеджмента”, использованный в ISO/IEC 17021, заменяется термином “система
менеджмента пищевых продуктов” в контексте этих технических условий.
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ISO/TS 22003:2007(R)
5 Общие требования
5.1 Общие вопросы
Применяются все требования, данные в Разделе 5 в ISO/IEC 17021:2006.
5.2 Контроль беспристрастности
Орган сертификации и любая часть аналогичной официальной организации не должны предлагать или
давать консультации по анализу опасностей, по FSMS или по системе менеджмента.
Если организация нанимает аудитора, о котором известно, что он давал консультации по анализу
опасностей, по FSMS или по системе менеджмента для данной организации, то в течение двух лет
после окончания консультаций этот факт, вероятно, будет представлять большую угрозу для
беспристрастности.
Термин “консультация по системе менеджмента”, упомянутый в 5.2 в ISO/IEC 17021:2006. заменяется в
контексте этих технических условий термином “консультации по анализу опасностей, по FSMS или по
системе менеджмента”.
6 Структурные требования
Применяются все требования, данные в Разделе 6 в ISO/IEC 17021:2006.
7 Требования к ресурсам
7.1 Компетентность руководства и персонала
Применяются все требования, данные в Разделе 7.1 в ISO/IEC 17021:2006.
Кроме того, орган сертификации должен владеть процессами для обеспечения персонала
достаточными знаниями, соответствующими категориям (см. Приложение A), в которых он работает.
7.2 Персонал, участвующий в деятельности по сертификации
7.2.1 Общие вопросы
7.2.1.1 Применяются все требования, данные в Разделе 7.2 в ISO/IEC 17021:2006.
7.2.1.2 Орган сертификации должен обеспечить, чтобы весь персонал, участвующий в
деятельности по аудиту и сертификации, обладал следующими личными качествами. Персонал
должен быть
a) порядочным (т.е. справедливым, правдивым, искренним, честным и благоразумным),
b) широких взглядов (т.е. желающим рассматривать альтернативные идеи или точки зрения),
c) дипломатичным (т.е. тактичным в обращении с людьми),
d) наблюдательным (т.е. активно воспринимающим физическое окружение и поступки),
e) проницательным (т.е. инстинктивно осознающим и способным понимать ситуации),
f) гибким (т.е. быстро приспосабливаться к различным ситуациям),
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g) упорным (т.е. настойчивым, сосредоточенным на достижении целей),
h) решительным (т.е. делать своевременные выводы на основе логических рассуждений и анализа), и
i) уверенным в себе (т.е. поступать и действовать независимо при эффективном взаимодействии с
другими).
7.2.2 Персонал, проводящий анализ контракта
7.2.2.1 Образование
Орган сертификации должен обеспечить, чтобы персонал, проводящий анализ контракта, имел знания,
соответствующие среднему образованию.
7.2.2.2 Обучение проблемам безопасности пищевых продуктов
Орган сертификации должен обеспечить, чтобы персонал, проводящий анализ контракта, успешно
закончил обучение
a) принципам анализа опасностей и критической контрольной точки (HACCP), оценке и анализу
опасностей,
b) принципам менеджмента безопасности пищевых продуктов, включая программы предварительных
условий (PRPs), и
c) соответствующим стандартам по FSMS (например, ISO 22000).
7.2.2.3 Обучение аудиту
Орган сертификации должен обеспечить, чтобы персонал, проводящий анализ контракта, успешно
закончил обучение процессам аудита на основе руководства, данного в ISO 19011.
ПРИМЕЧАНИЕ Для персонала, проводящего анализ контракта, не является обязательным наличие или
поддержание аудиторских навыков.
7.2.2.4 Компетентность
Орган сертификации должен обеспечить, чтобы персонал, проводящий анализ контракта,
демонстрировал способность применять знания и навыки в следующих областях:
a) классификация заявителей по категориям и секторам в цепи производства и потребления
пищевых продуктов;
b) оценка продуктов, процессов и методов заявителей;
c) использование компетентности аудиторов и требований к FSMS;
d) определение времени для аудита (см. Приложение B) и требований к продолжительности аудита;
e) политика органа сертификации и процедуры, связанные с анализом контракта.
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7.2.3 Персонал, предоставляющий сертификацию
7.2.3.1 Общие вопросы
Орган сертификации должен обеспечить, чтобы персонал, который принимает решение о выдаче
сертификации, имел такое же образование, обучение вопросам безопасности пищевых продуктов,
обучение аудиту и опыт работы, которые требуются для аудитора в одной категории (см.
Приложение A).
ПРИМЕЧАНИЕ Для персонала, предоставляющего сертификацию, не является обязательным наличие или
поддержание аудиторских навыков.
7.2.3.2 Компетентность
Орган сертификации должен обеспечить, чтобы персонал, предоставляющий сертификацию,
демонстрировал способность применять знания и навыки в следующих областях:
a) существующие принципы HACCP;
b) понимание PRPs;
c) идентификация рисков для безопасности пищевых продуктов ;
d) характеристики и менеджмент рисков для безопасности пищевых продуктов, критические
контрольные точки (CCPs) и способность оценивать эффективность выбранных мер контроля;
e) исправления и корректирующие действия, которые должны быть предприняты для безопасности
пищевых продуктов;
f) оценка потенциальных рисков для безопасности пищевых продуктов, связанных с цепью поставки
пищевых продуктов;
g) законы и регламенты, соответствующие безопасности пищевых продуктов, чтобы можно было
проводить эффективный аудит FSMS;
h) продукты, процессы и методы;
i) существующие требования к системам менеджмента безопасности пищевых продуктов ;
j) соответствующие стандарты;
k) оценка и анализ аудиторского отчета на точность и компетентность;
l) оценка и анализ эффективности корректирующих действий;
m) процесс сертификации.
7.2.4 Аудиторы
7.2.4.1 Образование
Орган сертификации должен обеспечить, чтобы аудиторы имели знания, соответствующие
профессиональному образованию, которое включает общую микробиологию и общую химию.
Орган сертификации должен обеспечить, чтобы аудиторы имели знания, соответствующие
профессиональному образованию, которое включает курсы по отраслевой категории в цепи
производства и потребления пищевых продуктов, в которой они проводят аудиты FSMS.
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ISO/TS 22003:2007(R)
ПРИМЕРЫ
a) Для пищевой промышленности (Категории C, D, E, F, G и H в Таблице A.1): пищевая микробиология, основы
обработки пищевых продуктов и химия пищевых продуктов, включая .пищевой анализ.
b) Для сельского хозяйства (растения) (Категория B в Таблице A.1): растениеводство.
c) Для сельского хозяйства (животные) (Категории A и F в Таблице A.1): животноводство.
d) Для упаковочной промышленности/пищевого машиностроения/пищевой технологии (Категории от I до M в
Таблице A.1): курсы по науке/технологии в области данной дисциплины.
7.2.4.2 Обучение вопросам безопасности пищевой промышленности
Орган сертификации должен обеспечить, чтобы аудиторы успешно закончили обучение, включающее
a) принципы HACCP, оценку и анализ опасностей и
b) принципы менеджмента безопасности пищевых продуктов, включая PRPs.
Курс(ы) обучения должны признаваться промышленностью (и ее акционерами) как соответствующие и
компетентные. Одобрение или сертификация курсов обучения независимым органом с
соответствующей экспертизой могут дать некоторую гарантию, что эти курсы удовлетворяют
установленным критериям.
7.2.4.3 Обучение аудиту
Орган сертификации должен обеспечить, чтобы аудиторы успешно закончили обучение
a) методам аудита на основе ISO 19011 и
b) соответствующим стандартам по FSMS (например, ISO 22000).
7.2.4.4 Опыт работы
Для первой квалификации аудитора в одной или более категориях орган сертификации должен
обеспечить, чтобы аудитор имел как минимум пятилетний опыт работы с полной занятостью в
промышленности, связанной с цепью производства и потребления пищевых продуктов, включая как
минимум два года работы в области гарантии качества или безопасности пищевых продуктов в
пищевой промышленности, розничной торговле, инспекции или правоприменении либо в аналогичных
областях.
Число лет общего опыта работы может быть уменьшено на один год, если аудитор получил
соответствующее профессиональное образование.
7.2.4.5 Аудиторский опыт
Для первой квалификации орган сертификации должен обеспечить, чтобы в течение последних трех
лет аудитор отработал как минимум двенадцать аудитодней для проверки FSMS как минимум в
четырех организациях под руководством квалифицированного аудитора.
ПРИМЕЧАНИЕ Аудитодни для FSMS включают аудитодни по ISO 9001 в пищевой промышленности или другие
аудиты FSMS.
Для перехода к новой категории орган сертификации должен продемонстрировать, что аудитор имеет
требуемую компетентность на основе соответствующего образования по 7.2.4.1, обучения, связанного
с безопасностью пищевых продуктов, в новой категории или
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ISO/TS 22003:2007(R)
шесть месяцев опыта работы в новой категории, или
четыре аудита FSMS под контролем квалифицированного аудитора в новой категории.
Для поддержания квалификации аудитора орган сертификации должен обеспечить, чтобы аудиторы
выполнили или
как минимум пять внешних аудитов в год, включая по крайней мере два аудита FSMS, или
как минимум четыре внешних аудита FSMS на месте или десять аудитодней для FSMS в год.
7.2.4.6 Компетентность
7.2.4.6.1 Компетентность аудиторов должна быть записана [см. 5.5 c) в ISO 19011:2002] для каждой
категории и сектора (см. Приложение A). Орган сертификации должен предоставить доказательство
успешной оценки.
7.2.4.6.2 Орган сертификации должен обеспечить, чтобы аудиторы продемонстрировали
способность применять знания и навыки в следующих областях.
a) Принципы, процедуры и методы аудита: обеспечить, чтобы аудитор мог применять их
соответственно в различных аудитах и обеспечить, чтобы аудиты проводились согласованно и
систематически. Аудитор должен уметь
применять принципы, процедуры и методы аудита,
эффективно планировать и организовывать работу,
проводить аудит в согласованное, запланированное время,
строить приоритеты и концентрироваться на важных вопросах,
собирать информацию посредством проведения эффективных интервью, прослушиваний,
изучения и анализа документов, записей и данных,
понимать уместность и последствия выборочных методов для проведения аудита,
проверять точность собранной информации,
подтверждать достаточность и правомерность аудиторских показаний для поддержки выводов
и заключений аудита,
оценивать те факторы, которые могут повлиять на надежность выводов и заключений аудита,
использовать рабочую документацию для записи аудиторских действий,
готовить аудиторские отчеты,
соблюдать конфиденциальность и защиту информации и
эффективно общаться, или посредством личных лингвистических способностей, или через
переводчика.
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ISO/TS 22003:2007(R)
b) Система менеджмента и справочные документы: обеспечить, чтобы аудитор понимал область
аудита и применял критерии аудита. Знания и навыки в этой области должны включать
применение систем менеджмента к различным организациям,
взаимодействие между компонентами системы менеджмента,
стандарты на систему менеджмента безопасности пищевых продуктов, применяемые
процедуры или другие документы о системе менеджмента, используемые как критерии аудита,
признание различий между справочными документами и их приоритета,
применение справочных документов к различным аудиторским ситуациям и
информационные системы и технологии для санкционирования, безопасности, распределения
и контроля документов, данных и записей.
c) Организационные ситуации: обеспечить, чтобы аудитор понимал рабочий контекст организации.
Знания и навыки в этой области должны включать
...
TECHNICAL ISO/TS
SPECIFICATION 22003
First edition
2007-02-15
Food safety management systems —
Requirements for bodies providing audit
and certification of food safety
management systems
Systèmes de management de la sécurité des denrées alimentaires —
Exigences pour les organismes procédant à l'audit et à la certification
de systèmes de management de la sécurité des denrées alimentaires
Reference number
ISO/TS 22003:2007(E)
©
ISO 2007
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ISO/TS 22003:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO/TS 22003:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Principles. 2
5 General requirements. 2
5.1 General. 2
5.2 Management of impartiality . 2
6 Structural requirements . 3
7 Resource requirements. 3
7.1 Competence of management and personnel. 3
7.2 Personnel involved in the certification activities .3
7.3 Use of individual external auditors and external technical experts . 8
7.4 Personnel records . 8
7.5 Outsourcing. 8
8 Information requirements . 8
9 Process requirements . 9
9.1 General requirements. 9
9.2 Initial audit and certification . 10
9.3 Surveillance activities . 12
9.4 Recertification . 12
9.5 Special audits. 12
9.6 Suspending, withdrawing or reducing the scope of certification . 12
9.7 Appeals . 12
9.8 Complaints . 12
9.9 Records of applicants and clients . 12
10 Management system requirements for certification bodies. 12
Annex A (normative) Classification of food chain categories. 13
Annex B (informative) Minimum audit time . 14
Bibliography . 16
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ISO/TS 22003:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
This document is being issued in the Technical Specification series of publications (according to the ISO/IEC
Directives, Part 1, 3.1) as a “prospective standard for provisional application” in the field of food safety
because there is an urgent need for guidance on how standards in this field should be used to meet an
identified need.
This document is not to be regarded as an “International Standard”. It is proposed for provisional application
so that information and experience of its use in practice may be gathered. Comments on the content of this
document should be sent to the ISO Central Secretariat.
A review of this Technical Specification will be carried out not later than 3 years after its publication with the
options of: extension for another 3 years; conversion into an International Standard; or withdrawal.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 22003 was prepared by Technical Committee ISO/TC 34, Food products, in collaboration with
ISO Committee on conformity assessment (ISO/CASCO).
iv © ISO 2007 – All rights reserved
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ISO/TS 22003:2007(E)
Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line with its
policy.
Requirements for FSMSs can originate from a number of sources, and this Technical Specification has been
developed to assist in the certification of FSMSs that fulfil the requirements of ISO 22000, Food safety
management systems — Requirements for any organization in the food chain. The contents of this Technical
Specification may also be used to support certification of FSMSs that are based on other sets of specified
FSMS requirements.
This Technical Specification is intended for use by bodies that carry out audit and certification of FSMSs. It
gives generic requirements for such certification bodies performing audit and certification in the field of food
safety management systems. Such bodies are referred to as certification bodies. This wording should not be
an obstacle to the use of this Technical Specification by bodies with other designations that undertake
activities covered by the scope of this document. Indeed, this Technical Specification should be usable by any
body involved in the assessment of FSMSs.
Certification activities involve the audit of an organization's FSMS. The form of attestation of conformity of an
organization's FSMS to a specific FSMS standard (for example ISO 22000) or other specified requirements is
normally a certification document or a certificate.
It is for the organization being certified to develop its own management systems (including ISO 22000 FSMS,
other sets of specified FSMS requirements, quality management systems, environmental management
systems or occupational health and safety management systems) and, other than where relevant legislative
requirements specify to the contrary, it is for the organization to decide how the various components of these
will be arranged. The degree of integration between the various management system components will vary
from organization to organization. It is therefore appropriate for certification bodies that operate in accordance
with this Technical Specification to take into account the culture and practices of their clients with respect to
the integration of their FSMSs within the wider organization.
© ISO 2007 – All rights reserved v
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TECHNICAL SPECIFICATION ISO/TS 22003:2007(E)
Food safety management systems — Requirements for bodies
providing audit and certification of food safety management
systems
1 Scope
This Technical Specification
⎯ defines the rules applicable for the audit and certification of a food safety management system (FSMS)
complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements), and
⎯ provides the necessary information and confidence to customers about the way certification of their
suppliers has been granted.
Certification of FSMSs (named “certification” in this Technical Specification) is a third-party conformity
assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party
conformity assessment bodies (named “certification body/bodies” in this Technical Specification).
NOTE 1 Certification of an FSMS is sometimes also called “registration”, and certification bodies are sometimes called
“registrars”.
NOTE 2 A certification body can be non-governmental or governmental (with or without regulatory authority).
NOTE 3 This Technical Specification is primarily intended to be used as a criteria document for the accreditation or
peer assessment of certification bodies which seek to be recognized as being competent to certify that an FSMS complies
with ISO 22000. It is also intended to be used as a criteria document by regulatory authorities and industry consortia which
engage in direct recognition of certification bodies to certify that an FSMS complies with ISO 22000. Some of its
requirements could also be found useful by any other parties involved in the conformity assessment of such certification
bodies, and in the conformity assessment of any bodies that undertake to certify the compliance of FSMSs with criteria
additional to or other than those in ISO 22000.
FSMS certification does not attest to the safety or fitness of the products of an organization within the food
chain. However, ISO 22000 requires an organization to meet all applicable food-safety-related statutory and
regulatory requirements through its management system.
It is important to note that certification of an FSMS according to ISO 22000 is a management system
certification and not a product certification.
Other FSMS users can use the concepts and requirements of this Technical Specification provided that the
requirements are adapted as necessary.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO 22000:2005, Food safety management systems — Requirements for any organization in the food chain
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ISO/TS 22003:2007(E)
ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles
ISO/IEC 17021:2006, Conformity assessment — Requirements for bodies providing audit and certification of
management systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17021,
ISO 22000 and the following apply.
NOTE In this Technical Specification, the terms “product” and “service” are used separately, which is not in
accordance with the definition of product given in ISO/IEC 17000.
3.1
hazard analysis and critical control point
HACCP
system which identifies, evaluates and controls hazards which are significant for food safety
NOTE Adapted from Reference [8].
3.2
food safety management system
FSMS
set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives,
used to direct and control an organization with regard to food safety
NOTE See 3.2.1, 3.2.2 and 3.2.3 of ISO 9000:2005.
4 Principles
The principles given in Clause 4 of ISO/IEC 17021:2006 are the basis for the subsequent specific
performance and descriptive requirements in this Technical Specification. This Technical Specification does
not give specific requirements for all situations that can occur. These principles should be applied as guidance
for the decisions that may need to be made for unanticipated situations. Principles are not requirements.
The term “management system” used in ISO/IEC 17021 shall be replaced by “food safety management
system” in the context of this Technical Specification.
5 General requirements
5.1 General
All the requirements given in Clause 5 of ISO/IEC 17021:2006 apply.
5.2 Management of impartiality
The certification body and any part of the same legal entity shall not offer or provide hazard analysis
consultancy, FSMS consultancy or management system consultancy.
The fact that the organization employing the auditor is known to have provided hazard analysis consultancy,
FSMS consultancy or management system consultancy on the management system, within two years
following the end of the consultancy, is likely to be considered as a high threat to impartiality.
2 © ISO 2007 – All rights reserved
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ISO/TS 22003:2007(E)
The term “management system consultancy” mentioned in 5.2 of ISO/IEC 17021:2006 shall be replaced in the
context of this Technical Specification by “hazard analysis consultancy, FSMS consultancy or management
system consultancy”.
6 Structural requirements
All the requirements given in Clause 6 of ISO/IEC 17021:2006 apply.
7 Resource requirements
7.1 Competence of management and personnel
All the requirements given in 7.1 of ISO/IEC 17021:2006 apply.
Additionally, the certification body shall have processes to ensure that personnel have appropriate knowledge
relevant to the categories (see Annex A) in which it operates.
7.2 Personnel involved in the certification activities
7.2.1 General
7.2.1.1 All the requirements given in 7.2 of ISO/IEC 17021:2006 apply.
7.2.1.2 The certification body shall ensure that all personnel involved in the audit and certification
activities possess the following personal attributes. The personnel shall be
a) ethical (i.e. fair, truthful, sincere, honest and discreet),
b) open-minded (i.e. willing to consider alternative ideas or points of view),
c) diplomatic (i.e. tactful in dealing with people),
d) observant (i.e. actively aware of physical surroundings and activities),
e) perceptive (i.e. instinctively aware of and able to understand situations),
f) versatile (i.e. adjust readily to different situations),
g) tenacious (i.e. persistent, focused on achieving objectives),
h) decisive (i.e. reach timely conclusions based on logical reasoning and analysis), and
i) self-reliant (i.e. act and function independently while interacting effectively with others).
7.2.2 Personnel carrying out contract review
7.2.2.1 Education
The certification body shall ensure that personnel carrying out contract review have the knowledge
corresponding to a secondary education.
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ISO/TS 22003:2007(E)
7.2.2.2 Food safety training
The certification body shall ensure that personnel carrying out contract review have successfully completed
training in
a) hazard analysis and critical control point (HACCP) principles, hazard assessment and hazard analysis,
b) food safety management principles including prerequisite programmes (PRPs), and
c) relevant FSMS standards (e.g. ISO 22000).
7.2.2.3 Audit training
The certification body shall ensure that personnel carrying out contract review have successfully completed
training in audit processes based on the guidance given in ISO 19011.
NOTE It is not mandatory for personnel carrying out contract review to have or to maintain audit experience.
7.2.2.4 Competences
The certification body shall ensure that personnel carrying out contract review demonstrate the ability to apply
knowledge and skills in the following areas:
a) classification of applicants in food chain categories and sectors;
b) assessment of applicant products, processes and practices;
c) deployment of FSMS auditor competences and requirements;
d) determination of audit time (see Annex B) and duration requirements;
e) certification body's policies and procedures related to contract review.
7.2.3 Personnel granting certification
7.2.3.1 General
The certification body shall ensure that the personnel who take the decision on granting certification have the
same education, food safety training, audit training and work experience as required for an auditor in one
category (see Annex A).
NOTE It is not mandatory for personnel granting certification to have or to maintain audit experience.
7.2.3.2 Competences
The certification body shall ensure that personnel granting certification demonstrate the ability to apply
knowledge and skills in the following areas:
a) current principles of HACCP;
b) understanding of PRPs;
c) identification of food safety hazards;
d) implementation and management of food safety hazards, critical control points (CCPs) and the ability to
assess the effectiveness of selected control measures;
e) corrections and corrective actions to be taken with regards to food safety matters;
4 © ISO 2007 – All rights reserved
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ISO/TS 22003:2007(E)
f) assessment of potential food safety hazards linked to the food supply chain;
g) laws and regulations relevant to food safety, in order to be able to conduct an effective audit of the FSMS;
h) products, processes and practices;
i) relevant food safety management system requirements;
j) relevant standards;
k) assessment and review of an audit report for accuracy and completeness;
l) assessment and review of the effectiveness of corrective actions;
m) the certification process.
7.2.4 Auditors
7.2.4.1 Education
The certification body shall ensure that auditors have the knowledge corresponding to a post-secondary
education that includes general microbiology and general chemistry.
The certification body shall also ensure that auditors have the knowledge corresponding to a post-secondary
education that includes courses in the food chain industry category in which they conduct FSMS audits.
EXAMPLES
a) For the food industry (Categories C, D, E, F, G and H in Table A.1): food microbiology, food processing fundamentals
and food chemistry including food analysis.
b) For farming (plants) (Category B in Table A.1): crop production.
c) For farming (animals) (Categories A and F in Table A.1): animal production.
d) For packaging/food machine/engineering industry (Categories I to M in Table A.1): science/engineering courses
related to the discipline.
7.2.4.2 Food safety training
The certification body shall ensure that auditors have successfully completed training in
a) HACCP principles, hazard assessment and hazard analysis, and
b) food safety management principles including PRPs.
The training course(s) should be recognized by the industry (and its stakeholders) as being appropriate and
relevant. The approval or certification of the training courses by an independent body with the relevant
expertise can provide some assurance that the course meets specified criteria.
7.2.4.3 Audit training
The certification body shall ensure that auditors have successfully completed training in
a) audit techniques based on ISO 19011, and
b) relevant FSMS standards (e.g. ISO 22000).
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ISO/TS 22003:2007(E)
7.2.4.4 Work experience
For a first qualification of an auditor in one or more categories, the certification body shall ensure that the
auditor has a minimum of five years of full-time work experience in the food-chain-related industry, including at
least two years of work in quality assurance or food safety functions within food production or manufacturing,
retailing, inspection or enforcement, or the equivalent.
The number of years of total work experience may be reduced by one year if the auditor has completed
appropriate post-secondary education.
7.2.4.5 Audit experience
For a first qualification, the certification body shall ensure that within the last three years the auditor has
performed at least twelve FSMS audit days in at least four organizations under the leadership of a qualified
auditor.
NOTE FSMS audit days include audit days dealing with ISO 9001 in the food industry or other FSMS audits.
For extension to a new category, the certification body shall demonstrate that the auditor has the required
competences through relevant education as required in 7.2.4.1, food-safety-related training in the new
category, and either
⎯ six months of work experience in the new category, or
⎯ four FSMS audits under the supervision of a qualified auditor in the new category.
For maintaining the qualification of the auditor, the certification body shall ensure that auditors have performed
either
⎯ a minimum of five external audits per year, including at least two FSMS audits, or
⎯ a minimum of four FSMS on-site external audits or ten FSMS audit days per year.
7.2.4.6 Competences
7.2.4.6.1 The competences of auditors shall be recorded [see 5.5 c) of ISO 19011:2002] for each category
and sector (see Annex A). The certification body shall provide evidence of a successful evaluation.
7.2.4.6.2 The certification body shall ensure that auditors demonstrate the ability to apply knowledge and
skills in the following areas.
a) Audit principles, procedures and techniques: to enable the auditor to apply those appropriate to different
audits and to ensure that audits are conducted in a consistent and systematic manner. An auditor shall be
able
⎯ to apply audit principles, procedures and techniques,
⎯ to plan and organize the work effectively,
⎯ to conduct the audit within the agreed time schedule,
⎯ to prioritize and focus on matters of significance,
⎯ to collect information through effective interviewing, listening, observing and reviewing documents,
records and data,
⎯ to understand the appropriateness and consequences of using sampling techniques for auditing,
⎯ to verify the accuracy of collected information,
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ISO/TS 22003:2007(E)
⎯ to confirm the sufficiency and appropriateness of audit evidence to support audit findings and
conclusions,
⎯ to assess those factors that can affect the reliability of the audit findings and conclusions,
⎯ to use work documents to record audit activities,
⎯ to prepare audit reports,
⎯ to maintain the confidentiality and security of information, and
⎯ to communicate effectively, either through personal linguistic skills or through an interpreter.
b) Management system and reference documents: to enable the auditor to comprehend the scope of the
audit and apply audit criteria. Knowledge and skills in this area shall cover
⎯ the application of management systems to different organizations,
⎯ interaction between the components of the management system,
⎯ food safety management system standards, applicable procedures or other management system
documents used as audit criteria,
⎯ recognizing differences between, and the priority of, the reference documents,
⎯ application of the reference documents to different audit situations, and
⎯ information systems and technology for authorization, security, distribution and control of documents,
data and records.
c) Organizational situations: to enable the auditor to comprehend the organization's operational context.
Knowledge and skills in this area shall cover
⎯ organizational size, structure, functions and relationships,
⎯ general business processes and related terminology, and
⎯ cultural and social customs of the auditee.
d) Applicable laws, regulations and other requirements relevant to the discipline: to enable the auditor to
work within, and be aware of, the requirements that apply to the organization being audited. Knowledge
and skills in this area shall cover
⎯ local, regional and national codes, laws and regulations,
⎯ contracts and agreements,
⎯ international treaties and conventions, and
⎯ other requirements to which the organization subscribes.
7.2.4.6.3 The certification body shall ensure that auditors demonstrate the ability to apply terminology,
knowledge and skills in the following food safety specific areas:
a) current principles of HACCP;
b) relevant PRPs for the considered category(ies) (see Annex A);
c) identification of food safety hazards;
d) methodologies used for determination, implementation and management of control measures (PRPs,
operational PRPs and CCPs) and the ability to assess the effectiveness of selected control measures;
© ISO 2007 – All rights reserved 7
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ISO/TS 22003:2007(E)
e) corrections and corrective actions to be taken with regards to food safety matters;
f) assessment of potential food safety hazards linked to the food supply chain;
g) evaluation of the relevance of the applicable PRPs, including establishing or selecting an appropriate
evaluation method or guide for these PRPs for the category(ies) considered (see Annex A);
h) laws and regulations relevant to food safety in order to
...
SLOVENSKI STANDARD
SIST-TS ISO/TS 22003:2011
01-junij-2011
Sistemi vodenja varnosti živil - Zahteve za organe, ki izvajajo presoje in
certificiranje sistemov vodenja varnosti živil
Food safety management systems -- Requirements for bodies providing audit and
certification of food safety management systems
Systèmes de management de la sécurité des denrées alimentaires -- Exigences pour les
organismes procédant à l'audit et à la certification de systèmes de management de la
sécurité des denrées alimentaires
Ta slovenski standard je istoveten z: ISO/TS 22003:2007
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
67.020 Procesi v živilski industriji Processes in the food
industry
SIST-TS ISO/TS 22003:2011 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST-TS ISO/TS 22003:2011
---------------------- Page: 2 ----------------------
SIST-TS ISO/TS 22003:2011
TECHNICAL ISO/TS
SPECIFICATION 22003
First edition
2007-02-15
Food safety management systems —
Requirements for bodies providing audit
and certification of food safety
management systems
Systèmes de management de la sécurité des denrées alimentaires —
Exigences pour les organismes procédant à l'audit et à la certification
de systèmes de management de la sécurité des denrées alimentaires
Reference number
ISO/TS 22003:2007(E)
©
ISO 2007
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SIST-TS ISO/TS 22003:2011
ISO/TS 22003:2007(E)
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Published in Switzerland
ii © ISO 2007 – All rights reserved
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SIST-TS ISO/TS 22003:2011
ISO/TS 22003:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Principles. 2
5 General requirements. 2
5.1 General. 2
5.2 Management of impartiality . 2
6 Structural requirements . 3
7 Resource requirements. 3
7.1 Competence of management and personnel. 3
7.2 Personnel involved in the certification activities .3
7.3 Use of individual external auditors and external technical experts . 8
7.4 Personnel records . 8
7.5 Outsourcing. 8
8 Information requirements . 8
9 Process requirements . 9
9.1 General requirements. 9
9.2 Initial audit and certification . 10
9.3 Surveillance activities . 12
9.4 Recertification . 12
9.5 Special audits. 12
9.6 Suspending, withdrawing or reducing the scope of certification . 12
9.7 Appeals . 12
9.8 Complaints . 12
9.9 Records of applicants and clients . 12
10 Management system requirements for certification bodies. 12
Annex A (normative) Classification of food chain categories. 13
Annex B (informative) Minimum audit time . 14
Bibliography . 16
© ISO 2007 – All rights reserved iii
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SIST-TS ISO/TS 22003:2011
ISO/TS 22003:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
This document is being issued in the Technical Specification series of publications (according to the ISO/IEC
Directives, Part 1, 3.1) as a “prospective standard for provisional application” in the field of food safety
because there is an urgent need for guidance on how standards in this field should be used to meet an
identified need.
This document is not to be regarded as an “International Standard”. It is proposed for provisional application
so that information and experience of its use in practice may be gathered. Comments on the content of this
document should be sent to the ISO Central Secretariat.
A review of this Technical Specification will be carried out not later than 3 years after its publication with the
options of: extension for another 3 years; conversion into an International Standard; or withdrawal.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 22003 was prepared by Technical Committee ISO/TC 34, Food products, in collaboration with
ISO Committee on conformity assessment (ISO/CASCO).
iv © ISO 2007 – All rights reserved
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SIST-TS ISO/TS 22003:2011
ISO/TS 22003:2007(E)
Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line with its
policy.
Requirements for FSMSs can originate from a number of sources, and this Technical Specification has been
developed to assist in the certification of FSMSs that fulfil the requirements of ISO 22000, Food safety
management systems — Requirements for any organization in the food chain. The contents of this Technical
Specification may also be used to support certification of FSMSs that are based on other sets of specified
FSMS requirements.
This Technical Specification is intended for use by bodies that carry out audit and certification of FSMSs. It
gives generic requirements for such certification bodies performing audit and certification in the field of food
safety management systems. Such bodies are referred to as certification bodies. This wording should not be
an obstacle to the use of this Technical Specification by bodies with other designations that undertake
activities covered by the scope of this document. Indeed, this Technical Specification should be usable by any
body involved in the assessment of FSMSs.
Certification activities involve the audit of an organization's FSMS. The form of attestation of conformity of an
organization's FSMS to a specific FSMS standard (for example ISO 22000) or other specified requirements is
normally a certification document or a certificate.
It is for the organization being certified to develop its own management systems (including ISO 22000 FSMS,
other sets of specified FSMS requirements, quality management systems, environmental management
systems or occupational health and safety management systems) and, other than where relevant legislative
requirements specify to the contrary, it is for the organization to decide how the various components of these
will be arranged. The degree of integration between the various management system components will vary
from organization to organization. It is therefore appropriate for certification bodies that operate in accordance
with this Technical Specification to take into account the culture and practices of their clients with respect to
the integration of their FSMSs within the wider organization.
© ISO 2007 – All rights reserved v
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SIST-TS ISO/TS 22003:2011
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SIST-TS ISO/TS 22003:2011
TECHNICAL SPECIFICATION ISO/TS 22003:2007(E)
Food safety management systems — Requirements for bodies
providing audit and certification of food safety management
systems
1 Scope
This Technical Specification
⎯ defines the rules applicable for the audit and certification of a food safety management system (FSMS)
complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements), and
⎯ provides the necessary information and confidence to customers about the way certification of their
suppliers has been granted.
Certification of FSMSs (named “certification” in this Technical Specification) is a third-party conformity
assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party
conformity assessment bodies (named “certification body/bodies” in this Technical Specification).
NOTE 1 Certification of an FSMS is sometimes also called “registration”, and certification bodies are sometimes called
“registrars”.
NOTE 2 A certification body can be non-governmental or governmental (with or without regulatory authority).
NOTE 3 This Technical Specification is primarily intended to be used as a criteria document for the accreditation or
peer assessment of certification bodies which seek to be recognized as being competent to certify that an FSMS complies
with ISO 22000. It is also intended to be used as a criteria document by regulatory authorities and industry consortia which
engage in direct recognition of certification bodies to certify that an FSMS complies with ISO 22000. Some of its
requirements could also be found useful by any other parties involved in the conformity assessment of such certification
bodies, and in the conformity assessment of any bodies that undertake to certify the compliance of FSMSs with criteria
additional to or other than those in ISO 22000.
FSMS certification does not attest to the safety or fitness of the products of an organization within the food
chain. However, ISO 22000 requires an organization to meet all applicable food-safety-related statutory and
regulatory requirements through its management system.
It is important to note that certification of an FSMS according to ISO 22000 is a management system
certification and not a product certification.
Other FSMS users can use the concepts and requirements of this Technical Specification provided that the
requirements are adapted as necessary.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO 22000:2005, Food safety management systems — Requirements for any organization in the food chain
© ISO 2007 – All rights reserved 1
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SIST-TS ISO/TS 22003:2011
ISO/TS 22003:2007(E)
ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles
ISO/IEC 17021:2006, Conformity assessment — Requirements for bodies providing audit and certification of
management systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17021,
ISO 22000 and the following apply.
NOTE In this Technical Specification, the terms “product” and “service” are used separately, which is not in
accordance with the definition of product given in ISO/IEC 17000.
3.1
hazard analysis and critical control point
HACCP
system which identifies, evaluates and controls hazards which are significant for food safety
NOTE Adapted from Reference [8].
3.2
food safety management system
FSMS
set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives,
used to direct and control an organization with regard to food safety
NOTE See 3.2.1, 3.2.2 and 3.2.3 of ISO 9000:2005.
4 Principles
The principles given in Clause 4 of ISO/IEC 17021:2006 are the basis for the subsequent specific
performance and descriptive requirements in this Technical Specification. This Technical Specification does
not give specific requirements for all situations that can occur. These principles should be applied as guidance
for the decisions that may need to be made for unanticipated situations. Principles are not requirements.
The term “management system” used in ISO/IEC 17021 shall be replaced by “food safety management
system” in the context of this Technical Specification.
5 General requirements
5.1 General
All the requirements given in Clause 5 of ISO/IEC 17021:2006 apply.
5.2 Management of impartiality
The certification body and any part of the same legal entity shall not offer or provide hazard analysis
consultancy, FSMS consultancy or management system consultancy.
The fact that the organization employing the auditor is known to have provided hazard analysis consultancy,
FSMS consultancy or management system consultancy on the management system, within two years
following the end of the consultancy, is likely to be considered as a high threat to impartiality.
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The term “management system consultancy” mentioned in 5.2 of ISO/IEC 17021:2006 shall be replaced in the
context of this Technical Specification by “hazard analysis consultancy, FSMS consultancy or management
system consultancy”.
6 Structural requirements
All the requirements given in Clause 6 of ISO/IEC 17021:2006 apply.
7 Resource requirements
7.1 Competence of management and personnel
All the requirements given in 7.1 of ISO/IEC 17021:2006 apply.
Additionally, the certification body shall have processes to ensure that personnel have appropriate knowledge
relevant to the categories (see Annex A) in which it operates.
7.2 Personnel involved in the certification activities
7.2.1 General
7.2.1.1 All the requirements given in 7.2 of ISO/IEC 17021:2006 apply.
7.2.1.2 The certification body shall ensure that all personnel involved in the audit and certification
activities possess the following personal attributes. The personnel shall be
a) ethical (i.e. fair, truthful, sincere, honest and discreet),
b) open-minded (i.e. willing to consider alternative ideas or points of view),
c) diplomatic (i.e. tactful in dealing with people),
d) observant (i.e. actively aware of physical surroundings and activities),
e) perceptive (i.e. instinctively aware of and able to understand situations),
f) versatile (i.e. adjust readily to different situations),
g) tenacious (i.e. persistent, focused on achieving objectives),
h) decisive (i.e. reach timely conclusions based on logical reasoning and analysis), and
i) self-reliant (i.e. act and function independently while interacting effectively with others).
7.2.2 Personnel carrying out contract review
7.2.2.1 Education
The certification body shall ensure that personnel carrying out contract review have the knowledge
corresponding to a secondary education.
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7.2.2.2 Food safety training
The certification body shall ensure that personnel carrying out contract review have successfully completed
training in
a) hazard analysis and critical control point (HACCP) principles, hazard assessment and hazard analysis,
b) food safety management principles including prerequisite programmes (PRPs), and
c) relevant FSMS standards (e.g. ISO 22000).
7.2.2.3 Audit training
The certification body shall ensure that personnel carrying out contract review have successfully completed
training in audit processes based on the guidance given in ISO 19011.
NOTE It is not mandatory for personnel carrying out contract review to have or to maintain audit experience.
7.2.2.4 Competences
The certification body shall ensure that personnel carrying out contract review demonstrate the ability to apply
knowledge and skills in the following areas:
a) classification of applicants in food chain categories and sectors;
b) assessment of applicant products, processes and practices;
c) deployment of FSMS auditor competences and requirements;
d) determination of audit time (see Annex B) and duration requirements;
e) certification body's policies and procedures related to contract review.
7.2.3 Personnel granting certification
7.2.3.1 General
The certification body shall ensure that the personnel who take the decision on granting certification have the
same education, food safety training, audit training and work experience as required for an auditor in one
category (see Annex A).
NOTE It is not mandatory for personnel granting certification to have or to maintain audit experience.
7.2.3.2 Competences
The certification body shall ensure that personnel granting certification demonstrate the ability to apply
knowledge and skills in the following areas:
a) current principles of HACCP;
b) understanding of PRPs;
c) identification of food safety hazards;
d) implementation and management of food safety hazards, critical control points (CCPs) and the ability to
assess the effectiveness of selected control measures;
e) corrections and corrective actions to be taken with regards to food safety matters;
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f) assessment of potential food safety hazards linked to the food supply chain;
g) laws and regulations relevant to food safety, in order to be able to conduct an effective audit of the FSMS;
h) products, processes and practices;
i) relevant food safety management system requirements;
j) relevant standards;
k) assessment and review of an audit report for accuracy and completeness;
l) assessment and review of the effectiveness of corrective actions;
m) the certification process.
7.2.4 Auditors
7.2.4.1 Education
The certification body shall ensure that auditors have the knowledge corresponding to a post-secondary
education that includes general microbiology and general chemistry.
The certification body shall also ensure that auditors have the knowledge corresponding to a post-secondary
education that includes courses in the food chain industry category in which they conduct FSMS audits.
EXAMPLES
a) For the food industry (Categories C, D, E, F, G and H in Table A.1): food microbiology, food processing fundamentals
and food chemistry including food analysis.
b) For farming (plants) (Category B in Table A.1): crop production.
c) For farming (animals) (Categories A and F in Table A.1): animal production.
d) For packaging/food machine/engineering industry (Categories I to M in Table A.1): science/engineering courses
related to the discipline.
7.2.4.2 Food safety training
The certification body shall ensure that auditors have successfully completed training in
a) HACCP principles, hazard assessment and hazard analysis, and
b) food safety management principles including PRPs.
The training course(s) should be recognized by the industry (and its stakeholders) as being appropriate and
relevant. The approval or certification of the training courses by an independent body with the relevant
expertise can provide some assurance that the course meets specified criteria.
7.2.4.3 Audit training
The certification body shall ensure that auditors have successfully completed training in
a) audit techniques based on ISO 19011, and
b) relevant FSMS standards (e.g. ISO 22000).
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7.2.4.4 Work experience
For a first qualification of an auditor in one or more categories, the certification body shall ensure that the
auditor has a minimum of five years of full-time work experience in the food-chain-related industry, including at
least two years of work in quality assurance or food safety functions within food production or manufacturing,
retailing, inspection or enforcement, or the equivalent.
The number of years of total work experience may be reduced by one year if the auditor has completed
appropriate post-secondary education.
7.2.4.5 Audit experience
For a first qualification, the certification body shall ensure that within the last three years the auditor has
performed at least twelve FSMS audit days in at least four organizations under the leadership of a qualified
auditor.
NOTE FSMS audit days include audit days dealing with ISO 9001 in the food industry or other FSMS audits.
For extension to a new category, the certification body shall demonstrate that the auditor has the required
competences through relevant education as required in 7.2.4.1, food-safety-related training in the new
category, and either
⎯ six months of work experience in the new category, or
⎯ four FSMS audits under the supervision of a qualified auditor in the new category.
For maintaining the qualification of the auditor, the certification body shall ensure that auditors have performed
either
⎯ a minimum of five external audits per year, including at least two FSMS audits, or
⎯ a minimum of four FSMS on-site external audits or ten FSMS audit days per year.
7.2.4.6 Competences
7.2.4.6.1 The competences of auditors shall be recorded [see 5.5 c) of ISO 19011:2002] for each category
and sector (see Annex A). The certification body shall provide evidence of a successful evaluation.
7.2.4.6.2 The certification body shall ensure that auditors demonstrate the ability to apply knowledge and
skills in the following areas.
a) Audit principles, procedures and techniques: to enable the auditor to apply those appropriate to different
audits and to ensure that audits are conducted in a consistent and systematic manner. An auditor shall be
able
⎯ to apply audit principles, procedures and techniques,
⎯ to plan and organize the work effectively,
⎯ to conduct the audit within the agreed time schedule,
⎯ to prioritize and focus on matters of significance,
⎯ to collect information through effective interviewing, listening, observing and reviewing documents,
records and data,
⎯ to understand the appropriateness and consequences of using sampling techniques for auditing,
⎯ to verify the accuracy of collected information,
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⎯ to confirm the sufficiency and appropriateness of audit evidence to support audit findings and
conclusions,
⎯ to assess those factors that can affect the reliability of the audit findings and conclusions,
⎯ to use work documents to record audit activities,
⎯ to prepare audit reports,
⎯ to maintain the confidentiality and security of information, and
⎯ to communicate effectively, either through personal linguistic skills or through an interpreter.
b) Management system and reference documents: to enable the auditor to comprehend the scope of the
audit and apply audit criteria. Knowledge and skills in this area shall cover
⎯ the application of management systems to different organizations,
⎯ interaction between the components of the management system,
⎯ food safety management system standards, applicable procedures or other management system
documents used as audit criteria,
⎯ recognizing differences between, and the priority of, the reference documents,
⎯ application of the reference documents to different audit situations, and
⎯ information systems and technology for authorization, security, distribution and control of documents,
data and records.
c) Organizational situations: to enable the auditor to comprehend the organization's operational context.
Knowledge and skills in this area shall cover
⎯ organizational size, structure, functions and relationships,
⎯ general business processes and related terminology, and
⎯ cultural and social customs of the auditee.
d) Applicable laws,
...
SLOVENSKI STANDARD
oSIST-TS ISO/TS 22003:2011
01-april-2011
Sistemi vodenja varnosti živil - Zahteve za organe, ki izvajajo presoje in
certificiranje sistemov vodenja varnosti živil
Food safety management systems -- Requirements for bodies providing audit and
certification of food safety management systems
Systèmes de management de la sécurité des denrées alimentaires -- Exigences pour les
organismes procédant à l'audit et à la certification de systèmes de management de la
sécurité des denrées alimentaires
Ta slovenski standard je istoveten z: ISO/TS 22003:2007
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
67.020 Procesi v živilski industriji Processes in the food
industry
oSIST-TS ISO/TS 22003:2011 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST-TS ISO/TS 22003:2011
TECHNICAL ISO/TS
SPECIFICATION 22003
First edition
2007-02-15
Food safety management systems —
Requirements for bodies providing audit
and certification of food safety
management systems
Systèmes de management de la sécurité des denrées alimentaires —
Exigences pour les organismes procédant à l'audit et à la certification
de systèmes de management de la sécurité des denrées alimentaires
Reference number
ISO/TS 22003:2007(E)
©
ISO 2007
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Published in Switzerland
ii © ISO 2007 – All rights reserved
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oSIST-TS ISO/TS 22003:2011
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Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Principles. 2
5 General requirements. 2
5.1 General. 2
5.2 Management of impartiality . 2
6 Structural requirements . 3
7 Resource requirements. 3
7.1 Competence of management and personnel. 3
7.2 Personnel involved in the certification activities .3
7.3 Use of individual external auditors and external technical experts . 8
7.4 Personnel records . 8
7.5 Outsourcing. 8
8 Information requirements . 8
9 Process requirements . 9
9.1 General requirements. 9
9.2 Initial audit and certification . 10
9.3 Surveillance activities . 12
9.4 Recertification . 12
9.5 Special audits. 12
9.6 Suspending, withdrawing or reducing the scope of certification . 12
9.7 Appeals . 12
9.8 Complaints . 12
9.9 Records of applicants and clients . 12
10 Management system requirements for certification bodies. 12
Annex A (normative) Classification of food chain categories. 13
Annex B (informative) Minimum audit time . 14
Bibliography . 16
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
This document is being issued in the Technical Specification series of publications (according to the ISO/IEC
Directives, Part 1, 3.1) as a “prospective standard for provisional application” in the field of food safety
because there is an urgent need for guidance on how standards in this field should be used to meet an
identified need.
This document is not to be regarded as an “International Standard”. It is proposed for provisional application
so that information and experience of its use in practice may be gathered. Comments on the content of this
document should be sent to the ISO Central Secretariat.
A review of this Technical Specification will be carried out not later than 3 years after its publication with the
options of: extension for another 3 years; conversion into an International Standard; or withdrawal.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 22003 was prepared by Technical Committee ISO/TC 34, Food products, in collaboration with
ISO Committee on conformity assessment (ISO/CASCO).
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Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line with its
policy.
Requirements for FSMSs can originate from a number of sources, and this Technical Specification has been
developed to assist in the certification of FSMSs that fulfil the requirements of ISO 22000, Food safety
management systems — Requirements for any organization in the food chain. The contents of this Technical
Specification may also be used to support certification of FSMSs that are based on other sets of specified
FSMS requirements.
This Technical Specification is intended for use by bodies that carry out audit and certification of FSMSs. It
gives generic requirements for such certification bodies performing audit and certification in the field of food
safety management systems. Such bodies are referred to as certification bodies. This wording should not be
an obstacle to the use of this Technical Specification by bodies with other designations that undertake
activities covered by the scope of this document. Indeed, this Technical Specification should be usable by any
body involved in the assessment of FSMSs.
Certification activities involve the audit of an organization's FSMS. The form of attestation of conformity of an
organization's FSMS to a specific FSMS standard (for example ISO 22000) or other specified requirements is
normally a certification document or a certificate.
It is for the organization being certified to develop its own management systems (including ISO 22000 FSMS,
other sets of specified FSMS requirements, quality management systems, environmental management
systems or occupational health and safety management systems) and, other than where relevant legislative
requirements specify to the contrary, it is for the organization to decide how the various components of these
will be arranged. The degree of integration between the various management system components will vary
from organization to organization. It is therefore appropriate for certification bodies that operate in accordance
with this Technical Specification to take into account the culture and practices of their clients with respect to
the integration of their FSMSs within the wider organization.
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oSIST-TS ISO/TS 22003:2011
TECHNICAL SPECIFICATION ISO/TS 22003:2007(E)
Food safety management systems — Requirements for bodies
providing audit and certification of food safety management
systems
1 Scope
This Technical Specification
⎯ defines the rules applicable for the audit and certification of a food safety management system (FSMS)
complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements), and
⎯ provides the necessary information and confidence to customers about the way certification of their
suppliers has been granted.
Certification of FSMSs (named “certification” in this Technical Specification) is a third-party conformity
assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party
conformity assessment bodies (named “certification body/bodies” in this Technical Specification).
NOTE 1 Certification of an FSMS is sometimes also called “registration”, and certification bodies are sometimes called
“registrars”.
NOTE 2 A certification body can be non-governmental or governmental (with or without regulatory authority).
NOTE 3 This Technical Specification is primarily intended to be used as a criteria document for the accreditation or
peer assessment of certification bodies which seek to be recognized as being competent to certify that an FSMS complies
with ISO 22000. It is also intended to be used as a criteria document by regulatory authorities and industry consortia which
engage in direct recognition of certification bodies to certify that an FSMS complies with ISO 22000. Some of its
requirements could also be found useful by any other parties involved in the conformity assessment of such certification
bodies, and in the conformity assessment of any bodies that undertake to certify the compliance of FSMSs with criteria
additional to or other than those in ISO 22000.
FSMS certification does not attest to the safety or fitness of the products of an organization within the food
chain. However, ISO 22000 requires an organization to meet all applicable food-safety-related statutory and
regulatory requirements through its management system.
It is important to note that certification of an FSMS according to ISO 22000 is a management system
certification and not a product certification.
Other FSMS users can use the concepts and requirements of this Technical Specification provided that the
requirements are adapted as necessary.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO 22000:2005, Food safety management systems — Requirements for any organization in the food chain
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ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles
ISO/IEC 17021:2006, Conformity assessment — Requirements for bodies providing audit and certification of
management systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17021,
ISO 22000 and the following apply.
NOTE In this Technical Specification, the terms “product” and “service” are used separately, which is not in
accordance with the definition of product given in ISO/IEC 17000.
3.1
hazard analysis and critical control point
HACCP
system which identifies, evaluates and controls hazards which are significant for food safety
NOTE Adapted from Reference [8].
3.2
food safety management system
FSMS
set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives,
used to direct and control an organization with regard to food safety
NOTE See 3.2.1, 3.2.2 and 3.2.3 of ISO 9000:2005.
4 Principles
The principles given in Clause 4 of ISO/IEC 17021:2006 are the basis for the subsequent specific
performance and descriptive requirements in this Technical Specification. This Technical Specification does
not give specific requirements for all situations that can occur. These principles should be applied as guidance
for the decisions that may need to be made for unanticipated situations. Principles are not requirements.
The term “management system” used in ISO/IEC 17021 shall be replaced by “food safety management
system” in the context of this Technical Specification.
5 General requirements
5.1 General
All the requirements given in Clause 5 of ISO/IEC 17021:2006 apply.
5.2 Management of impartiality
The certification body and any part of the same legal entity shall not offer or provide hazard analysis
consultancy, FSMS consultancy or management system consultancy.
The fact that the organization employing the auditor is known to have provided hazard analysis consultancy,
FSMS consultancy or management system consultancy on the management system, within two years
following the end of the consultancy, is likely to be considered as a high threat to impartiality.
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The term “management system consultancy” mentioned in 5.2 of ISO/IEC 17021:2006 shall be replaced in the
context of this Technical Specification by “hazard analysis consultancy, FSMS consultancy or management
system consultancy”.
6 Structural requirements
All the requirements given in Clause 6 of ISO/IEC 17021:2006 apply.
7 Resource requirements
7.1 Competence of management and personnel
All the requirements given in 7.1 of ISO/IEC 17021:2006 apply.
Additionally, the certification body shall have processes to ensure that personnel have appropriate knowledge
relevant to the categories (see Annex A) in which it operates.
7.2 Personnel involved in the certification activities
7.2.1 General
7.2.1.1 All the requirements given in 7.2 of ISO/IEC 17021:2006 apply.
7.2.1.2 The certification body shall ensure that all personnel involved in the audit and certification
activities possess the following personal attributes. The personnel shall be
a) ethical (i.e. fair, truthful, sincere, honest and discreet),
b) open-minded (i.e. willing to consider alternative ideas or points of view),
c) diplomatic (i.e. tactful in dealing with people),
d) observant (i.e. actively aware of physical surroundings and activities),
e) perceptive (i.e. instinctively aware of and able to understand situations),
f) versatile (i.e. adjust readily to different situations),
g) tenacious (i.e. persistent, focused on achieving objectives),
h) decisive (i.e. reach timely conclusions based on logical reasoning and analysis), and
i) self-reliant (i.e. act and function independently while interacting effectively with others).
7.2.2 Personnel carrying out contract review
7.2.2.1 Education
The certification body shall ensure that personnel carrying out contract review have the knowledge
corresponding to a secondary education.
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7.2.2.2 Food safety training
The certification body shall ensure that personnel carrying out contract review have successfully completed
training in
a) hazard analysis and critical control point (HACCP) principles, hazard assessment and hazard analysis,
b) food safety management principles including prerequisite programmes (PRPs), and
c) relevant FSMS standards (e.g. ISO 22000).
7.2.2.3 Audit training
The certification body shall ensure that personnel carrying out contract review have successfully completed
training in audit processes based on the guidance given in ISO 19011.
NOTE It is not mandatory for personnel carrying out contract review to have or to maintain audit experience.
7.2.2.4 Competences
The certification body shall ensure that personnel carrying out contract review demonstrate the ability to apply
knowledge and skills in the following areas:
a) classification of applicants in food chain categories and sectors;
b) assessment of applicant products, processes and practices;
c) deployment of FSMS auditor competences and requirements;
d) determination of audit time (see Annex B) and duration requirements;
e) certification body's policies and procedures related to contract review.
7.2.3 Personnel granting certification
7.2.3.1 General
The certification body shall ensure that the personnel who take the decision on granting certification have the
same education, food safety training, audit training and work experience as required for an auditor in one
category (see Annex A).
NOTE It is not mandatory for personnel granting certification to have or to maintain audit experience.
7.2.3.2 Competences
The certification body shall ensure that personnel granting certification demonstrate the ability to apply
knowledge and skills in the following areas:
a) current principles of HACCP;
b) understanding of PRPs;
c) identification of food safety hazards;
d) implementation and management of food safety hazards, critical control points (CCPs) and the ability to
assess the effectiveness of selected control measures;
e) corrections and corrective actions to be taken with regards to food safety matters;
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f) assessment of potential food safety hazards linked to the food supply chain;
g) laws and regulations relevant to food safety, in order to be able to conduct an effective audit of the FSMS;
h) products, processes and practices;
i) relevant food safety management system requirements;
j) relevant standards;
k) assessment and review of an audit report for accuracy and completeness;
l) assessment and review of the effectiveness of corrective actions;
m) the certification process.
7.2.4 Auditors
7.2.4.1 Education
The certification body shall ensure that auditors have the knowledge corresponding to a post-secondary
education that includes general microbiology and general chemistry.
The certification body shall also ensure that auditors have the knowledge corresponding to a post-secondary
education that includes courses in the food chain industry category in which they conduct FSMS audits.
EXAMPLES
a) For the food industry (Categories C, D, E, F, G and H in Table A.1): food microbiology, food processing fundamentals
and food chemistry including food analysis.
b) For farming (plants) (Category B in Table A.1): crop production.
c) For farming (animals) (Categories A and F in Table A.1): animal production.
d) For packaging/food machine/engineering industry (Categories I to M in Table A.1): science/engineering courses
related to the discipline.
7.2.4.2 Food safety training
The certification body shall ensure that auditors have successfully completed training in
a) HACCP principles, hazard assessment and hazard analysis, and
b) food safety management principles including PRPs.
The training course(s) should be recognized by the industry (and its stakeholders) as being appropriate and
relevant. The approval or certification of the training courses by an independent body with the relevant
expertise can provide some assurance that the course meets specified criteria.
7.2.4.3 Audit training
The certification body shall ensure that auditors have successfully completed training in
a) audit techniques based on ISO 19011, and
b) relevant FSMS standards (e.g. ISO 22000).
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7.2.4.4 Work experience
For a first qualification of an auditor in one or more categories, the certification body shall ensure that the
auditor has a minimum of five years of full-time work experience in the food-chain-related industry, including at
least two years of work in quality assurance or food safety functions within food production or manufacturing,
retailing, inspection or enforcement, or the equivalent.
The number of years of total work experience may be reduced by one year if the auditor has completed
appropriate post-secondary education.
7.2.4.5 Audit experience
For a first qualification, the certification body shall ensure that within the last three years the auditor has
performed at least twelve FSMS audit days in at least four organizations under the leadership of a qualified
auditor.
NOTE FSMS audit days include audit days dealing with ISO 9001 in the food industry or other FSMS audits.
For extension to a new category, the certification body shall demonstrate that the auditor has the required
competences through relevant education as required in 7.2.4.1, food-safety-related training in the new
category, and either
⎯ six months of work experience in the new category, or
⎯ four FSMS audits under the supervision of a qualified auditor in the new category.
For maintaining the qualification of the auditor, the certification body shall ensure that auditors have performed
either
⎯ a minimum of five external audits per year, including at least two FSMS audits, or
⎯ a minimum of four FSMS on-site external audits or ten FSMS audit days per year.
7.2.4.6 Competences
7.2.4.6.1 The competences of auditors shall be recorded [see 5.5 c) of ISO 19011:2002] for each category
and sector (see Annex A). The certification body shall provide evidence of a successful evaluation.
7.2.4.6.2 The certification body shall ensure that auditors demonstrate the ability to apply knowledge and
skills in the following areas.
a) Audit principles, procedures and techniques: to enable the auditor to apply those appropriate to different
audits and to ensure that audits are conducted in a consistent and systematic manner. An auditor shall be
able
⎯ to apply audit principles, procedures and techniques,
⎯ to plan and organize the work effectively,
⎯ to conduct the audit within the agreed time schedule,
⎯ to prioritize and focus on matters of significance,
⎯ to collect information through effective interviewing, listening, observing and reviewing documents,
records and data,
⎯ to understand the appropriateness and consequences of using sampling techniques for auditing,
⎯ to verify the accuracy of collected information,
6 © ISO 2007 – All rights reserved
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oSIST-TS ISO/TS 22003:2011
ISO/TS 22003:2007(E)
⎯ to confirm the sufficiency and appropriateness of audit evidence to support audit findings and
conclusions,
⎯ to assess those factors that can affect the reliability of the audit findings and conclusions,
⎯ to use work documents to record audit activities,
⎯ to prepare audit reports,
⎯ to maintain the confidentiality and security of information, and
⎯ to communicate effectively, either through personal linguistic skills or through an interpreter.
b) Management system and reference documents: to enable the auditor to comprehend the scope of the
audit and apply audit criteria. Knowledge and skills in this area shall cover
⎯ the application of management systems to different organizations,
⎯ interaction between the components of the management system,
⎯ food safety management system standards, applicable procedures or other management system
documents used as audit criteria,
⎯ recognizing differences between, and the priority of, the reference documents,
⎯ application of the reference documents to different audit situations, and
⎯ information systems and technology for authorization, security, distribution and control of documents,
data and records.
c) Organizational situations: to enable the auditor to comprehend the organization's operational context.
Knowledge and skills in this area shall cover
⎯ organizational size, structure, functions and relationships,
⎯ general business processes and related terminology, and
⎯ cultural and social customs of the auditee.
d)
...
SPÉCIFICATION ISO
TECHNIQUE 22003
Première édition
2007-02-15
Systèmes de management de la sécurité
des denrées alimentaires — Exigences
pour les organismes procédant à l'audit
et à la certification de systèmes de
management de la sécurité des denrées
alimentaires
Food safety management systems — Requirements for bodies
providing audit and certification of food safety management systems
Numéro de référence
ISO/TS 22003:2007(F)
©
ISO 2007
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ISO/TS 22003:2007(F)
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ii © ISO 2007 – Tous droits réservés
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ISO/TS 22003:2007(F)
Sommaire Page
Avant-propos. iv
Introduction . v
1 Domaine d'application. 1
2 Références normatives . 2
3 Termes et définitions. 2
4 Principes. 2
5 Exigences générales . 3
5.1 Généralités . 3
5.2 Gestion de l'impartialité . 3
6 Exigences structurelles . 3
7 Exigences relatives aux ressources. 3
7.1 Compétence de la direction et du personnel. 3
7.2 Personnel intervenant dans les activités de certification . 3
7.3 Intervention d'auditeurs et d'experts techniques externes individuels. 9
7.4 Enregistrements relatifs au personnel . 9
7.5 Externalisation . 9
8 Exigences relatives aux informations . 9
9 Exigences relatives aux processus . 10
9.1 Exigences générales . 10
9.2 Évaluation et certification initiales. 11
9.3 Activités de surveillance. 13
9.4 Renouvellement de la certification . 13
9.5 Audits particuliers . 13
9.6 Suspension, retrait ou réduction du périmètre de la certification. 13
9.7 Appels . 13
9.8 Plaintes . 13
9.9 Enregistrements relatifs aux demandeurs et aux clients. 13
10 Exigences relatives au système de management des organismes de certification. 13
Annexe A (normative) Classification des catégories de la chaîne alimentaire . 14
Annexe B (informative) Durée minimale de l'audit. 15
Bibliographie . 17
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ISO/TS 22003:2007(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
Dans d'autres circonstances, en particulier lorsqu'il existe une demande urgente du marché, un comité
technique peut décider de publier d'autres types de documents normatifs:
⎯ une Spécification publiquement disponible ISO (ISO/PAS) représente un accord entre les experts dans
un groupe de travail ISO et est acceptée pour publication si elle est approuvée par plus de 50 % des
membres votants du comité dont relève le groupe de travail;
⎯ une Spécification technique ISO (ISO/TS) représente un accord entre les membres d'un comité technique
et est acceptée pour publication si elle est approuvée par 2/3 des membres votants du comité.
Le présent document est publié dans la série des Spécifications techniques (conformément au
paragraphe 3.1 de la partie 1 des Directives ISO/CEI) comme «norme prospective d'application provisoire»
dans le domaine de la sécurité des denrées alimentaires en raison de l'urgence d'avoir une indication quant à
la manière dont il convient d'utiliser les normes dans ce domaine pour répondre à un besoin déterminé.
Ce document ne doit pas être considéré comme une «Norme internationale». Il est proposé pour une mise en
œuvre provisoire, afin de recueillir des informations et d'acquérir de l'expérience quant à son application dans
la pratique. Il est de règle d'envoyer les observations éventuelles relatives au contenu de ce document au
Secrétariat central de l'ISO.
Il sera procédé à un nouvel examen de cette Spécification technique au plus tard trois ans après sa
publication, avec la faculté d'en prolonger la validité pendant trois autres années, de le transformer en Norme
internationale ou de l'annuler.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO/TS 22003 a été élaborée par le comité technique ISO/TC 34 Produits alimentaires, en collaboration
avec le Comité ISO pour l'évaluation de la conformité (ISO/CASCO).
iv © ISO 2007 – Tous droits réservés
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ISO/TS 22003:2007(F)
Introduction
La certification du système de management de la sécurité des denrées alimentaires (SMSDA) d'une
organisation est l'un des moyens permettant d'assurer que l'organisation a mis en œuvre un SMSDA
conforme à sa politique.
Les exigences applicables aux SMSDA peuvent émaner d'un certain nombre de sources et la présente
Spécification technique a été élaborée pour apporter une aide à la certification des SMSDA qui satisfont aux
exigences de l'ISO 22000, Systèmes de management de la sécurité des denrées alimentaires — Exigences
pour tout organisme appartenant à la chaîne alimentaire. Le contenu de la présente Spécification technique
peut également servir à accompagner la certification des SMSDA qui sont fondés sur d'autres ensembles
d'exigences spécifiées en la matière.
La présente Spécification technique est destinée à l'usage des organismes qui auditent et qui certifient des
SMSDA. Elle définit des exigences génériques applicables aux organismes de certification procédant à l'audit
et à la certification dans le domaine des SMSDA. Ces organismes sont appelés organismes de certification. Il
convient que ce libellé ne fasse pas obstacle à l'utilisation de la présente Spécification technique par des
organismes désignés différemment entreprenant des activités couvertes par le domaine d'application décrit
dans ce document. En effet, il convient que la présente Spécification technique puisse être utilisée par tout
organisme impliqué dans l'évaluation de SMSDA.
Les activités de certification comprennent l'audit du SMSDA d'une organisation. La manière d'attester la
conformité de ce système à une norme spécifique de SMSDA (par exemple ISO 22000) ou à d'autres
exigences spécifiées prend généralement la forme d'un document de certification ou d'un certificat.
Il incombe à l'organisation soumise à la procédure de certification de mettre au point ses propres systèmes de
management (y compris un SMSDA conforme à l'ISO 22000, d'autres ensembles d'exigences spécifiées en la
matière, des systèmes de management de la qualité, des systèmes de management environnemental ou des
systèmes de management de l'hygiène et de la sécurité au travail) et, sauf spécifications contraires dans les
exigences réglementaires applicables, il appartient à l'organisation de décider de l'agencement des divers
composants desdits systèmes. Le degré d'intégration entre les divers composants des systèmes de
management variera d'une organisation à l'autre. Il est donc approprié pour les organismes de certification qui
opèrent conformément à la présente Spécification technique de prendre en compte la culture et les pratiques
de leurs clients, eu égard à l'intégration de leurs SMSDA dans un cadre plus large.
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SPÉCIFICATION TECHNIQUE ISO/TS 22003:2007(F)
Systèmes de management de la sécurité des denrées
alimentaires — Exigences pour les organismes procédant à
l'audit et à la certification de systèmes de management de la
sécurité des denrées alimentaires
1 Domaine d'application
La présente Spécification technique
⎯ définit les règles applicables à l'audit et à la certification d'un système de management de la sécurité des
denrées alimentaires (SMSDA) conforme aux exigences de l'ISO 22000 (ou à d'autres ensembles
d'exigences spécifiées en la matière);
⎯ fournit aux clients les informations nécessaires sur la manière de procéder à la certification de leurs
fournisseurs et leur donne ainsi confiance dans cette certification.
La certification des SMSDA (désignée «certification» dans la présente Spécification technique) est une
activité d'évaluation de la conformité par tierce partie (voir l'ISO/CEI 17000:2004, 5.5). Les organismes
exerçant cette activité sont par conséquent des organismes d'évaluation de la conformité par tierce partie
[désignés «organisme(s) de certification» dans la présente Spécification technique].
NOTE 1 La certification d'un SMSDA est parfois également appelée «enregistrement», et les organismes de
certification sont parfois désignés «organismes d'enregistrement».
NOTE 2 Un organisme de certification peut être gouvernemental (avec ou sans pouvoir réglementaire) ou non
gouvernemental.
NOTE 3 La présente Spécification technique est essentiellement destinée à être utilisée comme référentiel pour
l'accréditation ou l'évaluation par des pairs des organismes de certification qui cherchent à se faire reconnaître comme
étant compétents pour certifier qu'un SMSDA est conforme à l'ISO 22000. Elle est également destinée à être utilisée
comme référentiel par des autorités réglementaires et des consortiums industriels qui procèdent à la reconnaissance
directe des organismes de certification qui certifient qu'un SMSDA est conforme à l'ISO 22000. Certaines de ses
exigences peuvent aussi s'avérer utiles pour toute autre partie pouvant être impliquée dans l'évaluation de la conformité
de tels organismes de certification et dans l'évaluation de la conformité de tout organisme qui réalise la certification de la
conformité des SMSDA à des critères complémentaires à l'ISO 22000 ou différents de ceux énoncés dans cette dernière.
La certification d'un SMSDA n'atteste pas la sécurité ou l'aptitude à l'emploi des produits d'une organisation
appartenant à la chaîne alimentaire. Cependant, l'ISO 22000 exige qu'une organisation satisfasse à
l'ensemble des exigences législatives et réglementaires en vigueur liées à la sécurité des denrées
alimentaires au travers de son système de management.
Il est important de noter que la certification d'un SMSDA conforme à l'ISO 22000 est une certification de
système de management et non une certification de produits.
D'autres utilisateurs de SMSDA peuvent utiliser les concepts et les exigences de la présente Spécification
technique, à condition d'adapter les exigences selon les besoins.
© ISO 2007 – Tous droits réservés 1
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ISO/TS 22003:2007(F)
2 Références normatives
Les documents de référence suivants sont indispensables pour l'application du présent document. Pour les
références datées, seule l'édition citée s'applique. Pour les références non datées, la dernière édition du
document de référence s'applique (y compris les éventuels amendements).
ISO 19011:2002, Lignes directrices pour l'audit des systèmes de management de la qualité et/ou de
management environnemental
ISO 22000:2005, Systèmes de management de la sécurité des denrées alimentaires — Exigences pour tout
organisme appartenant à la chaîne alimentaire
ISO/CEI 17000:2004, Évaluation de la conformité — Vocabulaire et principes généraux
ISO/CEI 17021:2006, Évaluation de la conformité — Exigences pour les organismes procédant à l'audit et à la
certification de systèmes de management
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l'ISO/CEI 17000,
l'ISO/CEI 17021 et l'ISO 22000 ainsi que les suivants s'appliquent.
NOTE Dans la présente Spécification technique, les termes «produit» et «service» sont employés séparément, ce
qui n'est pas conforme à la définition de «produit» donnée dans l'ISO/CEI 17000.
3.1
analyse des dangers et points critiques pour leur maîtrise
HACCP
système qui identifie, évalue et maîtrise les dangers significatifs au regard de la sécurité des denrées
alimentaires
NOTE Adapté de la Référence [8].
3.2
système de management de la sécurité des denrées alimentaires
SMSDA
ensemble d'éléments corrélés ou interactifs permettant d'établir une politique et des objectifs et d'atteindre
ces objectifs, utilisé pour orienter et maîtriser une organisation en matière de sécurité des denrées
alimentaires
NOTE Voir 3.2.1, 3.2.2 et 3.2.3 de l'ISO 9000:2005.
4 Principes
Les principes énoncés dans l'Article 4 de l'ISO/CEI 17021:2006 servent de base pour les exigences
spécifiques de performance et les exigences descriptives données dans la présente Spécification technique.
Cette Spécification technique ne fournit pas d'exigences spécifiques applicables à toutes les situations
susceptibles de survenir. Il convient de considérer ces principes comme des recommandations à appliquer en
cas de décisions à prendre dans des situations imprévues. Ces principes ne constituent pas des exigences.
L'expression «système de management» employée dans l'ISO/CEI 17021:2006 doit être remplacée par
«système de management de la sécurité des denrées alimentaires» dans le contexte de la présente
Spécification technique.
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ISO/TS 22003:2007(F)
5 Exigences générales
5.1 Généralités
Toutes les exigences énoncées dans l'Article 5 de l'ISO/CEI 17021:2006 s'appliquent.
5.2 Gestion de l'impartialité
L'organisme de certification et toute autre partie de la même entité juridique ne doivent pas proposer ou
fournir des prestations de conseil en matière d'analyse des dangers, de SMSDA ou de système de
management.
Le fait que l'on sache que l'organisme employant l'auditeur a fourni, sur le système de management, des
prestations de conseil en matière d'analyse des dangers, de SMSDA ou de système de management dans les
deux ans précédant le début de l'audit, est susceptible d'être considéré comme une menace importante pour
l'impartialité.
L'expression «conseils en matière de système de management» mentionnée en 5.2 de l'ISO/CEI 17021:2006
doit être remplacée dans le cadre de la présente Spécification technique par «conseils en matière d'analyse
des dangers, de SMSDA ou de système de management».
6 Exigences structurelles
Toutes les exigences énoncées dans l'Article 6 de l'ISO/CEI 17021:2006 s'appliquent.
7 Exigences relatives aux ressources
7.1 Compétence de la direction et du personnel
Toutes les exigences énoncées en 7.1 de l'ISO/CEI 17021:2006 s'appliquent.
En outre, l'organisme de certification doit disposer de processus lui garantissant que le personnel possède
une connaissance appropriée des catégories (voir Annexe A) qui entrent dans son périmètre d'action.
7.2 Personnel intervenant dans les activités de certification
7.2.1 Généralités
7.2.1.1 Toutes les exigences énoncées en 7.2 de l'ISO/CEI 17021:2006 s'appliquent.
7.2.1.2 L'organisme de certification doit s'assurer que tous les personnels impliqués dans les activités
d'audit et de certification possèdent les qualités personnelles suivantes. Le personnel doit être
a) intègre (c'est-à-dire juste, attaché à la vérité, sincère, honnête et discret),
b) ouvert d'esprit (c'est-à-dire soucieux de prendre en considération des idées ou des points de vue
différents),
c) diplomate (c'est-à-dire faisant preuve de tact dans les relations avec les autres),
d) observateur (c'est-à-dire activement attentif aux activités et à leur environnement physique),
e) perspicace (c'est-à-dire appréhendant instinctivement et capable de comprendre les situations),
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ISO/TS 22003:2007(F)
f) polyvalent (c'est-à-dire s'adaptant facilement à différentes situations),
g) tenace (c'est-à-dire persévérant, concentré sur l'atteinte des objectifs),
h) capable de décision (c'est-à-dire capable de tirer en temps voulu des conclusions fondées sur un
raisonnement et une analyse logiques),
i) autonome (c'est-à-dire agissant et travaillant de son propre chef tout en établissant des relations
efficaces avec les autres).
7.2.2 Personnel réalisant la revue de contrat
7.2.2.1 Formation
L'organisme de certification doit s'assurer que les personnes réalisant la revue de contrat possèdent les
connaissances correspondant à un niveau d'enseignement secondaire.
7.2.2.2 Formation en matière de sécurité des denrées alimentaires
L'organisme de certification doit s'assurer que les personnes intervenant dans la revue de contrat ont suivi
avec succès une formation relative
a) aux principes de l'analyse des dangers et des points critiques pour leur maîtrise (HACCP), à l'évaluation
des dangers et à l'analyse des dangers,
b) aux principes de management de la sécurité des denrées alimentaires, y compris les programmes
prérequis (PRP), et
c) aux normes correspondantes de SMSDA (par exemple l'ISO 22000).
7.2.2.3 Formation à l'audit
L'organisme de certification doit s'assurer que les personnes intervenant dans la revue de contrat ont suivi
avec succès une formation relative aux processus d'audit fondée sur l'ISO 19011.
NOTE Pour les personnes intervenant dans la revue de contrat, il n'est pas obligatoire d'avoir une expérience en
matière d'audit ou de la tenir à jour.
7.2.2.4 Compétences
L'organisme de certification doit s'assurer que les personnes intervenant dans la revue de contrat démontrent
la capacité d'appliquer leurs connaissances et leurs compétences dans les domaines suivants:
a) la classification des demandeurs dans les catégories et les secteurs de la chaîne alimentaire;
b) l'évaluation des produits, des procédés et des pratiques des demandeurs;
c) le déploiement des compétences des auditeurs et des exigences de SMSDA;
d) la détermination de la date de l'audit (voir Annexe B) et les exigences en matière de durée;
e) les politiques et les modes opératoires de l'organisme de certification liés à la revue de contrat.
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ISO/TS 22003:2007(F)
7.2.3 Personnel délivrant la certification
7.2.3.1 Généralités
L'organisme de certification doit s'assurer que les personnes qui prennent la décision de délivrer une
certification possèdent le même niveau de formation, la même formation en matière de sécurité des denrées
alimentaires, la même formation à l'audit et la même expérience professionnelle exigés pour un auditeur dans
une catégorie (voir Annexe A).
NOTE Pour les personnes intervenant dans la délivrance d'une certification, il n'est pas obligatoire d'avoir une
expérience en matière d'audit ou de la tenir à jour.
7.2.3.2 Compétences
L'organisme de certification doit s'assurer que les personnes intervenant dans la délivrance d'une certification
démontrent la capacité d'appliquer leurs connaissances et leurs compétences dans les domaines suivants:
a) les principes HACCP actuellement en vigueur;
b) la compréhension des programmes prérequis (PRP);
c) l'identification des dangers liés à la sécurité des denrées alimentaires;
d) la mise en œuvre et la gestion des dangers liés à la sécurité des denrées alimentaires, des points
critiques pour la maîtrise, ainsi que la capacité d'évaluer l'efficacité des mesures de maîtrise
sélectionnées;
e) les corrections et les actions correctives à prendre en matière de sécurité des denrées alimentaires;
f) l'évaluation de dangers potentiels liés à la sécurité des denrées alimentaires et associés à la chaîne
alimentaire;
g) les législations et les réglementations en matière de sécurité des denrées alimentaires afin de pouvoir
réaliser un audit efficace du SMSDA;
h) les produits, les procédés et les pratiques;
i) les exigences pertinentes des SMSDA;
j) les normes pertinentes;
k) l'évaluation et la revue d'un rapport d'audit quant à son exactitude et à sa complétude;
l) l'évaluation et la revue de l'efficacité des actions correctives;
m) le processus de certification.
7.2.4 Auditeurs
7.2.4.1 Formation
L'organisme de certification doit s'assurer que les auditeurs possèdent les connaissances correspondant à un
niveau d'enseignement postsecondaire comprenant des cours de microbiologie générale et de chimie
générale.
L'organisme de certification doit s'assurer que les auditeurs possèdent les connaissances correspondant à un
niveau d'enseignement postsecondaire qui comporte des cours relatifs à la catégorie de l'industrie de la
chaîne alimentaire où ils mènent des audits de SMSDA.
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ISO/TS 22003:2007(F)
EXEMPLES
a) Pour l'industrie alimentaire (Catégories C, D, E, F, G et H dans le Tableau A.1): microbiologie des aliments, principes
fondamentaux de la transformation des aliments et chimie des aliments, y compris l‘analyse des denrées
alimentaires.
b) Pour l'agriculture (végétaux) (Catégorie B dans le Tableau A.1): production végétale.
c) Pour l'agriculture (animaux) (Catégories A et F dans le Tableau A.1): production animale.
d) Pour les industries de l'emballage, des machines alimentaires et du génie des procédés (Catégories I à M dans le
Tableau A.1): cours de science et d'ingénierie liés à la discipline.
7.2.4.2 Formation en matière de sécurité des denrées alimentaires
L'organisme de certification doit s'assurer que les auditeurs ont suivi avec succès une formation relative
a) aux principes HACCP, à l'évaluation des dangers et à l'analyse des dangers, et
b) aux principes de management de la sécurité des denrées alimentaires, y compris les programmes
prérequis (PRP).
Il est recommandé que le ou les cours de formation soient reconnus par l'industrie (et par ses parties
prenantes) comme étant appropriés et pertinents. Leur approbation ou certification par un organisme
indépendant possédant l'expertise correspondante peut fournir une certaine assurance de la conformité du
cours aux critères spécifiés.
7.2.4.3 Formation à l'audit
L'organisme de certification doit s'assurer que les auditeurs ont suivi avec succès une formation relative
a) aux techniques d'audit fondées sur l'ISO 19011, et
b) aux normes correspondantes de SMSDA (par exemple l'ISO 22000).
7.2.4.4 Expérience professionnelle
Pour une première qualification d'un auditeur dans une ou plusieurs catégories, l'organisme de certification
doit s'assurer que l'auditeur possède au minimum cinq ans d'expérience professionnelle à temps plein dans
l'industrie liée à la chaîne alimentaire correspondante, dont au moins deux ans d'activité dans des postes
ayant trait à l'assurance qualité ou à la sécurité des denrées alimentaires dans le domaine de la production ou
fabrication alimentaire, de la vente au détail, de l'inspection ou de l'application de la loi ou l'équivalent.
Le nombre total d'années d'expérience professionnelle peut être réduit d'un an si l'auditeur a suivi avec
succès une formation postsecondaire appropriée.
7.2.4.5 Expérience d'audit
Pour une première qualification, l'organisme de certification doit s'assurer que l'auditeur a effectué, au cours
des trois dernières années, au minimum 12 journées d'audit de SMSDA dans au moins quatre organisations
sous la supervision d'un auditeur qualifié.
NOTE Les journées d'audit de SMSDA incluent des journées d'audit par rapport à l'ISO 9001 dans l'industrie
alimentaire ou d'autres audits de SMSDA.
6 © ISO 2007 – Tous droits réservés
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ISO/TS 22003:2007(F)
Pour l'extension à une nouvelle catégorie, l'organisme de certification doit démontrer que l'auditeur possède
les compétences requises grâce à une formation pertinente telle que requise en 7.2.4.1, à une formation liée
à la sécurité des denrées alimentaires dans la nouvelle catégorie et soit
⎯ six mois d'expérience professionnelle dans la nouvelle catégorie, soit
⎯ quatre audits de SMSDA réalisés sous la supervision d'un auditeur qualifié dans la nouvelle catégorie.
Pour le maintien de la qualification de l'auditeur, l'organisme de certification doit s'assurer que les auditeurs
ont réalisé soi
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