ISO/TS 22004:2005
(Main)Food safety management systems — Guidance on the application of ISO 22000:2005
Food safety management systems — Guidance on the application of ISO 22000:2005
ISO/TS 22004:2005 provides generic guidance that can be applied in the use of ISO 22000.
Systèmes de management de la sécurité des denrées alimentaires — Recommendations pour l'application de l'ISO 22000:2005
L'ISO/TS 22004:2005 fournit les recommandations génériques pouvant être appliquées à l'ISO 22000.
Sistemi vodenja varnosti živil - Smernice za uporabo ISO 22000:2005
Ta tehnična specifikacija zagotavlja splošne smernice, ki so na voljo pri uporabi ISO 22000.
OPOMBA: Kjer ni omenjena podtočka ISO 22000, smernice niso podane.
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ТЕХНИЧЕСКИЕ ISO/TS
УСЛОВИЯ 22004
Первое издание
2005-11-15
Системы менеджмента безопасности
пищевых продуктов. Руководство по
применению ISO 22000:2005
Food safety management systems – Guidance on the application of
ISO 22000:2005
Ответственность за подготовку русской версии несёт GOST R
(Российская Федерация) в соответствии со статьёй 18.1 Устава ISO
Ссылочный номер
ISO/TS 22004:2005(R)
©
ISO 2005
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ISO/TS 22004:2005(R)
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ISO/TS 22004:2005(R)
Содержание Страница
1 Область применения .1
2 Нормативные ссылки .1
3 Термины и определения .1
4 Руководство по применению ISO 22000:2005, Раздел 4. Система менеджмента
безопасности пищевых продуктов .1
4.1 Общие положения .1
4.2 Требования к документации.1
5 Руководство по применению ISO 22000:2005, Раздел 5. Ответственность
руководства.2
5.1 Обязательства руководства .2
5.2 Политика в области безопасности пищевых продуктов.2
5.3 Планирование системы менеджмента безопасности пищевых продуктов .2
5.4 Ответственность и полномочия.2
5.5 Руководитель группы обеспечения безопасности пищевых продуктов.3
5.6 Обмен информацией .3
5.7 Готовность к аварийным ситуациям и реакция на них .4
5.8 Анализ со стороны руководства.4
6 Руководство по применению ISO 22000:2005, Раздел 6. Менеджмент ресурсов.4
6.1 Обеспечение ресурсами.4
6.2 Людские ресурсы .4
6.3 Инфраструктура.4
6.4 Производственная среда.4
7 Руководство по применению ISO 22000:2005, Раздел 7. Планирование и реализация
безопасных продуктов .4
7.1 Общие положения .4
7.2 Программы создания предварительных условий .6
7.3 Предварительные шаги для облегчения анализа опасностей .6
7.4 Анализ опасностей.7
7.5 Разработка оперативных программ создания предварительных условий .9
7.6 Создание плана НАССР (анализа опасностей по критическим контрольным точкам).9
7.7 Обновление предварительной информации и документов, указанных в программах
предварительных требований и плане НАССР.11
7.8 Планирование верификации.11
7.9 Система прослеживаемости.11
7.10 Управление несоответствием.11
8 Руководство по применению ISO 22000:2005, Раздел 8. Валидация, верификация и
улучшение системы менеджмента безопасности пищевых продуктов.12
8.1 Общие положения .12
8.2 Валидация комбинаций мер контроля.12
8.3 Управление мониторингом и измерениями .13
8.5 Улучшение.14
Библиография.15
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ISO/TS 22004:2005(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. ISO осуществляет тесное сотрудничество с
международной электротехнической комиссией (IEC) по всем вопросам стандартизации в области
электротехники.
Проекты международных стандартов разрабатываются согласно правилам, привёденным в
Директивах ISO/IEC, Часть 2.
Основной задачей технических комитетов является подготовка международных стандартов. Проекты
международных стандартов, принятые техническими комитетами, рассылаются комитетам-членам на
голосование. Для публикации в качестве международного стандарта требуется одобрение не менее 75 %
комитетов-членов, принявших участие в голосовании.
В других обстоятельствах, в частности, когда существует срочная потребность рынка в таких
документах, технический комитет может принять решение опубликовать нормативный документ иного
типа:
⎯ общедоступные технические условия ISO (ISO/PAS), представляющие собой соглашение
между техническими экспертами рабочей группы ISO и принятые к публикации при
условии одобрения, по меньшей мере, 50 % членов основного технического комитета,
принимавших участие в голосовании;
⎯ технические условия ISO (ISO/TS), представляющие собой соглашение между членами
технического комитета и принятые к публикации при условии одобрения 2/3 членов
технического комитета, принимавших участие в голосовании.
Документы ISO/PAS или ISO/TS пересматриваются через три года с целью принятия решения либо о
продлении их действия на следующие три года, либо о пересмотре и публикации в качестве
международного стандарта, либо о прекращении действия. Если принимается решение о продлении
действия ISO/PAS и ISO/TS, они пересматриваются снова через три года, после чего они должны быть
либо преобразованы в международный стандарт, либо отменены.
Следует иметь в виду, что, возможно, некоторые элементы настоящего документа могут быть
объектом патентных прав. ISO не несет ответственность за определение некоторых или всех таких
патентных прав.
ISO/TS 22004 разработан Техническим комитетом ISO/ТC, 34, Пищевые продукты.
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ISO/TS 22004:2005(R)
Введение
0.1 Общие положения
Принятие системы менеджмента безопасности пищевых продуктов организацией, вовлеченной в цепь
производства и потребления пищевых продуктов, является полезным инструментом для обеспечения
соответствия требованиям, установленным законом, законодательным актом, регламентом и/или
потребителями.
На проект и внедрение организацией системы менеджмента безопасности пищевых продуктов влияют
различные факторы, в частности, опасности, связанные с пищевыми продуктами, поставляемая
продукция, применяемые технологические процессы и размер и структура организации. Данные
технические условия предоставляют руководство по применению ISO 22000, который базируется на
принципах НАССР (анализ опасностей по критическим контрольным точкам) в соответствии с
[4]
Кодексом Комиссии по продуктам питания (Codex Alimentarius Commission) , и предназначен для
применения наряду с релевантными стандартами, опубликованными этой Комиссией.
0.2 Цепь производства и потребления пищевых продуктов и процессный подход
ISO 22000 способствует утверждению подхода к цепи производства и потребления пищевых продуктов
при разработке, внедрении и повышении эффективности и действенности системы менеджмента
безопасности пищевых продуктов. В этом отношении в ISO 22000 от организации требуется учесть
воздействия цепи производства и потребления пищевых продуктов до и по результатам ее операций
при разработке и внедрении системы менеджмента безопасности пищевых продуктов.
Для эффективной и результативной работы организация должна определять и управлять
многочисленными связанными между собой действиями. Деятельность, связанная с использованием
ресурсов и управляемая с целью облегчения преобразования исходного продукта в конечный продукт,
рассматривается как процесс. Часто конечный продукт одного процесса непосредственно образует
исходный продукт следующего процесса.
Применение системы процессов в пределах одной организации, наряду с определением
взаимодействий и управлением этими процессами, можно назвать “процессным подходом”.
Преимуществом процессного подхода является осуществляемый контроль, который обеспечивает
связь между отдельными процессами в рамках системы процессов, а также их комбинацию и
взаимодействие.
При использовании в системе менеджмента безопасности пищевых продуктов такой подход
подчеркивает значение
а) понимания и выполнения требований,
b) необходимости рассматривать процессы с точки зрения безопасности пищевых продуктов и
прослеживаемости,
с) получения результатов в отношении рабочих характеристик и эффективности процесса, и
d) непрерывного улучшения процессов, основанного на объективном измерении.
Заинтересованные стороны играют важную роль в определении требований как вводных данных.
Мониторинг удовлетворенности заинтересованных сторон требует оценки информации, связанной с их
восприятием, выполняет ли организация их требования или нет.
Модель системы менеджмента безопасности пищевых продуктов на основе процессов, показанная на
Рисунке 1, иллюстрирует связи процесса, представленные в Разделах 4 – 8 ISO 22000:2005. Модель,
показанная на Рисунке 1, не показывает процессы детально.
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ISO/TS 22004:2005(R)
Рисунок 1 – Концепция непрерывного улучшения
0.3 Связь с ISO 9001
ISO 22000 предназначен для согласованной работы с ISO 9001 и поддерживающими его стандартами.
ISO 9001 представляет требования в системе менеджмента качества, которую организации могут
использовать для внутреннего применения, или для сертификации или в целях, указанных в договоре.
ISO 9001 сосредоточен на эффективности системы менеджмента качества с позиции удовлетворения
требований потребителя. ISO 22000 обеспечивает важные элементы системы менеджмента
безопасности пищевых продуктов с аналогичными целями.
0.4 Совместимость с другими системами менеджмента
Данные технические условия не включают руководства в отношении других систем менеджмента,
таких как системы, связанные с менеджментом защиты окружающей среды, гигиены труда и
безопасности, управления финансами или менеджментом риска. Тем не менее, ISO 22000 дает
возможность организации присоединить или интегрировать свою собственную систему менеджмента
безопасности пищевых продуктов с соответствующими системами менеджмента. Организация имеет
возможность адаптировать имеющуюся у нее систему(ы) менеджмента, чтобы создать систему
менеджмента безопасности пищевых продуктов, выполняющую требования ISO 22000.
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ТЕХНИЧЕСКИЕ УСЛОВИЯ ISO/TS 22004:2005(R)
Системы менеджмента безопасности пищевых продуктов.
Руководство по применению ISO 22000:2005
1 Область применения
Данные технические условия обеспечивают общее руководство по применению ISO 22000.
ПРИМЕЧАНИЕ Там, где не упомянут подраздел ISO 22000, указания не приводятся.
2 Нормативные ссылки
Следующие ссылочные документы необходимы для использования данного документа. Для жестких
ссылок применимо только указанное издание. Для плавающих ссылок применимо последнее издание
ссылочного документа (включая все изменения).
ISO 22000:2005, Системы менеджмента безопасности пищевых продуктов. Требования к
организации в цепи производства и потребления пищевых продуктов
3 Термины и определения
Применительно к этому документу используются термины и определения, приведенные в ISO 22000.
4 Руководство по применению ISO 22000:2005, Раздел 4. Система
менеджмента безопасности пищевых продуктов
4.1 Общие положения
Для разработки и внедрения системы менеджмента безопасности пищевых продуктов организация может,
согласно ISO 22000, использовать внешние источники, при условии, что такие разработанные извне
процессы внедряются, обслуживаются и обновляются в соответствии с требованиями ISO 22000.
Более того, ISO 22000 позволяет любой организации, в частности, небольшой и не до конца
сформированной организации, внедрить разработанную и созданную извне комбинацию программ
создания предварительных условий (prerequisite programme(s) [PRP(s)], оперативных программ
создания предварительных условий [PRP(s)] и планы анализа опасностей по критическим контрольным
точкам (НАССР), при условии, что она сможет продемонстрировать, что
а) эта комбинация разработана в соответствии с требованиями ISO 22000, установленными для
анализа опасностей, [PRP(S)] и плана НАССР.
b) приняты конкретные меры для адаптирования в данной организации разработанной извне
комбинации, и
с) эта комбинация внедрена и работает в соответствии с другими требованиями ISO 22000.
4.2 Требования к документации
Организации рекомендуется использовать документы из внешних источников, относящиеся к
безопасности пищевых продуктов, в различных областях своей деятельности, например, при
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ISO/TS 22004:2005(R)
выполнении нормативных, регламентных требований и требований потребителя. В некоторых
ситуациях электронная документация может потребовать соответствия требованиям регламента.
Тип и объем документации возможно будет отличаться от организации к организации ввиду объема и
сложности деятельности и компетенции персонала, а также степени применения комбинаций [PRP(S)],
оперативных [PRP(S)] и планов НАССР, разработанных внешними источниками.
Если используются разработанные вне организации комбинации [PRP(S)], оперативных [PRP(S)] и
планов НАССР, их пригодность следует подтвердить документально, и эта документация должна
составлять часть системы менеджмента безопасности пищевых продуктов.
Там где ISO 22000 касается документально подтвержденной процедуры или утверждения, это следует
толковать таким образом, что эта процедура или утверждение созданы, подтверждены документально,
внедрены, пересматриваются и поддерживаются в рабочем состоянии данной организацией как часть
системы менеджмента безопасности пищевых продуктов. Документы, которые обычно образуют часть
системы, включают технические условия на продукт, планы НАССР, оперативные [PRP(S)] и [PRP(S)] и
другие требуемые оперативные процедуры, включая контракты для любых процессов от внешних
источников (например, контроль пестицидов, испытания продукции). Документы, используемые данной
организацией, должны иметься тогда и там, где они требуются, и могут быть в любом применяемом
формате (например, на бумаге, в электронном формате или формате изображения).
Критической деятельностью любой организации является сохранение соответствующих записей на
установленные периоды времени и в контролируемых условиях. Организация должна основывать свое
решение на сохранении записи, если рассматривает использование по назначению и ожидаемый срок
хранения в цепи производства и потребления пищевых продуктов.
5 Руководство по применению ISO 22000:2005, Раздел 5. Ответственность
руководства
5.1 Обязательства руководства
Способ, посредством которого организация обеспечивает свидетельство обязательства высшего
руководства по разработке и внедрению системы менеджмента безопасности пищевых продуктов,
включает осведомление сотрудников и инициативы руководства, связанные с разработкой и
внедрением системы.
5.2 Политика в области безопасности пищевых продуктов
Политика в области безопасности пищевых продуктов является основой любой системы менеджмента
безопасности пищевых продуктов. Эта политика определяет измеримые цели и задачи. Измеримая
деятельность может включать идентификацию и выполнение операций по улучшению любого аспекта
этой системы (например, уменьшение числа отмен/отзывов, уменьшение возникновения посторонних
органов).
Цели должны быть конкретными, измеримыми, достижимыми, релевантными и ограниченными
сроками.
5.3 Планирование системы менеджмента безопасности пищевых продуктов
Указаний не приводится.
5.4 Ответственность и полномочия
Указаний не приводится.
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5.5 Руководитель группы обеспечения безопасности пищевых продуктов
Руководитель группы обеспечения безопасности пищевых продуктов является центральным лицом в
системе менеджмента безопасности пищевых продуктов любой организации и должен быть членом
этой организации и разбираться в вопросах, связанных с безопасностью пищевых продуктов. Там где
руководитель группы обеспечения безопасности пищевых продуктов имеет другие обязанности в
рамках организации, это не должно противоречить обязанностям, связанным с безопасностью
пищевых продуктов.
В обязанности руководителя группы обеспечения безопасности пищевых продуктов может входить
связь с внешними организациями по вопросам, связанным с системой менеджмента безопасности
пищевых продуктов.
Рекомендуется, чтобы руководитель группы обеспечения безопасности пищевых продуктов обладал
базовыми знаниями в области менеджмента гигиены и применения принципов НАССР.
5.6 Обмен информацией
Цель любого обмена информацией заключается в обеспечении необходимого взаимодействия.
ISO 22000 требует, чтобы в рамках системы менеджмента безопасности пищевых продуктов
происходил как обмен информацией как внутри организации, так и вне ее.
В задачи внешнего обмена входит обмен информацией с целью обеспечения того, чтобы любая
соответствующая опасность контролировалась на одном этапе по цепи производства и потребления
пищевых продуктов путем интерактивного обмена информацией, например,
а) по всем направлениям цепи производства и потребления пищевых продуктов в отношении
опасностей пищевых продуктов, которые данная организация не может контролировать и
которые должны контролироваться на других этапах цепи производства и потребления
пищевых продуктов,
b) с потребителями на основе взаимного принятия требуемого (потребителем) уровня
безопасности пищевых продуктов, и
с) с законодательными и контролирующими органами и другими организациями.
Внешний обмен информацией является способом, посредством которого данная организация и
организация извне приходят к соглашению путем договора или других средств о требуемом уровне
безопасности пищевых продуктов и о возможностях выработки согласованных требований. Каналы
обмена информацией с законодательными и контролирующими органами и другими организациями
следует создавать как основу обеспечения принятия общественностью уровня безопасности пищевых
продуктов и гарантии надежности данной организации.
Обучение назначенных лиц в области обмена информацией может также стать важным аспектом.
Система обмена информацией внутри организации должна обеспечить наличие достаточного объема
необходимой информации и данных и доступность их для всех лиц, вовлеченных в выполнение
различных операций и процедур. Руководитель группы обеспечения безопасности пищевых продуктов
играет главную роль в области внутреннего обмена информацией по вопросам безопасности пищевых
продуктов в рамках организации. Обмен информацией персоналом в рамках организации следует
осуществлять четко и своевременно в отношении разработки и внедрения новых видов продукции, а
также запланированного изменения сырья и ингредиентов, производственных систем и процессов
и/или потребителей и требований потребителей. В частности, следует обратить внимание на обмен
информацией в отношении изменений нормативных и законодательных требований, новых или
возникающих опасностей пищевых продуктов и метода контроля этих новых опасностей.
Любой член организации, узнавший о чем-либо, что может повлиять на безопасность пищевых
продуктов, должен также знать, каким образом сообщить об этом событии.
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5.7 Готовность к аварийным ситуациям и реакция на них
Организация должна знать о потенциально аварийных ситуациях, которые могут включать, например,
пожар, наводнение, биотерроризм и саботаж, отключение энергии, дорожно-транспортные
происшествия и загрязнение окружающей среды.
5.8 Анализ со стороны руководства
Анализ системы со стороны руководства обеспечивает руководство возможностью оценки выполнения
организацией задач отношении политики в области безопасности пищевых продуктов и общей
эффективности системы менеджмента безопасности пищевых продуктов.
6 Руководство по применению ISO 22000:2005, Раздел 6. Менеджмент ресурсов
6.1 Обеспечение ресурсами
Указаний не приводится.
6.2 Людские ресурсы
Обучение следует поддерживать на таком уровне, который обеспечивает, чтобы все сотрудники
организации знали свои обязанности по обслуживанию системы менеджмента безопасности пищевых
продуктов. В программы учебных семинаров следует включить, например, содержание программы,
имя и должность преподавателя, оценки обучающихся, итоговую оценку обучающихся, формулировку
необходимости повторного обучения.
6.3 Инфраструктура
Инфраструктура для организации включает здания, технологическое оборудование, энерго- и
водоснабжение, близлежащие области и обслуживание.
6.4 Производственная среда
Производственная среда должна включать меры предотвращения перекрестного загрязнения,
требования к рабочей зоне, требования к защите от эксплуатационного износа, а также наличие и
расположение производственных средств служащего.
7 Руководство по применению ISO 22000:2005, Раздел 7. Планирование и
реализация безопасных продуктов
7.1 Общие положения
ISO 22000 требует, чтобы при разработке системы менеджмента безопасности пищевых продуктов
организация использовала динамический и систематический процессный подход. Это достигается
путем эффективной разработки, внедрения, мониторинга запланированной деятельности,
поддержания в рабочем состоянии и верификации мер контроля, обновления процессов производства
пищевых продуктов и производственной среды, а также соответствующих действий в случае
производства продукции, не соответствующей требованиям.
Раздел 7 ISO 22000:2005 обращается к планированию (см. Рисунок 2) и оперативным фазам, тогда как
раздел 8 обращается к фазам действия и контроля. Поддержание системы в рабочем состоянии и
улучшение системы рассмотрено посредством ряда циклов планирования, валидации, мониторинга,
верификации и обновления, требования к которым описаны в этих двух разделах. Изменения системы
в рамках оперативной системы можно вызвать на любом из этих этапов.
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ISO/TS 22004:2005(R)
ISO 22000 признает традиционную концепцию разделения мер контроля на две группы
[предварительные условия и меры, принимаемые в критических контрольных точках (critical control
points) [(ССРs)] в логическом порядке для создания, внедрения и контроля системы менеджмента
безопасности пищевых продуктов. Меры контроля группируют в три группы следующим образом:
а) программы создания предварительных условий [PRP(s)], которые управляют основными
условиями и деятельностью; [PRP(S)] выбирают не с целью контроля конкретных
идентифицированных опасностей, а для поддержания гигиены, производственной среды, среды
переработки и/или обращения (см. 7.2 ISO 22000:2005);
b) оперативные программы создания предварительных условий (оперативные [PRP(S)]), которые
управляют теми мерами контроля, которые анализ опасностей определяет как необходимые меры
контроля идентифицированных опасностей до приемлемых уровней и которые не управляются
иным образом планом НАССР;
с) план НАССР для управления теми мерами контроля, которые анализ опасностей идентифицирует
как необходимые для контроля идентифицированных опасностей до приемлемых уровней и
которые применяются в критических контрольных точках (CCPs).
Категоризация мер контроля облегчает применение различных стратегий управления к каждой группе
в отношении валидации, мониторинга и верификации мер контроля несоответствий, включая
обращение с полученным продуктом.
Центральным элементом планирования является проведение анализа опасностей для определения
тех опасностей, которые необходимо контролировать (см. 7.4.3 ISO 22000:2005), степень требуемого
контроля для удовлетворения приемлемых уровней и комбинация мер контроля, которые могут это
обеспечить (см. 7.4.4 ISO 22000:2005). Чтобы облегчить это, нужны предварительные шаги (см. 7.3
ISO 22000:2005) для доставки и организации соответствующей информации.
Анализ опасностей определяет соответствующие меры контроля и позволяет отнести их к тем
категориям, которыми предполагается управлять посредством плана НАССР и/или оперативных
[PRP(S)], соответственно, поможет при последующем планировании деталей, как внедрять эти меры,
следить, верифицировать и обновлять (см. 7.5 – 7.8 ISO 22000:2005).
Организация может использовать внешние источники для разработки комбинации мер контроля, при
условии, что они удовлетворяют требованиям 7.2 – 7.8 ISO 22000:2005.
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ISO/TS 22004:2005(R)
Рисунок 2 ─ Планирование безопасных пищевых продуктов
7.2 Программы создания предварительных условий
Указаний не приведено.
7.3 Предварительные шаги для облегчения анализа опасностей
Происхождение сырья, ингредиентов и продуктов, контактирующих с пищевым продуктом, необходимо
принимать в расчет, если это может повлиять на оценку возникновения опасностей и уровней этих
опасностей. Информация, которую необходимо учитывать
...
TECHNICAL ISO/TS
SPECIFICATION 22004
First edition
2005-11-15
Food safety management systems —
Guidance on the application of
ISO 22000:2005
Systèmes de management de la sécurité des denrées alimentaires —
Lignes directrices relatives à l'application de l'ISO 22000:2005
Reference number
ISO/TS 22004:2005(E)
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ISO/TS 22004:2005(E)
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ISO/TS 22004:2005(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Guidance on the use of ISO 22000:2005, Clause 4: Food safety management system . 1
4.1 General requirements . 1
4.2 Documentation requirements . 1
5 Guidance on the use of ISO 22000:2005, Clause 5: Management responsibility . 2
5.1 Management commitment . 2
5.2 Food safety policy . 2
5.3 Food safety management system planning . 2
5.4 Responsibility and authority . 2
5.5 Food safety team leader . 2
5.6 Communication . 3
5.7 Emergency preparedness and response . 3
5.8 Management review . 3
6 Guidance on the use of ISO 22000:2005, Clause 6: Resource management . 3
6.1 Provision of resources . 3
6.2 Human resources . 4
6.3 Infrastructure . 4
6.4 Work environment . 4
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe products . 4
7.1 General . 4
7.2 Prerequisite programmes . 5
7.3 Preliminary steps to enable hazard analysis . 6
7.4 Hazard analysis . 6
7.5 Establishing the operational prerequisite programmes . 8
7.6 Establishing the HACCP plan . 8
7.7 Updating of preliminary information and documents specifying the PRPs and
the HACCP plan . 10
7.8 Verification planning . 10
7.9 Traceability system . 10
7.10 Control of nonconformity . 10
8 Guidance on the use of ISO 22000:2005, Clause 8: Validation, verification and improvement
of the food safety management system . 10
8.1 General . 10
8.2 Validation of control measure combinations . 11
8.3 Control of monitoring and measuring . 11
8.4 Food safety management system verification . 11
8.5 Improvement . 12
Bibliography . 13
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ISO/TS 22004:2005(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.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further
three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed,
it is reviewed again after a further three years, at which time it must either be transformed into an International
Standard or be withdrawn.
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 22004 was prepared by Technical Committee ISO/TC 34, Food products.
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ISO/TS 22004:2005(E)
Introduction
0.1 General
The adoption of a food safety management system by an organization involved in the food chain is a useful tool
for ensuring compliance with requirements specified by law, statute, regulation and/or customers.
The design and implementation of an organization's food safety management system are influenced by varying
factors, in particular food safety hazards, the products provided, the processes employed and the size and
structure of the organization. This Technical Specification gives guidance on the use of ISO 22000, which is
[4]
based on the principles of HACCP as described by the Codex Alimentarius Commission and is designed to
be applied together with relevant standards published by that organization.
0.2 Food chain and process approach
ISO 22000 promotes the adoption of a food chain approach when developing, implementing and improving the
effectiveness and efficiency of a food safety management system. In this regard, in ISO 22000 the organization
is required to consider the effects of the food chain prior to and subsequent to its operations when developing
and implementing the food safety management system.
For an organization to function effectively and efficiently, it has to identify and manage numerous linked
activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs,
is considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification of interactions
and the management of these processes can be referred to as the “process approach.”
An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as their combination and interaction.
When used within a food safety management system, such an approach emphasizes the importance of
a) understanding and fulfilling the requirements,
b) the need to consider processes in terms of food safety and traceability,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
Interested parties play a significant role in defining requirements as inputs. Monitoring the satisfaction of
interested parties requires evaluation of information relating to their perception of whether the organization has
met their requirements or not.
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ISO/TS 22004:2005(E)
The model of a process-based food safety management system shown in Figure 1 illustrates the process
linkages presented in Clauses 4 to 8 of ISO 22000:2005. The model shown in Figure 1 does not show the
processes at a detailed level.
Figure 1 — Concept of continuous improvement
0.3 Relationship with ISO 9001
ISO 22000 has been designed to work in harmony with ISO 9001 and its supporting standards. ISO 9001
provides requirements for a quality management system that can be used for internal application by
organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements. ISO 22000 provides the essential elements of a food
safety management system for similar purposes.
0.4 Compatibility with other management systems
This Technical Specification does not include guidance specific to other management systems, such as those
particular to environmental management, occupational health and safety management, financial management,
or risk management. However, ISO 22000 enables an organization to align or integrate its own food safety
management system with related management systems. It is possible for an organization to adapt its existing
management system(s) in order to establish a food safety management system that follows the requirements of
ISO 22000.
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TECHNICAL SPECIFICATION ISO/TS 22004:2005(E)
Food safety management systems — Guidance on the
application of ISO 22000:2005
1Scope
This Technical Specification provides generic guidance that can be applied in the use of ISO 22000.
NOTE Where a subclause of ISO 22000 is not mentioned, guidance is not given.
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 22000:2005, Food safety management systems — Requirements for any organization in the food chain
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22000 apply.
4 Guidance on the use of ISO 22000:2005, Clause 4: Food safety management
system
4.1 General requirements
External competences may be used by the organization to develop and implement a food safety management
system according to ISO 22000 provided that it is ensured that such outsourced processes have been
developed and are implemented, monitored, maintained and updated in compliance with the requirements of
ISO 22000.
Moreover, ISO 22000 allows any organization, in particular a small and/or less developed organization, to
implement an externally developed and established combination of prerequisite programme(s) [PRP(s)],
operational PRP(s) and Hazard Analysis and Critical Control Point (HACCP) plans provided that it can be
demonstrated that
a) this combination has been developed in compliance with the requirements of ISO 22000 specified for the
hazard analysis, PRP(s) and HACCP plan,
b) specific measures have been undertaken to adapt the externally developed combination to the organization,
and
c) this combination has been implemented and is operated in accordance with the other requirements of
ISO 22000.
4.2 Documentation requirements
The organization should use documents of external origin relevant for food safety in its various activities, for
example in meeting statutory, regulatory and customer requirements. In some situations, electronic
documentation may be required to comply with regulatory requirements.
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The type and extent of documentation will probably differ from one organization to another due to the size and
complexity of the activity and the competence of personnel, as well as the extent of the use of externally
developed combinations of PRPs, operational PRPs and HACCP plans.
If externally developed combinations of PRPs, operational PRPs and HACCP plans are used, their suitability
should be documented and this documentation should be a part of the food safety management system.
Where ISO 22000 refers to a documented procedure or statement, this should be interpreted to mean that the
procedure or statement is established, documented, implemented, reviewed and maintained by the
organization as part of the food safety management system. Documents that usually form part of the system
include product specifications, HACCP plans, operational PRPs and PRPs and other required operating
procedures, including contracts for any outsourced processes (e.g. pest control, product testing). The
documents used by the organization should be available when and where required and may be in any valid
format (e.g. paper, electronic or picture).
A critical activity for any organization is the retention of appropriate records for specified periods and under
controlled conditions. The organization should base its decision on record retention when it has considered the
intended use of its products and the expected shelf-life along the food chain.
5 Guidance on the use of ISO 22000:2005, Clause 5: Management responsibility
5.1 Management commitment
The method whereby the organization provides evidence of top management commitment to the food safety
management system includes the setting of awareness and leadership initiatives linked to the development and
implementation of the system.
5.2 Food safety policy
The food safety policy is the basis of any organization's food safety management system. Measurable
objectives and targets are defined in this policy. Measurable activities may include identification and
implementation of activities to improve any aspect of the system (e.g. reduce the number of recalls/withdrawals,
decrease the occurrence of foreign bodies).
Objectives should be specific, measurable, achievable, relevant and time-framed.
5.3 Food safety management system planning
No guidance is given.
5.4 Responsibility and authority
No guidance is given.
5.5 Food safety team leader
The food safety team leader is central to the food safety management system of any organization and should be
a member of the organization and should understand its food safety issues. Where the food safety team leader
has other responsibilities within the organization, these should not conflict with food safety responsibilities.
The responsibility of the food safety team leader may include liaison with external parties on matters relating to
the food safety management system.
It is recommended that the food safety team leader have a basic knowledge of hygiene management and
application of the HACCP principles.
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5.6 Communication
The purpose of any communication is to ensure that the necessary interactions occur.
ISO 22000 requires that both external and internal communication takes place as part of the food safety
management system.
External communication aims to exchange information in order to ensure that any relevant hazard is controlled
at one step through the food chain by interaction, for example,
a) up and down the food chain, for food safety hazard(s) that may not or cannot be controlled by the
organization and which consequently need(s) to be controlled at other steps in the food chain,
b) with customers as the basis for mutual acceptance of the level of food safety required (by the customer),
and
c) with statutory and regulatory authorities and other organizations.
External communication is the method whereby the organization and the external organization agree by
contract or other means upon the level of food safety required and on the capability of delivering to the agreed
requirements. Channels of communication with statutory and regulatory authorities and other organizations
should be established as a basis for providing public acceptance of the level of food safety and for ensuring the
reliability of the organization.
Training of designated personnel in communication skills may be an important aspect as well.
The internal communication system of the organization should ensure that sufficient and relevant information
and data are available to all personnel involved in the various operations and procedures. The food safety team
leader has a major role in the area of the internal communication of food safety issues within the organization.
Communication to personnel within in the organization should be carried out in a clear and timely manner on the
development and launch of new products, as well as intended changes in raw materials and ingredients,
production systems and processes and/or customers and customer requirements. In particular, attention should
be given to the communication of changes in statutory and regulatory requirements, new or emerging food
safety hazards, and the method of control of these new hazards.
Any member of the organization seeing something which may have an impact on food safety should know how
to report this event.
5.7 Emergency preparedness and response
The organization should be aware of potential emergency situations which may include, for example, fire,
flooding, bioterrorism and sabotage, energy failure, vehicle accidents and contamination of the environment.
5.8 Management review
The management reviews provide management with an opportunity to assess the performance of the
organization in meeting the objectives with respect to its food safety policy and the overall effectiveness of the
food safety management system.
6 Guidance on the use of ISO 22000:2005, Clause 6: Resource management
6.1 Provision of resources
No guidance is given.
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6.2 Human resources
Training should be maintained at a level that ensures that all employees know their responsibilities to maintain
the food safety management system. Details of training sessions should include, for example, programme
content, name and qualifications of the trainer, final assessment of trainees, and establishment of the
requirement for retraining.
6.3 Infrastructure
The infrastructure for the organization includes buildings, process equipment, utilities, surrounding areas and
supporting services.
6.4 Work environment
The work environment can include measures to prevent cross contamination, work space requirements,
protective work wear requirements, and the availability and location of employee facilities.
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe
products
7.1 General
ISO 22000 requires that the organization use a dynamic and systematic process approach to develop the food
safety management system. This is achieved through effective development, implementation, monitoring of
planned activities, maintenance and verification of control measures, updating the food processes and process
environment, and through appropriate actions in the event of the production of nonconformities.
Clause 7 of ISO 22000:2005 addresses planning (see Figure 2) and operating phases, whereas Clause 8
addresses checking and acting phases. Maintenance and improvement of the system is addressed through a
number of cycles of planning, validation, monitoring, verification and updating required in these two clauses.
Within an operating system, system changes can be initiated at any of these phases.
ISO 22000 reorganizes the traditional concept of dividing control measures into two groups [prerequisites and
measures applied at critical control points (CCPs)] in a logical order for the development, implementation and
control of the food safety management system. Control measures are grouped into three groups, as follows:
a) prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPs are not
selected for the purpose of controlling specific identified hazards but for the purpose of maintaining a
hygienic production, processing and/or handling environment (see 7.2 of ISO 22000:2005);
b) operational prerequisite programmes (operational PRPs) that manage those control measures that the
hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are not
otherwise managed by the HACCP plan;
c) a HACCP plan to manage those control measures that the hazard analysis identifies as necessary to
control identified hazards to acceptable levels, and which are applied at critical control points (CCPs).
Categorization of control measures facilitates the application of different management strategies to each group
with respect to validation, monitoring, and verification of measures to control nonconformities, including
handling of resulting products.
The core element of the planning is the conduct of the hazard analysis to determine those hazards that need to
be controlled (see 7.4.3 of ISO 22000:2005), the degree of control required to meet acceptable levels and the
combination of control measures that can deliver this (see 7.4.4 of ISO 22000:2005). To enable this, preliminary
steps are needed (see 7.3 of ISO 22000:2005) to furnish and organize relevant information.
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The hazard analysis determines the appropriate control measures and permits their categorization into those
that are to be managed by the HACCP plan and/or operational PRPs, respectively, and will assist in the
subsequent design of the details on how the measures are to be implemented, monitored, verified and kept
updated (see 7.5 to 7.8 of ISO 22000:2005).
External competences may be used by the organization to develop the combination of control measures,
provided that they meet the requirements of 7.2 to 7.8 of ISO 22000:2005.
Key
[4]
Steps addressed by the Codex Alimentarius HACCP Guidelines
Steps specific to ISO 22000
NOTE Cross-references refer to ISO 22000:2005.
Figure 2 — Planning of safe foods
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7.2 Prerequisite programmes
No guidance is given.
7.3 Preliminary steps to enable hazard analysis
The origin of the raw materials, ingredients and product contact materials should be taken into account when
they might impact the evaluation of the occurrence of hazards and the levels of these hazards. The information
to be taken into account may be different from the original information required to maintain traceability (see 7.9
of ISO 22000:2005).
The information to be taken into account with respect to the concept of “shelf life” is the period during which the
product maintains its microbiological safety and suitability at a specified storage temperature and under other
specified conditions, which may or may not be the same as the durability specifications used in product
labelling.
The information on intended use is needed to assist in identifying appropriate acceptable levels of hazards and
in selecting control measure combinations that achieve that level.
7.4 Hazard analysis
7.4.1 General
No guidance is given.
7.4.2 Hazard identification and determination of acceptable levels
Where statutory and regulatory authorities have established maximum limits, objectives, targets or end product
and/or process criteria for a specific hazard/product combination, the hazard in question automatically becomes
relevant for that product.
The “acceptable level” means the level of a particular hazard in the end product of the organization that is
needed at the next step in the food chain to ensure food safety; it refers to the acceptable level in foods for direct
consumption only when the next step is actual consumption. The acceptable level in the end product should be
determined through information obtained from one or more of the sources below:
1)
a) objectives, targets or end product criteria established by statutory and regulatory authorities in the country
of sale;
2)
b) specifications or other information communicated by the organization constituting the subsequent step in
the food chain (often the customer), in particular for end products intended for further processing or use
other than direct consumption;
2)
c) the maximum levels found acceptable by the food safety team , taking into account acceptable levels
agreed on with the customer and/or established by law and, in the absence thereof, through scientific
literature and professional experience.
1) According to Codex Alimentarius, such targets can be expressed by authorities as Food Safety Objectives (FSO) and/or
Performance Objectives (PO), where an FSO is the maximum frequency and/or concentration of a hazard in a food at the
time of consumption that provides or contributes to the appropriate level of health protection (ALOP), and where a PO is the
maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of
consumption that provides or contributes to a food safety objective or a
...
SLOVENSKI STANDARD
SIST-TS ISO/TS 22004:2011
01-junij-2011
Sistemi vodenja varnosti živil - Smernice za uporabo ISO 22000:2005
Food safety management systems -- Guidance on the application of ISO 22000:2005
Systèmes de management de la sécurité des denrées alimentaires -- Recommendations
pour l'application de l'ISO 22000:2005
Ta slovenski standard je istoveten z: ISO/TS 22004:2005
ICS:
67.020 Procesi v živilski industriji Processes in the food
industry
SIST-TS ISO/TS 22004:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS ISO/TS 22004:2011
TECHNICAL ISO/TS
SPECIFICATION 22004
First edition
2005-11-15
Food safety management systems —
Guidance on the application of
ISO 22000:2005
Systèmes de management de la sécurité des denrées alimentaires —
Lignes directrices relatives à l'application de l'ISO 22000:2005
Reference number
ISO/TS 22004:2005(E)
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PDF disclaimer
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© ISO 2005
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Published in Switzerland
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ISO/TS 22004:2005(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Guidance on the use of ISO 22000:2005, Clause 4: Food safety management system . 1
4.1 General requirements . 1
4.2 Documentation requirements . 1
5 Guidance on the use of ISO 22000:2005, Clause 5: Management responsibility . 2
5.1 Management commitment . 2
5.2 Food safety policy . 2
5.3 Food safety management system planning . 2
5.4 Responsibility and authority . 2
5.5 Food safety team leader . 2
5.6 Communication . 3
5.7 Emergency preparedness and response . 3
5.8 Management review . 3
6 Guidance on the use of ISO 22000:2005, Clause 6: Resource management . 3
6.1 Provision of resources . 3
6.2 Human resources . 4
6.3 Infrastructure . 4
6.4 Work environment . 4
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe products . 4
7.1 General . 4
7.2 Prerequisite programmes . 5
7.3 Preliminary steps to enable hazard analysis . 6
7.4 Hazard analysis . 6
7.5 Establishing the operational prerequisite programmes . 8
7.6 Establishing the HACCP plan . 8
7.7 Updating of preliminary information and documents specifying the PRPs and
the HACCP plan . 10
7.8 Verification planning . 10
7.9 Traceability system . 10
7.10 Control of nonconformity . 10
8 Guidance on the use of ISO 22000:2005, Clause 8: Validation, verification and improvement
of the food safety management system . 10
8.1 General . 10
8.2 Validation of control measure combinations . 11
8.3 Control of monitoring and measuring . 11
8.4 Food safety management system verification . 11
8.5 Improvement . 12
Bibliography . 13
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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.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further
three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed,
it is reviewed again after a further three years, at which time it must either be transformed into an International
Standard or be withdrawn.
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 22004 was prepared by Technical Committee ISO/TC 34, Food products.
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Introduction
0.1 General
The adoption of a food safety management system by an organization involved in the food chain is a useful tool
for ensuring compliance with requirements specified by law, statute, regulation and/or customers.
The design and implementation of an organization's food safety management system are influenced by varying
factors, in particular food safety hazards, the products provided, the processes employed and the size and
structure of the organization. This Technical Specification gives guidance on the use of ISO 22000, which is
[4]
based on the principles of HACCP as described by the Codex Alimentarius Commission and is designed to
be applied together with relevant standards published by that organization.
0.2 Food chain and process approach
ISO 22000 promotes the adoption of a food chain approach when developing, implementing and improving the
effectiveness and efficiency of a food safety management system. In this regard, in ISO 22000 the organization
is required to consider the effects of the food chain prior to and subsequent to its operations when developing
and implementing the food safety management system.
For an organization to function effectively and efficiently, it has to identify and manage numerous linked
activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs,
is considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification of interactions
and the management of these processes can be referred to as the “process approach.”
An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as their combination and interaction.
When used within a food safety management system, such an approach emphasizes the importance of
a) understanding and fulfilling the requirements,
b) the need to consider processes in terms of food safety and traceability,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
Interested parties play a significant role in defining requirements as inputs. Monitoring the satisfaction of
interested parties requires evaluation of information relating to their perception of whether the organization has
met their requirements or not.
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The model of a process-based food safety management system shown in Figure 1 illustrates the process
linkages presented in Clauses 4 to 8 of ISO 22000:2005. The model shown in Figure 1 does not show the
processes at a detailed level.
Figure 1 — Concept of continuous improvement
0.3 Relationship with ISO 9001
ISO 22000 has been designed to work in harmony with ISO 9001 and its supporting standards. ISO 9001
provides requirements for a quality management system that can be used for internal application by
organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements. ISO 22000 provides the essential elements of a food
safety management system for similar purposes.
0.4 Compatibility with other management systems
This Technical Specification does not include guidance specific to other management systems, such as those
particular to environmental management, occupational health and safety management, financial management,
or risk management. However, ISO 22000 enables an organization to align or integrate its own food safety
management system with related management systems. It is possible for an organization to adapt its existing
management system(s) in order to establish a food safety management system that follows the requirements of
ISO 22000.
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TECHNICAL SPECIFICATION ISO/TS 22004:2005(E)
Food safety management systems — Guidance on the
application of ISO 22000:2005
1Scope
This Technical Specification provides generic guidance that can be applied in the use of ISO 22000.
NOTE Where a subclause of ISO 22000 is not mentioned, guidance is not given.
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 22000:2005, Food safety management systems — Requirements for any organization in the food chain
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22000 apply.
4 Guidance on the use of ISO 22000:2005, Clause 4: Food safety management
system
4.1 General requirements
External competences may be used by the organization to develop and implement a food safety management
system according to ISO 22000 provided that it is ensured that such outsourced processes have been
developed and are implemented, monitored, maintained and updated in compliance with the requirements of
ISO 22000.
Moreover, ISO 22000 allows any organization, in particular a small and/or less developed organization, to
implement an externally developed and established combination of prerequisite programme(s) [PRP(s)],
operational PRP(s) and Hazard Analysis and Critical Control Point (HACCP) plans provided that it can be
demonstrated that
a) this combination has been developed in compliance with the requirements of ISO 22000 specified for the
hazard analysis, PRP(s) and HACCP plan,
b) specific measures have been undertaken to adapt the externally developed combination to the organization,
and
c) this combination has been implemented and is operated in accordance with the other requirements of
ISO 22000.
4.2 Documentation requirements
The organization should use documents of external origin relevant for food safety in its various activities, for
example in meeting statutory, regulatory and customer requirements. In some situations, electronic
documentation may be required to comply with regulatory requirements.
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The type and extent of documentation will probably differ from one organization to another due to the size and
complexity of the activity and the competence of personnel, as well as the extent of the use of externally
developed combinations of PRPs, operational PRPs and HACCP plans.
If externally developed combinations of PRPs, operational PRPs and HACCP plans are used, their suitability
should be documented and this documentation should be a part of the food safety management system.
Where ISO 22000 refers to a documented procedure or statement, this should be interpreted to mean that the
procedure or statement is established, documented, implemented, reviewed and maintained by the
organization as part of the food safety management system. Documents that usually form part of the system
include product specifications, HACCP plans, operational PRPs and PRPs and other required operating
procedures, including contracts for any outsourced processes (e.g. pest control, product testing). The
documents used by the organization should be available when and where required and may be in any valid
format (e.g. paper, electronic or picture).
A critical activity for any organization is the retention of appropriate records for specified periods and under
controlled conditions. The organization should base its decision on record retention when it has considered the
intended use of its products and the expected shelf-life along the food chain.
5 Guidance on the use of ISO 22000:2005, Clause 5: Management responsibility
5.1 Management commitment
The method whereby the organization provides evidence of top management commitment to the food safety
management system includes the setting of awareness and leadership initiatives linked to the development and
implementation of the system.
5.2 Food safety policy
The food safety policy is the basis of any organization's food safety management system. Measurable
objectives and targets are defined in this policy. Measurable activities may include identification and
implementation of activities to improve any aspect of the system (e.g. reduce the number of recalls/withdrawals,
decrease the occurrence of foreign bodies).
Objectives should be specific, measurable, achievable, relevant and time-framed.
5.3 Food safety management system planning
No guidance is given.
5.4 Responsibility and authority
No guidance is given.
5.5 Food safety team leader
The food safety team leader is central to the food safety management system of any organization and should be
a member of the organization and should understand its food safety issues. Where the food safety team leader
has other responsibilities within the organization, these should not conflict with food safety responsibilities.
The responsibility of the food safety team leader may include liaison with external parties on matters relating to
the food safety management system.
It is recommended that the food safety team leader have a basic knowledge of hygiene management and
application of the HACCP principles.
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5.6 Communication
The purpose of any communication is to ensure that the necessary interactions occur.
ISO 22000 requires that both external and internal communication takes place as part of the food safety
management system.
External communication aims to exchange information in order to ensure that any relevant hazard is controlled
at one step through the food chain by interaction, for example,
a) up and down the food chain, for food safety hazard(s) that may not or cannot be controlled by the
organization and which consequently need(s) to be controlled at other steps in the food chain,
b) with customers as the basis for mutual acceptance of the level of food safety required (by the customer),
and
c) with statutory and regulatory authorities and other organizations.
External communication is the method whereby the organization and the external organization agree by
contract or other means upon the level of food safety required and on the capability of delivering to the agreed
requirements. Channels of communication with statutory and regulatory authorities and other organizations
should be established as a basis for providing public acceptance of the level of food safety and for ensuring the
reliability of the organization.
Training of designated personnel in communication skills may be an important aspect as well.
The internal communication system of the organization should ensure that sufficient and relevant information
and data are available to all personnel involved in the various operations and procedures. The food safety team
leader has a major role in the area of the internal communication of food safety issues within the organization.
Communication to personnel within in the organization should be carried out in a clear and timely manner on the
development and launch of new products, as well as intended changes in raw materials and ingredients,
production systems and processes and/or customers and customer requirements. In particular, attention should
be given to the communication of changes in statutory and regulatory requirements, new or emerging food
safety hazards, and the method of control of these new hazards.
Any member of the organization seeing something which may have an impact on food safety should know how
to report this event.
5.7 Emergency preparedness and response
The organization should be aware of potential emergency situations which may include, for example, fire,
flooding, bioterrorism and sabotage, energy failure, vehicle accidents and contamination of the environment.
5.8 Management review
The management reviews provide management with an opportunity to assess the performance of the
organization in meeting the objectives with respect to its food safety policy and the overall effectiveness of the
food safety management system.
6 Guidance on the use of ISO 22000:2005, Clause 6: Resource management
6.1 Provision of resources
No guidance is given.
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6.2 Human resources
Training should be maintained at a level that ensures that all employees know their responsibilities to maintain
the food safety management system. Details of training sessions should include, for example, programme
content, name and qualifications of the trainer, final assessment of trainees, and establishment of the
requirement for retraining.
6.3 Infrastructure
The infrastructure for the organization includes buildings, process equipment, utilities, surrounding areas and
supporting services.
6.4 Work environment
The work environment can include measures to prevent cross contamination, work space requirements,
protective work wear requirements, and the availability and location of employee facilities.
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe
products
7.1 General
ISO 22000 requires that the organization use a dynamic and systematic process approach to develop the food
safety management system. This is achieved through effective development, implementation, monitoring of
planned activities, maintenance and verification of control measures, updating the food processes and process
environment, and through appropriate actions in the event of the production of nonconformities.
Clause 7 of ISO 22000:2005 addresses planning (see Figure 2) and operating phases, whereas Clause 8
addresses checking and acting phases. Maintenance and improvement of the system is addressed through a
number of cycles of planning, validation, monitoring, verification and updating required in these two clauses.
Within an operating system, system changes can be initiated at any of these phases.
ISO 22000 reorganizes the traditional concept of dividing control measures into two groups [prerequisites and
measures applied at critical control points (CCPs)] in a logical order for the development, implementation and
control of the food safety management system. Control measures are grouped into three groups, as follows:
a) prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPs are not
selected for the purpose of controlling specific identified hazards but for the purpose of maintaining a
hygienic production, processing and/or handling environment (see 7.2 of ISO 22000:2005);
b) operational prerequisite programmes (operational PRPs) that manage those control measures that the
hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are not
otherwise managed by the HACCP plan;
c) a HACCP plan to manage those control measures that the hazard analysis identifies as necessary to
control identified hazards to acceptable levels, and which are applied at critical control points (CCPs).
Categorization of control measures facilitates the application of different management strategies to each group
with respect to validation, monitoring, and verification of measures to control nonconformities, including
handling of resulting products.
The core element of the planning is the conduct of the hazard analysis to determine those hazards that need to
be controlled (see 7.4.3 of ISO 22000:2005), the degree of control required to meet acceptable levels and the
combination of control measures that can deliver this (see 7.4.4 of ISO 22000:2005). To enable this, preliminary
steps are needed (see 7.3 of ISO 22000:2005) to furnish and organize relevant information.
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The hazard analysis determines the appropriate control measures and permits their categorization into those
that are to be managed by the HACCP plan and/or operational PRPs, respectively, and will assist in the
subsequent design of the details on how the measures are to be implemented, monitored, verified and kept
updated (see 7.5 to 7.8 of ISO 22000:2005).
External competences may be used by the organization to develop the combination of control measures,
provided that they meet the requirements of 7.2 to 7.8 of ISO 22000:2005.
Key
[4]
Steps addressed by the Codex Alimentarius HACCP Guidelines
Steps specific to ISO 22000
NOTE Cross-references refer to ISO 22000:2005.
Figure 2 — Planning of safe foods
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7.2 Prerequisite programmes
No guidance is given.
7.3 Preliminary steps to enable hazard analysis
The origin of the raw materials, ingredients and product contact materials should be taken into account when
they might impact the evaluation of the occurrence of hazards and the levels of these hazards. The information
to be taken into account may be different from the original information required to maintain traceability (see 7.9
of ISO 22000:2005).
The information to be taken into account with respect to the concept of “shelf life” is the period during which the
product maintains its microbiological safety and suitability at a specified storage temperature and under other
specified conditions, which may or may not be the same as the durability specifications used in product
labelling.
The information on intended use is needed to assist in identifying appropriate acceptable levels of hazards and
in selecting control measure combinations that achieve that level.
7.4 Hazard analysis
7.4.1 General
No guidance is given.
7.4.2 Hazard identification and determination of acceptable levels
Where statutory and regulatory authorities have established maximum limits, objectives, targets or end product
and/or process criteria for a specific hazard/product combination, the hazard in question automatically becomes
relevant for that product.
The “acceptable level” means the level of a particular hazard in the end product of the organization that is
needed at the next step in the food chain to ensure food safety; it refers to the acceptable level in foods for direct
consumption only when the next step is actual consumption. The acceptable level in the end product should be
determined through information obtained from one or more of the sources below:
1)
a) objectives, targets or end product criteria established by statutory and regulatory authori
...
SLOVENSKI STANDARD
oSIST-TS ISO/TS 22004:2011
01-april-2011
Sistemi vodenja varnosti živil - Smernice za uporabo ISO 22000:2005
Food safety management systems -- Guidance on the application of ISO 22000:2005
Systèmes de management de la sécurité des denrées alimentaires -- Recommendations
pour l'application de l'ISO 22000:2005
Ta slovenski standard je istoveten z: ISO/TS 22004:2005
ICS:
67.020 Procesi v živilski industriji Processes in the food
industry
oSIST-TS ISO/TS 22004:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST-TS ISO/TS 22004:2011
TECHNICAL ISO/TS
SPECIFICATION 22004
First edition
2005-11-15
Food safety management systems —
Guidance on the application of
ISO 22000:2005
Systèmes de management de la sécurité des denrées alimentaires —
Lignes directrices relatives à l'application de l'ISO 22000:2005
Reference number
ISO/TS 22004:2005(E)
©
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Published in Switzerland
©
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Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Guidance on the use of ISO 22000:2005, Clause 4: Food safety management system . 1
4.1 General requirements . 1
4.2 Documentation requirements . 1
5 Guidance on the use of ISO 22000:2005, Clause 5: Management responsibility . 2
5.1 Management commitment . 2
5.2 Food safety policy . 2
5.3 Food safety management system planning . 2
5.4 Responsibility and authority . 2
5.5 Food safety team leader . 2
5.6 Communication . 3
5.7 Emergency preparedness and response . 3
5.8 Management review . 3
6 Guidance on the use of ISO 22000:2005, Clause 6: Resource management . 3
6.1 Provision of resources . 3
6.2 Human resources . 4
6.3 Infrastructure . 4
6.4 Work environment . 4
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe products . 4
7.1 General . 4
7.2 Prerequisite programmes . 5
7.3 Preliminary steps to enable hazard analysis . 6
7.4 Hazard analysis . 6
7.5 Establishing the operational prerequisite programmes . 8
7.6 Establishing the HACCP plan . 8
7.7 Updating of preliminary information and documents specifying the PRPs and
the HACCP plan . 10
7.8 Verification planning . 10
7.9 Traceability system . 10
7.10 Control of nonconformity . 10
8 Guidance on the use of ISO 22000:2005, Clause 8: Validation, verification and improvement
of the food safety management system . 10
8.1 General . 10
8.2 Validation of control measure combinations . 11
8.3 Control of monitoring and measuring . 11
8.4 Food safety management system verification . 11
8.5 Improvement . 12
Bibliography . 13
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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.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further
three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed,
it is reviewed again after a further three years, at which time it must either be transformed into an International
Standard or be withdrawn.
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 22004 was prepared by Technical Committee ISO/TC 34, Food products.
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Introduction
0.1 General
The adoption of a food safety management system by an organization involved in the food chain is a useful tool
for ensuring compliance with requirements specified by law, statute, regulation and/or customers.
The design and implementation of an organization's food safety management system are influenced by varying
factors, in particular food safety hazards, the products provided, the processes employed and the size and
structure of the organization. This Technical Specification gives guidance on the use of ISO 22000, which is
[4]
based on the principles of HACCP as described by the Codex Alimentarius Commission and is designed to
be applied together with relevant standards published by that organization.
0.2 Food chain and process approach
ISO 22000 promotes the adoption of a food chain approach when developing, implementing and improving the
effectiveness and efficiency of a food safety management system. In this regard, in ISO 22000 the organization
is required to consider the effects of the food chain prior to and subsequent to its operations when developing
and implementing the food safety management system.
For an organization to function effectively and efficiently, it has to identify and manage numerous linked
activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs,
is considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification of interactions
and the management of these processes can be referred to as the “process approach.”
An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as their combination and interaction.
When used within a food safety management system, such an approach emphasizes the importance of
a) understanding and fulfilling the requirements,
b) the need to consider processes in terms of food safety and traceability,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
Interested parties play a significant role in defining requirements as inputs. Monitoring the satisfaction of
interested parties requires evaluation of information relating to their perception of whether the organization has
met their requirements or not.
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The model of a process-based food safety management system shown in Figure 1 illustrates the process
linkages presented in Clauses 4 to 8 of ISO 22000:2005. The model shown in Figure 1 does not show the
processes at a detailed level.
Figure 1 — Concept of continuous improvement
0.3 Relationship with ISO 9001
ISO 22000 has been designed to work in harmony with ISO 9001 and its supporting standards. ISO 9001
provides requirements for a quality management system that can be used for internal application by
organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements. ISO 22000 provides the essential elements of a food
safety management system for similar purposes.
0.4 Compatibility with other management systems
This Technical Specification does not include guidance specific to other management systems, such as those
particular to environmental management, occupational health and safety management, financial management,
or risk management. However, ISO 22000 enables an organization to align or integrate its own food safety
management system with related management systems. It is possible for an organization to adapt its existing
management system(s) in order to establish a food safety management system that follows the requirements of
ISO 22000.
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oSIST-TS ISO/TS 22004:2011
TECHNICAL SPECIFICATION ISO/TS 22004:2005(E)
Food safety management systems — Guidance on the
application of ISO 22000:2005
1Scope
This Technical Specification provides generic guidance that can be applied in the use of ISO 22000.
NOTE Where a subclause of ISO 22000 is not mentioned, guidance is not given.
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 22000:2005, Food safety management systems — Requirements for any organization in the food chain
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22000 apply.
4 Guidance on the use of ISO 22000:2005, Clause 4: Food safety management
system
4.1 General requirements
External competences may be used by the organization to develop and implement a food safety management
system according to ISO 22000 provided that it is ensured that such outsourced processes have been
developed and are implemented, monitored, maintained and updated in compliance with the requirements of
ISO 22000.
Moreover, ISO 22000 allows any organization, in particular a small and/or less developed organization, to
implement an externally developed and established combination of prerequisite programme(s) [PRP(s)],
operational PRP(s) and Hazard Analysis and Critical Control Point (HACCP) plans provided that it can be
demonstrated that
a) this combination has been developed in compliance with the requirements of ISO 22000 specified for the
hazard analysis, PRP(s) and HACCP plan,
b) specific measures have been undertaken to adapt the externally developed combination to the organization,
and
c) this combination has been implemented and is operated in accordance with the other requirements of
ISO 22000.
4.2 Documentation requirements
The organization should use documents of external origin relevant for food safety in its various activities, for
example in meeting statutory, regulatory and customer requirements. In some situations, electronic
documentation may be required to comply with regulatory requirements.
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The type and extent of documentation will probably differ from one organization to another due to the size and
complexity of the activity and the competence of personnel, as well as the extent of the use of externally
developed combinations of PRPs, operational PRPs and HACCP plans.
If externally developed combinations of PRPs, operational PRPs and HACCP plans are used, their suitability
should be documented and this documentation should be a part of the food safety management system.
Where ISO 22000 refers to a documented procedure or statement, this should be interpreted to mean that the
procedure or statement is established, documented, implemented, reviewed and maintained by the
organization as part of the food safety management system. Documents that usually form part of the system
include product specifications, HACCP plans, operational PRPs and PRPs and other required operating
procedures, including contracts for any outsourced processes (e.g. pest control, product testing). The
documents used by the organization should be available when and where required and may be in any valid
format (e.g. paper, electronic or picture).
A critical activity for any organization is the retention of appropriate records for specified periods and under
controlled conditions. The organization should base its decision on record retention when it has considered the
intended use of its products and the expected shelf-life along the food chain.
5 Guidance on the use of ISO 22000:2005, Clause 5: Management responsibility
5.1 Management commitment
The method whereby the organization provides evidence of top management commitment to the food safety
management system includes the setting of awareness and leadership initiatives linked to the development and
implementation of the system.
5.2 Food safety policy
The food safety policy is the basis of any organization's food safety management system. Measurable
objectives and targets are defined in this policy. Measurable activities may include identification and
implementation of activities to improve any aspect of the system (e.g. reduce the number of recalls/withdrawals,
decrease the occurrence of foreign bodies).
Objectives should be specific, measurable, achievable, relevant and time-framed.
5.3 Food safety management system planning
No guidance is given.
5.4 Responsibility and authority
No guidance is given.
5.5 Food safety team leader
The food safety team leader is central to the food safety management system of any organization and should be
a member of the organization and should understand its food safety issues. Where the food safety team leader
has other responsibilities within the organization, these should not conflict with food safety responsibilities.
The responsibility of the food safety team leader may include liaison with external parties on matters relating to
the food safety management system.
It is recommended that the food safety team leader have a basic knowledge of hygiene management and
application of the HACCP principles.
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5.6 Communication
The purpose of any communication is to ensure that the necessary interactions occur.
ISO 22000 requires that both external and internal communication takes place as part of the food safety
management system.
External communication aims to exchange information in order to ensure that any relevant hazard is controlled
at one step through the food chain by interaction, for example,
a) up and down the food chain, for food safety hazard(s) that may not or cannot be controlled by the
organization and which consequently need(s) to be controlled at other steps in the food chain,
b) with customers as the basis for mutual acceptance of the level of food safety required (by the customer),
and
c) with statutory and regulatory authorities and other organizations.
External communication is the method whereby the organization and the external organization agree by
contract or other means upon the level of food safety required and on the capability of delivering to the agreed
requirements. Channels of communication with statutory and regulatory authorities and other organizations
should be established as a basis for providing public acceptance of the level of food safety and for ensuring the
reliability of the organization.
Training of designated personnel in communication skills may be an important aspect as well.
The internal communication system of the organization should ensure that sufficient and relevant information
and data are available to all personnel involved in the various operations and procedures. The food safety team
leader has a major role in the area of the internal communication of food safety issues within the organization.
Communication to personnel within in the organization should be carried out in a clear and timely manner on the
development and launch of new products, as well as intended changes in raw materials and ingredients,
production systems and processes and/or customers and customer requirements. In particular, attention should
be given to the communication of changes in statutory and regulatory requirements, new or emerging food
safety hazards, and the method of control of these new hazards.
Any member of the organization seeing something which may have an impact on food safety should know how
to report this event.
5.7 Emergency preparedness and response
The organization should be aware of potential emergency situations which may include, for example, fire,
flooding, bioterrorism and sabotage, energy failure, vehicle accidents and contamination of the environment.
5.8 Management review
The management reviews provide management with an opportunity to assess the performance of the
organization in meeting the objectives with respect to its food safety policy and the overall effectiveness of the
food safety management system.
6 Guidance on the use of ISO 22000:2005, Clause 6: Resource management
6.1 Provision of resources
No guidance is given.
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6.2 Human resources
Training should be maintained at a level that ensures that all employees know their responsibilities to maintain
the food safety management system. Details of training sessions should include, for example, programme
content, name and qualifications of the trainer, final assessment of trainees, and establishment of the
requirement for retraining.
6.3 Infrastructure
The infrastructure for the organization includes buildings, process equipment, utilities, surrounding areas and
supporting services.
6.4 Work environment
The work environment can include measures to prevent cross contamination, work space requirements,
protective work wear requirements, and the availability and location of employee facilities.
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe
products
7.1 General
ISO 22000 requires that the organization use a dynamic and systematic process approach to develop the food
safety management system. This is achieved through effective development, implementation, monitoring of
planned activities, maintenance and verification of control measures, updating the food processes and process
environment, and through appropriate actions in the event of the production of nonconformities.
Clause 7 of ISO 22000:2005 addresses planning (see Figure 2) and operating phases, whereas Clause 8
addresses checking and acting phases. Maintenance and improvement of the system is addressed through a
number of cycles of planning, validation, monitoring, verification and updating required in these two clauses.
Within an operating system, system changes can be initiated at any of these phases.
ISO 22000 reorganizes the traditional concept of dividing control measures into two groups [prerequisites and
measures applied at critical control points (CCPs)] in a logical order for the development, implementation and
control of the food safety management system. Control measures are grouped into three groups, as follows:
a) prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPs are not
selected for the purpose of controlling specific identified hazards but for the purpose of maintaining a
hygienic production, processing and/or handling environment (see 7.2 of ISO 22000:2005);
b) operational prerequisite programmes (operational PRPs) that manage those control measures that the
hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are not
otherwise managed by the HACCP plan;
c) a HACCP plan to manage those control measures that the hazard analysis identifies as necessary to
control identified hazards to acceptable levels, and which are applied at critical control points (CCPs).
Categorization of control measures facilitates the application of different management strategies to each group
with respect to validation, monitoring, and verification of measures to control nonconformities, including
handling of resulting products.
The core element of the planning is the conduct of the hazard analysis to determine those hazards that need to
be controlled (see 7.4.3 of ISO 22000:2005), the degree of control required to meet acceptable levels and the
combination of control measures that can deliver this (see 7.4.4 of ISO 22000:2005). To enable this, preliminary
steps are needed (see 7.3 of ISO 22000:2005) to furnish and organize relevant information.
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The hazard analysis determines the appropriate control measures and permits their categorization into those
that are to be managed by the HACCP plan and/or operational PRPs, respectively, and will assist in the
subsequent design of the details on how the measures are to be implemented, monitored, verified and kept
updated (see 7.5 to 7.8 of ISO 22000:2005).
External competences may be used by the organization to develop the combination of control measures,
provided that they meet the requirements of 7.2 to 7.8 of ISO 22000:2005.
Key
[4]
Steps addressed by the Codex Alimentarius HACCP Guidelines
Steps specific to ISO 22000
NOTE Cross-references refer to ISO 22000:2005.
Figure 2 — Planning of safe foods
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7.2 Prerequisite programmes
No guidance is given.
7.3 Preliminary steps to enable hazard analysis
The origin of the raw materials, ingredients and product contact materials should be taken into account when
they might impact the evaluation of the occurrence of hazards and the levels of these hazards. The information
to be taken into account may be different from the original information required to maintain traceability (see 7.9
of ISO 22000:2005).
The information to be taken into account with respect to the concept of “shelf life” is the period during which the
product maintains its microbiological safety and suitability at a specified storage temperature and under other
specified conditions, which may or may not be the same as the durability specifications used in product
labelling.
The information on intended use is needed to assist in identifying appropriate acceptable levels of hazards and
in selecting control measure combinations that achieve that level.
7.4 Hazard analysis
7.4.1 General
No guidance is given.
7.4.2 Hazard identification and determination of acceptable levels
Where statutory and regulatory authorities have established maximum limits, objectives, targets or end product
and/or process criteria for a specific hazard/product combination, the hazard in question automatically becomes
relevant for that product.
The “acceptable level” means the level of a particular hazard in the end product of the organization that is
needed at the next step in the food chain to ensure food safety; it refers to the acceptable level in foods for direct
consumption only when the next step is actual consumption. The acceptable level in the end product should be
determined through information obtained from one or more of the sources below:
1)
a) objectives, targets or end product criteria established by statutory and reg
...
SPÉCIFICATION ISO/TS
TECHNIQUE 22004
Première édition
2005-11-15
Systèmes de management de la sécurité
des denrées alimentaires —
Recommandations pour l'application de
l'ISO 22000:2005
Food safety management systems — Guidance on the application of
ISO 22000:2005
Numéro de référence
ISO/TS 22004:2005(F)
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Version française parue en 2006
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ii © ISO 2005 – Tous droits réservés
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ISO/TS 22004:2005(F)
Sommaire Page
Avant-propos. v
Introduction . vi
1 Domaine d'application. 1
2 Références normatives . 1
3 Termes et définitions. 1
4 Directives pour l'application de l'ISO 22000:2005, Article 4: Système de management de la
sécurité des denrées alimentaires. 1
4.1 Exigences générales . 1
4.2 Exigences relatives à la documentation. 2
5 Directives pour l'application de l'ISO 22000:2005, Article 5: Responsabilité de la direction . 2
5.1 Engagement de la direction. 2
5.2 Politique de sécurité des denrées alimentaires . 2
5.3 Planification du système de management de la sécurité des denrées alimentaires. 2
5.4 Responsabilité et autorité. 2
5.5 Responsable de l'équipe chargée de la sécurité des denrées alimentaires . 3
5.6 Communication. 3
5.7 Préparation et réponse aux urgences . 3
5.8 Revue de direction. 4
6 Directives pour l'application de l'ISO 22000:2005, Article 6: Management des ressources. 4
6.1 Mise à disposition des ressources . 4
6.2 Ressources humaines. 4
6.3 Infrastructures. 4
6.4 Environnement de travail. 4
7 Directives pour l'application de l'ISO 22000:2005, Article 7: Planification et réalisation de
produits sûrs . 4
7.1 Généralités . 4
7.2 Programmes prérequis. 5
7.3 Étapes initiales permettant l'analyse des dangers. 5
7.4 Analyse des dangers. 7
7.5 Établissement des programmes prérequis opérationnels . 9
7.6 Établissement du plan HACCP. 9
7.7 Mise à jour des informations initiales et des documents spécifiant les programmes
prérequis et le plan HACCP . 10
7.8 Planification de la vérification . 10
7.9 Système de traçabilité. 10
7.10 Maîtrise des non-conformités. 10
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8 Directives pour l'application de l'ISO 22000:2005, Article 8: Validation, vérification et
amélioration du système de management de la sécurité des denrées alimentaires. 12
8.1 Généralités. 12
8.2 Validation et combinaisons de mesures de contrôle. 12
8.3 Contrôle de la surveillance et du mesurage. 12
8.4 Vérification du système de management de la sécurité des denrées alimentaires. 13
8.5 Amélioration . 14
Bibliographie . 15
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ISO/TS 22004:2005(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.
Une ISO/PAS ou ISO/TS fait l'objet d'un examen après trois ans afin de décider si elle est confirmée pour trois
nouvelles années, révisée pour devenir une Norme internationale, ou annulée. Lorsqu'une ISO/PAS ou
ISO/TS a été confirmée, elle fait l'objet d'un nouvel examen après trois ans qui décidera soit de sa
transformation en Norme internationale soit de son annulation.
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 22004 a été élaborée par le comité technique ISO/TC 34, Produits alimentaires.
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ISO/TS 22004:2005(F)
Introduction
0.1 Généralités
L'adoption d'un système de management de la sécurité des denrées alimentaires par un organisme
intervenant dans la chaîne alimentaire est typiquement un outil utilisable pour satisfaire aux exigences légales,
statutaires, réglementaires et/ou des clients.
La conception et la mise en œuvre, pour un organisme, d'un système de management de la sécurité des
denrées alimentaires dépendent de nombreux facteurs, en particulier des dangers liés à la sécurité des
denrées alimentaires, des produits fabriqués, des procédés mis en œuvre, de la taille et de la structure de
l'organisme. La présente Spécification technique fournit des recommandations pour l'application de
[4]
l'ISO 22000 qui repose sur les principes HACCP tels que décrits par la Commission du Codex Alimentarius ,
et qui est élaborée pour être appliquée conjointement avec les normes pertinentes établies par cette
organisation.
0.2 Approches chaîne alimentaire et processus
L'ISO 22000 encourage l'adoption d'une approche chaîne alimentaire lors du développement, de la mise en
œuvre et de l'amélioration de l'efficacité et de l'efficience d'un système de management de la sécurité des
denrées alimentaires. À cet effet, l'ISO 22000 exige que l'organisme prenne en compte les effets de la chaîne
alimentaire avant et après ses opérations, lors du développement et de la mise en œuvre du système de
management de la sécurité des denrées alimentaires.
Pour qu'un organisme fonctionne de manière efficace et efficiente, il doit identifier et gérer de nombreuses
activités corrélées. Toute activité utilisant des ressources et gérée de manière à permettre la transformation
d'éléments d'entrée en éléments de sortie, est considérée comme un processus. L'élément de sortie d'un
processus constitue souvent l'élément d'entrée du processus suivant.
L'«approche processus» désigne l'application d'un système de processus au sein d'un organisme, ainsi que
l'identification, des interactions et le management de ces processus.
L'un des avantages de l'approche processus est la maîtrise permanente qu'elle permet sur les relations entre
les différents processus au sein du système de processus, ainsi que sur leurs combinaisons et interactions.
Lorsqu'elle est utilisée dans un système de management de la sécurité des denrées alimentaires, cette
approche souligne l'importance
a) de comprendre les exigences et d'y satisfaire,
b) de considérer les processus en termes de sécurité des denrées alimentaires et de traçabilité,
c) de mesurer la performance et l'efficacité des processus, et
d) d'améliorer en continu les processus sur la base de mesures objectives.
Les parties intéressées jouent un rôle important dans la définition des exigences en tant qu'éléments d'entrée.
La surveillance de la satisfaction des parties intéressées exige l'évaluation des informations relatives à la
perception des parties intéressées sur le niveau de réponse de l'organisme à leurs exigences.
Le modèle de système de management de la sécurité des denrées alimentaires basé sur les processus
présenté à la Figure 1 illustre les relations entre les processus décrits dans les Articles 4 à 8 de
l'ISO 22000:2005. Le modèle montré en Figure 1 ne détaille pas les processus présentés.
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ISO/TS 22004:2005(F)
Figure 1 — Concept de l'amélioration continue
0.3 Relations avec l'ISO 9001
L'ISO 22000 a été élaborée de manière à s'intégrer harmonieusement à l'ISO 9001 et à ses normes de
support. L'ISO 9001 spécifie les exigences relatives à un système de management de la qualité qui peuvent
être utilisées par les organismes en interne ou à des fins de certification ou contractuelles. Elle porte
essentiellement sur l'efficacité du système de management de la qualité à satisfaire aux exigences des clients.
L'ISO 22000 spécifie les éléments essentiels d'un système de management de la sécurité des denrées
alimentaires à des fins similaires.
0.4 Compatibilité avec d'autres systèmes de management
La présente Spécification technique ne comporte pas de recommandations spécifiques à d'autres systèmes
de management, tels que le management environnemental, le management de l'hygiène et de la sécurité au
travail, la gestion financière ou le management des risques. Toutefois, l'ISO 22000 permet à un organisme
d'aligner son propre système de management de la sécurité des denrées alimentaires sur les systèmes de
management connexes, ou de l'y intégrer. Il est possible, pour un organisme, d'adapter son ou ses systèmes
de management existants afin d'établir un système de management de la sécurité des denrées alimentaires
satisfaisant aux exigences de l'ISO 22000.
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SPÉCIFICATION TECHNIQUE ISO/TS 22004:2005(F)
Systèmes de management de la sécurité des denrées
alimentaires — Recommandations pour l'application de
l'ISO 22000:2005
1 Domaine d'application
La présente Spécification technique fournit les recommandations génériques pouvant être appliquées à
l'ISO 22000.
NOTE Aucune recommandation n'est indiquée lorsqu'un paragraphe de l'ISO 22000 n'est pas mentionné.
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 22000:2005, Systèmes de management de la sécurité des denrées alimentaires — Exigences pour tout
organisme appartenant à la chaîne alimentaire
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l'ISO 22000 s'appliquent.
4 Recommandations pour l'application de l'ISO 22000:2005, Article 4: Système de
management de la sécurité des denrées alimentaires
4.1 Exigences générales
Des compétences externes peuvent être utilisées par l'organisme pour développer et mettre en œuvre un
système de management de la sécurité des denrées alimentaires conformément à l'ISO 22000, à condition
que ces processus externalisés aient été développés et soient mis en œuvre, surveillés, maintenus et mis à
jour conformément aux exigences de l'ISO 22000.
De plus, l'ISO 22000 permet à tout organisme, en particulier un organisme de taille réduite et/ou moins
développé, de mettre en œuvre une combinaison de programmes prérequis (PRP), de programmes prérequis
opérationnels (oPRP) et de plans HACCP développés et mis au point en externe, à condition qu'il puisse être
démontré
a) qu'elle a été développée conformément aux exigences de l'ISO 22000 spécifiées pour l'analyse des
dangers, le PRP et le plan HACCP,
b) que des mesures spécifiques ont été entreprises pour adapter à l'organisme le système développé en
externe,
c) qu'elle a été mise en œuvre et est utilisée conformément aux autres exigences de l'ISO 22000.
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ISO/TS 22004:2005(F)
4.2 Exigences relatives à la documentation
Il convient que l'organisme utilise des documents externes relatifs à la sécurité des denrées alimentaires dans
ses différentes activités, par exemple pour satisfaire aux exigences légales, réglementaires et des clients.
Dans certains cas, une documentation électronique peut être nécessaire pour satisfaire aux exigences
réglementaires.
Le type et l'étendue de la documentation seront probablement différents d'un organisme à l'autre en raison de
la taille et de la complexité de l'activité, de la compétence du personnel, ainsi que de l'étendue de l'utilisation
des combinaisons de PRP, oPRP et plans HACCP développées en externe.
Si des combinaisons de PRP, oPRP et plans HACCP développées en externe sont utilisées, il convient que
leur pertinence soit documentée et que la documentation fasse partie du système de management de la
sécurité des denrées alimentaires.
Lorsque l'ISO 22000 se réfère à une procédure ou une déclaration documentée, il convient que celle-ci soit
interprétée comme étant établie, documentée, mise en œuvre, revue et maintenue par l'organisme dans le
cadre du système de management de la sécurité des denrées alimentaires. Les documents faisant
généralement partie du système comprennent les spécifications relatives aux produits, les plans HACCP, les
programmes prérequis (PRP) et les programmes prérequis opérationnels (oPRP) ainsi que d'autres
procédures de fonctionnement, y compris les contrats relatifs à tout processus externalisé, par exemple la
maîtrise des nuisibles et l'essai des produits. Il convient que les documents utilisés par l'organisme soient
disponibles là et quand ils sont requis; ils peuvent se présenter sous tout format valide (par exemple papier,
électronique ou image).
La conservation d'enregistrements appropriés, pour des périodes spécifiées et dans des conditions maîtrisées,
représente une activité critique pour tout organisme. Il convient que l'organisme base sa décision d'archivage
des enregistrements en ayant pris en considération l'usage prévu de ses produits et la durée de vie attendue
tout au long de la chaîne alimentaire.
5 Recommandations pour l'application de l'ISO 22000:2005, Article 5:
Responsabilité de la direction
5.1 Engagement de la direction
La méthode utilisée par l'organisme pour fournir la preuve de l'engagement de la direction dans le système de
management de la sécurité des denrées alimentaires inclut la mise en place d'initiatives de sensibilisation et
de leadership liées au développement et à la mise en œuvre du système.
5.2 Politique de sécurité des denrées alimentaires
La politique de sécurité des denrées alimentaires est la base de tout système de management de la sécurité
des denrées alimentaires d'un organisme. Dans cette politique, des objectifs et des cibles mesurables sont
définis. Les activités mesurables peuvent inclure l'identification et la mise en œuvre d'activités pour améliorer
tout aspect du système (par exemple pour réduire le nombre de rappels/retraits, pour diminuer l'occurrence
de corps étrangers).
Il convient que les objectifs soient spécifiques, mesurables, réalisables, pertinents et définis dans le temps.
5.3 Planification du système de management de la sécurité des denrées alimentaires
Aucune recommandation n'est fournie.
5.4 Responsabilité et autorité
Aucune recommandation n'est fournie.
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ISO/TS 22004:2005(F)
5.5 Responsable de l'équipe chargée de la sécurité des denrées alimentaires
Le responsable de l'équipe chargée de la sécurité des denrées alimentaires est au centre du système de
management de la sécurité des denrées alimentaires de tout organisme et il convient qu'il soit membre de
l'organisme et qu'il comprenne les problèmes liés à la sécurité des denrées alimentaires. Lorsqu'il exerce
d'autres responsabilités au sein de l'organisme, il convient que celles-ci ne soient pas en contradiction avec
celles qu'il assume dans le domaine de la sécurité des denrées alimentaires.
La responsabilité du responsable de l'équipe chargée de la sécurité des denrées alimentaires peut
comprendre les échanges avec les parties externes à l'organisme sur des questions relatives au système de
management de la sécurité des denrées alimentaires.
Il est recommandé que le responsable de l'équipe chargée de la sécurité des denrées alimentaires ait des
connaissances de base en matière d'hygiène et d'application des principes HACCP.
5.6 Communication
L'objectif de toute communication est de s'assurer que les interactions requises ont bien lieu.
L'ISO 22000 exige que la communication, tant interne qu'externe, fasse partie du système de management de
la sécurité des denrées alimentaires.
La communication externe vise à échanger des informations afin de s'assurer que tout danger pertinent est
maîtrisé à une étape de la chaîne alimentaire, par exemple par interaction
a) en amont et en aval de la chaîne alimentaire, sur le ou les dangers liés à la sécurité des denrées
alimentaires qui ne peuvent pas être maîtrisés par l'organisme et qui, par conséquent, nécessitent une
maîtrise à d'autres étapes de la chaîne alimentaire,
b) avec les clients comme base d'une acceptation mutuelle du niveau de sécurité des denrées alimentaires
requis (par le client),
c) avec les autorités réglementaires et légales et d'autres organismes.
La communication externe est la méthode par laquelle l'organisme et l'organisme externe se mettent d'accord
soit par contrat, soit par un autre moyen, sur le niveau de sécurité des denrées alimentaires requis et sur la
capacité de se conformer aux exigences convenues. Il convient que les canaux de communication avec les
autorités réglementaires et légales et les autres organismes soient établis en tant que base pour obtenir une
acceptation publique du niveau de sécurité des denrées alimentaires et une fiabilité de l'organisme.
La formation en matière de communication du personnel désigné peut également être un aspect important.
Il convient que le système de communication interne d'un organisme garantisse que des informations et
données suffisantes et pertinentes sont mises à la disposition de toute personne impliquée dans les
différentes opérations et modes opératoires. Le responsable de l'équipe chargée de la sécurité des denrées
alimentaires a un rôle majeur dans le domaine de la communication interne des problèmes liés à la sécurité
des denrées alimentaires au sein de l'organisme. Il convient d'informer de manière claire et en temps voulu le
personnel sur le développement et le lancement de nouveaux produits, ainsi que sur les changements prévus
dans les matières premières et les ingrédients, les systèmes de production et les processus, et/ou les clients
et leurs exigences. Il convient de porter une attention particulière à la communication de modifications dans
les exigences réglementaires et légales, de l'émergence ou de l'apparition de nouveaux dangers liés à la
sécurité des denrées alimentaires, et de la méthode de maîtrise de ces nouveaux dangers.
Il convient que tout membre de l'organisme sache comment rendre compte de tout incident pouvant influer sur
la sécurité des denrées alimentaires.
5.7 Préparation et réponse aux urgences
Il convient que l'organisme soit conscient des situations d'urgence potentielles, par exemple les incendies, les
inondations, le bioterrorisme et le sabotage, les pannes de courant, les accidents routiers et la contamination
de l'environnement.
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ISO/TS 22004:2005(F)
5.8 Revue de direction
Les revues de direction fournissent aux directeurs l'opportunité d'évaluer d'une part, la performance de
l'organisme en ce qui concerne le respect des objectifs relatifs à la politique de sécurité des denrées
alimentaires et d'autre part, l'efficacité globale du système de management de la sécurité des denrées
alimentaires.
6 Recommandations pour l'application de l'ISO 22000:2005, Article 6: Management
des ressources
6.1 Mise à disposition des ressources
Aucune recommandation n'est fournie.
6.2 Ressources humaines
Il convient de maintenir les formations à un niveau permettant d'assurer que tous les employés connaissent
leurs responsabilités pour maintenir le système de management de la sécurité des denrées alimentaires. Il
convient que les renseignements sur les séances de formation incluent, par exemple, le contenu du
programme, le nom et les qualifications du formateur, l'évaluation finale des élèves et la mise en place d'une
exigence de remise à niveau.
6.3 Infrastructures
Les infrastructures d'un organisme comprennent les bâtiments, les équipements associés aux procédés, les
installations, les zones environnantes et les services support.
6.4 Environnement de travail
L'environnement de travail peut inclure des mesures pour éviter la contamination croisée, des exigences
relatives à l'espace de travail, aux vêtements de protection, à la disponibilité et à l'emplacement des
installations destinées aux employés.
7 Recommandations pour l'application de l'ISO 22000:2005, Article 7: Planification
et réalisation de produits sûrs
7.1 Généralités
L'ISO 22000 exige que l'organisme utilise une approche processus dynamique et systématique pour
développer le système de management de la sécurité des denrées alimentaires. Celle-ci est réalisable par un
développement, une mise en œuvre, une surveillance des activités planifiées, une maintenance et une
vérification des mesures de maîtrise efficaces, par la mise à jour des processus liés aux aliments et de leur
environnement, et grâce à des actions appropriées en cas de production de non-conformités.
L'Article 7 de l'ISO 22000:2005 traite des phases de planification (voir Figure 2) et de fonctionnement tandis
que l'Article 8 traite des phases de vérification et d'action. La maintenance et l'amélioration du système sont
traitées à travers plusieurs cycles de planification, de validation, de surveillance, de vérification et de mise à
jour requises dans ces deux articles. Au sein d'un système opérationnel, des changements de système
peuvent être mis en place à n'importe laquelle de ces phases.
L'ISO 22000 réorganise le concept traditionnel de répartition des mesures de maîtrise en deux groupes
[prérequis et mesures appliqués aux points critiques pour la maîtrise (CCP)] dans un ordre logique pour le
développement, la mise en œuvre et la maîtrise du système de management de la sécurité des denrées
alimentaires. Les mesures de maîtrise sont réparties en trois groupes de la manière suivante:
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ISO/TS 22004:2005(F)
a) les programmes prérequis (PRP) qui régissent les conditions et activités de base; les PRP ne sont pas
sélectionnés pour maîtriser les dangers identifiés spécifiques mais pour maintenir un environnement
hygiénique de production, de traitement et/ou de manipulation (voir l'ISO 22000:2005, 7.2);
b) les programmes prérequis opérationnels (oPRP) qui régissent les mesures de maîtrise que l'analyse de
dangers identifie comme nécessaires pour maîtriser les dangers identifiés à des niveaux acceptables et
qui ne sont pas gérées par le plan HACCP;
c) un plan HACCP qui régit les mesures de maîtrise que l'analyse de dangers identifie comme nécessaires
pour maîtriser les dangers identifiés à des niveaux acceptables et qui sont appli
...
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