SIST EN 13980:2002
(Main)Potentially explosive atmospheres - Application of quality systems
Potentially explosive atmospheres - Application of quality systems
1.1 General
This European Standard specifies particular requirements and information for establishing and maintaining a quality system in accordance with the requirements of Annex IV and Annex VII of Directive 94/9/EC.
It is intended for use by manufacturers, notified bodies and regulatory authorities.
Therefore, when notified bodies assess the quality systems of manufacturers this document is intended to be the basis of the initial assessment and subsequent visits.
1.2 Application
Only those requirements in clause 7 of this European Standard pertaining to the difference between Annex IV and VII of the Directive may be excluded, provided that conformity of the product can still be demonstrated.
Permissible exclusions with respect to Annex VII of Directive 94/9/EC are as follows:
7.1 Planning of product realisation;
7.2.3 Customer communication;
7.4 Purchasing;
7.5.1 Control of production and service provision;
7.5.2 Validation of processes for production and service provision;
7.5.3 Identification and traceability.
No explicit requirements in Annex IV and VII relate to the concept of "continuous improvement". As a consequence, references in this European Standard to the requirements of EN¬ ISO¬ 9001:2000 exclude this concept.
Explosionsgefährdete Bereiche - Anwendung von Qualitätsmanagementsystemen
1.1 Allgemeines
Diese Europäische Norm legt besondere Anforderungen an und Informationen über die Einführung und Aufrechterhaltung eines Qualitätsmanagementsystems fest, das den Anforderungen der Anhänge IV und VII von Richtlinie 94/9/EWG entspricht.Sie ist für die Anwendung durch Hersteller, Benannte Stellen und Bestimmungen erlassende Behörden vorge-sehen.Deshalb ist dieses Dokument bei der Bewertung der Qualitätsmanagementsysteme von Herstellern durch Benannte Stellen als Grundlage der Anfangsbewertung und nachfolgender Überwachungsaudits vorgesehen.
1.2 Anwendung
Es dürfen nur diejenigen Anforderungen in Abschnitt 7 dieser Europäischen Norm, die den Unterschieden zwischen Anhang IV und Anhang VII der Richtlinie entsprechen, ausgeschlossen werden, vorausgesetzt, dass die Konformität des Produktes weiterhin nachgewiesen werden kann.Zulässige Ausschlüsse hinsichtlich Anhang VII der Richtlinie 94/9/EG sind die Folgenden:7.1 Planung der Produktrealisierung7.2.3 Kommunikation mit dem Kunden7.4 Beschaffung7.5.1 Lenkung der Produktion und der Dienstleistungserbringung7.5.2 Validierung der Prozesse zur Produktion und zur Dienstleistungserbringung7.5.3 Kennzeichnung und RückverfolgbarkeitEs gibt keine ausdrücklichen Anforderungen in den Anhängen IV und VII, die sich auf den Begriff der "ständigen Verbesserung" beziehen. Folglich schließen Verweisungen auf Anforderungen der EN ISO 9001:2000 in dieser Europäischen Norm diesen Begriff aus.
Atmospheres explosibles - Application des systemes qualité
Potencialno eksplozivne atmosfere – Uporaba sistemov za kakovost
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Potentially explosive atmospheres - Application of quality systemsPotencialno eksplozivne atmosfere – Uporaba sistemov za kakovostAtmospheres explosibles - Application des systemes qualitéExplosionsgefährdete Bereiche - Anwendung von Qualitätsmanagementsystemen13.230Varstvo pred eksplozijoExplosion protection03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:SIST EN 13980:2002enTa slovenski standard je istoveten z:EN 13980:200201-december-2002SIST EN 13980:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13980October 2002ICS 03.120.10; 13.230English versionPotentially explosive atmospheres - Application of qualitysystemsAtmosphères explosibles - Application des systèmesqualitéExplosionsgefährdete Bereiche - Anwendung vonQualitätsmanagementsystemenThis European Standard was approved by CEN on 12 September 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13980:2002 E
EN 13980:2002 (E)2ContentspageForeword.4Introduction.51Scope.62Normative references.63Terms and definitions.74Quality management system.84.1General requirements.84.2Documentation requirements.84.2.1General.84.2.2Quality manual.84.2.3Control of documents.84.2.4Control of quality records.95Management responsibility.95.1Management commitment.95.2Customer focus.95.3Quality policy.95.4Planning.95.4.1Quality objectives.95.4.2Quality management system planning.95.5Responsibility, authority and communication.105.5.1Responsibility and authority.105.5.2Management representative.105.5.3Internal communication.105.6Management review.105.6.1General.105.6.2Review input.115.6.3Review output.116Resource management.116.1Provision of resources.116.2Human resources.116.2.1General.116.2.2Competence, awareness and training.116.3Infrastructure.116.4Work environment.117Product realisation.117.1Planning of product realisation.117.2Customer-related processes.117.2.1Determination of requirements related to the product.117.2.2Review of requirements related to the product.127.2.3Customer communication.127.3Design and development.127.4Purchasing.127.4.1Purchasing process.127.4.2Purchasing information.137.4.3Verification of purchased product.137.5Production and service provision.147.5.1Control of production and service provision.147.5.2Validation of processes for production and service provision.14
EN 13980:2002 (E)37.5.3Identification and traceability.147.5.4Customer property.147.5.5Preservation of product.147.6Control of monitoring and measuring devices.148Measurement, analysis and improvement.158.1General.158.2Monitoring and measurement.158.2.1Customer satisfaction.158.2.2Internal audit.158.2.3Monitoring and measurement of processes.168.2.4Monitoring and measurement of product.168.3Control of non-conforming product.168.4Analysis of date.178.5Improvement.178.5.1Continual improvement.178.5.2Corrective action.178.5.3Preventive action.17Annex A (informative)
Information relevant to particular types of protection.18Annex B (informative)
Verification criteria for sintered components used as an integral part of a typeof protection.25Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or otherprovisions of EU Directives.28Bibliography.29
EN 13980:2002 (E)4ForewordThis document EN 13980:2002 has been prepared by Technical Committee CEN/TC 305 "Potentially explosiveatmospheres - Explosion prevention and protection", the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by April 2003, and conflicting national standards shall be withdrawn at the latest byApril 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.In this European Standard the annexes A and B are informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.
EN 13980:2002 (E)5IntroductionThis European Standard is complementary to EN ISO 9000 and EN ISO 9001 and is applicable to productsintended for use in potentially explosive atmospheres. Its purpose is to embrace manufacturing practices that areappropriate to these products.It does not preclude the use of other quality systems that are compatible with the objectives of EN ISO 9001.
EN 13980:2002 (E)61 Scope1.1 GeneralThis European Standard specifies particular requirements and information for establishing and maintaining a qualitysystem in accordance with the requirements of Annex IV and Annex VII of Directive 94/9/EC.It is intended for use by manufacturers, notified bodies and regulatory authorities.Therefore, when notified bodies assess the quality systems of manufacturers this document is intended to be thebasis of the initial assessment and subsequent visits.1.2 ApplicationOnly those requirements in clause 7 of this European Standard pertaining to the difference between Annex IV andVII of the Directive may be excluded, provided that conformity of the product can still be demonstrated.Permissible exclusions with respect to Annex VII of Directive 94/9/EC are as follows:7.1Planning of product realisation;7.2.3Customer communication;7.4Purchasing;7.5.1Control of production and service provision;7.5.2Validation of processes for production and service provision;7.5.3Identification and traceability.No explicit requirements in Annex IV and VII relate to the concept of “continuous improvement”. As a consequence,references in this European Standard to the requirements of EN ISO 9001:2000 exclude this concept.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).prEN 13237-1, Potentially explosive atmospheres – Explosion prevention and protection — Part 1: Terms anddefinitions for equipment and protective systems intended for use in potentially explosive atmospheres.EN 45012, General requirements for bodies operating assessment and certification/registration of quality systems(ISO/IEC Guide 62:1996).EN 45014, General criteria for suppliers declaration of conformity (ISO/IEC Guide 22:1996).EN ISO 9000:2000, Quality management system - Concepts and vocabulary (ISO 9000:2000).EN ISO 9001:2000, Quality management system – Requirements (ISO 9001:2000).
EN 13980:2002 (E)73 Terms and definitionsFor the purposes of this European Standard the terms and definitions given in prEN 13237-1 andEN ISO 9000:2000 and following apply.3.1manufacturerorganisation, situated at a stated location or locations, that carries out or controls such stages in the manufacture,assessment, handling and storage of a product that enables it to accept responsibility for continued compliance ofthe product with the relevant requirements and undertakes all obligations in that connectionNOTEThe term “manufacturer” is used instead of “organisation” as used in EN ISO 9001:2000. For the purposes of thisstandard they are interchangeable.3.2contractrequirements forming an agreement between a manufacturer and a customer and transmitted by any appropriatemeans3.3customer complaintany reported written or verbal allegation made by a customer which concerns the identity, quality, durability, safety,security, conformity or performance of any equipment or protective system or component as defined in the EC type-examination certificate3.4productequipment, protective systems, devices, components and their combinations, as well as software and service asdefined in 3.4.2 of EN ISO 9000:20003.5schedule drawingdrawing referenced in the EC type-examination certificate (e.g. in the schedule or the report)3.6related drawingdrawing not referenced in the EC type-examination certificate, but used for example, for detailed manufacture ofcomponent parts3.7equipment documenttechnical documentation as defined in Annex III of the Directive and product/production quality assurance notifications3.8manufacturers documentthose documents required by a manufacturer but not subject to assessment by a notified body when making anapplication for either an EC type-examination certificate or product/production quality assurance notification.
Forexample, instructions, related drawings, data sheets and sales literature3.9type of protectionspecific measures applied to product to avoid ignition of a surrounding explosive atmosphere
EN 13980:2002 (E)84 Quality management system4.1 General requirements4.1 of EN ISO 9001:2000 applies.The quality system shall ensure compliance of the product with the type described in the EC type-examinationcertificate.4.2 Documentation requirements4.2.1 General4.2.1 of EN ISO 9001:2000 applies.4.2.2 Quality manual4.2.2 of EN ISO 9001:2000 applies.4.2.3 Control of documents4.2.3 of EN ISO 9001:2000 applies.a) Equipment documents and manufacturer’s documents shall be controlled;b) Documented procedures shall ensure that information contained within manufacturer’s documents iscompatible with equipment documents. The manufacturer shall not initially approve or subsequently amendrelated drawings unless they are in compliance with the schedule drawings;c) The quality system shall ensure that no factor (type, characteristic, position etc.) defined within the EC type-examination certificate and technical documentation (e.g. schedule drawings) is modified;d) There shall be a documented system that refers all related drawings to the relevant schedule drawings,e) Where there are common schedule drawings associated with more than one EC type-examination certificate,there shall be a documented system to ensure simultaneous supplementary action in the event of anamendment to such drawings;NOTE Some manufacturers use common components with common drawing numbers on more than one product.
Someof these products can have different persons responsible for them.
Therefore, if one product with a common component anddrawing number is revised to meet a need and the necessary supplementary certificate obtained, there needs to be a system forensuring that any other certificates that call up such components are also subject to supplementary certification in order to avoidthose products not being in compliance with their equipment documents.f)Where a manufacturer also has drawings for products not intended for use in potentially explosiveatmospheres then the manufacturer shall have a system that enables both the related drawings and scheduledrawings to be clearly identifiedNOTEThe following examples indicate some methods of achieving this:-the use of visual markers;-the use of a unique series of drawing numbers, e.g. all drawings concerning a certified product have an Ex prefixto the drawing number.g)The manufacturer shall document which notified body is responsible for the quality system notification for eachEC type-examination certificate;h)Where equipment documents or manufacturer’s documents are passed to a third party, they shall be providedin a way that is not misleading.
EN 13980:2002 (E)94.2.4 Control of quality records4.2.4 of EN ISO 9001:2000 applies.NOTEIt is in the manufacturer’s interests to retain adequate quality records to demonstrate conformity of the product.Examples of documents requiring control and retention are:¾ those arising from regulatory requirements;¾ customer order;¾ contract review;¾ training records;¾ inspection and test data (per batch);¾ calibration data;¾ sub-contractor evaluation;¾ delivery data (customer, delivery date and quantity, including serial numbers where available).5 Management responsibility5.1 Management commitment5.1 of EN ISO 9001:2000 applies.5.2 Customer focus5.2 of EN ISO 9001:2000 applies.5.3 Quality policy5.3 of EN ISO 9001:2000 applies.5.4 Planning5.4.1 Quality objectives5.4.1 of EN ISO 9001:2000 applies.5.4.2 Quality management system planning5.4.2 of EN ISO 9001:2000 applies.The quality system shall ensure that the product conforms to the type described in the EC type-examinationcertificate. All the elements, requirements and provisions adopted by the manufacturer shall be documented in asystematic and orderly manner in the form of written policies, procedures and instructions. The quality systemdocumentation shall permit a consistent interpretation of quality programmes, plans, manuals and records.The manufacturer shall facilitate an arrangement whereby the notified body may audit aspects of the suppliersoperations that affect the type of protection.
EN 13980:2002 (E)105.5 Responsibility, authority and communication5.5.1 Responsibility and authority5.5.1 of EN ISO 9001:2000 applies.Responsibilities and authority for the following shall be defined:a) the effective co-ordination of activities with respect to products
intended for use in potentially explosiveatmospheres;b) the need to liase with the notified body responsible for the issue of the EC type-examination certificate withrespect to any proposed change to the design defined in the EC type-examination certificate and the technicaldocumentation;c) the need to liase with the notified body responsible for the assessment of the quality system with respect tointended updating of
the quality system;NOTE It is not practicable for the manufacturer to inform the notified body each time the quality system is updated.
It isonly practicable to inform the notified body of “substantial” updating of the quality system relevant to the type of protection.Similarly, it is not practicable to specify in general terms what types of updating are or are not “substantial”.
It is thereforerecommended that the manufacturer establishes and maintains a system for categorising updates as “substantial” or not andinforming the notified body as appropriate.d) the authorising of initial approval and changes to related drawings, where appropriate;e) the authorising of concessions (see 8.3 f));f) informing its customer of any applicable special conditions for safe use and any schedules of limitations;NOTE 1Certificates with a suffix X can contain special conditions for safe use. Component certificates, with a suffix U cancontain schedules of limitations.NOTE 2For each EC type-examination certificate it is recommended that an authorised person is appointed who shouldhave responsibility and authority for the above activities so providing an unambiguous focal point within the organization.5.5.2 Management representative5.5.2 of EN ISO 9001:2000 applies.5.5.3 Internal communication5.5.3 of EN ISO 9001:2000 applies.5.6 Management review5.6.1 General5.6.1 of EN ISO 9001:2000 applies.a) the maximum intervals between reviews should normally be 12 months and shall not exceed 14 months;b) top management shall chair the review;c) the person(s) responsible for the activities as detailed in 5.5.1 shall participate in the review.
EN 13980:2002 (E)115.6.2 Review input5.6.2 of EN ISO 9001:2000 applies.The review shall include the overall effectiveness of the quality management system with respect to productsintended for use in potentially explosive atmospheres.NOTEResults of audits should include both internal audits and those conducted by other parties (e.g. the notified body).5.6.3 Review output5.6.3 of EN ISO 9001:2000 applies.6 Resource management6.1 Provision of resources6.1 of EN ISO 9001:2000 applies.6.2 Human resources6.2.1 General6.2.1 of EN ISO 9001:2000 applies.6.2.2 Competence, awareness and training6.2.2 of EN ISO 9001:2000 applies.6.3 Infrastructure6.3 of EN ISO 9001:2000 applies.6.4 Work environment6.4 of EN ISO 9001:2000 applies.7 Product realisation7.1 Planning of product realisation7.1 of EN ISO 9001:2000 applies.NOTEExamples are given in annexes A and B.7.2 Customer-related processes7.2.1 Determination of requirements related to the product7.2.1 of EN ISO 9001:2000 applies.The product category and marking shall be included.
EN 13980:2002 (E)127.2.2 Review of requirements related to the product7.2.2 of EN ISO 9001:2000 applies.The review shall ensure that any stated customer requirement is compatible with the EC type-examinationcertificate e.g. ambient temperature range.7.2.3 Customer communication7.2.3 of EN ISO 9001:2000 applies.7.3 Design and developmentNot within the scope of this standard.7.4 Purchasing7.4.1 Purchasing process7.4.1 of EN ISO 9001:2000 applies.a) While manufacture, test and final inspection may be sub-contracted, the responsibility for ensuringconformance
with the EC type-examination certificate shall not be sub-contracted;b) Suppliers providing a product, process, or service that can affect the product’s compliance with the EC type-examination certificate shall only be selected after an evaluation has demonstrated that they have thecapability of ensuring compliance with all specified requirements;1) The evaluation shall be made by one or more of the following methods:¾ the supplier has third party quality system certification to the appropriate standard and scope issuedby an accredited body which can demonstrate that it operates in compliance with EN 45012. This canbe achieved by an accredited certification;¾ a documented evaluation which provides objective evidence that the supplier can provide product,process or service that are fit for purpose;¾ a documented site assessment to ensure that all relevant controls are available, documented,understood and effective.NOTEThe evaluation should take the following into account:¾ criticality of the product, process or service;¾ degree of difficulty, or variability in the manufacturing process;¾ location of the supplier and hence the effectiveness of communications;¾ does the supplier, in turn sub-contract the product, process or service;2) Suppliers providing calibration services shall be evaluated on their ability to meet stated requirements;3) Where the features affecting the type of protection can not be verified at a later stage e. g. encapsulatedintrinsically safe circuits, then the evaluation shall include initial and periodic site assessments at thesuppliers premises to ensure relevant controls are available, documented, understood and effective;c) Suppliers not used for a period exceeding one year shall be re-evaluated prior to the placing of the contract;
EN 13980:2002 (E)13NOTE"re-evaluation" means to treat the supplier as a new supplier and therefore 7.4.1 b) is applicable.d) Requirements b) and c) are not mandatory for products, processes or services where the manufacturer fullyverifies each item for conformance;e) The ongoing ability of the supplier to provide conforming product, process or service shall be reviewed atperiods not exceeding one year.NOTE 1“review” is a process by which the manufacturer demonstrates the ongoing suitability of their suppliers e. g.receiving inspection report analysis.NOTE 2The terms “re-evaluation” and “review” are different and should not be mixed.7.4.2 Purchasing information7.4.2 of EN ISO 9001:2000 applies.a) The purchasing documents shall clearly describe the specific requirements pertaining to subcontracted productset out in the EC type-examination certificate and the equipment documents (e.g. for process control, testing orinspection);b) For items where conformance cannot be verified after manufacture (e.g. encapsulated intrinsically safecircuits), the purchasing information shall set out the specific quality procedures, resources and sequence ofactivi
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