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General practical guide for ATEX quality assurance system

General practical guide for ATEX quality assurance system

General practical guide for implementation ATEX quality assurance system for production process according to module D (annex V) of ATEX directive

Genral practical guide for implementation ATEX quality assurance system for production process

The purpose of this guide is to give general practical solutions to the producers of explosion-proof products, which have already implemented ISO 9001 requirements and certified for it, to add the needed information and documents required by specific requirements of EN ISO/IEC 80079-34:2020 to their existing quality management system documentation.

4.1 Understanding the organization and its context: 

  • to add the subject of "compliance Ex designed and produced product with its relevant EU type examination certificate and relevant technical documentation", as one of the internal issues in the analysis of the issues affect the organization ability to achieve the intended result(s) of its quality management system, (e.g. effects of non-complaince Ex product with its relevant ATEX certificate and drawings), 

  • to specify the affect(s) on organization, including opportunties and threats; and

  • to define appropriate actions to reduce or eliminate the effects of threats and/or exploiting opportunities.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedure: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001  

4.2 Understanding the needs and expectations of interested parties: without specific requirements additional to ISO 9001

4.3 Determining the scope of the quality management system:  without specific requirements additional to ISO 9001 

4.4 Quality management system and its processes:

an executive method including a control checklist for "ensuring that the Ex Product conforms to the type described in the EU type examination certificate and the relevant technical documentation" shall be included in one of the procedures or other documents of the quality management system or as an independent document of the QMS.

the checkpoints for the above-mentioned control consist two groups, including:

  • general points; and

  • control points relevant to the specific protection type(s) of the equipment.

the methods of control consist:

  • visual check of the equipment against the relevant information included in ATEX certificate and product technical file; and

  • checking technical documentation and manufacturer's documentation which are exclusively relevant to the product.

a sample for template of the control checklist is downloadable from here.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedure: Yes

Obligation How to record the outputs of the implementation of this requirement: Creating an independent record  

5.1.1 Leadership and commitment - General: without specific requirements additional to ISO 9001 

5.1.2 Customer focus: without specific requirements additional to ISO 9001 

5.2.1 Establishing the quality policy: without specific requirements additional to ISO 9001 

5.2.2 Communicating the quality policy: without specific requirements additional to ISO 9001 

5.3 Organizational roles, responsibilities and authorities: 

a formal letter for job appointment for Ex authorized person, should be issued by top manager together with an attachment including responsibilites and authorities of the Ex authorized person, including below content: 

  • the effective co-ordination of activities with respect to Ex Products;

  • the liaison with the ATEX and/or IECEx certification body which is responsible for issuance certificate (e.g. EU type examination) for Ex product, with respect to any proposed change to the design defined in the certificate and the technical documentation;

  • the liaison with the certification body which is responsible for the verification of the quality management system and issuance ATEX-QAN or IECEx-QAR, with respect to intended "substantial" updating of the quality management system relevant to the Type of Protection, including any update of the quality management system having consequences on Ex Products compliance, the change of an Ex authorized person and other similar changes.

  • the authorization of initial approval and changes to related drawings of Ex-product(s);

  • the authorization of concessions, except the not permitted situations in which the Ex Products that take the Ex Products outside the design as defined in the certificate and technical documentation.

  • ensuring the accuracy of relevant information regarding Ex Product given to the customer for any sales literature and installation instructions including applicable Specific Conditions of Use and any Schedule of Limitations;

  • the effective coordination of manufacturing processes related to Ex Products including externally provided products, services and processes.

Note 1: In the case of a manufacturer with multiple manufacturing sites an Ex authorized person with relevant responsibilities shall be appointed for each site.

Note 2: the date of the job appointment for Ex authorize representative, should be determined with a sufficient duration, for example at least 3 months, before the date of internal audit of ATEX quality management system.

Obligation to develop an independent document or inclusion in existing ISO 9001 system documents: Yes

Obligation How to record the outputs of the implementation of this requirement: Creating an independent record for communicating the job appointment, from top manager to the Ex authorized person.

6.1 Actions to address risks and opportunities: without specific requirements additional to ISO 9001 

6.2 Quality objectives and planning to achieve them: without specific requirements additional to ISO 9001 

6.3 Planning of changes: without specific requirements additional to ISO 9001

7.1.1 Support - Resources - General: without specific requirements additional to ISO 9001

7.1.2 People: without specific requirements additional to ISO 9001

7.1.3 Infrastructure: without specific requirements additional to ISO 9001

7.1.4 Environment for the operation of processes: without specific requirements additional to ISO 9001

7.1.5 Monitoring and measuring resources: 

control and measuring devices which are used to check

  • incoming material;

  • semi-manufactured product;

  • final Ex-product; and

  •  parameters for relevant production process,

must be calibrated or verified by one of the follwoing methods: 

  • an ILAC traceable accredited calibration certificate; or 

  • a non-accredited calibration certificate including at least follwoing information: 

    • an unambiguous identification of the item calibrated; 

    • evidence that the measurements are traceable to international or national measurement standards;

    • the method of calibration;

    • a statement of compliance with any relevant specification;

    • the calibration results;

    • the uncertainty of measurement, where necessary;

    • the environmental conditions, where relevant;

    • the date of calibration;

    • the signature of the person under whose authority the certificate was issued;

    • the name and address of the issuing organization and the date of issue of the certificate; 

    • a unique identification of the calibration certificate.

  • a documented verification of the device against a calibrated reference measuring or control device.

    • download a sample verification checklist

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures:No

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

 7.1.6 Organizational knowledge: without specific requirements additional to ISO 9001

7.2 , 7.3 Competence and awareness: 

Below requirement should be added to the existing procedure(s) for "training or qualifying" and "ensuring awareness" of the organization staffs. 

Identifying all persons have an impact on the compliance of Ex Products, including the below job positions, and ensuring that all of them are trained, competent and aware of Ex aspects in quality policy, qualiyu objectives, how to contribute to effectiveness of Ex-QMS and implications of not confrming with requirements of Ex-QMS.

  • Ex authorized person(s),

  • manufacturing,

  • inspecting,

  • testing,

  • sales,

  • marketing,

  • supply management,

  • calibration and

  • quality control services; and

  • other services

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures:Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

7.4 Communication

There should be a controled list for the performed communications for explosion-proof issues, in below issues:

  • for internal communications: 

    • manufacturer Ex-QMS documentation;

    • technical documentation;

    • Ex-certificates.

    • nonconforming products placed on the market (if any).

  • external communications with: 

    • clients of Ex product;

    • Ex certification bodies;

    • providers or suppliers relevant to Ex product;

    • Ex authprized representative (if any);

    • relevant importers for exported Ex product; 

    • relevant distributors of Ex products;

    • authorities relevant to Ex product.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: No

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

7.5.1 Documented information - General

  • the method and control form for ensure compliance of Ex-Products with their certificates and technical documentation, should be defined as an independent procedure or as a part of another existing procedure of QMS; 

  • the existing quality manual, quality policy, procedures, quality programs and plans and other QMS documents, should be revised according to specific requirements of EN ISO/IEC 80079-34.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

 7.5.3 Control of documented Information

  • Part a) Both definitions for "technical documentation" and "manufacturer's documentation" with specifying the the types of documents that are part of each group, should be added to documented information procedure or to similar document;

    Aspect

    Technical Documentation

    Manufacturer’s Documentation

    Purpose

    Demonstrates design compliance of the Ex product with relevant standards.

    Ensures consistent, controlled manufacturing of the Ex product.

    Focus

    How the product is designed and why it is explosion-safe.

    How the product is produced, inspected, tested, and controlled during production.

    Audience

    Certification bodies, auditors, design engineers

    Production staff, QA staff, auditors

    Level

    Product-specific and engineering-focused.

    Process-specific and manufacturing-focused.

    Traceability

    Shows conformity with Ex type certificate and standards.

    Shows conformity with the product’s approved design and QMS requirements.

    Typical Format

     Drawings, analyses, engineering reports

    Procedures, forms, instructions, records.

    main examples

    • Product design drawings and schematics (schedule drawings) 

    • Bills of materials (BOM) Explosion-protection design features (e.g., flamepaths, clearances)

    • Design calculations and safety margins

    • Test reports (type tests, routine tests)

    • Risk assessments or ignition hazard analyses

    • Specifications for critical components

    • Software/firmware design documents (where applicable)

    • Marking drawings

    • Technical justification documents (e.g., temperature-class assessment)

    • Product related drawings

    • Manufacturing procedures and work instructions

    •  Process flow charts

    •  Assembly instructions

    •  Inspection and test procedures

    •  Calibration and maintenance procedures for equipment used in production

    •  Incoming materials and supplier control documents

    •  Production records and traceability records

    •  Control plans and quality checks

    •  Control of nonconforming product procedures

    •  Packaging and storage instructions

  • Part b) a sample documented procedure in the form of a control checklist, named "Checklist for Compatibility of Manufacturer Documentation with Technical Documentation" for the purpose of ensuring that information contained within manufacturer’s documentation is compatible with the technical documentation, is downloadable from here. 

  • Part c) The "Ex-product factor(s) modification control form" which is downloadable from here, should exist in quality management system to ensure that no factor (type, characteristic, position etc.) defined within the ATEX certificate and technical documentation is modified unless otherwise permitted by the notified body.

  • Part d) a sample of documented system that refers all related drawings to the relevant schedule drawings, is downloadable from here.

  • Part e) where there are

    • common schedule drawings associated with more than one certificate; or

    • common components with common drawing numbers on more than one product and then have more than one person responsible for the end products;

below requirements should be fulfilled: 

1- existence a documented system to ensure simultaneous supplementary action(s) in the event of an amendment to such schedule drawings; and

2- assurance obtained that change to the component for the one product is not implemented without approval from the responsible persons for all end-products that use that component.

a sample form for "information and change management for common schedule drawings associated with more than one certificate(s)" to fulfull above requirements is downloadable from here. 

Part f) in case that the manufacturer produce also non Ex-products, one or more below efficient methods should be used for a clear identification of schedule drawings and related drawings for Ex-products and separation them against the drawings for non Ex-products:

  • use of visual markers in Ex schedule and related drawings; 

  • use an Ex prefix to the drawing number;

  • define a comprehensive list with separation all Ex and non-Ex drawings including schedule and related ones.

Part g,i) Periodic checks for validity Ex certificates, relevant certification bodies and applicable standards and regulations to the certified product and relevant quality management system, should be done. a sample list is downloadable from here. 

  • below checks should be periodically done, two months before the date mentioned in the column "Next audit due / validity expiry date" (deadline for  every surveillance and reissuance of QAN/QAR)

    • validity of notified body / IECEx CB;

    • applicable standard(s) to existing product certificate and QAN/QAR;

    • validity status of the product certificate.

  • reviewing and updating the list, should be done periocically, upon:

    • issuance of a new certificate;

    • change in certification body responsibilities;

    • completion of each surveillance audit;

    • withdrawal, suspension, or revision of the product type certificate and QAN/QAR.

  • review and update must be done by Ex responsible person(s) relevant to each certified Ex-product type.

  • for QAN/QAR, in case of change notified body / IECEx CB, the information of the new body and new QAN / QAR, should be mentioned in a new line of the list.

  • reference documented information (accreditation and authorization certificates) relevant to validity of the ATEX notified body / IECEx CB should be maintained. 

Part h) in cases of passing technical documentation and manufacturer's documentation to a third party, adopting methods to prevent any misleading, including examples of which are given in below, should be included in the documented information procedure or to similar document.

  • passing the last valid version of documents exist in quality management system; 

  • ensuring existence “controlled copy” mark on the documents before passing; 

  • passing only the documents which have been already released by the relevant authorized person;

  • using secure portals or encrypted email for passing;

  • using digital signature for passing; 

  • making Non-disclosure agreements (NDAs) with the party who receive the docments;

  • accompanying release notes or transmittal forms with the documents to be passed (to minimize the risk of misinterpretation), including: 

    • Purpose of the transfer; 

    • List of documents included; 

    • Revision numbers; 

    • Notes on partial data or limits of applicability.

  • alignment with certification limits: ensuring that documentation clearly states below issues, prevents misleading assumptions.  

    • what is covered by the Ex certification and what is not;

    • relevance to the certified product(s).

  • controlled communication: providing a single point of contact for the third party (e.g., ATEX responsible) for passing the documents, to avoid contradictory or unofficial information being shared.

Samples of passing technical and manufacturer's documentation to applicable relevant third parties: 

Example 1 — Submission to a Notified Body (NB)

  • General assembly drawings 

  • Risk assessment report

  • Marking label in draft version

  • Quality plan related to Ex production

  • User manual of Ex product

Example 2 — Submission to a Certification Body for QAR/QAN assessment

  • Process flow descriptions

  • Calibration procedures

  • Production control procedures

  • Traceability procedures

Example 3 — Passing information to a subcontractor or supplier

  • instructions for particular operations for production the components to be supplied, e.g. Tolerances essential to Ex safety or Surface treatment specifications;

  • inspection requirements for the components or material to be supplied

Example 4 — Providing documentation to a customer 

  • Declaration of Conformity

  • Ex certificate

  • Installation, operation & maintenance manual (IOM)

  • Data sheets

Example 5 — Sharing information with a service/repair center

  • Repair guideline

  • Safety-related checks

  • Verification procedures

Example 6 — External auditors (ISO 9001, 80079-34, customer audit)

  • Organizational charts

  • Document control procedures

  • Examples of controlled technical files

  • Training records related to Ex manufacturing

Part j) retaining below mentioned quality records relevant to quality management system for explosion proof products for a minimum of 10 years, should be added to the existing list of quality records for ISO 9001.

  • those arising from regulatory requirements, e.g. EU Declaration of Conformity for an Ex product and Notified Body ATEX certificate;

  • quality documented information, e.g. Quality Manual describing the quality management system for Ex products and Controlled procedure for “Control of Nonconforming Ex Products”;

  • responsibilities and authorities for Ex relevant roles assignment and communication within the organization, e.g. a matrix showing responsibilities for the Ex Responsible Person, Design Engineer, and Manufacturing Inspector and Organizational chart highlighting the appointed “Person Responsible for Manufacturing of Ex Equipment;

  • customer order, e.g. sales order of Ex produced products and purchase order for Ex components needed to be supplied; 

  • contract review, e.g. completed “Contract Review Checklist” confirming the feasibility of supplying Ex e motors to customer specifications, and records of technical clarification between customer and the organization confirming ambient temperature rating

  • training records, e.g. training log for production and quality control staffs who completed the coursed relevant to explosion proof requirements, and competencies periodic check for relevant staffs. 

  • design and development changes, e.g. engineering change notice (ECN) modifying the Ex products, and updated drawing revision showing changes on Ex product with the relevant justification and risk assessment results.

  • inspection and test data (per batch), e,g, batch test report for For a certain number of tested equipment showing routine test results, and records of inspection for incoming material and components.

  • calibration data, e.g. internal calibration or verification results for the measurement devices used for routine tests, and calibration certificates for measurement device which are provided by external calibration labs.

  • manufacturing traceability, e.g. serial number register in Ex product linking it's serial number to the relevant production batch and material lot, and traceability sheet listing operator ID, date, and components used for each assembled Ex product.

  • sub-contractor evaluation. e.g. supplier audit report for incoming material or components or supplied services such as machining flamepath surfaces, and approved suppliers list entry showing Ex-relevant qualification and re-approval date.

  • delivery data (customer, delivery date and quantity, including serial numbers where available), e.g. delivery note showing customer name, shipment date, quantity, and serial numbers of Ex products, and dispatch record for the forwarded Ex products, including certificate copies sent to the customer.

  • other documented information, if needed.

8.1 Operational planning and control 

to control and ensure compliance of production processes for Ex Products with the requirements of the EU type examination certificate, perform an internal audit on all processes relevant to the Ex certified product, download and use the ckecklist which has been defined based on annex A and annex B of EN ISO/IEC 80079-34:2020.

Note: completion the part of annex B is applicable if only elements with non-measurable paths used as an integral part of a Type of Protection exist in the Ex product.

8.2.3 Review of the requirements for products and services;

8.2.4. Changes to requirements for products and services

for the purpose of performing an effective contract review on requirements of the customer of Ex product, both the initial review and the revew of changes (if any), a sample form which is downloadable from here, could be used independently or in case that there is a basic form for contract review for ISO 9001 existing system, the content of this proposed form, could be added to the existing form.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: No

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

Important note: the requirements of 8.3 (including 8.3.1, 8.3.2, 8.3.3, 8.3.4 and 8.3.5) except 8.3.6, are not applicable for Explosion-proof products manufacturing process and therefore no any documentation is needed for the mentioned clauses.

8.3.6 Design and development changes

for the purpose of an effective change in Ex product design, a sample form which is downloaded from here, could be used independently or in case that there is a basic form for managing design change for ISO 9001 existing system, the content of this proposed form, could be added to the existing form.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: No

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

8.4.1 Control of externally provided processes, products and services - General 

Note: requirements of this clause (8.4.1) are not fully mandatory for products, processes or services, where the manufacturer verifies conformance according to 8.4.2.

Demonstrating the fulfillment of the specific requirement of 8.4.1 of EN ISO/IEC 80079-34:2020, could be done by completion the first alternative part of "evaluation form for Ex product, process, or service suppliers" (download from here).

for completion the first step of part 1.2 of evaluation form for Ex product, process, or service suppliers, download and complete the checklist for Selection the level of possible control and verification by supplier. 

in addition to the criteria which has been already determined for the evaluation, selection, monitoring of performance, and re-evaluation of external providers in the relevant procedure for the current management system documentation for ISO 9001, below requirements should be added too:

  • Possibility for outsourcing below processes relevant to Ex manufacturing quality management system:

    • manufacture, test and final inspection of the Ex product could be outsourced (sub-contracted); but 

    • the responsibility for ensuring conformance of the Ex product with the relevant Ex certificate and the technical documentation shall not be sub-contracted.

  • re-evaluation (if needed): external providers not used for a period exceeding one year shall be re-evaluated in accordance with with the above-mentioned arrangement and the results should be completed in a new revision of the "first alternative part" of evaluation form for Ex product, process, or service suppliers, and then a contract or a purchase order with the supplier could be placed;

  • priodic performance review: the ongoing ability of the external providers to provide conforming product, process or service shall be reviewed at periods not exceeding one year, by analyzing the inspection reports of their supplied products or services.

  • facilitating an arrangement in case that the QAN certification body may also need to verify aspects of any external provider’s operation that affects the Type of Protection. e.g by presence the auditor of the certification body for onsite assessment.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

8.4.2 Type and extent of control 

a. for purchased processes, products and services that can compromise the Type of Protection of the final Ex product, the manufacturer shall demonstrate the supplied product’s compliance with the Ex final product certificate, considering: 

  • the nature of the product; and

  • the nature of the external provider.

download checklist for ensuring compliance of the supplied product with relevant Ex final product certificate

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

b. below requirements, should be added to the present procedure for outsourcing in ISO 9001 system:

1. deciding what type of verification is required for a particular purchased process, product or service, considering below points:

  • the nature of the purchased product;

  • the external provider; and

  • how critical it is to the Type of Protection. 

2. deciding if the external proviser should carry out verification and in case of positive decision, for determining the level of verification, "selection the level of possible verification by supplier" for particular purchased item should be done, based on the assessment checklist.

The output of this evaluation leads to one of the following:

  • Manufacturer performs all incoming verification;

  • Shared verification (provider conducts some tests/inspections; manufacturer confirms key characteristics);

  • External provider is authorized to perform verification and supplies only a Declaration of Conformity (DoC).

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

c. below requirements, should be added to the present procedure for outsourcing in ISO 9001 system:

Providing a declaration of conformity (DOC) by external provider with no further verification of the process, product or service is required, in the case that the external provider is fully capable of: 

  • producing, which is done based on the checklist for "evaluation of capability for extenal provider of Ex product for production".

and 

  • verifying the process, product or service, which is done according to the part 2 of the point b) above.

Note: the checklists which are subject of "Selection the level of possible control and verification by supplier" (8.4.2 b) and "Evaluation checklist for external provider production capability" (8.4.2 c), could be combined and integrated. 

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

d. below requirements, regarding "routine tests", should be added to the present procedure for outsourcing in ISO 9001 system:

  • responsibility of performing the routine tests (by manufacturer or supplier), should be defined by manufacturer, in each supplying contract.

  • in case that the responsibility for performing the routine tests is given to the external provider by supplying contract, the below requirements should be defined:

    • performing it on each and every product to be supplied;

    • the requirement for detail of control, described in purchasing information document (e.g. incoming material control plan) and be communicated to the supplier; 

    • routine test results should be provided in the form of an independent report or within the declaration of conformity by the supplier.

 Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

e. requirements, regarding "purchased products which their verification cannot be carried out after manufacture", should be added to the present procedure for outsourcing in ISO 9001 system:

the product shall only be accepted if supplied with a declaration of conformity which specifically stating compliance to the purchase documents.

e.g. a quality plan, that lists the factors that together demonstrate conformity of an internal part of an encapsulated intrinsically safe circuit.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

f. the checkpoints by which the manufacturer of Ex product becomes able to demonstrate conformity of "sample inspections or tests" with the entire supplied batch, in checking the supplied Ex product batch, are defined in the relevant evaluation checklist.

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: Yes

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

g. checking the training and specialist skills or knowledge, required for verification, including below points: 

  • training material exists and maintained;

  • specialist skill has been defined;

  • knowledge or background;

  • training records are maintained.

the control result of the above points, are recorded in the part (g) of the second alternative of "evaluation form for Ex product, process, or service suppliers".

Obligation to develop an independent procedure or inclusion in existing ISO 9001 system procedures: No

Obligation How to record the outputs of the implementation of this requirement: inclusion or add to the existing records of ISO 9001

 
 
 
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