EN ISO/CEI 80079-34:2011-09

ISO/IEC 80079-34:2011 Explosive atmospheres -- Part 34: Application of quality systems for equipment manufacture

EN ISO/CEI 80079-34:2011 is the standard that replaces the EN 13980 standard.

This standard is based on ISO 9001 - 2008 edition and includes some specific requirements related to ATEX and Ex products.

As defined in the certifications rules and ATEX 94/9/EC directive depending of technology and products, the quality system for manufacturing of the certified products must be assessed according rules and a quality notification must be delivered by a notified body (if the manufacturer of the products respects the rules).

These rules are now for ATEX 94/9/EC certification defined in the EN ISO/CEI 80079-34:2011 standard.

Hereafter are defined the aditional part that are checked during these audits.

First of all you must remember that when an Ex product is certified by a notified body in Europe or an ExCB (according IECEx rules), then the product must be manufactured according the type of the product that was certified. For this aspect a certification file with drawings and documents accepted by the notified body is registered both by the notified body and the manufacturer. This certification file is the basis of the audit.

The manufacturer must prove to the auditor that the manufactured products are similar to the certified product. Some requirements in terms of links between the documentation from the certification file and the detailled drawings used for manufacturing, must prove that all is under control. These requirement is mainly present in chapters 4.2.3 and 7.5.

In major cases, the manufacturer is not allowed to modify the certified product. However it is possible to make changes when the Ex protection mode is not affected. For this case, the modifications are classified in 2 types :

• major modification (that impact the protection mode and that have to be accepted or revalidated by the notified body in charge of the certification - or an other notified body)
• minor modification that do not impact the protection mode. In this case the manufacturer is free to make changes. 

In order to be able to classify these kind of modifications, the manufacrturer must be trained to Ex rules and standards. A requirement in competency is requested by the standard for this aspect (chapter 6.2.2).

In addition, a person must be identified inside the organization chart to take into account these modifications on the manufactured products. A requirement in authority is also requested for this aspect in chapter 5.5.2.

When type tests are requested during manufacturing (pressure test, ...) then the manufacturer must be able to prove that the device used for this specific test is under control and linked with the national accreditation authority and that the tests results are linked, traceable to international or national measurement standards (see chapter 7.6).

The last big requirement that is put inside this standard is that when a product that is not complying with the Ex certificate, and having been supplied to customers, then the manufacturer’s customer can be identified, The objective of requirement of chapter 8.3 is to be able to find other products that have been delivered to other customers and for which a potential danger has been identified. An other sentence of the standard say that for all nonconforming product that has been supplied to a customer, the manufacturer shall maintain records, for a minimum period of 10 years. This links to chapter 4.2.4 of the standard.

All these previous requirements comes in addition to ISO 9001 standard. We can point out some little differences.

A first difference with ISO 9001 standard is in relation with the exclusions of some chapter of ISO 9001 such as Design and development (chapter 7.3). The reason for this is that the design of the product is checked during the certification of the product by the notified body.

An other difference is on the internal audit periodicity (chapter 8.2.2) with an interpretation that differs depending of the auditor. The objectives is not to check all the processes within a period of 12-14 months, but only to the elements of of the quality system as described in this standard to ensure that the products are in conformity with the Ex certificate.

Finally, for ATEX certification some other requirements of the ATEX 94/9/EC directive are checked during the audit.

The documents required by ATEX 94/9/EC Directive or the various modules are defined below: 

Annex II 1.0.6. Instruction manual 
a) All equipment and protective systems must be accompanied by an instruction manual (...) 
The instruction manual is part of the technical documentation. The manufacturer must keep the records of this instruction the same duration as the one specified for the technical documentation. 
Annex III al. 9 The manufacturer or his authorized representative established within the Community must keep with the technical documentation copies of EC type-examination certificates and their additions certificates for a period of at least ten years from the last date of manufacture of the equipment or protective system. 
Annex IV al. 5 The manufacturer shall make available to the national authorities for a period of at least ten years from the last date of manufacture of the device: 

• The documentation referred to in 3.1 second indent 
• The adjustments referred to in the second paragraph of 3.4, 
• The decisions and reports from the notified body in the final paragraph of 3.4, and in 4.3 and 4.4. 

Annex V al.3. (...) The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period of at least ten years from the last date of manufacture of the device. 
Annex VI al. 3 The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period of at least ten years from the last date of manufacture of the device. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available shall be the person responsible for placing the apparatus or protective system on the Community market 
Annex VII al. 5 The manufacturer shall make available to the national authorities for a period of at least ten years from the last date of manufacture of the device: 

• The documentation referred to in 3.1, third indent, 
• The adjustments referred to in the second paragraph of 3.4, 
• The decisions and reports from the notified body in the final paragraph of 3.4, and in 4.3 and 4.4. 

Annex VIII al. 2 The manufacturer shall establish the technical documentation described in point 3; the manufacturer or his authorized representative established within the Community must keep it at the disposal of the national authorities for inspection purposes for a period of at least ten years from the last date of manufacture of the device. 

These elements are mainly related to the documentation (instructions and EC type declaration of conformity), the marking (marking plate) and are identified in the following chapter :

• § 4.2.3 : controle of records 
  • Link between the equipment, the EC type examination certificate and the CoC (b, d, e - OD 005)
  • Technical documents - (Directive 94/9/EC A III al. 9)
  • Major / minor changes (modifications)  / no factor defined within the EC type examination certificate and technical documentation is modified; (c - OD 005 - b,d  § 5.5.1 - OD 005)
  • Instructions -EC declaration of conformity - (Notice - annexe II § 1.0.6 de la directive 94/9/CE)
  • Identification of the notified body (NB) in charge of the Quality system inspection - (g - EN 13980)
  • identification of   ATEX / non- ATEXproductions / system that enables both ATEX /  non-ATEX related drawings and  drawings to be clearly identified - (f – OD 005)
  • Technical documentation shall be maintained for a period ending at least 10 years after the last equipment (…) was manufactured - (8.3 a – OD 005) - (Directive 94/9/EC A III al. 9) (8.3 a - EN 13980)

Hereafter is given the content of the standard with the different color signification

• text similar both to ISO 9001:2008 and EN ISO/CEI 80079-34:2011
• text that is not applicable to EN ISO/CEI 80079-34:2011
• text of ISO 9001:2008 with additionnal requirements introduced by ISO/CEI 80079-34:2011

CONTENTS OF THE STANDARD

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, training and awareness
6.3 Infrastructure
6.4 Work environment
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning 
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
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
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring equipmentt
8 Measurement, analysis and improvement 
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data 
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
Annex A (informative) Information relevant to particular types of protection and specific products
Annex B (informative) Verification criteria for elements with non-measurable paths used as an integral part of a type of protection
Bibliography
Table A.1 – Component/feature compatibility