IECEx Quality System Requirements for Manufacturers - OD 005

This Operational Document, OD 005 sets out the IECEx System requirements for manufacturer’s quality system, relating to the production of Ex products. 
OD 005, IECEx Quality System Requirements for Manufacturers, has now been published in two parts: 

  • Part 1: Guidance on the establishment and maintenance of a quality system 
  • Part 2: Audit Checklist 

This Document needs to be read in conjunction with ISO 9001:2008. 

You can download these documents on the www.iecex.com website at the following address : 


​Part 1: Guidance on the establishment and maintenance of a quality system 

The content of the first part of the document is very similar to the content of ISO/IEC 80079-34:2011 Explosive atmospheres -- Part 34: Application of quality systems for equipment manufacture

CONTENTS OF part 1 of OD 005

Hereafter is given the content of the document 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 that is added to EN ISO/CEI 80079-34:2011
  • text of ISO 9001:2008 with additionnal requirements introduced by ISO/CEI 80079-34:2011

 

 

INTRODUCTION
1 Scope
1.1 General
1.2 Permissible exclusions
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 (in the scope of EN ISO/CEI 80079-34:2011 but not in the scope of OD 005)
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

 


Part 2: Audit Checklist 

This second part of the document is a checklist based this time on the OD 005-1 document.

This document is a basis of most ExCB where performing their audits.