Guidelines for the application of ISO 9001:2015 published 1st November
Fourteen months behind schedule, the Technical Specification ISO/TS 9002:2016 (a.k.a. ISO 9002), Guidelines for the application of ISO 9001:2015, has been published. This surprise news (the last we heard was in March 2016 when it was still at an early development stage) is greatly welcomed. It solves many problems - more that its title suggests!
And anyone using ISO 9001 MUST get a copy of this Technical Specification.
The purpose and scope of ISO 9002
ISO/TS 9002 gives clause-by-clause guidance and examples to enable users, regardless of the size of the organization, to implement their own quality management system. As the requirements of ISO 9001 are generic, this document can be used by organizations of all types, sizes, levels of maturity and in all sectors and geographic locations. Note that it is intended for all organizations irrespective of size or economic sector - originally the intention was to address the needs of the service sector and of SMEs, two groups that have had difficulty with interpreting ISO 9001 in the past.
The intended application of ISO 9002
From the Introduction: "ISO 9001 contains requirements that can be objectively audited or evaluated. This document includes examples, descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization. While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes."
ISO/TS 9002 does not provide any additional requirements, but gives examples of what organizations can do to apply the clauses of ISO 9001 most effectively.
The problems solved or mollified by ISO 9002
For those transitioning to ISO 9001:2015:
The new sections of the ISO 9001 standard pose a significant challenge - context of the organisation, a risk-based approach, expanded requirements regarding the process approach and regarding top management, etc. For the Quality Manager and other management representatives this technical specification, with its copious examples, will be invaluable. It answers questions about a) what constitutes a sufficient response to a requirements, b) how to address 'missing' requirements for a quality manager, a management representative, mandatory written procedures, preventive action, and so on, c) meeting new requirements, the adequacy of documentation, the extent of record-keeping, etc..
For Consultants and others implementing a QMS to meet ISO 9001:2015 requirements:
Discussions between consultant and client will be greatly facilitated by these QMS Guidelines. By reference to the examples, consultants will be able to justify the systems they propose, convince clients that the system is not too complex, not overburdened by documentation, explain difficult (and perhaps alien) concepts such as context of the organisation and risk-based thinking, etc.
For Audit Program Managers (APM) and Internal Auditors:
While "not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes," the examples and guidance included in the specification give a clear indication of what constitutes an adequate body of objective evidence to demonstrate fulfillment of individual requirements. APMs can be confident as to the state of readiness on their QMS' for Certification Body Audit.
For Certification Body (CB) Audit Teams:
Similarly, for Lead Auditors and their Audit Teams, the specification provides informal criteria against which to present adverse findings. Largely, it takes the auditor's opinion out of the discussion - given the non-specific requirements of many ISO 9001 requirements, there are many opportunities for disagreement between Auditor and Auditee. We can anticipate that Closing Meetings will include rational and calm discussion of findings and not, as would be the case without ISO/TS 9002, descend into heated argument with accusations of opinionated over-interpretation of the standard's requirements by CB Auditors.
How relevant then are these Guidelines to ISO 9001?
In our opinion, this is a very important document, and anyone using ISO 9001 MUST get a copy of this Technical Specification.
For more information, and perhaps to buy a copy of the Technical Specification, go to the ISO Website.