Essential Reading for Consultants, Lead Auditors and others working for Certification Bodies
The ISO Technical Committee 176 (ISO/TC 176) on Quality Management, the committee responsible for the ISO 9000 family of Quality Management System (QMS) standards, also publishes several supporting documents (called Guidance Documents) for the purpose of supplementing the implementation and improvement of effective quality management systems.
Most of these Guidance Documents have been revised within the past 2 years - time to get updated copies, perhaps.
Lead Auditors and others working for Certification Bodies will find them invaluable as will those maintaining management systems. And they're not applicable to ISO 9001 alone - they can also be applied to ISO 13485, ISO 14001, ISO 45001 and other Management System Standards.
Guidance Documents for the Application of ISO 9001:2015
ISO/TC 176 has published ISO/TS 9002:2016 Quality management systems - Guidelines for the application of ISO 9001:2015. Originally to have been published simultaneously with the revised ISO 9001 Standard in September 2015, there has been a delay and publication eventually happened in late 2016.
This document gives valuable guidance to the application of ISO 9001:2015 to service organisations and to SMEs generally. There is also a companion for smaller organizations, namely, ISO SME Handbook:2016 from ISO/TC 176.
Additional Guidance on ISO 9001 Requirements on Documentation
There are 15 additional ISO 9001 guidance documents that have been published on various topics related to ISO 9001 principles and practices:
- ISO 10001:2018 Quality management -- Customer satisfaction -- Guidelines for codes of conduct for organizations
- ISO 10002:2018 Quality management -- Customer satisfaction -- Guidelines for customer complaint handling procedure in organizations
- ISO 10003:2007 Quality management -- Customer satisfaction -- Guidelines for dispute resolution external to organizations
- ISO 10004:2018 Quality management -- Customer satisfaction -- Guidelines for monitoring and measuring
- ISO 10005:2018 Quality management systems -- Guidelines for quality plans
- ISO 10006:2017 Quality management systems -- Guidelines for quality management in projects
- ISO 10007:2017 Quality management systems -- Guidelines for configuration management
- ISO 10008:2013 Quality management -- Customer satisfaction -- Guidelines for business-to-consumer electronic commerce transactions
- ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring equipment
- ISO/TR 10013:2001 Guidelines for quality management system documentation
- ISO 10014:2006 Quality management -- Guidelines for realizing financial and economic benefits
- ISO 10015:1999 Quality management -- Guidelines for training
- ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
- ISO 10018:2012 Quality management -- Guidelines on people involvement and competence
- ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services
As the titles indicate, these are all for "guidance" not for "certification", in the same way that ISO 9004 is used. Yes, that’s the seventeenth and final guidance document we’ve identified: ISO 9004:2018, Managing for the sustained success of an organization -- A quality management approach.
As you can see from the dates of publication, some of these documents have been around a long time but all are currently listed on the ISO website. They continue to be developed and can be very useful when difficult situations or when Quality Managers and Consultants need a reference document for backup to their recommendations..
NOTE: Table B.1 of Annex B to ISO 9001:2015 indicates the clause in the Standard where each guideline document would typically be applied.
So if you're implementing ISO 9001, perhaps you can find some opportunities and/or an elegant solution to a QMS problem among them?
[Author's Note: Originally published in Oct 2015, this post has been brought up-to-date as of July 2019.]
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Note: First published in July 2019; revised and updated in December 2021.
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