A 'must read' for Consultants, Lead Auditors & other CB officers

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 many supporting documents (Guidance Documents) to support the implementation and improvement of effective quality management systems.

Some of these Guidance Documents have been revised in the past three years; check that you have the latest version (see the list below).

Lead Auditors and others working for Certification Bodies will find them invaluable, as will those maintaining management systems.  And they do not apply to ISO 9001 requirements 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 applying ISO 9001:2015.  This document provides valuable guidance on applying ISO 9001:2015 to service organizations and SMEs in general. There is also a companion for smaller organizations, namely, ISO 9001:2015 for Small Enterprises – What to do?, published in 2016 by the ISO/TC 176.

Additional Guidance on ISO 9001 Requirements on Documentation

Seventeen additional ISO 9001 guidance documents have been published on various topics related to ISO 9001 principles and practices.  This is an ongoing series, with the latest guide having been published in 2022:

• 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 10003:2018 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 10008:2022 Quality management -- Customer satisfaction -- Guidelines for business-to-consumer electronic commerce transactions
  
  
• ISO 10010:2022 Quality Management - Guidance to understand, evaluate, and improve organizational quality culture
 
• ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring equipment.  Note: a new edition is currently under development.
 
• ISO 10013:2021 Guidelines for quality management system documentation
 
• ISO 10014:2021 Quality management -- Guidelines for realizing financial and economic benefits
 
• ISO 10015:2019 Quality management -- Guidelines for training
 
• ISO 10017:2021 Guidance on statistical techniques for ISO 9001:2000
 
• ISO 10018:2020 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
  
  
• ISO/TS 10020:2022 Quality management systems — Organizational change management — Processes

As the titles indicate, these are for "guidance," not "certification," as with ISO 9004.  Yes, that’s the twentieth and final guidance document we’ve identified:

• ISO 9004:2018, Managing for the sustained success of an organization -- A quality management approach.

As shown by the publication dates, some of these documents have been available for a long time, but all are currently listed on the ISO website. They continue to be developed and can be very useful in difficult situations or when Quality Managers and Consultants need a reference document to support 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, you could find some opportunities and/or an elegant solution to a QMS problem among them.

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