ISO 9001 Quality Manual
It is hard to believe that it’s been a full year since we started out current article series (DIY ISO 9001 Implementation). While we initially thought we could present all the needed information in twelve months, it looks like this series will continue a little longer. Our goal is to complete this body of work by the end of March.
Today we wrap up the actual ISO 9001 system development work with this article and then shift our focus for the remainder of the series to system implementation and certification activities. The final development piece is creation of a formal “ISO 9001 Quality Manual”. While optional, this document can still provide value as a key part of the management system by providing a repository for high-level management system information or processes that don’t warrant a separate procedure.
Previous versions of ISO 9001 required development and control of a ISO 9001 quality manual document, however, the 2015 version of the standard deleted this requirement. If you find that you don’t need this document to capture and retain certain management system information, then there is no need to develop it. You can always develop this document later if needed.
While not required, we find that this document can be useful for documenting information that doesn’t really fit in any of the other management system documents. It is also a great reference document to provide to your registrar or auditor which provides a road map to your management system. This document might be a good place to capture the following information:
- General management and leadership responsibilities,
- Quality policy,
- References and links to quality objectives,
- Scope of the management system,
- Management system exclusions,
- Company background or profile information,
- Approach to meeting core ISO 9001 principles such as process approach, risk, or context,
- Miscellaneous management system block diagrams, process maps, and flow charts,
- Organizational roles and responsibilities including organizational charts,
- Cross references,
- Process matrix or list all key processes and associated attributes (see ISO 9001 clause 4.4),
- Other key management system information??
In the past this document was always referred to as the Quality Manual, but you are free to title it whatever you want. The example policy document provided with the ISO 9001 eCoach system is called a Management System Manual. Just like any other ISO 9001 document, this manual must be approved, maintained, and controlled within your document control or revision control system.
Please note that a google search will return hundreds if not thousands of example “Quality Manuals”, many of which were developed for previous versions of the ISO 9001 standard. While it might be tempting to use these documents as templates for a similar document within your organization, we recommend that you develop a document that fits your company. Many of these older manuals simply regurgitated the basic requirements of the ISO 9001 standard and provided little or no value to the organization or other stakeholders.
Some form of high-level policy document which provides an overview of the ISO 9001 management system and captures key system information is probably warranted in most organizations. Consider the need for such a document within your organization and management system and proceed accordingly. Remember that the information captured in your ISO 9001 quality manual should be of value to internal personnel as well as external parties such as registrars, auditors, and customers.