The future of the Quality Manual in ISO 9001:2015

A Quality Manual will no longer be a mandatory document, according to the available version of the DIS ISO 9001:2015 standard (to find out more about upcoming changes, read this article: 5 Main Changes Expected in ISO 9001:2015 from the 2014 Draft International Standard (DIS)). How did that happen? The Quality Manual was one of the first documents that a certification body asked for before the certification audit. How has it suddenly lost its purpose and importance?

The dark side of the Quality Manual

Most Quality Manuals manage to formally meet the requirements of the ISO 9001 standard, and yet miss the point of the document. The result is one of the most fundamental documents of a QMS that no one reads – except for a few masochistic certification auditors.

I have often run into Quality Manuals with 20+ (sometimes even 50+) pages, and I started wondering whether it should be called a “quality management system,” or a “quantity management system.” There was too much duplicated or unnecessary information, and so many details that I ended up feeling sorry for the tree that was cut down to make paper for this pile of unnecessary information.

Having a Quality Manual, in my opinion, wasn’t a bad idea. It is a document where the organization presents itself, its quality management system, and even its way of thinking and approach to quality management. Common practice was to (besides the requirements from clause 4.2.2) include some requirements from clause 4.1 and some other requirements that were easier to document through a Quality Manual.

A lucid, short, and clear Quality Manual gives the impression of an organization that knows what it is doing – an organization that really manages its quality management system. A good Quality Manual facilitates the job of the auditor, and gives him the opportunity to better audit the system – and, with his observations, really contribute to improvement of the system.  And what is more important, such Quality Manual is useful to the management representative and process owners because it provides an overall insight into the quality management system.

Big companies often require their suppliers to have a quality management system, and they may demand to see a Quality Manual during selection of suppliers. What impression does your Quality Manual give about your company? A bulky Quality Manual says that you would rather spend resources instead of applying a creative approach.

Writing a good Quality Manual is not that hard: define the scope of your QMS, list the exclusions (to find out more about exclusions in ISO 9001:2008, read this article What is an acceptable exclusion in clause 7 of ISO 9001) if there are any exclusions, and justifications for them, describe interactions between your processes (preferably through a process flowchart), and list all the QMS procedures you use – and that is all. See also Writing a short Quality Manual.

To be or not to be

With or without a Quality Manual, organizations will still need some overall QMS document. There will still be a need to send the certification body a document that will describe your system, as well as sending it to big clients. Although it’s no longer mandatory, all requirements from the Quality Manual, except 4.2.2 b), remain in the new version of the standard. The scope of the QMS and interactions between the processes still need to be defined. These requirements are even more detailed in the new version, and they still must be in some form of documented information.

The new version of the standard has some new requirements that need to be met as documented information, which can be easily included in a Quality Manual – for example, the context of the organization.

Same idea, different form

This new non-mandatory document (whatever we call it) that will replace the Quality Manual will contain all remaining requirements from clause 4.2.2, and I would add some new ones.

This new document should provide the following information about the organization:

  • We are XYZ company;
  • we are producing this and providing these services;
  • we apply a quality management system to these processes;
  • we don’t apply these clauses of the standard for these reasons;
  • these are our processes and their interactions;
  • and, this is the internal and external context in which we operate.

This can be considered an oversimplification, and of course all this information can’t be placed in just one paragraph, but this document would make sense and it would meet most of the requirements from clause 4 of the new version of the standard. Additionally, the organization’s mission and vision can be added, and this document can effectively become the brochure that will introduce your company to future clients.

This new version of the standard is not a slave to formality (Is this a good thing? Only time will tell…) and will require a more creative approach for getting the maximum out of each requirement, adapting to the organization’s needs instead of piling up useless documents.

Click here to see a preview of a Quality Manual that is adapted for a smaller company.

Advisera Strahinja Stojanovic
Strahinja Stojanovic

Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.