By Kristin Case
Prior to the release of the 2015 version, the ISO 9001 standard had required only three items be documented in the organization’s quality manual:
“The organization shall establish and maintain a quality manual that includes:
a) The scope of the quality management system, including details of and justifications for any exclusions,
b) The documented procedures established for the quality management system, or reference to them, and
c) A description of the interaction between the processes of the quality management system.”
So, you needed
- A documented scope,
- Reference to your procedures, and
- A description of how your QMS processes interacted.
And, yet, somehow, organizations interpreted this to mean they should precisely and faithfully copy the verbiage from the standard itself, replacing only a few key words. In the timespan of 30 days, I read two quality manuals, both over 30 pages in length and both for micro-businesses of less than 10 employees. I would argue this was an inefficient way to be ineffective.
There are some excellent reasons for maintaining a quality manual:
- Can provide documentation structure
- Can present a concise overview of system
- Can provide a location for scope, policy, and objectives
- Can present the sequence and interaction of processes
Of course, when an organization essentially copies the ISO 9001 standard into its manual, it misses the opportunity for providing a documentation structure, presenting a concise overview of the system, stating the scope, policy, and objectives, and presenting the sequence and interaction of quality management system processes.
Guidelines for a manual – ISO 10013:2001 version
There is an ISO standard that provides guidelines for quality management system documentation. It hasn’t been updated since 2001 and I think I could safely describe it as “dated” so I don’t recommend using it as a guideline, but I want to present its recommendations on a manual only to demonstrate contrast with what I recommend in 2019.
As this publication (known as a technical report) was only a guideline, it doesn’t use the word “shall.” It is only making recommendations and uses the word “should.” And this is the list the guideline says you should have in your manual:
- Table of contents
- Evidence of review, approval, and revision
- Quality policy and objectives
- Org. chart/Responsibilities and authorities
- Description of the quality management system
Guidelines for a manual – Kristin’s version
And now we can contrast this with my recommendations for a quality manual.
If your manual is concise enough, you do not need a table of contents. I’ve seen manuals that are two to five pages that included every suggestion I’m presenting here.
Evidence of review, approval, and revision. (This is one of two bullet points on which I agree with ISO 10013.)
The scope of the quality management system was literally one of only three required items to be in the manual, and somehow it was left out of ISO 10013. If you are going to have a quality manual, I recommend you describe the scope of your system in it. Also, I would include your quality policy and objectives, including the calculations for how those objectives are measured. (As an example, I’ve easily seen 20 different ways to calculate “on-time delivery” so go ahead and describe how your organization will calculate your objectives.) I would not include targets in the manual. In most organizations, targets are frequently changing and better presented elsewhere.
Present a high-level org chart. Nothing fancy. No names. Titles for the top row and departments below that. The manual is no place for a full description of responsibilities and authorities.
Provide some context. Either list the organization’s issues and interested parties and what information is monitored related to them or provide the reader with where in the organization this information can be found.
References—If you are going to include references in your manual (and here I’m talking about external references—the ones your organization did not write—for example, regulations, national or international standards, industry specifications): make sure you need to include them. And whether you are referencing internal or external references, don’t include their revision level. Otherwise, every time one of those references is updated, your manual is no longer current.
Arguably, the most important part of the manual is the description of the quality management system. This should be a representation. It should be a picture, model, flowchart, swim lane diagram, or any other graphic that helps portray your organization’s quality management system. (I believe this is why so many organizations simply parrot the standard; they do not have a conceptual framework for their own system and believe that copying the standard is the “safest” choice to “describe the quality management system.”) It is not a safe choice. It is not a good choice. The current ISO 9001 standard requires that the organization determine the processes needed for their QMS and their sequence and interaction. (One good way to prove you’ve determined those processes, their sequence and interaction is to actually document them.)
Lastly, I think it is an exceptional idea to use the manual to provide the framework or structure for lower-tier documentation. Again, back in previous versions of the standard, references to procedures were required in the manual. Rather than a table that lists all your procedures, I suggest simply showing on your QMS model where the procedures apply. Redacted examples are shown below.
Each of the three examples above provides both the interaction between processes of the quality management system while also showing the documentation structure and referencing the reader to related procedures or work instructions for those processes that are documented.
About the author
Kristin Case is an ASQ Fellow and Baldrige Performance Excellence Program Examiner, Senior Examiner and Team Leader. She has over 20 years of expertise in designing, implementing, and improving quality management systems. Her company, CaseConsults, has grown from a part‐time consulting practice into a menu‐driven selection of services designed to help organizations efficiently implement or improve their quality management systems. Click here to learn more about CaseConsults.