QMS Document Hierarchy and Quality Manuals

I'm curious about the number of document hierarchy levels used in new or most Quality Management Systems today. Would anyone be willing to share? 1) Manual 2) Policy 3) Procedures 4) Work Instructions 5) Records. Any additional levels out there? Maybe Operating Instructions or Corporate Instructions? Also, does anyone know the latest trend on creating or not creating QMS manuals based on the ISO 9001:2015 standard. Are business replacing the manual with new approaches? Thanks in advance for your replies! I can't wait to hear from my trusted peers!

9 Replies

Where I am, we have 4 levels: Manual, SOP, Work Instructions, Forms. As far as the Manual, we still utilize ours and find most of our customers still ask for it when filling out yearly surveys or when setting up an audit with us. I would be interested in seeing other answers when it comes to different approaches on this!

Sounds good. Thanks for taking the time to share Janine! Greatly appreciated!

I'm referring the hierarchy different from traditional way of policy,manual,procedures and records- this will give you broad spectrum and we can fit this in any industrty.

Level-1- Governance documents- Policy, Legal requirements, legislation & contract documents

Level-2 Controlling documents- Quality plan,manual,etc

Level-3- Implementation documents- All kind of procedures, work instructions,

Level-4 Quality records/records- design reports, manufacturer data book, inspection reports etc.

Regarding Quality manual- i 'm seeing many of my contractors still maintaining the manuals ,this may be an added benefit for them .

Regards,

Vaithiyanathan

David Woods
29 Posts

Hi Michelle,

Your list of documents is pretty much standard. Initially a lot of companies were Gung Ho about getting rid of the Quality Manual. However, they soon began to realize that the Quality Manual was the best way of the illustrating the context of the organization to new hires as well as orienting auditors. Thanks for your post, great discussion topic!

Kind Regards,

David Woods

Hi David ,

I agree with you ,initially many thought that they get rid of the quality manual with 2015 version of ISO 9001 , but later realised the benefit of maintaining the manual.

Duke Okes
184 Posts

Your list is typically used, with the exception that the Policy is included in the Manual.

Now that the standard is less documentation intensive, the number of levels and documents is likely to be more dependent in the size of the organization (I helped a small machine shop do the manual and procedures as one document, and they didn't need instructions due to the use of drawings and qualified machinists), the industry (highly regulated likely to have lots more documents and levels), complexity of the product/processes (e.g., can training/education suffice), etc.

This is a great overview Vaithiyanathan, especially for a large organizations. This gives me more to consider, which is what I was hoping for. Thank you for your reply!

Thanks for the confirmation David. I have heavily used the manual with auditors in the past as well. Good to hear from you.

I understand Duke. Thanks for mentioning the size and complexity of an organization; this is a very important point. I've been trying to think outside of the box and am looking for new ideas that would support a large organization. Any and all thoughts are appreciated!