Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008

Re: Integrated Management System Manual

Believe me, *many* people will appreciate your work.

In addition, this has turned out to be an excellent extended discussion on quality and integrated systems manuals especially with regard to content. I have made it a "FAQ" thread in this forum.

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

Wow, I found this thread very informative. Thank you all for your opinions! I am planning on revising our QM because it is too structured to the standard -in my opinion. My problems are that the manual really is used by too many people for too many reasons- It has to be clear & concise for the auditor, needs to be 'readable' by management & employees and then you may need to 'show' it to the outside world, customers & such. Okay, so I'm wondering what your opinions are for my idea to write a separate 'quality statement' (for lack of better termonology for now) to show other people. I don't feel comfortable having so many others in the same industry going over my manual and possibly using my format. Maybe a couple pages long, covering the highlights? Am I being silly not wanting the whole world to see it? Thank you!

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

MsHeeler:

I agree with Marc - I think folks here would love to see your example. I for one have done the "QHSE" position a couple of times as well as other management positions - it would have been nice to have an integrated manual.

examples at the cove are always welcome!

R

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

I am glad I have joined the Elsmar Cove Forum


I have spent almost a hour reading this very interesting topic and I am impressed with the generous input of the experienced QMs and Auditors, members of the forum.

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

MsHeeler said:

I have had one auditor that really liked it, one that really hated it, and one that didn't even look at it.

Tell me if you find any mistakes.
View attachment 9753

MsHeeler

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No mistakes but a missed opportunity. The requirement for a quality manual is being deleted in ISO 9001:2015 but an organization will still have to document the system and the information normally in a quality manual. As a lead contract auditor for four major registrars I have seen a wide variety of quality manuals. Many, like yours, are a virtual replay of the standard and replace "The Organization shall" with the name of the company. You have included a generic quality policy in your template yet clause 4.2.2 does not require the quality manual to include the quality policy. One could identify the stated policy as the overall policy related to conformance to product requirements (quality) and indicate that specific policy statements regarding the clauses of ISO 9001 are included throughout the document. Therefore if this is done and a credible approach to managing each requirement is stated the manual could be identified as the "Quality Policy Manual" and be much more useful as a starting point for managing all requirements of the organization, including unique customer requirements. Frankly it is quite boring to read a manual that provides very little understanding of the organizations intentions. I have prepared dozens of policy manuals using this technique with virtually no negative feedback. Frankly it should make no difference what the auditor likes or dislikes. What is important is what value does the manual provide for the organization.

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

Its too bad for immature companies that a quality manual (QM) will not be required in the new standard. I always felt that quality manuals were to be used to describe the company's quality system. Not to regurgitate the standard but as a one stop shop that can point to how the company, in it own fashion, meets requirements. Immature companies tend to only do things unless forced and in some cases, sadly enough, certification and QM are the only items keeping quality in check. Working in the states the US is not known for its quality products anymore bar weapons, so we need all the help we can get. For mature companies, perhaps they don't need a QM but like the FMEA and Control plan it sure is nice to have a piece of literature that pulls together all the standards of workmanship in the company and give customers confidence that the company has an overriding standard of workmanship signed off by the President or CEO. Without it we tend to place the burden on a few people that know where all the global SOPs are.

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

Del Foster said:

No mistakes but a missed opportunity. The requirement for a quality manual is being deleted in ISO 9001:2015 but an organization will still have to document the system and the information normally in a quality manual. As a lead contract auditor for four major registrars I have seen a wide variety of quality manuals. Many, like yours, are a virtual replay of the standard and replace "The Organization shall" with the name of the company. You have included a generic quality policy in your template yet clause 4.2.2 does not require the quality manual to include the quality policy. One could identify the stated policy as the overall policy related to conformance to product requirements (quality) and indicate that specific policy statements regarding the clauses of ISO 9001 are included throughout the document. Therefore if this is done and a credible approach to managing each requirement is stated the manual could be identified as the "Quality Policy Manual" and be much more useful as a starting point for managing all requirements of the organization, including unique customer requirements. Frankly it is quite boring to read a manual that provides very little understanding of the organizations intentions. I have prepared dozens of policy manuals using this technique with virtually no negative feedback. Frankly it should make no difference what the auditor likes or dislikes. What is important is what value does the manual provide for the organization.

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What possible advantage would it be to a company to split their quality policy into small pieces and scatter it across various documents and procedures?

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

I just spent 2 days reviewing the Quality Manual a contract company did for the project I'm currently on. This is for a well-established 30 year old company manufacturing it's first medical device. Not only was the QM a regurgitation of ISO 13485, it had numerous redundancies throughout AND was 60 pages long. Add to that, they didn't bother to review the Quality Procedures it referred to (some of which they wrote and we revised) and there were glaring errors (e.g. QM states review of Quality Procedures is annual, the actual Procedure state it's every 3 years; stated Env Controls weren't necessary, etc.). In some sections they had 2 sentences and referred to the Procedure; in other sections (in way too many) it had several paragraphs to 1-2 pages of info and a reference to the Procedure. Lots of it was written in future tense: 'we will, we shall', instead of in present tense.

Granted, the contractor used a boilerplate template, but all a boilerplate does is help one to not reinvent the wheel...it still should be structured for the business that will be using it, and that wasn't done in this case by a long shot. I've never seen a QM that was this long and this non-beneficial. Considering how they wrote the Procedures and this QM it makes me wonder if some people have just gotten too complacent or if they simply don't take pride in their work anymore.

Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

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Re: Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:20

maaquilino said:

I just spent 2 days reviewing the Quality Manual a contract company did for the project I'm currently on. This is for a well-established 30 year old company manufacturing it's first medical device. Not only was the QM a regurgitation of ISO 13485, it had numerous redundancies throughout AND was 60 pages long. Add to that, they didn't bother to review the Quality Procedures it referred to (some of which they wrote and we revised) and there were glaring errors (e.g. QM states review of Quality Procedures is annual, the actual Procedure state it's every 3 years; stated Env Controls weren't necessary, etc.). In some sections they had 2 sentences and referred to the Procedure; in other sections (in way too many) it had several paragraphs to 1-2 pages of info and a reference to the Procedure. Lots of it was written in future tense: 'we will, we shall', instead of in present tense.

Granted, the contractor used a boilerplate template, but all a boilerplate does is help one to not reinvent the wheel...it still should be structured for the business that will be using it, and that wasn't done in this case by a long shot. I've never seen a QM that was this long and this non-beneficial. Considering how they wrote the Procedures and this QM it makes me wonder if some people have just gotten too complacent or if they simply don't take pride in their work anymore.

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In my 20 years as a contract auditor and consultant I have observed and kept abreast of all of the amendments and revisions of ISO 9001 and believe each update made it a better document for its intended purpose - to make it a true requirements document much like a request for proposal (RFP) statement of work (SOW). This is accomplished primarily by removing any language in the ISO 9001 (Requirements) standard that could be considered as prescriptive or indicating "how" in any sense.
The good news is that much of that prescriptive language, such as "a master list or equivalent shall" that was in ISO 9001:1994 can now be found in some of the guidance documents. The removal of the requirement for a quality manual in the 2015 standard does not imply in any way that an organization should not have a quality manual, in fact I suppose those who have had the good sense to prepare an appropriate one will still use it. ISO 8402 which was the terms and definitions document associated with the :1994 standards had many useful definitions that have since been removed. But an organization can still use them as well as new ones to fit their needs. I particularly like the earlier definition of a quality system as "the organizational structure, processes, procedures, and resources" an organization needs to achieve its purpose. If one would insert "policies" between org structure and procedures you would complete the definition of qms in terms of its elements. This might be a better focus for top management during qms review (5.6) to complete a more effective assessment of the "system" the standard calls for. What does your doctor check when you go in for a physical? weight, temperature, blood pressure, heart rate, etc. all of which give him some indicator of how well the human system is working. Too bad your contractor wasted so much of their time and yours writing meaningless "promises" rather than policies.