ISO9001 QMS: Quality Manual Examples & Templates

[SMHudson]

I am looking for some help and was hoping some of the members here can provide some assistance...it will be hugely appreciated. I need to create a Quality Manual for a procurement / services business where we outsource the manufacturing for our customers. Both with project and serial based production with customer IP, and serial production for our own IP.

- Does anyone have editable example documents of a Quality Manual / QMS they could share with me please or able to advise where I can source some?
- I am also interested in specific sections or Level 2 Procedures & Level 3 Templates and Work Instructions for:

1. Non Conformities Process, Root Cause Analysis and CAPA's
2. Reclamation / Claims handling
3. Supplier Audit Process, Template and Actions / Reporting

- Can anyone recommend any partners that I could work with in delivering ISO9001 certification i.e. training and support?

 

[Johnny Quality]

I need to create a Quality Manual

SMHudson,

Why do you need a quality manual? It's no longer a requirement of ISO 9001.

 

[SMHudson]

Johnny Quality, its something i have been asked to create as the company does not have any QMS. So its the start point just to get to grips with process manuals / procedures they have today and to assess gaps in some of the processes I mentioned. ISO9001 will come later as I need something in place before the end of the year...

 

[Tagin]

The attached cross-reference template may be more useful than a Quality Manual template, as the latter is often a condensed version of the QMS, so it presupposes an existing QMS. The cross-reference template is helpful for organizing existing docs for gap analysis as well as for a finalized reference of your QMS docs, along with a column for related information (records, databases, etc.) that can be useful when documenting your document/record controls.

 

[SMHudson]

The attached cross-reference template may be more useful than a Quality Manual template, as the latter is often a condensed version of the QMS, so it presupposes an existing QMS. The cross-reference template is helpful for organizing existing docs for gap analysis as well as for a finalized reference of your QMS docs, along with a column for related information (records, databases, etc.) that can be useful when documenting your document/record controls.

Thanks Tagin, certainly a very helpful template...I assume the standard process is to the collate existing procedures and templates that exist under each of those sections? So no longer independent manual just a checklist of all the relevant processes/procedures?

 

[Tagin]

Thanks Tagin, certainly a very helpful template...I assume the standard process is to the collate existing procedures and templates that exist under each of those sections? So no longer independent manual just a checklist of all the relevant processes/procedures?

Well, there is no "standard process" But yes, that is generally how I would proceed.

If there are a large number of processes, or the processes are large, another way to approach it is to try to apply the standard to each of these processes, one by one. Then, you could maintain multiple cross-references (one per process), as opposed to a single companywide cross-reference.

I think its helpful always keep in mind that 9001 is a PDCA-structured standard. For a smaller company, it may be easier to think in terms of one encompassing companywide PDCA, but in a larger company that is unwieldy and it instead makes sense to think in terms of independent per-process PDCAs.

This does not imply that larger companies have to have all separate docs for each clause; far from it. Clause 4-6 might be a single doc used for all business processes. Calibration might be a single support function group shared across business processes. And so on.

 

[Johnny Quality]

If the company no QMS then I'd start with a gap analysis.

 

[SMHudson]

Well, there is no "standard process" But yes, that is generally how I would proceed.

If there are a large number of processes, or the processes are large, another way to approach it is to try to apply the standard to each of these processes, one by one. Then, you could maintain multiple cross-references (one per process), as opposed to a single companywide cross-reference.

I think its helpful always keep in mind that 9001 is a PDCA-structured standard. For a smaller company, it may be easier to think in terms of one encompassing companywide PDCA, but in a larger company that is unwieldy and it instead makes sense to think in terms of independent per-process PDCAs.

This does not imply that larger companies have to have all separate docs for each clause; far from it. Clause 4-6 might be a single doc used for all business processes. Calibration might be a single support function group shared across business processes. And so on.

Once i have reviewed current documentation I will be in a much better position but it might be best to consolidate all of the info required into the sections in the template provided...and see what gaps there are

 

[SMHudson]

If the company no QMS then I'd start with a gap analysis.

That makes sense. Gap Analysis against the ISO9001 sections checklist?

 

[Johnny Quality]

Against all the clauses. Find evidence of conformance, celebrate where deserved and help fill gaps where gaps are needed.