How important is a Quality Manual - ISO 9001:2008 to 9001:2015

[LUV-d-4UM]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

dsanabria I will share my lessons learned after my first audit. Again the ISO standard does not require any documentation. Risk Based thinking is the main heart of the new standard. I am not confident of sharing stuff before the audit, OK?

 

[tony s]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

As a counterpoint to this, keeping the old structure can be confusing, both to the organization and to future auditors that may not have had experience to the old standard.

Isn't the old structure must include what was specified in ISO 9001:2008 clause 4.2.2? Even the 2008 version doesn't require or even recommend to have the sections of any organization's QM to match the clauses of ISO 9001.

 

[Big Jim]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

It was not required to match, never has been, but it was COMMON PRACTICE. So when they documentation is matched up to the standard, for whatever reason, IT IS IN FACT VERY CONFUSING when it no longer matches.

 

[tony s]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

Why would it be very confusing? Very confusing to whom?

 

[Big Jim]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

Anyone who is trying to match up the requirements to the standard, and from my extensive consulting and auditing experience that would be most users.

YMMV and I respect that.

 

[LUV-d-4UM]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

Do you have a quality Manual to 2008? Is that a regurgitation of the standard? Or is that a manual that you can all share with us so we can suggest how to improve it?

Then do the same thing to 2015 (regurgitate the standard). And whatever number you cannot MATCH to the old standard, just add it.

 

[tony s]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

Just to share my approach in writing a Quality Manual, the outline will usually include the following sections and subsections:
1. Introduction
1.1 Purpose
1.2 Revision History
1.3 Distribution of the QM
2. Organization Profile
2.1 Organization Chart
2.2 Mission
2.3 Vision
2.4 Strategic Directions
2.5 Quality Policy
3. Organization's QMS
3.1 Scope of the QMS
3.2 Justification for Exclusion
3.3 QMS Process Map (which lays out the Management, Core, and Support processes)
4. Management Processes (will include processes such as Strategic or Business Planning, Performance Review, Internal Audit, etc.);
5. Core Processes (will include Business Development, Product Quality Planning, Production, Quality Assurance, etc.);
6. Support Processes (will include Human Resource Management, Infrastructure Management, Information Management, etc.)

In each subsection of the Management, Core and Support Processes, the relevant documented procedures are referenced.

I'm comfortable with this approach since I don't have to change the outline just to match the clauses of ISO 9001 whenever the standard is revised.

 

[howste]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

Just to share my approach in writing a Quality Manual, the outline will usually include the following sections and subsections:
...

I like your thinking on the quality manual designed specifically for your organization.

I'm curious about the organization chart. I've always avoided org charts in quality manuals because you have to update the manual whenever someone changes positions. Do you use a generic chart with just titles and no names?

 

[tony s]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

The org chart is a generic one where only the title/positions are charted. Each position/title is supported by a Job Description being kept by the HR Department with a copy to the employee.

 

[Big Jim]

Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual

I know the question wasn't directed to me, but I would like to add that I also use an org chart in the quality manual most of the time as it helps answer the question about ensuring that the responsibilities and authorities are communicated. It is not a requirement to be in the manual by any means, and there are other ways to show R&A, but it does work.

I use titles only unless the client insists on names.