ISO 9001:2015 - Internal Auditing - Audit to the Standard?

[spacey]

Hello all,

Researching and working my way through the transition from 2008 to 2015 getting mixed signals about a quality manuals, some people have one some don't.

I haven't made my mind up yet what to recommend for our company as I am in two minds about having a manual.

We often get asked by clients for a copy of our quality manual so tempted to keep it, rather than send them a flowchart which shows everything.

But my question is this, deadline time is getting nearer for us with 9001:2015 and can I audit against the 9001:2015 standard and not our own manual as we have in the past?

Thanks

 

[howste]

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system;
a. conforms to:
1. the organization’s own requirements for its quality management system;
2. the requirements of this International Standard;
b. is effectively implemented and maintained.

The standard says you audit to determine that your system meets the requirements of your own QMS and ISO 9001. If you don't have a quality manual, then you don't need to audit to it, but will need to audit other documented QMS requirements. If you do have a quality manual, you need to verify that you've met any requirements in it.

If you don't decide if you're going to have a quality manual until a week before the next audit, you won't have time to audit against it. You need to get off the fence as soon as you can and move on. I've frequently said that when you make a decision about documenting something you need to determine who will use the information and what their needs and expectations are. Users of quality manuals generally include customers, auditors, and sometimes even your own personnel. You might call them "interested parties" which is what you find in clause 4.2 now. My personal preference is to have a quality manual.

 

[Randy]

The question about a manual or not having a manual is always interesting.

I keep wondering, if you were going to build yourself a house would you do it from memory and imagination or use a set of plans?

 

[Ajit Basrur]

Spot on Randy ... as always !

 

[spacey]

Howete, thanks for the reply

In the past two annual assessments our assessor has said we are to thorough with the paperwork and would be an idea to reduce it, which we have each time

With the new standard saw as an opportunity to reduce paperwork further to without a manual as the manual is to the standard and our old document control procedure covers all the documents.

What I did not want to do was write a new manual and then be asked whay have we done this as it is a personalised version for you of the standard.

 

[spacey]

The question about a manual or not having a manual is always interesting.

I keep wondering, if you were going to build yourself a house would you do it from memory and imagination or use a set of plans?

Randy, thanks for the reply.

Interesting analogy.

 

[howste]

Howste, thanks for the reply

In the past two annual assessments our assessor has said we are to thorough with the paperwork and would be an idea to reduce it, which we have each time

With the new standard saw as an opportunity to reduce paperwork further to without a manual as the manual is to the standard and our old document control procedure covers all the documents.

You only have too much documentation if the benefits of the documents are outweighed by problems that they cause. You and your team live with the documents every day. If they are causing problems by being too prescriptive, telling people to do the wrong things, or too cumbersome to update, then the auditor may have a point. I personally wouldn't start by cutting out the quality manual. I'd start by looking at the documents that haven't been updated in years.

What I did not want to do was write a new manual and then be asked whay have we done this as it is a personalised version for you of the standard.

The auditor can ask that question all s/he wants, but if the manual is useful to you, your customers, etc. then you should keep it. Of course if it's just window dressing and doesn't add value then feel free to toss it.