What should be changed in the ISO 9001:2015 Standard?

[AndyN]

they should be "doing what they say" at all times.

Unannounced internal audits, while are not desirable to the workforce, are very effective.

As lead internal auditor for my company, the members of the audit team are trained to try and make an internal audit a positive experience as best they can.
http://elsmar.com/Forums/images/smilies/I_agree.gif

If you don't involve management in the planning and preparation for the audit - which means they're not a surprize - you won't get the 'right' results. It doesn't matter if the auditors all have a masters in psychology and dress in clown suits, it won't make people accept them any better!

 

[JaneB]

That being said I also think that the Technical Committee should address the maintenance process and clarify the preventative maintenance aspect of this process.
Everyone knows that Preventative Maintenance of equipment and infrastructure is a good business practice...but there are no definitive requirements for this in the current version.

The Standard is intended to be applicable to any type of organisation, not just manufacturing-type businesses that rely heavily on plant and equipment, etc. Service businesses often don't.

 

[howste]

Everyone knows that Preventative Maintenance of equipment and infrastructure is a good business practice...but there are no definitive requirements for this in the current version.
Correct me if I am wrong about this.

How about this?

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software)...

 

[TSInternal]

Re: What should be changed in the ISO 9001:2014 Standard?

Scott,
I so agree. Working for and being a Internal Auditor for a design center, we have been through the same scenario, trying to prove we are compliant to a outside auditor just to be told we lack a checklist for a checklist.... its craziness.

 

[MichelleN]

I would suggest the following:
- 4.2.3 Control of documents
i: b) to review and update "as decided by the company" (or internally or something similar) instead of "as necessary"
ii: to provide a better definition for obsolete documents if possible (my previous manager didn't like the term "obsolete" and he changed it to "superseded" and he used his definition...and now...there are no longer obsolete documents in the company...and everybody could use them the way they want...!!! and the third party auditor didn't catch that during the last two audits. They are mostly electronic documents)
Also it should be indicated somewhere if the definitions provided in ISO 9001 or in ISO 9000:2005 are mandatory or not (same is applicable for other standards, too, like AS 9100 or ISO 13485, etc). It may seem childish to ask this but I had several problems related to definitions!!!

- re-add the "positive recall procedure" in case a product is needed to be used before all quality information is available (I don't know why this was removed while it's still there in AS 9100!)

-add about risk management, and probably about risk based auditing

-maybe add info @ 8.2.2, Internal audits, e.g. period covered to audit the whole system. Nowhere is indicated if one year or two years or even three. Dennis Arter indicated in his book that max three years, but it's nothing official, and it happened that not even the third party auditor who audited us knew about this: he asked me to demonstrate him that I covered several processes (e.g Design and Development) every year.

In my opinion some guidance attached to the standard might be beneficial. Also, I believe that the Manual could be non-mandatory, as soon as the Quality Policy, the system procedures and the matrix connecting the procedures and the standard can be provided.

Thanks.

 

[kgott]

Quality economics, a.k.a cost of quality

Sidney; I assume you mean the cost of poor quality?

 

[howste]

Also it should be indicated somewhere if the definitions provided in ISO 9001 or in ISO 9000:2005 are mandatory or not (same is applicable for other standards, too, like AS 9100 or ISO 13485, etc). It may seem childish to ask this but I had several problems related to definitions!!!

Here's what the standard currently says about this:

2 Normative references

The following referenced documents are indispensable for the application of this document...

ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

Is there another way that you'd like it worded?

 

[MichelleN]

Yes, I agree with you Howste, and for me that's fine.
However, a different wording it might show that better, not everybody would understand it properly, believe-me. I am talking about people with no quality experience, and no special desire to accept quality requirements. The standard now is so vague (than the 94 version) that it gives way to all kind of personal interpretations. Kind like...everybody believes he's an expert in understanding the requirements within.

 

[MichelleN]

I have a question with regard to 4.2.3 b): if the company doesn't indicate anywhere an interval for reviewing internal procedures and therefore (some of) the procedures are maybe 8-10 years old and there is no indication of such review how can an internal auditor raise an audit nonconformance for this requirement taking into consideration the exact wording from b)?? Especially when a manager (the audit manager!!) answers: it is /was not necessary. "As necessary" there was not a very good choice in my opinion.

 

[samsung]

I have a question with regard to 4.2.3 b): if the company doesn't indicate anywhere an interval for reviewing internal procedures and therefore (some of) the procedures are maybe 8-10 years old and there is no indication of such review how can an internal auditor raise an audit nonconformance for this requirement taking into consideration the exact wording from b)?? Especially when a manager (the audit manager!!) answers: it is /was not necessary. "As necessary" there was not a very good choice in my opinion.

The exact requirement is

A documented procedure shall be established to define the controls needed
b) to review and update as necessary and re-approve documents,

Review is mandatory and the term 'as necessary' relates to update. Having conducted a document review, you may not find anything to be updated but you will have to document how, and when a document has to be reviewed.