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

[BillG]

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

The quality manual has 5 requirements: the scope of the QMS, the exclusions in the QMS, the refernece to the procedures in the QMS, a description of the documentation structure of the QMS and the interaction and sequenceof the processes of the QMS. Therefore my new Quality Manuals now is 3 pages.

 

[howste]

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

The quality manual has 5 requirements: the scope of the QMS, the exclusions in the QMS, the refernece to the procedures in the QMS, a description of the documentation structure of the QMS and the interaction and sequenceof the processes of the QMS. Therefore my new Quality Manuals now is 3 pages.

You must deal with medical device quality manuals. ISO 9001 doesn't require documentation structure to be defined in the manual, but ISO 13485 does.

 

[JaneB]

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

Yes, good advice from John.

at least i can now tell people about the practical quality manual. only problem is 'old trad CB auditors' still subscribe to the old fashioned quality manual- that no body is interested to read, except new hires (who are required to read)

Strategies here include:

• take as much care in selecting your CB and also the auditor/s they send out to you as you would with any other important supplier, and
• be very well informed about what the Standard does say about the documentation requirements as well as what it does not

.
Your system - and its documentation - should be sane, sensible and work for you. It's not for any auditor to say what it should be or look like.

 

[Ka Pilo]

Now that the amendment of ISO 9001:2008 is done with, hopefully the TC 176 will have the courage to instill significant changes in the next revision of ISO 9001.

I thought we should start a thread so people could suggest possible changes to the standard. We have Cove members that participate in the US TAG and can convey (should they agree) our collective requests.

In my opinion, certain things need to be significantly revised.

The first one is preventive action. The TC 176 should re-phrase the requirements associated with preventive actions, so it can be meaningfully implemented in the real world. At present, the requirement is unclear and difficult to assess compliance against.

Another suggestion I have is for emphasis on process and system effectiveness. 8.2.3, for example, is completely disregarded by many organizations.

Quality economics, a.k.a cost of quality and mandatory review during management reviews is another candidate in my book.

Other ideas?

The current standard requires us to plan an audit programme "taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits." The TC 176 should consider both announced internal audits and a surprise internal audits. Experience has shown me that relevant functions or levels really do their bests during audit days and do some fixing only when the audit is coming soon.

 

[AndyN]

The current standard requires us to plan an audit programme "taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits." The TC 176 should consider both announced internal audits and a surprise internal audits. Experience has shown me that relevant functions or levels really do their bests during audit days and do some fixing only when the audit is coming soon.

Auditing is covered in ISO 19011. BTW - no one should be doing 'unannounced' internal audits!

 

[John Broomfield]

The current standard requires us to plan an audit programme "taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits." The TC 176 should consider both announced internal audits and a surprise internal audits. Experience has shown me that relevant functions or levels really do their bests during audit days and do some fixing only when the audit is coming soon.

Ka Pilo,

As soon as the auditors become managers (when workers "do their best") they are no longer working as auditors.

Operators, Supervisors, Managers and Directors monitoring the processes (per 8.2.3 - announced and unannounced) may be far more effective.

Hopefully audit is not replacing supervision, management and leadership.

When last did the auditors audit and report on the process of monitoring processes?

John

 

[Ka Pilo]

Auditing is covered in ISO 19011. BTW - no one should be doing 'unannounced' internal audits!

Thanks, Andy. I would appreciate if you could post here the paragraph/section that contains the exact statement about unannounced audits.

 

[AndyN]

Thanks, Andy. I would appreciate if you could post here the paragraph/section that contains the exact statement about unannounced audits.

There is nothing about unannounced audits in ISO 19011 - they are generally, speaking, not a good idea! You will not get any value from them!

 

[JaneB]

Operators, Supervisors, Managers and Directors monitoring the processes (per 8.2.3 - announced and unannounced) may be far more effective.

Hopefully audit is not replacing supervision, management and leadership.

Yes, indeedy.

Although I'd say IS more effective rather than 'may be'. But you were perhaps being polite.

 

[vanputten]

Andy

Stating there is no value to unannounced audits is quite a sweeping generalization. And I don't think it is true. You might get less value from an announced audit over an announced audit.

Are OSHA, Fire Departments, Underwriters Laboratory in the United States completely non-value add with their unannounced audits?