ISO 9001:2008 - Implementation in practice

[trainerbob]

Thanks for the document. It is a good reminder for all of us to pay attention to the changes when they are pertinent to our situation. It is good to see people talking about the intent of the standard and doing what makes sense for our organization. These are the things that set ISO apart from so many regulations and allow us to run our businesses in a logical and reasonable manner for our own efficiency and effectiveness. We need to make sure we meet the intent without getting all caught up in semantics and some strict interpretation.

 

[John Broomfield]

You are right that there is a temptation to quote, but it is usually better to 'translate' the requirement into your own language e.g. 5.6.2 c) 'process performance and product conformity' - who uses that terminology in normal business usage? Perhaps if we used 'how well our processes are doing and how often we get it right/wrong', more people would understand what we mean.

Agreed, some organizations implement the standard by adding another layer of paper that largely rewrites the standard. The other type of organization makes the system that runs the business conform to the standard. The former type of organization have their manual as a rewrite of the standard and procedures numbered after the clauses to "pass an audit". The latter organizations interpret the standard primarily to make the systems that run their businesses more effective. The former see more work in "implementing ISO 9001:2008" and the latter see the lack of any real changes in ISO 9001:2008 as an opportunity lost and move on without having to update their system documents.

Finally ISO and the IAF have publicly stated that ISO 9001:2008 contains no new requirements beyond ISO 9001:2000. This is somewhat contradicted by IRCA wanting their auditors to undertake 2 hours of training/study in the updated standard before conducting audits using ISO 9001:2008.

I suppose the real problem is for organizations whose legacy interpretations of the requirements differ widely from the clarifications provided in the new Notes.

 

[samsung]

I can't speak to what might be the case in India, but in the US the primary difference is that a statutory requirement is one that is the direct result of legislation (a law or statute being enacted by a state or federal legislature) while a regulatory requirement is a type of rule developed by an agency authorized (usually by statute) to regulate certain industries or businesses. Note that regulations normally carry the force of law, but are not the direct result of legislation.

Thanks for good explanation from which I infer that a similar system of legislature does prevail in India. It means that, e.g. complying with the Environment (Protection) act (in India) is a statutory requirement but on the other hand, complying with certain rules, directives or notifications issued by various State Pollution Control boards (empowered by the said Act) should come under the category of Regulatory requirements.

Thanks to Stijloor & Coury Ferguson as well for their valuable input.

Best regards,

 

[Colin]

Samsung, please be aware that we are only talking about statutory and regulatory requirements which are applicable to 'product intended for, or required by, a customer'

As stated in the Scope of ISO 9001:2008 (Note 1). It does not apply to all statutory and regulatory requirements applicable to an organisation.

 

[samsung]

Samsung, please be aware that we are only talking about statutory and regulatory requirements which are applicable to 'product intended for, or required by, a customer'

As stated in the Scope of ISO 9001:2008 (Note 1). It does not apply to all statutory and regulatory requirements applicable to an organisation.

Yes, I do agree as far as 9001 is concerned, these requirements are limited to 'Product' only but incase of 14001 & 18001, their scope extends to all 'applicable' requirements.

Thanks & best regards,

 

[neelu]

I note that you already covered the issue that I wanted to project through the thread 'Auditing to ISO 9001:2008' that I initiated. I regret that and really I could have continued the discussion in this thread!
As you have stated, IRCA's requirement of 2h CPD apparently contradicts the intent of ISO's statement that 2008 version offers only more clarity. But unfortunately there are people waiting in the wings to exploit the contradiction-some with training modules and others ready to offer consultancy in rewriting the docs.!

 

[AndyN]

But unfortunately there are people waiting in the wings to exploit the contradiction-some with training modules and others ready to offer consultancy in rewriting the docs.!

One mustn't forget that some people simply renumbered their ISO 9001/2 1994 documentation to 'align' with the 2000 requirements! Many were even told by auditors who should have known better not to do that!

In my eyes this opportunity may be what's needed to have those 'old fashioned' systems fixed to meet the new requirements! If that means a few consultants and trainers are offering a way to accomplish that, good for them! Whatever it takes, in my view!

 

[amanbhai]

I have taken a one day session on ISO 9001 new requirements. Trainer said when you need clarification of the ISO 90001 standard requirements, read the requirements of ISO 9004! My question is that is the ISO 9004 standard has also been revised with ISO 9001?

 

[Big Jim]

Not yet. It should follow in a few months.

 

[Sidney Vianna]

Trainer said when you need clarification of the ISO 90001 standard requirements, read the requirements of ISO 9004!

From ISO 9004:2009 Committee Draft.

This International Standard gives guidance that complements the use of ISO 9001 and other management system standards, but does not give guidance on their application, i.e. it is not a guide to ISO 9001.

The same blub is in the current version of ISO 9004.