ISO 9001:2008 - Implementation in practice

[Stijloor]

Yes, Off course you have to change your procedures when new version of standard is generated.

What Standard are you specifically referring to?

Stijloor.

 

[al40]

Hi, Al.Congratulations on the recommendation to transfer your certification to 9k08!

Next time you speak to your auditor perhaps you could ask him / her how an organization exceeds the requirements of 9k08?

The way I understand it if your organization needs a wide range of tools and techniques (because it suits your purpose) then the QMS has to stretch to accommodate - hey presto it is now an 9k08 requirement!

I think what he meant is that we had all the correct documentation in place and that we have implemented a very strong quality culture in our organization.

I think we all know word smithing when we see it especially from external auditors

Happy Holidays,

Al40

 

[Coury Ferguson]

Just went through my recertification audit and my Auditor commented that we had exceeded the requirements of ISO 9001:2008 and no changes were needed to my documentation.

Best regards,
Al40

Interesting comment by your assessor.

In my opinion if you want to really exceed the requirements of ISO9001:2008, base your Management system around ISO9004:200x then in my opinion you would meet and exceed the requirements of ISO9001:2008.

 

[Paul Simpson]

Yes, Off course you have to change your procedures when new version of standard is generated.

The only times you have to change a documented procedure are when:

1. The procedure that is documented changes (not the case here)
2. Your references change (moral of the story don't refer to the standard in your manual / procedures)

 

[JaneB]

The only times you have to change a documented procedure are when:

1. The procedure that is documented changes (not the case here)
2. Your references change (moral of the story don't refer to the standard in your manual / procedures)

I'm going to disagree here slightly. There are times when you need to refer to a Standard in a procedure - eg, there's a set of Standards we use in Australia that define requirements for fire & building safety checks, right down to the time intervals between checks. A procedure for such a business relies heavily on the various Standards and refers to them (otherwise, it would be duplicated & wasted effort).

So I would say instead: "if you do refer to a Standard, refer to it by name/number (but not version)". You then won't have to change it.

But - naturally, you must make sure that you have sound control over external documents such as any relevant Standards, so that you are informed of any updated one, and anyone needing to refer to it now refers to the (new) current version and not the old (supersed) one.

 

[samsung]

New ISO standard (9001:2008) has added one more word 'statutory' and now insists to comply with statutory requirements in addition to regulatory ones.

Is there any specific difference between these two words which seem very synonymous to each other ?

Valuable inputs appreciated.

Best regards,

 

[Coury Ferguson]

Here is the Dictionary definition:

Main Entry: stat·u·to·ry
Pronunciation:
Function: adjective
Date: 1766
1 : of or relating to statutes
2 : enacted, created, or regulated by statute <a statutory age limit>
— stat·u·to·ri·ly adverb

Main Entry: reg·u·late
Pronunciation:
Function: transitive verb
Inflected Form(s): reg·u·lat·ed; reg·u·lat·ing
Etymology: Middle English, from Late Latin regulatus, past participle of regulare, from Latin regula rule
Date: 15th century
1 a: to govern or direct according to rule b (1): to bring under the control of law or constituted authority (2): to make regulations for or concerning <regulate the industries of a country>
2: to bring order, method, or uniformity to <regulate one's habits>
3: to fix or adjust the time, amount, degree, or rate of <regulate the pressure of a tire>
— reg·u·la·tive adjective
— reg·u·la·to·ry adjective

 

[samsung]

Here is the Dictionary definition:

1 a: to govern or direct according to rule b (1): to bring under the control of law or constituted authority (2): to make regulations for or concerning <regulate the industries of a country>

Thanks for the response. What creates confusion is that the Rules & Regulations are made, enacted & enforced by the 'Statutory' bodies.

Some clarification with examples appreciated.

Best regards,

 

[Stijloor]

Thanks for the response. What creates confusion is that the Rules & Regulations are made, enacted & enforced by the 'Statutory' bodies.

Some clarification with examples appreciated.

Best regards,

I use a simple explanation:

Statutory: Required by a Statute - a Law. (City, County, State, Federal)

Regulatory: Required by a Regulatory Agency (FDA, FAA, etc.)

Stijloor.

 

[Jim Wynne]

Thanks for the response. What creates confusion is that the Rules & Regulations are made, enacted & enforced by the 'Statutory' bodies.

Some clarification with examples appreciated.

Best regards,

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.