ISO 9001 certification (registration) requirements - No commercial product or service

[Marc]

In the 'Old Days'... At least 3 months of records (preferably 6)

In the 'Old Days'...

The bottom line was you needed at least 3 months of records (preferably 6) as evidence to be able to show that systems function as designed. This was rarely an issue for established companies, even when they did some system changes to comply with ISO 9001.

There is the evidence of systems functioning as designed, and there is the internal audit aspect. You have to do a full round of internal audits prior to the registration audit. Technically you cannot do a round of internal audits for the same reason - You need to audit functioning systems.

Like I say - The 'old litmus' test was at least 3 months of records (preferably 6) from functioning systems.

 

[Sidney Vianna]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

In the 'Old Days'...

There is the evidence of systems functioning as designed, and there is the internal audit aspect. You have to do a full round of internal audits prior to the registration audit. Technically you cannot do a round of internal audits for the same reason - You need to audit functioning systems.

Like I say - The 'old litmus' test was at least 3 months of records (preferably 6) from functioning systems.

You are correct. The IAF Guidance to Guide 62 requires the organization to be able to demonstrate results from the internal audit and management review activities BEFORE they could be certified. The 3-month rule "tribal requirement" is legendary. However, it is not supported anywhere by an explicit requirement of the accredited certification process. Also, certain activities, such as assembly and inspection activities generate a lot of records. Others, such as design development, supplier monitoring, etc. might take much longer than 3 months to generate evidence and records that they are effectively implemented.

The key thing to remember IMHO is that, certification should mean that the system is implemented and in conformance with a given standard. And evidence of that is available. To certify a system that has not been implemented is like giving a birth certificate to a fetus in it's 3rd month of gestation.

 

[Marc]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

To certify a system that has not been implemented is like giving a birth certificate to a fetus in it's 3rd month of gestation.

The key is: "There must be evidence of systems functioning as designed". The necessary time frame is a function of the specific systems, the specific company scenario / systems; basically the length of time necessary to be able to prove all relevant systems are operating as designed.

For simple businesses a short time frame is sufficient, while more complex businesses require more time.

I am disappointed you compare a fetus to a business system.

 

[Paul Simpson]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

The key is: "There must be evidence of systems functioning as designed". The necessary time frame is a function of the specific systems, the specific company scenario / systems; basically the length of time necessary to be able to prove all relevant systems are operating as designed.

Agreed. The only thing I would say is that these rules are self imposed by the industry on itself. If they make no sense (as in my example) then the industry can issue itself a waiver to operate outside those rules. Under strictly controlled conditions.

For simple businesses a short time frame is sufficient, while more complex businesses require more time.

Very true.

I am disappointed you compare a fetus to a business system.

Am I the only one who thinks Sidney's analogy was a good one? It is a fact of life (no pun intended) that everything has its life cycle. This kind of term is used everywhere from reliability to marketing.

Anything that helps concepts to be better understood is a positive IMHO.

On an entirely separate but related topic are we on the cove starting to apply double standards. I remember on other threads arguing against organisations having limited scopes assessed and certified. Isn't this a case of exclusion of clauses 7.2, 7.4, 7.5, 7,6 with a view to bringing them in at a later stage!

 

[Marc]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

Am I the only one who thinks Sidney's analogy was a good one? It is a fact of life (no pun intended) that everything has its life cycle. This kind of term is used everywhere from reliability to marketing.

I just don't want to get any 'activists' upset about the analogy.

 

[Sidney Vianna]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

I am disappointed you compare a fetus to a business system.

I just don't want to get any 'activists' upset about the analogy.

Marc, I am fully aware of the Cove rules of engagement to avoid political, religious and non-related contentious issues. The intent of my analogy was not to compare a fetus to a business system. My intent was to try to make a point about sequence of events and it's chronology. If I offended anyone, my apologies.

 

[Jim Wynne]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

Marc, I am fully aware of the Cove rules of engagement to avoid political, religious and non-related contentious issues. The intent of my analogy was not to compare a fetus to a business system. My intent was to try to make a point about sequence of events and it's chronology. If I offended anyone, my apologies.

I can't see how anyone could have possibly been offended, but perhaps it might be best to go back to the analogy in my original response in this post--a building inspector issuing an occupancy permit before the building is constructed.

 

[Marc]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

Marc, I am fully aware of the Cove rules of engagement to avoid political, religious and non-related contentious issues. The intent of my analogy was not to compare a fetus to a business system. My intent was to try to make a point about sequence of events and it's chronology. If I offended anyone, my apologies.

Yeah - I'm kinda touchy right now. I got another 'nasty gram' a couple days ago over something I thought was silly. It just sorta hit me as something some people might take offense to. Sorry to be so touchy, but as you know it's not very often I do say something about content these days.

No big deal.

 

[BradM]

Re: In the 'Old Days'... At least 3 months of records (preferably 6)

Yeah - I'm kinda touchy right now. I got another 'nasty gram' a couple days ago over something I thought was silly. It just sorta hit me as something some people might take offense to. Sorry to be so touchy, but as you know it's not very often I do say something about content these days.

No big deal.

Your job is not an easy one. I think I could speak for most in saying that we greatly appreciate your efforts (and your moderators), and the excellence you maintain at the Cove. As you alluded to, as with many situations, there may be things going on in the background that others are unaware of. This behind-the-scenes activities can/do affect your actions.

I did not see the analogy in any light other than it's relational intent. However, I appreciate you erring on the side of integrity and neutrality.

Carry on, Captain!!

It's ARBOR DAY! Everyone go plant a tree!!

 

[Sidney Vianna]

Back on track?

Isn't this a case of exclusion of clauses 7.2, 7.4, 7.5, 7,6 with a view to bringing them in at a later stage!

Paul, exclusions can only be considered as long as they do not affect the organization's ability or responsibility, to provide product that meets customer and applicable regulatory requirements. I don't see how any organization can exclude 7.2 or 7.5. For them to exclude 7.2 it would mean they do not have customers. If you exclude 7.5, you don't have a product. Either way, in both instances, they would not have a QMS.