How much objective evidence is required for ISO9000 certification?

al40

Quite Involved in Discussions
#1
We have implemented our QMS, released our procedures and we're now doing our initial internal audits and I'm finding that we're lacking objective evidence in some areas. The problem is that the information just hasn't been generated yet.

I have not schedule our preassessment audit yet due to this problem my question is the following:

What is the ISO requirement for objective evidence for certification to ISO 9001:2000? If there is an requirement where is it located?

My President is asking "Can we be certified or will this delay our certification and why" my experience tells me we need the evidence to prove the system is working but I've been wrong in the past.

Please advise,

Al
 
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RoxaneB

Super Moderator
Super Moderator
#2
I like to see at least 3-4 months of evidence supporting the fact that you have a system in place.

What evidence is missing? Obviously your internal audit reports :) ...but what else?
 

al40

Quite Involved in Discussions
#3
RCBeyette said:
I like to see at least 3-4 months of evidence supporting the fact that you have a system in place.

What evidence is missing? Obviously your internal audit reports :) ...but what else?
Overall we missing objective evidence in areas of 7.3 - 7.3.7 and 7.5 Since we have not produced a development project through the entire design phase, we currently have two projects we're working on but none that have been through the entire design and development process yet.

I understand the "I like to see", but I have a president that wants to see it in writing why he would be prevented form obtaining ISO certification since he has the processes in place in his words "He's being penalized for lack of objective evidence and he is unable to find this requirement in ISO9001:2000".

:thanx:
 

Al Rosen

Staff member
Super Moderator
#4
Allen M. said:
Overall we missing objective evidence in areas of 7.3 - 7.3.7 and 7.5 Since we have not produced a development project through the entire design phase, we currently have two projects we're working on but none that have been through the entire design and development process yet.

I understand the "I like to see", but I have a president that wants to see it in writing why he would be prevented form obtaining ISO certification since he has the processes in place in his words "He's being penalized for lack of objective evidence and he is unable to find this requirement in ISO9001:2000".

:thanx:
There isn't anything within the standard that addresses registration. The objective evidence requirement is imposed by the registrar. So, your boss can claim compliance, but not registration. If he wants registration, find a registrar that will accept your word. For that matter, all that is required is a document review.:rolleyes: Surveilance audits would then just verify that no changes were made to your documentation. See where this is headed.
 

Randy

Super Moderator
#5
Allen M. said:
What is the ISO requirement for objective evidence for certification to ISO 9001:2000? If there is an requirement where is it located?


Al

There is no ISO requirement. There are only those requirements established by the IAF, Accreditation bodies and Certification/Registration bodies.
 
S

silly girl

#6
Lack of 'Objective' evidence

I have run into this many times myself, especially when implementing a new standard in anticipation of customer requirements that were not previously in place. Obviously it depends a lot on your registrar... however, my experience has been that when a process has not actually occurred yet you can still have objective evidence in the form of documented procedures, training records and operator knowledge.

I would not hesitate to register given the scenario you have described. It is most likely that the auditor will want to check the same process again at the next audit to see if the process occurred as described. This seems like it might be a good idea to talk with your registrar about what their requirements are.

My 2 :2cents:
 

al40

Quite Involved in Discussions
#7
silly girl said:
I have run into this many times myself, especially when implementing a new standard in anticipation of customer requirements that were not previously in place. Obviously it depends a lot on your registrar... however, my experience has been that when a process has not actually occurred yet you can still have objective evidence in the form of documented procedures, training records and operator knowledge.

I would not hesitate to register given the scenario you have described. It is most likely that the auditor will want to check the same process again at the next audit to see if the process occurred as described. This seems like it might be a good idea to talk with your registrar about what their requirements are.

My 2 :2cents:
Thanks for the info everyone , I have schedule a call with my registstrar. Will get back with results.

:thanx:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Please check this reply http://elsmar.com/Forums/showpost.php?p=112616&postcount=3

The basic train of requirements starts with the Accreditation Bodies invoking ISO Guide 62 as one of the criteria for Registrars to be accredited. ISO Guide 62 (to be replaced by ISO 17021) calls for “compliance with ISO 10011, which is an obsolete document, replaced by ISO 19011, which states:

“…Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process

Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted during a finite period of time and with finite resources. The appropriate use of sampling is closely related to the confidence that can be placed in the audit conclusions….”

So, you are required to have objective evidence to demonstrate that your quality system is operational, before being granted certification. Definitely some registrars are more “understanding” than others.

However, your scenario is not all that uncommon. Actually, there are some organizations that can spend several YEARS to go from a conceptual stage to finalized design validation. This is sometimes due to (deliberately) long (clinical) trials, to satisfy regulatory scrutiny. Sometimes is just due to extreme complexity of the item being designed, e.g., space shuttle. In those circumstances, it would be unfair for an organization to have to wait years until they finish a product design and development cycle, before being “certifiable”. Some Registrars that have their act together will have reasonable ways to work with organizations facing this type of scenarios.
 

al40

Quite Involved in Discussions
#9
Sidney Vianna said:
Please check this reply http://elsmar.com/Forums/showpost.php?p=112616&postcount=3

The basic train of requirements starts with the Accreditation Bodies invoking ISO Guide 62 as one of the criteria for Registrars to be accredited. ISO Guide 62 (to be replaced by ISO 17021) calls for “compliance with ISO 10011, which is an obsolete document, replaced by ISO 19011, which states:

“…Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process

Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted during a finite period of time and with finite resources. The appropriate use of sampling is closely related to the confidence that can be placed in the audit conclusions….”

So, you are required to have objective evidence to demonstrate that your quality system is operational, before being granted certification. Definitely some registrars are more “understanding” than others.

However, your scenario is not all that uncommon. Actually, there are some organizations that can spend several YEARS to go from a conceptual stage to finalized design validation. This is sometimes due to (deliberately) long (clinical) trials, to satisfy regulatory scrutiny. Sometimes is just due to extreme complexity of the item being designed, e.g., space shuttle. In those circumstances, it would be unfair for an organization to have to wait years until they finish a product design and development cycle, before being “certifiable”. Some Registrars that have their act together will have reasonable ways to work with organizations facing this type of scenarios.
Thanks Sidney,

I talked with my registrar and they said during my pre-assessment audit they would look at where we are and and what evidence is missing in order to make a fact based decision. They said that they would take into account that we have projects in the pipeline that can be reviewed at a later date or during the next follow-up audit and would not prevent us from being certified.


:thanx:
 
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