Minor Nonconformity for Lack of Job Descriptions in ISO 9001

[Big Jim]

Re: Nonconformity for lack of job descriptions in ISO 9001

The President and myself were the ones speaking with the auditor, we never once said that we required job descriptions. The auditor brought that up by himself, he asked us to see our job descriptions.
I agree job descriptions are useful, and we do use them for employees not in management, but we shouldnt be required to have them for managment personnel

Your ARE required to do something to determine competency requirements for ALL positions, INCLUDING MANAGEMENT. If you have not done so, with job descriptions or in some other manner, IT IS A NONCONFORMANCE.

 

[kgott]

Re: Nonconformity for lack of job descriptions in ISO 9001

Although I agree that this is not a well written nonconformance, the auditor is not completely off base.

Your position is a hold over from a misunderstanding of ISO 9001:2000 before the note in 6.2.1 was added.

True, job descriptions are not specifically required by ISO 9001:2008, something akin to it IS REQUIRED.

6.2.2 a The organization shall . . . determine the necessary competence for personnel performing work affecting conformity to product requirements . . .

The note from 6.2.1 cited by others provides some illumination here.

NOTE: Conformity of product requirements can be affected directly or indirectly by personnel performing ANY task within the quality management system (emphasis added).

If you choose to use some other way than job descriptions to define the competencies for management, you can do so. Make sure that any written procedures you may have on the topic don't pin you down though.

The point is that you do have to define the needed competencies for ALL employees that have anything to do with the quality management system.

I would like to add to Big Jim's post that the point he makes is very important because the world is changing and many people in organisations these days wear more than one hat and writing job descriptions these days is becoming somewhat obsolete because of it.

Defining in writing the competences that are required and how the competences are applied to the way things get done is whats important.

This requires firstly, that process descriptions describe what each roledoes at each stage of the process. Secondly, it must focus on the role competency not the job tile. Eg, a person having expertise in xyz makes abc decision.

 

[Marcelo]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

Your ARE required to do something to determine competency requirements for ALL positions, INCLUDING MANAGEMENT. If you have not done so, with job descriptions of in some other manner, IT IS A NONCONFORMANCE.

For a business standpoint, I do agree with you.

From the standpoint of the standard, as you mention, the requirement is

6.2.2 a The organization shall . . . determine the necessary competence for personnel performing work affecting conformity to product requirements

So you are only required to determine the necessary competence of people whose work affect conformity to product requirements, not all positions.

 

[Big Jim]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

For a business standpoint, I do agree with you.

From the standpoint of the standard, as you mention, the requirement is



So you are only required to determine the necessary competence of people whose work affect conformity to product requirements, not all positions.

The note in 6.2.1 that was added in the 2008 version clears up your misconception.

NOTE: Conformity to product requirements can be affected directly or indirectly by personnel performing ANY TASK within the quality management system (emphasis added).

Part of the transition training for 2008 covered this topic.

If you have someone in your organization that has nothing to do with your quality management system, you would be right, but that would be rare. Perhaps the accountant if they were only involved with financial matters, but I believe a case could be made that they are also involved.

 

[Marcelo]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

The note in 6.2.1 that was added in the 2008 version clears up your misconception.

NOTE: Conformity to product requirements can be affected directly or indirectly by personnel performing ANY TASK within the quality management system (emphasis added).

I would prefer the emphasis on CAN.

From the ISO/IEC directives

can - be able to, there is a possibility of, it is possible to

So, rephrasing the note:

It's possible that conformity to product requirements is affected directly or indirectly by personnel performing any task within the quality management system


Which seems to mean that the organization has to evaluate it's process and define which personnel can affect product requirements.

Which has more sense than a standard that requires that the guy cleaning the bathroom has WILL affect product requirements and then shall have it's competence determined

If you have someone in your organization that has nothing to do with your quality management system, you would be right, but that would be rare. Perhaps the accountant if they were only involved with financial matters, but I believe a case could be made that they are also involved.

In fact, the organization defines who is part of it's QMS. So yes, I can have anyone in my organization (which a clear justification) that is outside the scope of the QMS. For example, if I product a general purpose equipment, and medical devices, and I apply ISO 13485, I can exclude from the ISo 13485 QMS anyone not working with the medical device part.


That's why there's a requirement in 4.2.2 a) to define the the scope of the quality management system.

 

[Big Jim]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

I would prefer the emphasis on CAN.

From the ISO/IEC directives



So, rephrasing the note:

It's possible that conformity to product requirements is affected directly or indirectly by personnel performing any task within the quality management system


Which seems to mean that the organization has to evaluate it's process and define which personnel can affect product requirements.

Which has more sense than a standard that requires that the guy cleaning the bathroom has WILL affect product requirements and then shall have it's competence determined



In fact, the organization defines who is part of it's QMS. So yes, I can have anyone in my organization (which a clear justification) that is outside the scope of the QMS. For example, if I product a general purpose equipment, and medical devices, and I apply ISO 13485, I can exclude from the ISo 13485 QMS anyone not working with the medical device part.


That's why there's a requirement in 4.2.2 a) to define the the scope of the quality management system.

You mention those that are outside of the scope of registration. That is not the topic at hand.

You have also modified the wording of the standard to suit your own needs, which is not permitted. That seems to be what the OP is trying to do. They don't want to include management in the need to determine competencies, so they are not going to and they are fighting the auditor that called them on it.

 

[Marcelo]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

You mention those that are outside of the scope of registration.

I'm not talking about registration. I'm talking about the scope of the standard. The main problem here is in fact how some certifiers or registrars interpret the requirements.

You have also modified the wording of the standard to suit your own needs, which is not permitted.

Nope, I just used the ISO/IEC rules on what the word "can" means in all ISO/IEC standards.

Just take a look at the ISO/IEC Directives, Part 2, Rules for the structure and drafting of International Standards - Annex H - Verbal forms for the expression of provisions.

They don't want to include management in the need to determine competencies, so they are not going to and they are fighting the auditor that called them on it.

I'm not sure this is the case. The OP was dealing with the auditor forcing that the organization create job descriptions because the auditor thinks they are required by the standard. I just wanted to clarify that not all personnel will affect product quality. But the organization has to determine who affects. Not the auditor.

Anyway, I agree with you that management may, and usually will, affect product quality.

 

[sliebman]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

So here is what we have:

• an org chart that details the hierchy of the company,
• each procedure clearly states who is responsible, by title, and what the responsibilities are for that procedure or process,
• a clause in our manual that states "It is our policy that whenever a procedure or instruction asigns responsibility and authority for the performance of a task, the responsible party may delegate performance of the task to anyone they choos, providing they ensure that the: A. assignment is clear to and understood by the appointee, B. appointee is properly trained to perform the task, and C. results of the work performed meet the specified requirements.
• a matrix of all employees, with all compentancy catagories listed, and "Y" for those that an employee fills,
• a yearly (minimum) review of every employee using this matrix, along with all department heads (committee) to fully review the employees

I would agrue that with responsbilities and required skills/compentancies listed in all the procedures, and our reviews, we meet both clauses 6.2.1 and (even though he didnt site this one) 6.2.2 a.

 

[qusys]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

So here is what we have:

• an org chart that details the hierchy of the company,
• each procedure clearly states who is responsible, by title, and what the responsibilities are for that procedure or process,
• a clause in our manual that states "It is our policy that whenever a procedure or instruction asigns responsibility and authority for the performance of a task, the responsible party may delegate performance of the task to anyone they choos, providing they ensure that the: A. assignment is clear to and understood by the appointee, B. appointee is properly trained to perform the task, and C. results of the work performed meet the specified requirements.
• a matrix of all employees, with all compentancy catagories listed, and "Y" for those that an employee fills,
• a yearly (minimum) review of every employee using this matrix, along with all department heads (committee) to fully review the employees

I would agrue that with responsbilities and required skills/compentancies listed in all the procedures, and our reviews, we meet both clauses 6.2.1 and (even though he didnt site this one) 6.2.2 a.

The auditor should have collected the evidences on the field by interviewing personnel at all level to verify if 5.5.1 clause of ISO 9001 was met.
Did he do it?

 

[John Broomfield]

Re: Nonconformity for Lack of Job Descriptions in ISO 9001

So here is what we have:

• an org chart that details the hierchy of the company,
• each procedure clearly states who is responsible, by title, and what the responsibilities are for that procedure or process,
• a clause in our manual that states "It is our policy that whenever a procedure or instruction asigns responsibility and authority for the performance of a task, the responsible party may delegate performance of the task to anyone they choose, providing they ensure that the: A. assignment is clear to and understood by the appointee, B. appointee is properly trained to perform the task, and C. results of the work performed meet the specified requirements.
• a matrix of all employees, with all compentancy catagories listed, and "Y" for those that an employee fills,
• a yearly (minimum) review of every employee using this matrix, along with all department heads (committee) to fully review the employees

I would agrue that with responsbilities and required skills/compentancies listed in all the procedures, and our reviews, we meet both clauses 6.2.1 and (even though he didnt site this one) 6.2.2 a.

sliebman,

Looks good.

I would change B to appointee is competent to perform the task.

As an auditor I would be concerned about three things:

1. Who is competent to verify competence?
2. What about the undocumented procedures?
3. What about the leaders of the organization (with the scope of the QMS)?

These three concerns may be addressed by your matrix.

John