Interpreting Responsibility and Authority Clause 5.5.1 ISO 13485

  • Thread starter QualitySysISOAdmin
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R

Roland Cooke

#11
There's more to 5.5.1 than just the first line.

The second line demands independence for those doing work that involves quality (of the product).

For that we are looking to ensure that QC/QA doesn't report to Sales (for example), at least not without appropriate justification/controls. It can obviously get tricky in very small companies.
 
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zhang126

#12
Re: 5.5.1 Responsibility and Authority (help)

This should be covered automatically in your:
(a) Quality Manual
(b) Job Descriptions
(c) Management Reviews

So as indicated, it has to be documented.
:2cents:
+ organization chart
+ personnel file (CV, perfomrance evaluation, education/training records, position in the organization, job accountability etc.)
 

John Broomfield

Staff member
Super Moderator
#13
Hello,

My company is registering for ISO 13485 and we need some help on how to interpret section 5.5.1. It mentions that managment establishes the interrelation of personnel who manage, perform, and verify work affecting quality. It also states that management shall ensure the independence and authority necessary to perform these tasks.

Our question is, do we have to document this? I know the section does not mentioned that it has to be documented but we are afraid that when we get audited that we will not be able to prove the independence and authorities.

Is there any other suggestions other than documenting?
We would like not to document because we feel that if we were to do this that we would be tieing ourselves down and anytime any authorities change we have to update the document. If the change is not communicated to those who control that document then it will never get changed as appropriate.

Please help, we're open to all ideas at this point. :confused:
The documented organization chart is one way to show freedom of action. A posted letter from the CEO personally delegating independent authority to the Quality Manager, for example, also works very well.
 
S

sturey45

#14
Good Morning,

We were hit with a Non Conformance during our Re-certification and Transition audit to ISO 13485:2016 because we use initials as the person who approves final quality checks.

The non conformance was written "the identification and approval of employees who verify conformance is not clearly identified" and referenced 5.5.1.

We are a smaller company and do not have any issues identifying the initials, turn over is low. We use initials due to space on our documentation. Do we really need to have a list of the people who perform and verify work affecting quality and associated initials? Our QM defines the responsibility and interrelation, but confused to the finer points of this Non Conformance.

Our current practices may not be right, and any guidance would be appreciated.

Thanks
Stuart
 

Marcelo

Inactive Registered Visitor
#15
Good Morning,

We were hit with a Non Conformance during our Re-certification and Transition audit to ISO 13485:2016 because we use initials as the person who approves final quality checks.

The non conformance was written "the identification and approval of employees who verify conformance is not clearly identified" and referenced 5.5.1.

We are a smaller company and do not have any issues identifying the initials, turn over is low. We use initials due to space on our documentation. Do we really need to have a list of the people who perform and verify work affecting quality and associated initials? Our QM defines the responsibility and interrelation, but confused to the finer points of this Non Conformance.

Our current practices may not be right, and any guidance would be appreciated.

Thanks
Stuart
Responsibility and authority as required by ISO 13485 are related to the processes and tasks.

Responsibility is related to who is accountable for a result.

Authority is related to who can perform tasks that get results.

Although I may be responsible for a results, I may not be the one to perform the actions to get to that result. In this way, I would retain responsibility and would delegate the authority to other, tp perform the tasks in my name (please note that in this case retain responsibility but do not have authority anymore, so I cannot perform the tasks anymore, but I'm still accountable if the result is not obtained).

Another problem (more in line with the NC mentioned) is that people cannot verify tasks and results they are responsible for (otherwise there's a conflict of interests).

I'm not sure exactly what is the problem mentioned in the NC, but from experience (and the fact that you are small company), it's probably a mix of both.
 
S

sturey45

#16
:thanx:

Marcelo thank you for your reply. Your answer helped with the definitions and some bigger picture issues we have.

We were ultimately hit with the NC because we used initials instead of, I don't know, full names or something. Auditor was concerned we couldn't trace back who "approved" the work if that person was to leave. Didn't explain much in our report. :bonk:

Thanks again,
Stuart
 

Marcelo

Inactive Registered Visitor
#17
:thanx:

Marcelo thank you for your reply. Your answer helped with the definitions and some bigger picture issues we have.

We were ultimately hit with the NC because we used initials instead of, I don't know, full names or something. Auditor was concerned we couldn't trace back who "approved" the work if that person was to leave. Didn't explain much in our report. :bonk:

Thanks again,
Stuart
Any ID system which works would be ok in principle, you really do not have to have full names or whatever. That's I mentioned the more generic stuff, I'm not sure if that was the "real"basis for the NC. If the basis was really only the initials, it would be weird, because the standard do not define "how" the ID should be made.
 

Sam Lazzara

Trusted Information Resource
#18
I have employed a form called the "Personnel Signature Record" to address concerns with the use of initials instead of a signature.

Here is a link to it. You will see that the form also takes care of some things that are important to address for electronic signatures, if you utilize them.

There are no requirements for signature requirements in ISO 13485:2003 or 2016. There are signature requirements in FDA 21 CFR Part 820.

I am a bit mystified by your NC but I bet you would not have one if you had Personnel Signature Records or something similar like a Personnel Signature Log where you have each person print name, write their initials, and write their signature.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#19
We were hit with a Non Conformance during our Re-certification and Transition audit to ISO 13485:2016 because we use initials as the person who approves final quality checks.

The non conformance was written "the identification and approval of employees who verify conformance is not clearly identified" and referenced 5.5.1.
Apparently this auditor is not well versed in the new edition of 13485. The requirement s/he should have cited is the second sentence in the second paragraph of 8.2.6, which reads:
The identity of the person authorizing release of product shall be recorded.
 
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