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:

ISO 13485 does require that responsibilities and authorities be documented. This is certainly joined at the hip with that requirement, and regulatory auditors will expect to see it documented.

A common approach to this is to document by title and avoid using names of individuals. As people move in and out of positions, you won't need to update documents.

I think Responsibility and authority must be written down in order to avoid conflict who does what.

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:

Steve has hit it right in bulleted form :)

Hmm, I guess I thought it should say in the section that it required documented requirements as does other sections. I guess we have to ensure that management is not changing these requirements too often. As someone else commented, it's not so much that people are moving in and out of positions, it's that management keeps on creating new titles, and giving and taking responsibilites to/from people.

We'll have to sit down with our management and specify these requirements and how important it is to communicate them, futhermore, keeping the documents up to date.

There are four clause mentioned responsibilities and authorities:
5.5.1 Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
5.5.2 Management representative shall have responsibility and authority ...
7.3.1 c) the responsibilities and authorities for design and development
8.3 A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

As I understand the responsibilities and authorities of all personel are defined in 5.5.1, why the standard repeat the requirements in 5.5.2/7.3.1/8.3 ? Why there is no the same reuqirements for other clause like 7.1/7.4?
Are there some connections or differences?

Dear Jelly.
As per i think
5.5.1 is general statement to guide all those person who can affect system
While other are specific (pin point- SHALL) requirement for some specific positions.
:agree::agree:

Hmm, I guess I thought it should say in the section that it required documented requirements as does other sections.It does: "Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization." (my emphasis)

I guess we have to ensure that management is not changing these requirements too often. As someone else commented, it's not so much that people are moving in and out of positions, it's that management keeps on creating new titles, and giving and taking responsibilites to/from people.

We'll have to sit down with our management and specify these requirements and how important it is to communicate them, futhermore, keeping the documents up to date.
Let them know that they can change them as often as they'd like, but that it's their responsibility to ensure that the documentation is updated and appropriate communication takes place.

Thank you for your reply.

I definetly know they are specific requirements. But my question is why there is no such specific reuqirement for clause 7.1/7.4 or whatever

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.

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.)

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.