PROBLEM IN SCOPE OF ISO 13485

[mpfizer]

Hi,

We. manufacture Orthopedic implants namely Plates, Screws , Nails , hip & Knee joints , Spinal implants ,Cranio Maxillofacial implants and patient specific implants .

In our scope we had written Design, Development Manufacture and Distribution of sterile and non sterile orthopedic implants . For a long time we had no problem in any of the audits ,

We had an audit recently and the auditor has pointed out that our scope should read as Design, Development Manufacture and Distribution of sterile and non sterile Plates, Screws , Nails , hip & Knee joints , Spinal implants ,Cranio Maxillofacial implants and patient specific implants

He says without naming the items he cannot certify and according to him orthopedic implants is a very general term.
He also mentioned that clauses 7.3.1 to 7.3.10 are product related and hence for each of the above items viz plates , screws nails etc we need clause wise .He is of the view that ISO 13485 cannot just be a QMS or management system standard because of 7.3.1 to 7.3.10.

Any comments / suggestions on how to convince the auditor that all the above items ie plates, screws , nails etc are orthopedic implants and hence no need to list all of them or is my understanding wrong.

Any help would be highly appreciated.

Thanks
michelle

 

[Sidney Vianna]

Any help would be highly appreciated.

This is something to be discussed with a technical manager at the CB, not with an auditor on-site. As exemplified a number of times, some auditors cannot keep their egos in check and like to think they have limitless authority over things. Put this person in his/her place.

 

[Ed Panek]

To add what SV said, and not brought up mid audit! He sent the audit plan I assume for review in advance? Very unprofessional and the CB industry rep is a good ally.

 

[John Broomfield]

Michelle,

Do you have a marketing or strategic reason for keeping your broadly stated scope?

If not, it may be better for your customers and worse for your competitors to keep your scope statement fairly specific.

For example: Quality assurance | Nuffield Health and Quality Management | Stryker

These are the organizations responsible for my newly fitted hip joints.

John

 

[John C. Abnet]

In addition to what @Sidney Vianna and @Ed Panek stated...., why is it just NOW a problem, (my understanding based on your OP), considering the CB he/she is representing has been providing your organization certification for "...a long time..."?

Unbelievable.

Raise the issue direct with your CB. If nothing is resolved...file a formal appeal with the CB (they all have an appeals method).

Ridiculous.

Hope this helps.
Be well.

 

[mpfizer]

Michelle,

Do you have a marketing or strategic reason for keeping your broadly stated scope?

If not, it may be better for your customers and worse for your competitors to keep your scope statement fairly specific.

For example: Quality assurance | Nuffield Health and Quality Management | Stryker

These are the organizations responsible for my newly fitted hip joints.

John

Hi,

Yes, we manufacture Orthopedic implants which covers so many items hence did not go into specifically each and every item in the past.
But the other issue is that the auditor seems to think that ISO 13485 is more of a product related standard rather than a QMS standard, hence each and every item needs to be mentioned in the scope not just orthopedic implant. We will be taking up the matter with CB.

Thanks

Michelle

 

[John Broomfield]

Thank you Michelle, please let us know how it goes.