ISO 9001 Certification Audit of a Service Provider

[aliakbar]

Its a fact that the implementation of ISO 9001 is more in Production companies then in service organizations.

My company is providing technical services for Biomedical equipment. I know the methodologies that are utilized in certification audits,i,e, vertical/horizontal, trace back/forward audits. I would really appreciate it if I could get some concrete advice on how to satisfy our upcoming certificaiton audit for ISO9001 and how is an ISO 9001 Audit conducted on a service organization and which areas are the most important to be considered.

I have made sure the application of major processes given below thanx to my Lead auditor training for iso9001 and Elsmar Cove, but still I think i might be missing points

Namely,

4.2.3 Control of Documents ( still need some clarification on it)

4.2.4 Control of Records (how to make sure there are no NCs)


8.2.2 Internal Audits

8.3 Control of NC products (how to implement in service org.)

8.5.2 Corrective Action
8.5.3 Preventive Action

alongwith

Quality manual
Mgmt review
Calibration
Work manuals from our supplier as work instructions (is this allowed)
Capability maturity for Employees (will this do for clause 6 for HR )
Preventive Maintenance records and procedures
ISO training
Preservation of product
supplier evaluation
planning and validation records
objectives ( what measureable objectives can be set for support department)


Kindly also, let me know, What i maybe overlooking something which usually comes up in service organization certification audits.

I am sure the thread will be useful to all friends who are working on SERVQUAL in service organizations.

 

[Randy]

I have a unique idea on this........Ask your potential certification body what you need to do to satisfy their requirements for achieving certification.

 

[aliakbar]

I have a unique idea on this........Ask your potential certification body what you need to do to satisfy their requirements for achieving certification.

I have dont that, Our potential certification body told that our audit will take 3 man days but about the requirements they said that they will only inform us after me make the payments and the arrangements. They will tell us of our weak areas in pre-audit activities but that will be too late.

Any other ideas ?

 

[Colin]

Yoy say that your orgsnisation provides technical service to the biomedical industry, it is that which I would be most interested to see how you control. Sure, controlling documents and records needs looking at but these are really support processes to help ensure that you can deliver your main products/processes to satisfy customers.

In this respect, it doesn't matter what type of business you are, production or service.

So when I did the audit I would take a trace forward (or back) route through your organisation to see how you take on new business, design it (if included), purchase items/services and how you deliver that service. I would then check how 'happy' the customer is with what you do for them, etc, etc.

 

[Randy]

Too late for what?

It's always a good practice to be meeting all of the requirements between 4.1and 8.5.3 before going into an audit and having your system function for a bit. DO WHAT IS REQUIRED TO BE DONE BY THE STANDARD!

You can't get any more concrete than that.