Scope of Certification is Ringing Alarm Bells

[Marc]

I think it reflects more on the "quality" of the registrar than the company.

 

[Big Jim]

I think it reflects more on the "quality" of the registrar than the company.

Good point. I think it reflects on the quality of both. Perhaps my thinking is influenced by the quality management systems I have encountered, many of them as a CB auditor for companys seeking registration.

 

[pearsonow]

Having just re-written our scope ready for certification, having taken the job on part way through....

I find a well focussed scope actually a useful thing for the creation of the system - it allows me to focus on those area's which have an impact and ignore those which do not. I can then gradually expand the system to cover other area's but they don't have to be Certified as compliant (even though they would be), then when I'm due for my renewal audits I can alter the scope and include them. Eventually everything is covered, but I start with our core processes and departments.

 

[vanputten]

Hello Quality Priest:

Did the organization claim their breath analyzer distribution management system was registered to ISO 9001? Or did you ask them for their ISO 9001 certificate?

An organization can choose what product realization process is included in their scope.

If I have an organization that builds ships and cleans windows, I can choose which realization process is included.

Organization's whose customers ask for ISO 9001 registration or especially ISO 17025 accreditation play this game all of the time.

This is why TS 16949 has the following requirement for external laboratories: "the [external lab] shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration."

This issue here may be how Quality Priest phrased his question to the supplier. Does the supplier have an ISO 9001 registration that includes the product or service being provided?

 

[Big Jim]

Having just re-written our scope ready for certification, having taken the job on part way through....

I find a well focussed scope actually a useful thing for the creation of the system - it allows me to focus on those area's which have an impact and ignore those which do not. I can then gradually expand the system to cover other area's but they don't have to be Certified as compliant (even though they would be), then when I'm due for my renewal audits I can alter the scope and include them. Eventually everything is covered, but I start with our core processes and departments.

Excellent point.

I believe that should be one of the first things to determine when establishing a quality management system too. Only then can you truly determine what your core processes are. Scope, process determination, and organization chart are best done early, very early.

 

[pearsonow]

Indeed Jim - you need your scope to define your parameters, without it and a Quality Policy you are missing a mission statement.

To use a military term, without a concise mission statement how do you judge success - equally how do you judge 'failure'?

Everything in your QMS should support the achievement of the Quality Policy (mission) within the limits you have been set in the Scope (Boundries). In my (humble) opinion the Quality Professional, whoever that may be, cannot/should not set the Scope - it needs the agreement and support of higher management to ensure that the resultant system will be fit for purpose and do what they want it to do.

I could get any company certified to ISO 9001:2008 inside a week. But the scope of the certification would be so narrow that it would be completely valueless. The whole point of certification and the process is to improve things, not just to get ticks in boxes.

Ahem. (Olly Climbs down from soap box)

 

[JaneB]

Certainly think the scope is vague and doesn't indicate any product coverage. Entirely possible that it only covers services, but they're pulling a bit of a swifty by implying it also covers the product. You could follow it up with their certifier.