Not having "effectiveness" in the Quality Policy

[ixgunxi]

During our initial ISO13485 Stage II audit, the auditors gave us a minor for not having "effectiveness" in the quality policy. Clearly, I just missed that requirement. What types of corrective actions would be appropriate that, a documentation blunder will not occur such as this?

 

[Johndeere42]

Re: Quality Policy

Wow! We recently had our AS9100 Surveillance Audit and received a finding for the exact same thing; not addressing what 'effectiveness' means.

Yet when you read the Quality manual, the supporting documents, customer audits, the whole enchilada, it is pretty apparent that our system is effective.

Suspect that this is a new bright and shiny thing for the auditors to pick on......

My own personal opinion is that there are auditors that are beginning to insert their own opinions and biases into audits and hiding behind the shield of the Registrar to force compliance.

For the record, we are rejecting the finding and forcing the Registrar to define the specific requirement that mandates this.

 

[ixgunxi]

Re: Quality Policy

Johndeere42,

You are correct. You should reject the finding since "effectiveness" is not stated in AS9100. Although it is clearly defined in ISO13485. I overlooked the clause for effectiveness since the quality policy requirements are similar for both standards.

 

[Bev D]

Just state exactly that in your corrective action as the root cause and state that you will review the exact standard next time and maybe add a second qualified reviewer?....this is a trivial finding whose 'corrective action to prevent reoccurrence' can only be based on human action and is simply prone to error without much you can do to ensure it won't happen again....

 

[Ajit Basrur]

Re: Quality Policy

Johndeere42,

You are correct. You should reject the finding since "effectiveness" is not stated in AS9100. Although it is clearly defined in ISO13485. I overlooked the clause for effectiveness since the quality policy requirements are similar for both standards.

Could you state the entire nonconformance ?

Also does the nonconformance just say "effectiveness" or "maintain effectiveness" ?

 

[somashekar]

Re: Quality Policy

Johndeere42,

You are correct. You should reject the finding since "effectiveness" is not stated in AS9100. Although it is clearly defined in ISO13485. I overlooked the clause for effectiveness since the quality policy requirements are similar for both standards.

You have overlooked this specific ISO13485 quality policy requirement.
- Failure to include the "Maintaining the effectiveness of your QMS" in the quality policy.
Due to inadequate review and approval of the quality policy against the specific requirement of the ISO13485, within your management review.
Strengthen your management review input with inclusion of review of "Quality Policy" and "Quality Objectives"

 

[Statistical Steven]

During our initial ISO13485 Stage II audit, the auditors gave us a minor for not having "effectiveness" in the quality policy. Clearly, I just missed that requirement. What types of corrective actions would be appropriate that, a documentation blunder will not occur such as this?

I would assume the requirement is to have a quality policy and NOT what it says, though I know it requires an effective quality system. I think the best corrective action is to review and revise the quality policy. It's a minor finding and does not appear that your overall documentation system is out of compliance.

 

[isoalchemist]

No 13485 clearly calls out that:
Top management shall ensure that the quality policy ....
b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system

I tend to agree that demonstration of effectiveness is much better than having words are a piece of paper, but they appear to want them on a piece of paper also.

 

[somashekar]

No 13485 clearly calls out that:
Top management shall ensure that the quality policy ....
b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system

I tend to agree that demonstration of effectiveness is much better than having words are a piece of paper, but they appear to want them on a piece of paper also.

This "effectiveness" thing is not new to the ISO13485.
This is clearly in the base ISO9001 standard.
While I tend to agree as well., a management system driven from the top needs to spell out the policy in clarity and the standard is letting us know such words that will form the core policy to drive down with proper impact. The Standard is all about setting directions.
The reason to replace 'continually improve' with 'maintain' in the ISO13485 is also clearly reasoned within the clause 5.3.