ISO 17025 Clause 4.10 regarding Improvement

N

ninovm

#1
Hello guys!

Good day! I have a question regarding the clause 4.10 of 17025. I know you get the improvement ideas thru audits (internal & external), customer's feedback, CAPA's.

My question is do i need to make a separate form (ex. Improvement Form) in order to comply with this clause? Any suggestions?
 
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dwperron

Trusted Information Resource
#2
You guys come up with the "interesting" questions!

That clause has always been an issue, because it is so vague. It leaves a lot of discretion to your assessor as to how to interpret it. You will have to show how you are continually improving by using the tools listed in the clause. I have documented that in my Management Review, I have also been in systems that used a Preventive Action program to document continuous improvement. There is no particular "form" that you can fill out, you just need to document your efforts. Most labs do this all of the time as part of normal operations, they just don't bother to document it.

A question I have is whether you are working with an existing ISO 17025-2005 program or developing a new one. The proposed 17025-2017 handles this differently. It becomes part of the Quality Management "Options" program where you have 2 choices: Option A is to create your own quality management system and Option B is to use ISO 9001 registration. If you use Option A then this is what you will need to comply with:

8.6 Improvement (Option A)

8.6.1 The laboratory shall identify and select opportunities for improvement and implement any necessary actions.
NOTE Opportunities for improvement can be identified through the review of the operational procedures, the use of the policies, overall objectives, audit results, corrective actions, management review, risk assessment, analysis of data, and proficiency testing results.

8.6.2 The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be analyzed and used to improve the management system, laboratory activities and customer service.
NOTE Examples of the types of feedback include customer satisfaction surveys and review of reports with customers.
 
N

ninovm

#3
Actually, we are aiming to be accredited. I'm not well experienced with this QMS thing and they asked me to implement it.
 

dwperron

Trusted Information Resource
#4
Since you are aiming to be accredited I would suggest preparing for the ISO 17025-2017 revision which should be completed by the end of the year. On a practical basis, if you use clauses from the current 17025 version in your QMS you will end up amending them all after the new version is accepted because it uses an entirely different format for the document.
 
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