Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs?

[gary853]

We are an accredited ISO17025-2017 Metrology Lab.
For clarification-Do we need to comply to ISO 9001-2015?

 

[John C. Abnet]

We are an accredited ISO17025-2017 Metrology Lab.
For clarification-Do we need to comply to ISO 9001-2015?

Good day @gary853 ;
ISO 17025 allows for two options ("A" and "B" respectively) of meeting the requirements of clause 8 "Management System Requirements'.

Option "A" specifies the requirements to which your organization and your Accrediting Body must hold your organization accountable to.
Option "B" specifies that in regards to clause 8, your lab/systems must be "...in accordance with..." ISO 9001` in regard to ISO 17025
clauses 8.2~8.9.

If your organization is not ISO 9001 certified, then option "A" and "B" are of little difference, because your 17025 3rd party auditor will still need to verify either way. However, if your organization is ISO 9001 certified, then your 17025 3rd party auditor will most likely simply accept that ISO 9001 certification as being "..in accordance with..." specific to ISO 17025 clauses 8.2~8.9.

(Question: You indicate that your organization is already accredited to ISO 17025. I'm curious as to why this question is being raised. How is your organization currently showing evidence of "...in accordance with...." ??)

Hope this helps.

Be well.

 

[gary853]

Good day @gary853 ;
ISO 17025 allows for two options ("A" and "B" respectively) of meeting the requirements of clause 8 "Management System Requirements'.

Option "A" specifies the requirements to which your organization and your Accrediting Body must hold your organization accountable to.
Option "B" specifies that in regards to clause 8, your lab/systems must be "...in accordance with..." ISO 9001` in regard to ISO 17025
clauses 8.2~8.9.

If your organization is not ISO 9001 certified, then option "A" and "B" are of little difference, because your 17025 3rd party auditor will still need to verify either way. However, if your organization is ISO 9001 certified, then your 17025 3rd party auditor will most likely simply accept that ISO 9001 certification as being "..in accordance with..." specific to ISO 17025 clauses 8.2~8.9.

(Question: You indicate that your organization is already accredited to ISO 17025. I'm curious as to why this question is being raised. How is your organization currently showing evidence of "...in accordance with...." ??)

Hope this helps.

Be well.

John, Was asking because I am currently reviewing our system. Our system is set up to conform to ISO 90012015 clauses 8.2 -8.9. , was just seeking out other's opinion on whether we needed to address the entire standard.

 

[John C. Abnet]

Our system is set up to conform to ISO 90012015 clauses 8.2 -8.9. , was just seeking out other's opinion on whether we needed to address the entire standard.

Reminder @gary853 ;
Unless you mis-spoke in your previous message, the requirement is not to be in accordance with only ISO 9001:2015 clauses 8.2~8.9. The clauses 8.2~8.9 that are referenced, are specific to those clauses within ISO 17025. The option "B" requirement states "...the requirements of ISO 9001:2015".

...and does not limit it to only certain clauses of ISO 9001.

Hope this helps.

Be well.

 

[qualitymanagerTT]

John, Was asking because I am currently reviewing our system. Our system is set up to conform to ISO 90012015 clauses 8.2 -8.9. , was just seeking out other's opinion on whether we needed to address the entire standard.

Yes - you need to address all of ISO 9001:2015 if you are going to claim conformity with ISO/IEC 17025 clause 8.1.3.

Unless you are part of a larger organization, or have some other reason to address all the requirements of ISO 9001, it's easier to conform with ISO/IEC 17025 clause 8.1.2.

However, improving your lab management system by increasing conformity with ISO 9001 is one way to show how you address ISO/IEC 17205 clause 8.6.1.

 

[John Broomfield]

Don’t forget service quality.

Labs provide a service and may be well advised to include the design, delivery and continual improment of their services per ISO 9001.

 

[Steve_Berian]

Hi All, is there a comparison of requirements for ISO-17025-2017 vs ISO-9001-2015, or vs ISO-13485-2016? Please advise?

 

[John C. Abnet]

Good day @Steve_Berian ;
The standards themselves offer some insight. For example...ISO 13485 annex B describes the relationships with ISO 9001 (example embedded..
below...)

Hope this helps...be well.

 

[dwperron]

Hi All, is there a comparison of requirements for ISO-17025-2017 vs ISO-9001-2015, or vs ISO-13485-2016? Please advise?

Here is a chart for the 9001 / 17025 comparrison:

Compare ISO 9001:2015 to ISO 17025:2017