How to start implementing a QMS according to ISO 17025

[lodapl]

Hello everyone!

I am working in a metrology lab and I have been assigned the implementation of a QMS according to ISO 17025. Personally, I would like to obtain accreditation by the end of 2013 or first half of 2014, even though there is no time limit.
Before I was assigned this task, I had been doing calibration services so I have a pretty good idea of uncertainty and other technical aspects. Though one can always learn more and new things.

I've been wondering where to start. I researched for a lot of information on how to implement a QMS, and this is what I came up with:

• Identify main processes.
• Identify main roles and responsibilities.
• Write a procedure for creation of documents in the QMS.
• Elaborate documentation, always in coordination with each section in the company, following those already indentified processes.
• Supervise that everything is going according to what is documented.

After this, start with the Quality Manual, Policies, Roles and Responsibilities Manual and everything needed to comply with ISO 17025.

I think this is an idea that can be improved.

What dou you think? I would like to know a few suggestions on how to start implementing an ISO 17025 QMS.

Thank you!

Paul

 

[Jen Kirley]

Welcome to the Cove, Paul!

I think your plan so far is sound. You do not seem at all lost in the subject. If you get the feeling you want examples of tools for use with 17025, I suggest checking in our Post Attachments List - see the green button in the header. I did a search using key word "17025" and came up with this list of attachments, each located within a discussion on the subject.

Also see links to related threads at the bottom of this page, and others that you view.

As for the time frame, expect the accrediting body to want to see at least one full round of scheduled internal audits completed, evidence of corrective actions, and a management review before your accreditation audit can take place.

I hope this helps! You are among friends here.

 

[qusys]

Hello everyone!

I am working in a metrology lab and I have been assigned the implementation of a QMS according to ISO 17025. Personally, I would like to obtain accreditation by the end of 2013 or first half of 2014, even though there is no time limit.
Before I was assigned this task, I had been doing calibration services so I have a pretty good idea of uncertainty and other technical aspects. Though one can always learn more and new things.

I've been wondering where to start. I researched for a lot of information on how to implement a QMS, and this is what I came up with:

• Identify main processes.
• Identify main roles and responsibilities.
• Write a procedure for creation of documents in the QMS.
• Elaborate documentation, always in coordination with each section in the company, following those already indentified processes.
• Supervise that everything is going according to what is documented.

After this, start with the Quality Manual, Policies, Roles and Responsibilities Manual and everything needed to comply with ISO 17025.

I think this is an idea that can be improved.

What dou you think? I would like to know a few suggestions on how to start implementing an ISO 17025 QMS.

Thank you!

Paul

Hi,
if your organization is already certified vs ISO 9001 , I think that the accredidation to ISO 17025 will improve your processes. You are ok with the plan, I would only suggest the involvement and the sponsorship of the management given that the standards requires ad hoc mgmt review for the ISO 17025.
For this reanson,if you are already ISO 9001, you have an advantage.

 

[lodapl]

Welcome to the Cove, Paul!

I think your plan so far is sound. You do not seem at all lost in the subject. If you get the feeling you want examples of tools for use with 17025, I suggest checking in our Post Attachments List - see the green button in the header. I did a search using key word "17025" and came up with (link not allowed), each located within a discussion on the subject.

Also see links to related threads at the bottom of this page, and others that you view.

As for the time frame, expect the accrediting body to want to see at least one full round of scheduled internal audits completed, evidence of corrective actions, and a management review before your accreditation audit can take place.

I hope this helps! You are among friends here.

Hi Jennifer and thank you for your reply.

Didn't know about that button. Quite useful!

I'll look for more information in those attachments.
Regarding the time frame, approximately, how much time do all that you mentioned takes?

Hi,
if your organization is already certified vs ISO 9001 , I think that the accredidation to ISO 17025 will improve your processes. You are ok with the plan, I would only suggest the involvement and the sponsorship of the management given that the standards requires ad hoc mgmt review for the ISO 17025.
For this reanson,if you are already ISO 9001, you have an advantage.

Hi qusys, thank you for your reply.

Actually, we aren't certified in ISO 9001, our first certification would be ISO 17025 and we're working towards it. Though, I think it has similar requirements of a QMS as the ISO 9001.
Management is really into this new phase. I think the only inconvenience would be the budgeting

Thanks!

Paul

 

[Hershal]

First, get a copy of the Standard and read it. Read it first assuming nothing, just to get used to it.

Next, get training in the Standard. Training may be available from your accrediting body (AB). If you are in a country other than US, go to www.ilac.org and find the recognized AB that is closest to you. They may have training. If you are in US, then there are at least 6 ABs that can provide information and possibly training.

Next, your plan seems reasonable. Remember the KISS rule - Keep It Short and Simple. You MUST address every Clause of the Standard. However, as a calibration lab, some things may not apply. You address them by stating they do not apply and providing the reason.

Some things need to be addressed in the apex manual, but detail can be more easily provided in a lower level manual. Uncertainty is a good example there.

Contact the AB that according to the ILAC website is closest to you, remembering that if you choose to use a different AB, you may need to provide the reason why. That is acceptable, as it is the lab's choice on which ILAC Signatory to use. If you are in US, get quotes from ALL the US ABs before deciding which you will seek accreditation from. Also seek to talk to the Program Manager (by whatever name) for calibration.

Do an internal audit before the AB comes. Do a management review, and if the management review is hosted by a parent organization, then make sure the cal lab is SPECIFICALLY discussed and the minutes reflect that.

Make sure you have your best uncertainty estimated, and realize after the technical demonstrations you may need to demonstrate uncertainty for the assessor. If there are pfoficiency tests or inter-laboratory comparisons (PT/ILC) available, participate or at the very least be enrolled in them, before the AB comes for assessment.

Hope this helps.

Hello everyone!

I am working in a metrology lab and I have been assigned the implementation of a QMS according to ISO 17025. Personally, I would like to obtain accreditation by the end of 2013 or first half of 2014, even though there is no time limit.
Before I was assigned this task, I had been doing calibration services so I have a pretty good idea of uncertainty and other technical aspects. Though one can always learn more and new things.

I've been wondering where to start. I researched for a lot of information on how to implement a QMS, and this is what I came up with:

• Identify main processes.
• Identify main roles and responsibilities.
• Write a procedure for creation of documents in the QMS.
• Elaborate documentation, always in coordination with each section in the company, following those already indentified processes.
• Supervise that everything is going according to what is documented.

After this, start with the Quality Manual, Policies, Roles and Responsibilities Manual and everything needed to comply with ISO 17025.

I think this is an idea that can be improved.

What dou you think? I would like to know a few suggestions on how to start implementing an ISO 17025 QMS.

Thank you!

Paul

 

[lodapl]

Thank you very much, Hershal.

This will help quite a lot!
Regarding the training, I will be taking a course on interpretation of requirements of ISO 17025 which is around March or May i think.

There is only one National AB here and we will be addressing them for certification.

Again, thank you for your reply.

Paul

First, get a copy of the Standard and read it. Read it first assuming nothing, just to get used to it.

Next, get training in the Standard. Training may be available from your accrediting body (AB). If you are in a country other than US, go to (no url allowed) and find the recognized AB that is closest to you. They may have training. If you are in US, then there are at least 6 ABs that can provide information and possibly training.

Next, your plan seems reasonable. Remember the KISS rule - Keep It Short and Simple. You MUST address every Clause of the Standard. However, as a calibration lab, some things may not apply. You address them by stating they do not apply and providing the reason.

Some things need to be addressed in the apex manual, but detail can be more easily provided in a lower level manual. Uncertainty is a good example there.

Contact the AB that according to the ILAC website is closest to you, remembering that if you choose to use a different AB, you may need to provide the reason why. That is acceptable, as it is the lab's choice on which ILAC Signatory to use. If you are in US, get quotes from ALL the US ABs before deciding which you will seek accreditation from. Also seek to talk to the Program Manager (by whatever name) for calibration.

Do an internal audit before the AB comes. Do a management review, and if the management review is hosted by a parent organization, then make sure the cal lab is SPECIFICALLY discussed and the minutes reflect that.

Make sure you have your best uncertainty estimated, and realize after the technical demonstrations you may need to demonstrate uncertainty for the assessor. If there are pfoficiency tests or inter-laboratory comparisons (PT/ILC) available, participate or at the very least be enrolled in them, before the AB comes for assessment.

Hope this helps.