Quality Manual - ISO 17025 required Mandatory and Operational Procedures

[Mir11]

Since we are in the very beginning phase of implementing ISO 17025 in our lab, we need to develop its Quality Manual. I need to know what are the required mandatory and operational procedures? Are they same as one in ISO 9001 or does 17025 have additional procedures?

Your replies and help throughout the phase will be highly appreciated.

Regards,
Mir.

 

[Gmzita]

Mir -

My recommendation is that you obtain a copy of the Standard - ISO 17025:2005 revision. It lays out all of the requirements that a Testing or Calibration Lab needs to comply. It is different from the ISO 9000 series so an ISO 9000 based QA Manual will not cover what you need (and vice-versa). You can purchase the Standard directly from ISO or if you are in the USA - ANSI or NCSLI.

We are a calibration lab accredited to ISO 17025 - I found the easiest way to set up our QA Manual was to follow the Table of Contents in the Standard itself and flush out the sections with the required procedures and processes. It worked really well for us but you may want to tailor it to your facilities needs.

Also - have you looked into a Registrar yet? Most of them have very good guidelines on setting up your system and can be a very good resource. In the USA - there are approximately 6 - 8 recognized ABs - such as A2LA, NVLAP, ACLASS, etc. In the UK you can try UKAS. You can do a search in Elsmar to find a link to them all.

If I can help - please feel free to contact me. Good Luck.

Geralyn

 

[Jerry Eldred]

There is also an offician memo or letter out there that states that ISO17025 covers all the applicable portions of ISO9001. I fully agree with the previous poster. The first thing I did was read in detail through the standard - take a day or two and thoroughly read and understand it. That is an absolute must (no getting around it). I've found it helpful to lay out my quality manual with roughly matching paragraph numbering scheme (or at least order). It makes it easier to track in your quality manual how you will comply with each applicable paragraph of ISO17025. Just remember there are some sections about calibration, some about testing and some about both. It is important to discern that.

There is no short cut to writing a proper ISO17025 compliant quality manual/quality management system.

 

[primerizo]

Visit the web page www_metrycal_com. You ll find The Guide M-17025: is a set of editable documents in electronic format in Microsoft Office Word? and Excel?, which lead the user through the implementation of each of the requirements of ISO/IEC 17025:2005. The Guide M-17025 makes the implementation of the quality system ISO/IEC 17025 an easy job for the top manager, quality manager, head and technicians of the laboratory, with minimal training, in a simple, orderly, reliable, compact way and in the shortest time possible.

 

[Stijloor]

Visit the web page www_metrycal_com. You ll find The Guide M-17025: is a set of editable documents in electronic format in Microsoft Office Word? and Excel?, which lead the user through the implementation of each of the requirements of ISO/IEC 17025:2005. The Guide M-17025 makes the implementation of the quality system ISO/IEC 17025 an easy job for the top manager, quality manager, head and technicians of the laboratory, with minimal training, in a simple, orderly, reliable, compact way and in the shortest time possible.

Are you in any way associated with metrycal?

Stijloor, Forum Moderator.

 

[Hershal]

Since we are in the very beginning phase of implementing ISO 17025 in our lab, we need to develop its Quality Manual. I need to know what are the required mandatory and operational procedures? Are they same as one in ISO 9001 or does 17025 have additional procedures?

Your replies and help throughout the phase will be highly appreciated.

Regards,
Mir.

As has been posted, obtain the standard is the first place to start. In the US, it can be purchased easily at www.ncsli.org www.iccsafe.org and www.astm.org

Read the standard. Any place it states "policy and procedure" then a procedure is required.

Next, get training. Get training in ISO/IEC 17025:2005 and in uncertainty of measurement.

Pay attention to the Clauses. As an example, management review. All points in Clause 4.15.1 must be addressed in management review. Traceability of your measurements is something to take a look at.

Under ILAC rules, the lab must engage in at least one proficiency test or inter-laboratory comparison (PT/ILC), if one is available. This is because of the benchmarking.

There are other considerations too, of course, but once you have the standard and have received training, you will have a better idea of how to tailor your manual to the lab. Also, please feel free to post questions here.

As for selecting an accrediting body (AB), then go to www.ilac.org and find your country. If it is the US, there are six: IAS, NVLAP, A2LA, ACLASS, PJLA, L-A-B. If a different country, then the ILAC site is the easiest way to find your AB.

Hope this helps.

 

[Mallya]

I think. 17025 mandatory procedures are the same as 9001
the best way is to have same documents applicable for both std. but remember to state scope that they apply for both 9001 and 17025.
Importantly during implementation make sure you cover both std for example in MRM have them as separate agenda to avoid missing out of important issues

Rgs

Mallya

 

[zamclachia]

Since we are in the very beginning phase of implementing ISO 17025 in our lab, we need to develop its Quality Manual. I need to know what are the required mandatory and operational procedures? Are they same as one in ISO 9001 or does 17025 have additional procedures?

Your replies and help throughout the phase will be highly appreciated.

Regards,
Mir.

Hi there. The best you could do is to go through the standard and look for all the "shall" statements. This will also help you and your team understand the standards requirements.