ISO 17025 - Help in Getting accreditation- Where to start from

S

sufiz

So my company decided to get accredited with iso 17025 . Our lab has 5 machines only. As a engineer i decided to take responsibility considering that it will be easy.
But after reading standard and google search it feels like there is alot of work & documents need to be made.

So I’m confused now where to start from ..!

We are 9001:2015 certified so can borrow documents from there .. but seriously there must be some templates to work on ..

Help is appreciated.

If someone can help more with documents please pm. We can work something out for your time .

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Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome to the Cove!

I trust you have obtained the most recent version of the ISO/IEC 17025 specification?

Information is out there, ranging from (broken link removed) to a range of guidance documents and books you might obtain. The offerings include templates, but what reviews I see are not good. It would be better to write your own documentation as suits the needs of your system and personnel.

Educate yourself. ISO/IEC 17025 requirements include calculations of uncertainty, which is possible for an engineer but you will need to establish the methodology.

I hope this helps!
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
What parts of 17025 don't apply to you?

I don't have the book Complying with iso 17025 by UNIDO, so I cannot comment on it.

ISO/IEC 17025 was written for organizations that provide calibration services to others. Do you do that? If not, why pursue this accreditation?

I cannot comment on the appropriate content or extent of manuals and procedures either. In general, the more complex the operation, the more complex documentation is likely to be.

You will be expected to have proficiency testing for personnel. See the (broken link removed). Explanations for other requirements have historically been included in A2LA's (broken link removed), but they now have a FAQs page. It includes their advice on uncertainty.
 

JeantheBigone

Quite Involved in Discussions
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.

ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.

Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.
ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories

ISO 17025 does apply to testing laboratories and unless the lab is industry-specific so as to justify accreditation according to NADCAP or compliance with FDA GLP, ISO 17025 is probably one of the most widely accepted accreditations along with possibly A2LA.

Since your lab appears to be part of an ISO 9001 accredited operation, my question is why you need the ISO 17025. Usually captive laboratories can maintain a QS according to the existing ISO 9001 unless they have excess capacity and want to offer services to external customers.
 
S

sufiz

@jeanthebigone

Because my manager thinks ISO 9001 ensures the Quality system of lab but it doesn’t ensure the the testing results are accurate and comply with ISO standards.
Also few buyers have asked us to provide result from 3rd party lab because they are certified/well known (with any standard).
So we decided to get certified as well. So next time we don’t have to pay those third party labs for testing our product.

What you say.??


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Stijloor

Leader
Super Moderator
@jeanthebigone

Because my manager thinks ISO 9001 ensures the Quality system of lab but it doesn’t ensure the the testing results are accurate and comply with ISO standards.
Also few buyers have asked us to provide result from 3rd party lab because they are certified/well known (with any standard).
So we decided to get certified as well. So next time we don’t have to pay those third party labs for testing our product.

What you say.??


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Before you decide to have your laboratory accredited, perform a cost/benefit analysis. Yes, customers may have asked you about it, but accreditation may be more expensive then you think it is. You are also subject to regular audits to maintain your accreditation status. Not as easy.
 
S

sufiz

Before you decide to have your laboratory accredited, perform a cost/benefit analysis. Yes, customers may have asked you about it, but accreditation may be more expensive then you think it is. You are also subject to regular audits to maintain your accreditation status. Not as easy.



Accreditation cost is around

1000$/ annum
Accreditation auditor fee - 150$
Preparation fee - 300-500$

Ill be preparing myself so I’m saving consulting fee which can be another 1000$

Total can be - 1500$ approx

Where as one time product testing cost is around 400$


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itsbiodiversity

Involved In Discussions
Sufiz,

Your assessment of the situation is WAAAAAAY off from reality. Accreditation is around $2500 just for the on-site assessment, then add an additional $1K or so for travel expenses. This is a yearly expense. Proficiency testing averages at least $500 and must be completed on the scope of accreditation every four years. Any standards used must have an accredited calibration with uncertainties. You must have uncertainty budgets for all calibrations. You must have an entire QMS specific to 17025. Your posts almost come off as disrespectful to the amount of work it takes to get accredited. 17025 makes 9001 look like play-dough. I would be glad to help if you PM me, but you'll be paddling against the current trying to do it alone without previous experience specific to 17025. That's just my take. I have started multiple 17025 labs so I am not just "blowing smoke". Average time to get accredited is 6 months for someone knowing exactly what they are doing, and a year or more for others.
 
S

sufiz

Sufiz,

Your assessment of the situation is WAAAAAAY off from reality. Accreditation is around $2500 just for the on-site assessment, then add an additional $1K or so for travel expenses. This is a yearly expense. Proficiency testing averages at least $500 and must be completed on the scope of accreditation every four years. Any standards used must have an accredited calibration with uncertainties. You must have uncertainty budgets for all calibrations. You must have an entire QMS specific to 17025. Your posts almost come off as disrespectful to the amount of work it takes to get accredited. 17025 makes 9001 look like play-dough. I would be glad to help if you PM me, but you'll be paddling against the current trying to do it alone without previous experience specific to 17025. That's just my take. I have started multiple 17025 labs so I am not just "blowing smoke". Average time to get accredited is 6 months for someone knowing exactly what they are doing, and a year or more for others.



Its cheap in my country . And its fee is exactly 1000$/annum .. as for calibrations and calibration lab .. our laboratory is TESTING LAB , in which we perform TESTING OF PAPER and CORRUGATED SHEET.

We don’t sell or provide this testing services externally.just internal testing. And results are attached and send to customer free of cost with their every order..
We donot provide any calibration services or any calibration of equipments.

Though we do have equipments that need calibration like weight machine , load cell (in pressing machine) ..

Also except for uncertainty measurements (which I’m still learning about) section 1-4 are not that difficult.

We have lab SOP’s for machines And mostly documents that are needed under clause 4.

So either I’m missing a big part or misunderstood this or it may be not that difficult to take 6 months ..

Ill send you a pm.

And hopefully can go in right direction with your help.

Thanks.


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gpainter

Quite Involved in Discussions
I am going to chime in here and ask for some info also. I have not been around in a while but have found this site to be very helpful when I set up our QMS in another time. I too have been charged with accreditation to the current 17025. We manufacture furniture and have an in-house lab with one person. We test only to ANSI/ BIFMA Standards and will outsource our calibrations. We test because it is a requirement for one of our Customers. Does anyone have any good reads on this or guidance for a small company. Thanks in advance
 
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