Interpretation and Practical Application of ISO 17025 - Development of a System

C

Coleman Donnelly

#1
I have just been given the task of becoming 17025 certified and i want to know if there are any good resources that i can look through to help with interpetation and prctical application of the ISO standard.
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: 17025 development

Good morning,

I did a search using the key words "guidance 17025" and found this thread for you. It has some links for buying the standard and getting guidance documents as well.

After you get these items, study them and decide how your organization meets the "shalls" and where it does not. You can ask us specific questions at that point.

I hope this helps!
 

BradM

Staff member
Admin
#3
Re: 17025 development

Hello Coleman!

First thing would be to get a copy of the current standard. Second, there is a lot of history here on that standard. Using the search on that (if you haven't done it already) will be helpful.

Some questions:

1. What exactly is it that you do and your scope of work?
2. What kind of shape is your current QMS?
3. Have you already determined uncertainties for your measurement systems?
4. Have you identified the appropriate environment, and are you controlling, measuring, etc.?

Once you determine what your scope is going to be, it will give you some idea of how long (and how much resources) it will take. Making sure management understands and is behind that is a good idea.

We have some very knowledgable people here (unlike myself:tg:) in this area. Luckily, we have been fortunate to have a lot of newer Covers who are in metrology labs that contribute some helpful information.

So, hopefully we can help you in your quest.
 
C

crendfrey

#4
Re: 17025 development

Coleman,

Welcome…….

First, you are Accredited to 17025:2005.
Are you going to be testing, calibrating or both.

Most ABs have guidance documents posted on their web site.
There are a few interpretative documents out there.
Try searching the threads here. You will find volumes of great information.
You are not alone here. Give us a little more information about your lab and industry.
Many here will be willing to help.

The best advice I was given:
When you read the standard, you need to ask yourself
Not only what does this mean, but what does this mean to US.

17025:2005 is a broad reaching document intended (I believe) to encompass many types of laboratories.
 
C

Coleman Donnelly

#5
Well we are an automotive supplier of steel componets with the idea that it is in our best interest to maintain a certified lab so we can quote measuremeants for customers of similar products. In addition to this we would like to 'eventualy' begin calibrating our own gages as well as hopefully creating gages in house at some point down the line. We are currently TS certified.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
First thing.....get the Standard.....NCSLI has it at a fair price.

http://www.ncsli.org

Next, get training in uncertainty.....you will need it to get your scope ready.

You will need a lab manual. You can likely write it yourself if you have time. Otherwise get a consultant that is experienced with ISO/IEC 17025 specifically

Your internal auditor can do the QMS side of your lab internal audits, but not the technical side unless the person is a metrology professional or at least has training in the discipline(s) your lab will be involved in.

Management review is a big thing.....the lab review can be rolled up into the parent review if necessary, but the 17025 Standard, Clause 4.15.1 has a prescriptive agenda and all the topics must be addressed.

Proficiency testing or inter-laboratory comparison (PT/ILC) is a requirement under international recognition. You have to complete one prior to accreditation, then four years to complete your scope, under ILAC/APLAC rules.

Also, when you seek your accrediting body, do NOT sign with any of them till you talk to ALL of them.

This should get you going.....we look forward to the questions that you almost certainly will have.....just as we all did.....so ask, we will help if we can!
 
C

Coleman Donnelly

#7
Are there any suggestions for uncertanty training?
I already have a copy of the standard which is what led me to come here and ask a few questions as my head is still spinning from my first read through! Currently I am doing a gap study to determine areas that need improvement. I was kinda hoping for a plain speech check list just to get me heading in the right direction but i can't seem to find anything like that.
The plan is that we will write our own manual, and my boss would like to start moving foward in March :confused: so many more questions will follow I'm sure... Thanks in advance for all of the help I am sure I will find here.
 

BradM

Staff member
Admin
#8
Coleman, my best advice to you right now...

The post previous to yours was by Hershal. Click on his name and follow his posted threads. He will give you a substantial amount of background for uncertainty calculation, appropriate lab environment, etc.

As far as uncertainty, I believe the Certified Calibration Technician program through ASQ covers that (I may be wrong; someone correct if I am). I have a couple of books on it, if you would like the title.

As far as a checklist, Hershal's previous post would be a good start!:D
 
B

Benjamin28

#10
I believe the CCT covers very basic components of calibration although it may touch on the subject of uncertainty you would be much better off with specific uncertainty training by qualified professionals. The links provided will give you a good starter, I'd suggest though, that you might seek out someone who has been in your specific situation, through asq section, this forum, or other business networking. It'd be quite beneficial to get feedback from someone who instituted a 17025 cal lab under a TS certified company.

The gap analysis is a great starter for getting yourself moving along the road to accreditation and planning out your goals.

Take a look at some 17025 compliant quality manuals to give you some baseline examples there are many floating around on the internet, or you can request a copy from your current calibration suppliers for review.

http://www.a2la.org/training/IntroUncert.cfm would be a decent starter for UNC training.
 
Thread starter Similar threads Forum Replies Date
Q Contingency plan - IATF Sanctioned Interpretation 17 IATF 16949 - Automotive Quality Systems Standard 4
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
M MDR Article 22 Interpretation EU Medical Device Regulations 3
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
D IATF16949 - Interpretation of Customer Requirements clauses IATF 16949 - Automotive Quality Systems Standard 3
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Interpretation with regards to Ppk > Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 14
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
A OEM branding - My interpretation of the LVD Directive makes us a manufacturer CE Marking (Conformité Européene) / CB Scheme 3
P Average Peel Strength - Interpretation of BS EN 868-5:2018 and ASTM F0088/F0088M Other Medical Device Related Standards 2
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Interpretation of significant change - material change Canada Medical Device Regulations 3
R MDR Software Rule 11 Formal Interpretation EU Medical Device Regulations 7
A IATF Sanctioned Interpretation No. 7 - Type and Extent of Control (supplemental) IATF 16949 - Automotive Quality Systems Standard 4
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
G Medical Device "Immediate Container" Interpretation of Definition US Food and Drug Administration (FDA) 2
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
D EU MDR Corrigendum Interpretation EU Medical Device Regulations 3
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
qualprod P x I = Value interpretation for residual risk? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T CSA Z299.3-85 Nuclear interpretation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D VDA Trigger Matrix in the VDA 6.2 Manual - Interpretation and Use VDA Standards - Germany's Automotive Standards 3
B Interpretation of Customer Specific Requirements of Continental - Records Retention Customer and Company Specific Requirements 6
S Interpretation or Definition of ‘Once Every 5 Days’ ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N What is the interpretation I-MR-R chart in this question? Statistical Analysis Tools, Techniques and SPC 1
E ME (Medical Equipment) Systems - IEC 60601-1 Clause 16.1 Interpretation IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
P IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation IATF 16949 - Automotive Quality Systems Standard 12
B Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's ISO 14971 - Medical Device Risk Management 46
M IATF 16949 - 7.1.3.1 Plant, Facility, and Equipment Planning - Interpretation IATF 16949 - Automotive Quality Systems Standard 8
R Location Interpretation on Drawing - Hole to Hole? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T TS 16949 Clause 7.4.1.2 and Sanctioned Interpretation IATF 16949 - Automotive Quality Systems Standard 12
D Interpretation of new IAQG ruling - Audit duration for nonconformance verification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
K Interpretation of IEC 60601-1-2 Electromagnetic Compatibility – Requirements & tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Heat Treatment - Soaking time interpretation Manufacturing and Related Processes 5
D Interpretation of DOE interaction plot Using Minitab Software 8
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Interpretation of "Any or All"'? IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
G Interpretation of phrase - "Direct Authority" EASA and JAA Aviation Standards and Requirements 5
pittmatj Brazil: Interpretation of RDC 185 Other Medical Device Regulations World-Wide 6
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
M Interpretation of Plus/Minus Draft - Injection Molded Parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
E FDA Significant Change Interpretation - Guidance Document EU Medical Device Regulations 2
0 ISO 9001:2008 interpretation not the same per country? (Netherlands and France) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Multiple Standard Interpretation Queries Occupational Health & Safety Management Standards 4

Similar threads

Top Bottom