Understanding and implementing ISO 17025

D

dennisje182

#1
Hello everyone, I hope it is the right sub-forum,


Since I’m new here, I’ll introduce my situation a little bit first. I’m a newbie on quality systems but somehow I got hired to implement a ISO 17025 standard for this company that does 3D scanning, measuring of complicated organic and geometric forms and calibrating of measuring devices and 3d scanners (so it is a laboratory). I got hired as an Application engineer, but my boss thought it would be good to get to know the company by also doing this accreditation. When I started here beginning of April (small, 7 employees), they had already started the QM and a scope. The scope is about done and I’m trying to fill in the holes that are still there in the QM, the QM is done for about 80 %. I figured out how the QM relates to the standard, and I understand the hierarchy of the system (and found this forum looking for the difference between procedures and working instructions, which made me rewrite a few procedures and move a some stuff to WI).


Since it just became clear to me this week how the standard works (my boss didn’t have the standard, and like I said, I’m a newbie on quality systems), I would like to get some things verified for myself and I got some questions so I hope you all can help me. My boss isn’t a quality systems guru either and he thinks everything I do to get more overall insight on all the processes in his company are great (so I need to watch out I don’t forget my second thought below :p ).


My thoughts:
- Everywhere in the standard where it says shall there should be a policy in the QM, so also a procedure. In the procedures I refer to the relevant working instructions and forms. Right?
- Don’t write procedures just for the sake of having procedures for something. It has to add (and relate) to relevant points in the standard and QM?


Questions:
- Do procedures and working instructions both have flow charts?
- Is there something I should pay more (or less) attention to since this is a fairly small company.
- What is your thought on doing this without training? Is it doable since it is a small company? I believe my boss is hoping to start accreditation at the end of this year….
- How do you start implementing your procedures? Right now, when I wrote a procedure with WI’s I just inform everyone what it is, why it is, and how it works. Along the way I see, ask and observe how they work with it and what works well and what doesn’t work well.


Sorry for the long story but I could use all the advice and ideas you guys have for me :p It is going to be a hard and educational period of time for me:p


Thanks in advance
Dennis
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Re: Undertanding and implementing ISO 17025

- Do procedures and working instructions both have flow charts?
Flow charts are not required at all. This is a choice you have to make.

- Is there something I should pay more (or less) attention to since this is a fairly small company.
No. Just focus on the requirements.

- What is your thought on doing this without training? Is it doable since it is a small company? I believe my boss is hoping to start accreditation at the end of this year….
You can train by reading through discussion on topics you have more specific questions about. Of course, there are also books and other resources. Once you start to read you'll find this isn't rocket science and it is probable that most questions you have have already been asked and discussed here. Remember the forum "Search" function.

And while it's not aimed at 17025, read through http://Elsmar.com/Imp/ for some thoughts.


- How do you start implementing your procedures? Right now, when I wrote a procedure with WI’s I just inform everyone what it is, why it is, and how it works. Along the way I see, ask and observe how they work with it and what works well and what doesn’t work well.
Correct. You implement a procedure by training the people who have to use it / are affected by it. Then you start using it (if you aren't already).
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: Undertanding and implementing ISO 17025

Welcome to the Cove, and yes, this is the correct place.

One thing you should do is contact RvA, your National AB and see if they or EA, the Regional Cooperation, have specific requirements or other documents that amplify the standard.

On your thoughts, you are generally correct. You may want to point to the procedures and work instructions in the QM for the applicable sections.

Do NOT write things for the sake of writing them. If something does not apply, state that in the QM and state why, and move on.

On your questions, first, flowcharts are very acceptable, if they work for your organization. The key question, what is easiest for your personnel to use?

Pay attention to management review and internal audit first and foremost. They are valuable monitoring tools. Clause 4.15.1 has a prescriptive agenda, Proficiency Testing or Inter-Laboratory comparison (PT/ILC), if it exists for what the company does, is a requirement. If it does not, then you need to show how you comply with Clause 5.9.1. Traceability of your measurements must be solid, and that will go through the National Measurement Institute (NMI) for The Netherlands. Other than that, ask RvA what they suggest a lot of concentration on.

It is very doable. However, RvA may well want to see uncertainty calculations for you discipline(s), and that you may want to get training on.

Your implementation approach is sound for a small compny. Document it as RvA will ask.

And keep posting questions!
 
D

dennisje182

#4
Re: Undertanding and implementing ISO 17025

Thank you all for your quick response, I'll definitly drop some more questions in the near future, because I find this forum very informative and usefull! Keep it up
 

BradM

Staff member
Admin
#5
I just thought I would add a tiny thing in here.

Implementing and maintaining a measurement system under ISO 17025 is not cheap. I would assure a good business basis for it, making sure your management understands the costs and commitments to it.

I might consider writing a business plan- demonstrating the costs; pros/cons; benefits; etc.
 
#6
My advise, as one who was in charge of writing, implementing, and defending ISO 17020 and ISO 17025 for two companies now, use three basic principles: (1) have management involved with the process of obtaining the ISO 17025 and make sure they are bought into the reasons for this accreditaiton other than a marketing ploy or as a necessary evil just to do business; (2) the KISS principle; and (3) walk your talk and talk you walk.

First: do not make your procedures to comply too complicated and too detailed. No one wants their job to be complicated. Break things down to a group of functions and allow those functions to be fluid. An example is do not state in the QPM that you will use this one piece of software when in a few months it will be obsolete and your company has replaced the software which then means you will have to revise your quality manual. Just state that you will use the most up-to-date software and document that you will keep the manual for the software in a specific file or folder. Also document that people have been trained on new software as needed and keep that documentation on hand - this helps solve the training requirements. Your list of tools will change but your basic QPM does not. Note this does not work when the piece of software is what was written by the company for the company's use. Then you are going to have to include the pertinate parts of the software as it relates to the QPM, such as how it produces the reports, how it maintains the data, etc. Any time that the software is changed you will need to review and determine how does that affect the compliance against ISO 17025.

(Sidenote you will have to work with management and the HR person (note that may be the primary owner also) to set up a yearly training program and potentially a new employee training package, document this training, and have a single company location for the storage of all training records.)

Second: Document what you do right now. Go around and see what each person does. Then compare the step by step procdures against the basic principles of the ISO 17025 standard. If they comply you are finished and you have your document completed. You have documented what you are doing and you are doing what you have documented. Now if there is a non-conformance you have to sit down as a team and discuss how are we going to get ourselves in compliance. This way when you are audited the auditor can see that you are folowing your own documented procedures. Now the focus can be on do the procedures comply or not.

If the procedure or process does not comply then go back to item 1. Keep it simple. Get people involved and do not make it a position where you will be nagging. This is where the Management Review will come in handy. When the management is involved and they see that the process is not in compliance they will need to step in and facilitate the change or provide solutions. I have seen to many times where the upper management has stated just make the problem go away yet nothing has really been resolved. It may be a case where the corporate rules conflict with the principles of ISO 17025 and the corporate rules need to be tweeked.
 
#7
Re: Undertanding and implementing ISO 17025

... One thing you should do is contact RvA, your National AB and see if they or EA, the Regional Cooperation, have specific requirements or other documents that amplify the standard. ...
I will second what Hershal stated. I relied on my AB (Accreditaiton Body) and bounced a few questions off them. They even had a training session where I could learn more and gained some contacts at the AB that could answer my questions or at least point me to the right resources. Also it will be wise the management meets with the management of the AB. The relationship between the AB and the ISO 17025 lab is a partnership in helping the lab meet its vision. They should not be a hurdle to your company in conducting your business. The AB especially a couple of the auditors kept me grounded by reminding me of following basic consistent practices and making me document these processes. This can be a way to document the growth of a company or an individual manager.
 
D

dennisje182

#8
Re: Undertanding and implementing ISO 17025

I just thought I would add a tiny thing in here.

Implementing and maintaining a measurement system under ISO 17025 is not cheap. I would assure a good business basis for it, making sure your management understands the costs and commitments to it.

I might consider writing a business plan- demonstrating the costs; pros/cons; benefits; etc.
My direct executive is fully aware of all the costs that are involved and knows all the pros/cons. And ofcourse he is fully cooperative :)

My advise, as one who was in charge of writing, implementing, and defending ISO 17020 and ISO 17025 for two companies now, use three basic principles: (1) have management involved with the process of obtaining the ISO 17025 and make sure they are bought into the reasons for this accreditaiton other than a marketing ploy or as a necessary evil just to do business; (2) the KISS principle; and (3) walk your talk and talk you walk........
Thanks for your extensive advice! I do find it hard to involve my co-workers in the process (while I understand the importance of it). And I do feel a little bit like nagging, since they can be overloaded in their on work. And since this is a very technical company, it is very hard to interest them in what I need to do. So there is a thing I need to work on.

And I do have a quick question that just came to mind when I was roaming around our lab......Are extensive manuals (from the supplier) of the hardware we use sufficient as working instruction?
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#9
The manuals CAN be a good work instruction, but you may look at whether in fact it is. For example, the older Tektronix manuals (e.g., 1980s) were thick and only some sections applied. So for something like that, a simple work instruction cover sheet, giving a control number, and referencing the applicable section(s) may be all you need.

Hope this helps.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
I agree. I have worked with some companies that used equipment manuals as "work instructions"/procedures. In each case they did have to be "trained" and the company had to have a way to show that the operator training was effective. It was usually OJT type training. As Hershal pointed out, however, some equipment manuals do not have enough "content"/information to act as a stand alone work instruction.
 
Thread starter Similar threads Forum Replies Date
B Understanding and Implementing ISO 9001 in a Small Manufacturing Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Lost Cause for Understanding and Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
E Implementing ISO14001 with no training, experience or understanding of the standard Miscellaneous Environmental Standards and EMS Related Discussions 5
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 29
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
K Understanding IEC 60601-2-68 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause 15.4.2.1 d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Understanding Versions of Collateral and Particular Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Understanding, Analysis and Monitoring Quality Defects on Composite Components Statistical Analysis Tools, Techniques and SPC 3
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
Q Understanding Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
W Understanding PPAP Appearance Approval APQP and PPAP 22
V Understanding Automotive Coating for Seating Mechanism Components Manufacturing and Related Processes 1
M Understanding of Regression and ANOVA in Minitab Statistical Analysis Tools, Techniques and SPC 8
4 Understanding ILAC policy P14:12/2010 6.3 part a) General Measurement Device and Calibration Topics 28
H Understanding 8.2.3 M&M of Processes for our Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Understanding ISO 26262 Road Vehicle Functional Safety Other ISO and International Standards and European Regulations 2
arios Understanding adoption of a product to an existing Sterilization Cycle Other US Medical Device Regulations 1
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
S Understanding FDA rules regarding MDDS Status and Clinical Trials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom