Comply with 17025 or Customer?

Q

qaadrian

#1
Our calibration lab is working towards implementing ISO 17025. The cal lab is pressuring me (QA) to back off on some of the requirements. I responded OK, but you cannot take credit for compliance to 17025 on the calibration certificate. They objected. My question is this: If you comply with the customers calibration requirements, which do not include compliance to 17025, can you still take credit? Is there such a thing as partial compliance???

This issue is frustrating me. How do you meet both customer and 17025 requirements in a QA Program if the customer asks for something less than 17025 or if the cal lab intentionally does not comply with all of the requirements? How do you word this condition on the certificate? How do you answer an auditor when confronted with noncompliance to 17025, but comply with customer requirements? Thanks for the feedback.
 
Elsmar Forum Sponsor
A

Al Dyer

#2
...Your questions

...I responded OK, but you cannot take credit for compliance to 17025 on the calibration certificate. They objected.

What is the position of upper management?
Who is going to issue this "certificate"? I don't think a registrar would.

...If you comply with the customers calibration requirements, which do not include compliance to 17025, can you still take credit?

Credit for what? Meeting customer or registrar requirements?

...Is there such a thing as partial compliance???

Is there such a thing as almost pregnant?

...How do you meet both customer and 17025 requirements in a QA Program if the customer asks for something less than 17025 or if the cal lab intentionally does not comply with all of the requirements?

You are either 17025 compliant or not. Just make sure all customer requirements are included in the 17025 scheme. If the lab intentionally won't comply you have a bigger problem than can be handled here. Where is upper management?

...How do you answer an auditor when confronted with noncompliance to 17025, but comply with customer requirements?

You need to define what you want to do. It sounds as if there is a lack of communication and direction in your company.

If you are audited by a registrar to comply with 17025, you will fail, not much to answer. You will probably get a pat on the back for meeting customer requirements (if they are defined) and a report telling you where you do not comply.

ASD...
 
G

Graeme

#3
If your calibration lab implements ISO 17025 and are successfuly accredited, they will have made a major achievement. You can tell your customer that you are giving them everything they want plus a lot more. Top management can be confident that having the accreditation will draw even more customers. The people in the lab will have proof that their work really is as good as they have always told you it is.

By the way, ISO 17025 is a formal accreditation scheme, just like ISO 9000. (In the US, these accreditations are done by A2LA and NIST's NVLAP group.) A self-declaration of conformity (if that is what you are talking about) has only as much value as a customer is willing to give it.
 
R

Ryan Wilde

#4
Even under formal accreditation, you do have an out here. You are always allowed to deviate from 17025 in order to fulfill customer requirements, as long as you explain to your customer that what they are requesting is not in compliance with 17025 (preferrably in writing). After this, remove any references to 17025 from the calibration certificate and feel good that you did what the customer wanted.

The second part, with the cal lab intentionally not complying with all of the requirements. There is a term used quite often when you deal with government contracts known as 'legal metrology'. In other words, if you claim compliance with 17025, and do not comply, you are legally responsible for your actions, and yes, there are actual court cases that have covered this exact topic. If you can't get management to actually commit to backing 17025, explain that it is also a legal issue, and that if they claim compliance, especially on the calibration certificate (which is a legal document) then they had better ensure that it is so. If they still do not want to commit, I would personally advise them to scrap the idea of complying with 17025. Remember, the very first part of Management Responsibility is 'legally identifiable'.

Concerning how you word it on the certificate - you do not. If the calibration and system do not comply with 17025, then you cannot state it on the cert. The customer that requires you to deviate from 17025 must take the brunt of their auditor's wrath, but you have done your responsibility to comply with everything possible, and you can sleep well at night.

Ryan
 
Q

qaadrian

#5
Thanks you for answering my questions. If I may, I'd like to get specific. Section 5.10.1 of 17025 indicates that the results shall be reported.... The Lab is telling me that they are going paperless and that a certificate will not be issued if a customer does not ask for it. The Lab will use MetCal/MetTrack (a Fluke program) to store calibration data only. It may lack some of the information required in section 5.10.2, including a signature of the person authorizing the calibration results. I've heard that going paperless is acceptable. Can the Lab take credit for complying with 17025? Is there more that has to be done to support a paperless system and comply with 17025?
 
R

Ryan Wilde

#6
Originally posted by qaadrian:
Thanks you for answering my questions. If I may, I'd like to get specific. Section 5.10.1 of 17025 indicates that the results shall be reported....
In my experience, providing actual calibration data to the customer is not a requirement, as long as the data is available. The caveat here is that the customer requirements rule this area - if they want the data, they get it.

The Lab is telling me that they are going paperless and that a certificate will not be issued if a customer does not ask for it. The Lab will use MetCal/MetTrack (a Fluke program) to store calibration data only. It may lack some of the information required in section 5.10.2, including a signature of the person authorizing the calibration results.
Electronic signatures (or marks - whatever you like to call them) are acceptable as long as only the person whose "signature" is shown can provide that signature. If I'm not mistaken, MetCal/MetTrack requires passwords for data entry, which suffices in this regard. They may also be able to not provide a paper certificate, but again, that must be acceptable to the customer, and "acceptable" generally means "in writing".

I've heard that going paperless is acceptable. Can the Lab take credit for complying with 17025? Is there more that has to be done to support a paperless system and comply with 17025?
Yes and no. All paperless systems I've seen involve the issuing of electronic certificates, generally using PDF files, which can be digitally signed. I would contact the organization that you will (would) use to become accredited for the answer to that. As for more work, I believe that the non-issuance of any documentation will be a nightmare to control, because I guarantee that some customers will require it, the only way I can see it not being a problem is if you are an internal lab with no external customers and the CEO says it's peachy.

Ryan
 
R
#7
Check the third paragraph of 5.10.1. Specifically "written agreement" and "readily available". If you have both of these, there should be no finding.
Mike
 
Thread starter Similar threads Forum Replies Date
A How to comply with ISO/IEC 17025 Laboratory Requirements ISO 17025 related Discussions 7
D Who is required to comply with Guide 25 / ISO 17025 - Multi-feature variable gaging ISO 17025 related Discussions 3
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
R MDR standards - which standards to comply with ? EU Medical Device Regulations 3
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
B How to comply with IATF 16949:2016 9.3.2.1k - Management review IATF 16949 - Automotive Quality Systems Standard 2
S How to make Single Sign On (SSO) Comply e-sig requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Does a website needs to comply with Part 11? Qualification and Validation (including 21 CFR Part 11) 6
Q How to comply with ISO 9001:2015 Clause 7.4 Communication ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
SteveK A CE Marked Product that does not comply with the Standard EU Medical Device Regulations 7
H Job Descriptions to comply with ISO Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Medical devices are CE mark but not sold in EU - Need to comply with REACH? RoHS, REACH, ELV, IMDS and Restricted Substances 9
M How do you comply with 7.2.3 Customer Comunication AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Do I need to comply with both the MDD and the PED for my Medical Device? EU Medical Device Regulations 8
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
A Type of Materials to comply with IEC 60601 (Dental Laser Case) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Definition Comply - What does 'comply' mean to you? (Definition) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
O Comply with 21 CFR 11, but no other FDA regulations? Qualification and Validation (including 21 CFR Part 11) 4
J ISO 9001 Clause 7.5.2 Validation of Processes - How to comply? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
A ISO/TS 16949 - Comply SPC requirements Statistical Analysis Tools, Techniques and SPC 22
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
G What is meant by FAI (First Article Inspection) and how do we comply? AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 26
C Do all Class 1 Medical Devices (Electrical) have to comply with IEC60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
P Outsourced Manufacturing - Making Subcontractors comply with TL9000 TL 9000 Telecommunications Standard and QuEST 2
R Dielectric Strength of Triple Insulated Wire to comply with 2MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Fender1 How to comply with ISO 9001 and provide quick/short lead-time orders? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B Commitment to Comply - ISO 14001 Clause 4.2 - Environmental Policy ISO 14001:2015 Specific Discussions 6
G Are Component Manufacturers required to comply with ISO13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 4
G How to comply with 4.4.5 Contol of Documents - Documents of External Origion Miscellaneous Environmental Standards and EMS Related Discussions 6
J Which kind of medical equipment must comply with IEC60601-1-8? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Procedure for Translating User Documentation to comply with MEDDEV 2.5/5 Other Medical Device Regulations World-Wide 14
H Proprietary Processes - How to Protect and still comply when performing an FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D How To Comply with ISO 9001 Clause 6.2.2 d (Personnel Awareness) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
P ISO 14971 - Is it a guidance document or should we fully comply with it? ISO 14971 - Medical Device Risk Management 14
J Does my company's Business Plan Contents comply with requirements of TS 16949? IATF 16949 - Automotive Quality Systems Standard 2
AnaMariaVR2 Link between failure to comply w/ Lab PPE standards & ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
harrysons Automotive product transferring process what requirement to comply? IATF 16949 - Automotive Quality Systems Standard 3
L Questions: Plastic Food Container to comply with FDA US Food and Drug Administration (FDA) 6
Q Product Realization Procedure - How to comply with ISO 9001 Clause 7.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Suppliers Monitoring their Processes - How to comply with Clause 7.4.3.2 IATF 16949 - Automotive Quality Systems Standard 6
L How to comply with AS9100 Clause 7.6 - Monitoring and measuring devices to be used AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 31
I AS9100B Cl 7.5.1.3 - How to comply with validation of production tools requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K Quality Policy - Potential problem? Adding a Paragraph to Comply ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
N Requirements to Comply With FDA 21CFR820 For Invitro Diagnostic Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
N IVD Manafucturer in India - What Regulatory Requirements to Comply? ISO 13485:2016 - Medical Device Quality Management Systems 7
J How should customer complaints be handled to comply with ISO 9001? Customer Complaints 4
J How to comply with 7.2.1 - Customer Related Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q What do I need to comply with AS 9100 Clause 7.5.1.4 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2

Similar threads

Top Bottom