Who is required to hold ISO 17025 accreditation?

  • Thread starter Daniel M. Miller
  • Start date
D

Daniel M. Miller

#1
#1
My question is where do I find written clarification on who is and who is not required to hold the ISO/IEC Guide 25 / 17025 accreditation?

My company is a design and build manfacturer of variable gaging systems. We build anything from stand alone bench gages to fully automated PLC type in-line machines for dimensional measurement. We integrate technologies such as LVDT. capacitiance, eddy-current, laser, temperature sensors, weigh scales, force gages, etc. We do not manufacture gaging such as ring gages, plug gages, flush-pin gages, or dog-house style gages. We have been removed from the gage suppliers bid-list of one major automotive plant because we are not ISO/IEC Guide 25 / 17025 accreditated.

I have written the buyer and a quality engineer at this plant a letter stating that I will only use an accreditated laboratory for the calibration and certification of any gage setting master used to set gaging systems they purchase from us. They are unwilling to change their decision at this point.

I do not beleive that the intent of the QS 9000 Calibration Services 4.11.2.b.1 was written for an organization such as mine.

I could use any help on how to get this buyer and engineer to agree to restore us to the gage supplier bid-list.
 
Paper to QMS ad
Elsmar Forum Sponsor
A

Al Dyer

#2
#2
Daniel,

I agree with you, it sounds as if you are getting the "bums rush" from someone who has either their head up their ass or just got out of "college". Keep working your way up the chain of command! Hopefully you have the backing of top management who could and should be involved. If not, you might start thinking about working for a company that has management buy-in, approval, and common sense.

If you care to reply:

What level of upper management involvement is in place?

Assuming big 3 (2 and a half), which one? (DC)

The state of affairs is so in flux these days that we have to stand up and assert our voices and beliefs to the highest points possible!!!!

ASD.....
 
D

David McGan

#3
#3
Is it possible that the reason they insist on you being 17025/Guide 25 certified is that they would need a certified calibration lab to provide periodic recalibration of the equipment you manufacture. Since most people interpret QS to require the use of certified calibration labs, then if you are not certified, they would have to go searching for such a qualified lab.

Just because you are the OEM doesn't mean they can use you for calibration, unless they have determined there is no other certified calibration service available.

So.... maybe there is a "rest of the story."
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
K When is Bioburden Testing Required? Other Medical Device Related Standards 4
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
A When there is a 2 year lapse in production, is a full FAI required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Is it required to put"Rx only" on the home page of an app? Medical Device and FDA Regulations and Standards News 4
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
M When is FAI required? AS9100 8.5.1.3 and 8.4.3 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 1
B AIAG-VDA FMEA - When the new format will be required FMEA and Control Plans 5
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
Z EN 868-8 "required tests" - Rigid sterilization containers Other Medical Device Related Standards 0
D Design Verification - Is testing required? Design and Development of Products and Processes 5
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
A Calibration required by OEM General Measurement Device and Calibration Topics 2
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A Glass and brittle plastic Policy - Required per FSSC 220002-4? Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Is a specific day required in an expiration date? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T MDR Adverse Events Assessments - What qualifications are required? Other Medical Device Regulations World-Wide 3
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 8

Similar threads

Top Bottom