SBS - The best value in QMS software

Requirements for parameter based testing scope of accreditation

H

Hanr3

#1
Looking for information on requirements for parameter based testing scope of accreditation?

Most of the testing conducted is not standard, as in there is no Industry Standard. Most tests are unique and listing 200 testing methods that we may or may not run every year is not practical. We want to go to a parameter based scope of accreditation (ISO 17025). However we need some more information on the requirements to define the parameter.

I hesitate to list a parameter because I don't want this converstaion turned into a calibration discussion. For conversations sake, assume we are after a pressure parameter, assume hydraulic pressure. Pressure is on 80% of the tests. In other words what are the requirements we need to meet to establish a parameter based scope of accreditation?

Instrumentation set-up configuration chain?
MUA of chain?
Options on capturing proficency?
Define the Instrumentation set-up configuration.
 
Elsmar Forum Sponsor
H

Hanr3

#2
Is it safe to assume that this is new ground for most? I see 65 viewed the post, however there are no responses. I didn't think we were setting a precedent. Any input is greatly appreciated. Thoughts?
 
H

Hanr3

#3
114 views and no responses.
Maybe we are setting a precedent.
Thanks for the lack of feedback, can provide just as much information as 100 comments. :thanx:
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
I have worked with this when I was with an AB as senior staff. The real question for parameter-based accreditation does not center on the equipment. It centers on how the scope is to be documented.

Having said that, the equipment must be considered. For example, if the parameter is pressure, and the maximum pressure capability is 10,000 psi, then it could be documented as an up to or not to exceed. So, the parameters are the key, the equipment simply provides limits.

Hopefully this is not sought as a flexible scope. Those are available from a few ABs but have their own set of issues.

One break normally given to test labs that cal labs do not get, uncertainty is not included on scopes. However, the lab still should do one to prove they have the ability, because a customer can request it.

If the testing is non-standard, and there are no industry standards for it, then PT/ILC is unlikely. That will need to be documented, and one of the other options in Clause 5.9.1 must be used.
 
H

Hanr3

#5
I have worked with this when I was with an AB as senior staff. The real question for parameter-based accreditation does not center on the equipment. It centers on how the scope is to be documented.

Having said that, the equipment must be considered. For example, if the parameter is pressure, and the maximum pressure capability is 10,000 psi, then it could be documented as an up to or not to exceed. So, the parameters are the key, the equipment simply provides limits.

Hopefully this is not sought as a flexible scope. Those are available from a few ABs but have their own set of issues.

One break normally given to test labs that cal labs do not get, uncertainty is not included on scopes. However, the lab still should do one to prove they have the ability, because a customer can request it.

If the testing is non-standard, and there are no industry standards for it, then PT/ILC is unlikely. That will need to be documented, and one of the other options in Clause 5.9.1 must be used.
That is our planned scope. Scope based on equipment limits. Pressure up to 10,000 psi is a good example. Do we need to identify a test method that achieves the maximum equipment capability? How will the CAB validate our capabilities?

yes, we have an MUA budget, and can populate it with test equipment to calculate the MUA for the test in question.

Correct, 5.9.1 has been a challenge for several reasons. Transporting our Device Under Test is not cheap or realistic. There are maybe one or two other test facilities in the world that can handle testing our DUT. We have to ensure the process works properly, about all we can do. Simple quality checks are done before data is gathered. Records are maintained.

Thanks for the feedback. Sounds like we are on the right path.
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 2
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Composites - Freezer sensor requirements Manufacturing and Related Processes 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
J Requirements for registering Alcohol Wipes (70% IPA) in Canada Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
N German National Requirements - Safety Officer/Authorised Rep Other Medical Device Regulations World-Wide 0
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6

Similar threads

Top Bottom