ISO 13485 NIST Traceability requirements for calibration of test equipment

Raffy

Quite Involved in Discussions
#1
Hi :bigwave:
I am quite new to the requirements of ISO13485:2003.
One of our medical devices supplier is ISO13485 Certified in UK.
One of their scope is calibration of test equipment. They are the OEM of the said medical devices and falls under test equipment.
My concern is NIST Traceability not required for calibration of medical devices since they are ISO13485 Certified? Is it acceptable that a medical device calibration not traceable to a national/international standard as long as you are ISO13485 certified? Please advice. :frust:
Thank you very much in advance.
Best regards,
Raffy :cool:
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#3
Hello Raffy!

If I understand what you're asking, you have a supplier that calibrates instruments for you. This supplier is certified within ISO13485, but the calibrations that are performed are not traceable to a national standard.

To my knowledge, if the calibration standard does not maintain traceability to a national standard/ SI unit, it's not a calibration.

That activity may be referred to as some kind of verification or performance check. But if there is no traceability, it's not a suitable standard for calibration.
 

howste

Thaumaturge
Super Moderator
#4
One of their scope is calibration of test equipment. They are the OEM of the said medical devices and falls under test equipment.
If their scope includes calibration of their product under ISO 13485, then they must have traceability to national/international standards. Here's what ISO 13485 says:
ISO 13485:2003 said:
Where necessary to ensure valid results, measuring equipment shall a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.... Records of the results of calibration and verification shall be maintained.
My concern is NIST Traceability not required for calibration of medical devices since they are ISO13485 Certified? Is it acceptable that a medical device calibration not traceable to a national/international standard as long as you are ISO13485 certified? Please advice. :frust:
Per the above, traceable devices must be used, and they must maintain records. However, ISO 13485 does not require them to provide those records to YOU.

What does your purchasing information (PO or contract) specify to the supplier? These are the legal agreements between you and your suppliers. If your purchase order only specifies the product (without documentation) then they aren't required to provide the traceability information. If your PO specifies that they must provide traceability documentation, then they have to provide it.

I know many companies that will provide traceability information for an added cost. This needs to be negotiated BEFORE you buy. If you have the product without the traceability, then you may have to calibrate it yourself.
 
Thread starter Similar threads Forum Replies Date
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 5
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 8
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 4
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Impartiality of Internal Auditor ISO 9001/13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18

Similar threads

Top Bottom