SBS - The best value in QMS software

Outsourcing Calibration - NIST, OEM, and Calibration Laboratory

Tyranna

Involved In Discussions
#1
If a company sends out a piece of equipment to an accredited lab and specifies in the purchase order "that all calibration must be done by an ISO 17025 accredited lab traceable to NIST standards", would the lab performing the calibration know to perform such calibration to the OEM specs (including tolerances) and would that calibration be able to be traced back to NIST?

Also another question: Is it imperative that the PO contain exact instructions as to what calibration is required such as " calibrate to OEM specifications"?

I am under the impression that NIST develops standards independent of any OEM and that the measurement is what is traceable, not the OEM's specs.

Is that correct? Thank you for your help!
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Question regarding NIST, OEM, and Cal Lab

If a company sends out a piece of equipment to an accredited lab and specifies in the purchase order "that all calibration must be done by an ISO 17025 accredited lab traceable to NIST standards", would the lab performing the calibration know to perform such calibration to the OEM specs (including tolerances) and would that calibration be able to be traced back to NIST?
If you know that you're sending your device to an accredited lab, you shouldn't have to specify that in the PO. What you should specify, if it's what you want, is that calibrations must be performed in accordance with ISO 17025 requirements, even if the lab is accredited. Some labs play games with pricing based on whether or not the calibration (and the calibration certificate) is done under the accreditation umbrella.

As for OEM specifications, I suppose it would depend on the device(s) in question.

Also another question: Is it imperative that the PO contain exact instructions as to what calibration is required such as " calibrate to OEM specifications"?
There should be a quote from the calibration lab that tells what it is you're paying for and how much it costs. This is done in advance of the purchase order. Once you've told the lab what you want and the lab documents that in its quotation, you can just refer to the quotation in your PO--"Calibrate device x in accordance with quotation #12345."

I am under the impression that NIST develops standards independent of any OEM and that the measurement is what is traceable, not the OEM's specs.

Is that correct? Thank you for your help!
Traceability applies to calibration standards--the thing that is used for comparison, such as gage blocks or a signal generator--not to specifications for calibration or measurements themselves.
 
Thread starter Similar threads Forum Replies Date
Crusader 7.6 Calibration (referencing outsourcing) in the Quality Manual Quality Management System (QMS) Manuals 5
C Calibration Outsourcing vs. In House Calibration - Outrageous Costs of Calibration General Measurement Device and Calibration Topics 28
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 25
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Supplier Management outsourcing - Business idea Supplier Quality Assurance and other Supplier Issues 8
S Outsourcing manufacturing - Who controls the suppliers of parts to the CMO? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Outsourcing and internal controls Internal Auditing 1
B Outsourcing process design (8.3.3) IATF 16949 - Automotive Quality Systems Standard 1
T ISO 13485 for software outsourcing company ISO 13485:2016 - Medical Device Quality Management Systems 7
G Outsourcing Processes within the Same Company (ISO 13485) Quality Manager and Management Related Issues 4
smryan Compliance Officer Outsourcing? RoHS, REACH, ELV, GADSL, IECSC Other ISO and International Standards and European Regulations 5
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
R Microbiology Testing Outsourcing - Transport Qualification and Risk Assesssment Qualification and Validation (including 21 CFR Part 11) 2
J Definition Outsourcing - How Far Does it Go? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
J API Q1 9th Edition - Question on Outsourcing 5.6.1.6 Oil and Gas Industry Standards and Regulations 1
S Outsourcing a Core Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Medical Device Outsourcing Batch Traceability Requirements Other Medical Device and Orthopedic Related Topics 2
G Definition Work Transfer vs. Outsourcing Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
S Outsourcing PPAP Function APQP and PPAP 8
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Y ISO9001 Implementation for Business Process Outsourcing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Risk Management in Outsourcing Company ISO 14971 - Medical Device Risk Management 16
A Outsourcing Records Storage - Compliance Aspects to be considered during Audits Document Control Systems, Procedures, Forms and Templates 7
R Outsourcing of a Semi-Finished Product - Which major things to address in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
T Brief Survey for OEM's about Outsourcing Supplier Quality Assurance and other Supplier Issues 5
E Business Process Outsourcing - Training Plans for Employees where you deliver labour ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 and Medical Device Manufacturing Outsourcing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K What's the difference between Outsourcing and Work Transfer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J General Procedure for Outsourcing of Human Resources and Service Processes wanted Document Control Systems, Procedures, Forms and Templates 1
J Extending QMS Scope to External Company Site (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna From Human Resources to Outsourcing ? ISO expands work in five areas Other ISO and International Standards and European Regulations 4
O Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.3.6? IATF 16949 - Automotive Quality Systems Standard 6
B Distributor Outsourcing Value Added Services - Is it work transfer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
T To share and (hopefully) to hear feedback - Outsourcing to China Quality Manager and Management Related Issues 20
R ISO/TS 16949:2009 Clause 4.1 General Requirements (Outsourcing) Clarification IATF 16949 - Automotive Quality Systems Standard 6
L Outsourcing Special Processes such as Plating, Painting, NDT as related to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
L Outsourcing of Quality Tests (same company but different division) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Outsourcing manufacturing of final product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Terms & Conditions done by Outsourcing Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Outsourcing - Type of Control - Request for Interpretation on Clause 4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Business Process Outsourcing - Call Center QA SOPS for Telemarketing Campaigns Quality Manager and Management Related Issues 6
V Outsourcing Internal Quality Auditing functions Internal Auditing 26
D How does "outsourcing" get included in the FMEA and Control Plan? FMEA and Control Plans 4
J Is this Outsourcing, as per ISO 9001:2008? Financial/Insurance sector ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2008 clause 4.1 Outsourcing Process control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom