Who is REQUIRED to be an appraiser in MSA?

C

cjkurtz

#1
During a QS-9000 audit, would it be considered a non-conformity if GR&R's are conducted without appraisers who normally use the gage? The MSA says SHOULD, page 39, item 3.

Also, what if I cannot show that the parts selected for the study are not "selected from the process and represent its entire operating range"?

Anyone have experience with auditors/registrars concerning these details?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
As I understand the requirement for Gage R&R, both of these are required. If you do not do the 'should', you better have a very good explaination of why your alturnative methodology is appropriate and how it meets the 'intent'.
 
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