Who has the final say on which subclauses are applicable from a given standard?

M

milagre

#1
Hello everyone,

I am pretty new at this. I am wondering who is in charge of determining which subclauses are applicable from standards we want to prove our compliance with.

If the test report comes out of the test lab with a certain subclause marked "N/A", is there anyone during the TCF review or the audit who might dispute that? Or does the final determination rest with the test lab?
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hello everyone,

I am pretty new at this. I am wondering who is in charge of determining which subclauses are applicable from standards we want to prove our compliance with.

If the test report comes out of the test lab with a certain subclause marked "N/A", is there anyone during the TCF review or the audit who might dispute that? Or does the final determination rest with the test lab?
Test labs just test and consult with you prior to testing to determine the costs. You get better inputs with better test houses. Normally testing and reporting is the end event when you work with reputed test houses on a project basis for a new product. The particular standard to an extent guides you, however it is you and your own technical personnel who have to determine based on what has been designed. The technical review of the TCF done by the experts from NB do have the knowledge, however they may also need your guidance and technical justification to arrive on the common ground.
 
Thread starter Similar threads Forum Replies Date
B Z10 Occupational Health and Safety Standard - Has anyone seen the final version? Other ISO and International Standards and European Regulations 8
A Revision of MDD, 93/42/EEC - Has the final revision been published? ISO 13485:2016 - Medical Device Quality Management Systems 2
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 16
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 14
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Nicole Desouza Who has to be compliant with REACH Declarations? REACH and RoHS Conversations 11
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Would an MRP system that has been in use for over 10 years require validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
I Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
S Doubts about SPC taken in Machining - Part has +-0.01 Tolerance Statistical Analysis Tools, Techniques and SPC 5
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
P NPR Metric - What if Customer has relaxed measure? TL 9000 Telecommunications Standard and QuEST 1
D EU Harmonized Standards to which a company has declared compliance EU Medical Device Regulations 13
N Customer Survey Question Has Me Stumped - Compliance with Laws and Regulations Customer and Company Specific Requirements 4
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Who has had a Transition Audit from TS 16949 to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 120
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
M Remote Office only has Invoice Function - Audit Needed? IATF 16949 - Automotive Quality Systems Standard 0
W CPU BIST IEC 62304 - Embedded code has CPU instruction tests IEC 62304 - Medical Device Software Life Cycle Processes 2
Similar threads


















































Top Bottom