SBS - The best value in QMS software

Differences Between TS16949 and ISO 13485

#1
Dear Coves

Please advise the resource to research common elements and Difference between the QMS. ISO 13485 the one applies to medical devices and TS16949 the famous automotive system. Please advise from the tactical / engineering perspective.

QE.
 
Last edited by a moderator:
Elsmar Forum Sponsor

Randy

Super Moderator
#2
They have ISO 9001:2008 in common...Is that what you wanted?

The difference? 16949 is automotive and 13485 is medical and the differences are pretty evident in their titles
 
#3
Randy

I was trying to identify the differences and similarities at Tactical level. I mean to say at the engineering level.
 

Jim Wynne

Staff member
Admin
#4
I was trying to identify the differences and similarities at Tactical level. I mean to say at the engineering level.
It's not clear what you're trying to find out. Are you interested in differences in implementation? Differences in common practice as it relates to engineering? Design engineering? Manufacturing engineering?
 
#5
Jim Wynne, thanks for your email. I have a thought and as we brain storm it together we will have refinement. Right now I am trying to find out the convergence and divergence of practices for career evaluation purposes.


Now, back to the topic say Design and Manufacturing engineering both. Like say Design Controls, Production and Process Controls, Risk Management and CAPA processes are used in Medical device manufacturing - ISO 13485. What are the equivalents to these in Automotive world - ISO TS 16949 ?
 

Jim Wynne

Staff member
Admin
#6
Jim Wynne, thanks for your email. I have a thought and as we brain storm it together we will have refinement. Right now I am trying to find out the convergence and divergence of practices for career evaluation purposes.
I'm assuming that by "email" you meant "post," as I didn't send you an email message.

Now, back to the topic say Design and Manufacturing engineering both. Like say Design Controls, Production and Process Controls, Risk Management and CAPA processes are used in Medical device manufacturing - ISO 13485. What are the equivalents to these in Automotive world - ISO TS 16949 ?
I have no experience in medical devices, so I can't help very much, if at all. I was just trying to have you clarify your request. I do know, however, that all of the things you ascribe to medical device manufacturing are also required by TS16949. As Randy pointed out earlier, both standards are based on ISO 9001. I think that risk management, per se, is not emphasized as strongly in 16949 as it is in 13485, but I could be wrong about that.
 

howste

Thaumaturge
Super Moderator
#8
Dear Coves

Please advise the resource to research common elements and Difference between the QMS. ISO 13485 the one applies to medical devices and TS16949 the famous automotive system. Please advise from the tactical / engineering perspective.

QE.
Years ago I put together a comparison matrix that includes both TS 16949 and ISO 13485. You can find it here: DEAD LINK REMOVED

TS 16949 has been updated since then, but the requirements were not changed. You can use it to see side-by-side the differences of the two standards.


Refer this article that highlights the differences between ISO 9001 and ISO 13485. The 9001 concepts could be held valid for TS 16949.

Read HERE
Ajit, there's no link here as far as I can tell...
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
T PPAP differences between TS16949 and VDA APQP and PPAP 1
Q Differences Between TS16949 and 13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What are the differences between TS16949 and QS9000? QS-9000 - American Automotive Manufacturers Standard 3
N R&R for Differences between 2 measurements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
S Differences in CB expectations between the US and Europe Registrars and Notified Bodies 3
M What are the differences between "Process Flowchart form" and "Process Flow Diagram form"? IATF 16949 - Automotive Quality Systems Standard 4
K Differences between EN ISO 11607-1:2009 vs. 2017 Other Medical Device Related Standards 1
M What are the differences between TIR 13004:2013 and TIR 33? Other Medical Device Related Standards 2
H Differences between CQI 15 and CQI 17 IATF 16949 - Automotive Quality Systems Standard 0
A ISO 13485:2003 vs ISO 13485:2016 - What are the differences between the two? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Differences between IATF 16949 and AS9100 IATF 16949 - Automotive Quality Systems Standard 13
E Differences between IEC 60601-1-11:2015 and 2010 Other US Medical Device Regulations 0
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Y Differences between the Classic 7 QC Tools and New QC Tools Quality Tools, Improvement and Analysis 3
C Differences between IATF 16949:2016 vs ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 13
L Differences in the requirements between IEC 60601-1 3rd ed. and EN 60601-1:2006 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Q What are the differences between ISO 13485 vs. AS9100C ISO 13485:2016 - Medical Device Quality Management Systems 3
L AQL ANSI z1.4 & z1.9 - What are the differences between these 2 standards? AQL - Acceptable Quality Level 5
V Differences between ISO 13485 & FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Differences between Clauses 7.5, 8.2.3 and 8.2.4 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V Statistics - Designs - Differences between Orthogonality and Confounding Using Minitab Software 5
K Differences between ISO 9001 and API Q1. Other ISO and International Standards and European Regulations 1
M Differences between international and regional standards (EN, AAMI, CSA...) Other Medical Device Related Standards 6
C Control of Records - Differences between Controlled Documents and Controlled Records Records and Data - Quality, Legal and Other Evidence 18
S What are the differences between Traditional 510(k) and a PMA to meet 21 CFR 814.20 ? Other US Medical Device Regulations 3
O Differences between EN 61326-1:2006 and EN 61326-1:2013 CE Marking (Conformité Européene) / CB Scheme 2
K The differences between ISO 9001 vs a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Y Differences between Top Management, Management & Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W Differences between VDA 6.3 and ISO 9001 VDA Standards - Germany's Automotive Standards 2
G Differences between Quality Objectives and Business KPI's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Differences between an NCR and CAR Internal Auditing 9
M Differences between High, Medium, Low Risk Suppliers Supplier Quality Assurance and other Supplier Issues 5
G Differences between Design, Development, and Production Misc. Quality Assurance and Business Systems Related Topics 4
C Differences between ISO 9001:2008 and AS9100 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Differences between Conductive vs. Dissipative ESD Flooring Manufacturing and Related Processes 3
D Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH Q10 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
D Differences between (c)GMP for Drugs and Medical Devices Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A EN 60601-2-51 - Differences between the 2003 and the 2005 edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C What are the differences between Medical and Non Medical Grade Adhesives 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Differences between Business Process Reengineering (BPR) and Total Quality Management Quality Manager and Management Related Issues 3
V Differences between Quality Tools and Quality Concepts? Quality Tools, Improvement and Analysis 4
G What are the differences between US and EU Pharmacopeias? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 11
N Differences between a Safety Nonconformance and a Quality Nonconformance Nonconformance and Corrective Action 14
F Differences between ISO 9001 and ISO 9004 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Defining the differences between Prototype vs. Production Guidelines? Contract Review Process 5
S Differences between the SAE AS9100C and BS EN AS 9100:2009 versions of the standard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
V Similarities and Differences between EU & US GMPs (Good Manufacturng Processes) Document Control Systems, Procedures, Forms and Templates 8
J Definition Servicing circuit boards - Differences between Rework and Repair Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9

Similar threads

Top Bottom