The Essential VDA Standards - VDA 6.1, 6.2, 6.3, 6.4 and 6.5

Elsmar Forum Sponsor

antoine.dias

Quite Involved in Discussions
#3
VDA 6.1 is not "essential" anymore as ISO TS 16949 is accepted instead.

The other ones mentioned in Marc's list are specific for the German automotive market.

Best regards,

Antoine
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Yup - I was just doing some cleaning and such and something came up where I was looking at this forum and figured I'd throw in a quick reference of the 5 VDA standards that are applicable here. I know they're not applicable to most folks here, but for those browsing who come across this forum and are curious about what the VDA standards are, I figured this might give some basic information.

I should have included these:

Wikipedia reference-linkVerband_der_Automobilindustrie

Verband der Automobilindustrie e. V. - The German Association of the Automobile Industry (VDA)

The Verband der Automobilindustrie e. V. (VDA) is a German interest group of the German automobile industry, both automobile manufactures and automobile component suppliers. The group is located in Frankfurt, Germany. Current president since June 1, 2007 is the former federal minister of transport Matthias Wissmann. The VDA is hosting the world's largest motor show, the biannual Internationale Automobilausstellung (IAA) in Frankfurt.

The VDA published a series of standards and recommendations. Among those is the German Quality Management System (QMS) for the automobile industry. The fourth edition was issued in December 1998, and became mandatory for all German car makers on April 1, 1999.
 

Kales Veggie

People: The Vital Few
#5
VDA 6.3 (and variation of this standard) is used worldwide by automotive companies with German origin and adapted by companies that supply German car manufacturers such as Volkswagen.
 

Raffy

Quite Involved in Discussions
#7
Hi Marc,
Thank you for starting the information on VDA :)

Hi Howard,
Thank you also for the file you've shared. :)

Best regards,
Raffy :cool:
 
S

skartachi

#8
Hello,

we had today a certification audit for the ISO TS 16949 and the auditor ask for the process audits, and we present for him our planing and the finding for the process audit, and he asks also for the requierments of VDA regarding the process audit and realy I don't had any ansewrs for that, So please could help me for what are the most important requierement of process audit according to VDA and what is the differents point between ISO TS and VDA.

Many Thanks
Samir
 

Howard Atkins

Forum Administrator
Staff member
Admin
#9
VDA 6.3 is a format for process audits and is used by a number of companies that are certificated to TS.

There is no obligation to use this format if you are not required by a customer.
For more details see this search or these attachments (They might be out of date )
 
#10
Please, about POTENTIAL ANALYSIS included in VDA 6.3 why the number of question in the check list (see paragraph 7.1) are 38, while in the paragraph 9.2 with the Excel Potential Analysi the questions indicated there are 36 ?
Why this difference? Thank you
 
Thread starter Similar threads Forum Replies Date
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
M Informational TGA – Essential principles checklist (medical devices) Medical Device and FDA Regulations and Standards News 2
M Brazil and Japan - Essential requirements Other Medical Device Regulations World-Wide 3
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Essential Requirements Checklist - (MDD 93/42 / EEC) Misc. Quality Assurance and Business Systems Related Topics 2
M Informational TGA Webinar: Essential Principles to software Medical Device and FDA Regulations and Standards News 0
B Essential Performance of a Cone Beam Computed Tomography Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Z In which country is essential to have and IEC 60601 CB Report? Other Medical Device Related Standards 0
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
D IEC 60601-1 - Essential performance doesn't make sense IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
D Essential Requirements Checklist for Standalone Software CE Marking (Conformité Européene) / CB Scheme 10
Rincewind Pressure energy - Essential Requirements (MDD/MDR) EU Medical Device Regulations 2
D IEC 60601-1 - Performance limits for essential performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N Essential requirements checklist needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Essential performance, accompanying documents....confused IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K IEC 60601-1 and Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M IEC 60601 - Limits of agreement as Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Medical Device Changes and How to Assess Their Impacts to Essential Requirements EU Medical Device Regulations 2
A Essential Requirement Checklist For Medical Device CE Marking (Conformité Européene) / CB Scheme 4
A Policies Mandatory or essential for ISO 27001 implementation IEC 27001 - Information Security Management Systems (ISMS) 6
R Essential Performance of Mechanical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
K Essential Requirements Checklist references EU Medical Device Regulations 10
D IEC 60601-2-44: 202.101 Immunity Testing of Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
K New Product Essential Requirements Cheat Sheet EU Medical Device Regulations 6
A Regarding Essential Requirements Checklist ISO 13485:2016 - Medical Device Quality Management Systems 9
M Is it essential to do the Fractional Test for ETO Revalidation? ISO 13485:2016 - Medical Device Quality Management Systems 1
L "Potential" Essential Performance in IEC 60601-2-54 (Definition) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
E Particular standards, essential performance in EMC Immunity Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D What are the Essential Quality Books in the last 15 years Book, Video, Blog and Web Site Reviews and Recommendations 3
M "Basic Safety" versus "Essential Performance" IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
G Audit of essential QMS processes General Auditing Discussions 11
somashekar GMP (Good Manufacturing Practices) essential information URL Manufacturing and Related Processes 1
I Defending "No Essential Performance" for a Surgical Video Camera IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
R Minimum Essential Receiving Inspection (M.E.R.I.) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J Project Specific Documentation - Completion and filing of all essential records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Essential Requirements Checklist w/o ISO 13485 CE Marking (Conformité Européene) / CB Scheme 7
S Innovation in ER (Essential Requirements) Checklists EU Medical Device Regulations 6
L ISO 14971 - Annex C question C.2.34 "Essential performance" ISO 14971 - Medical Device Risk Management 2
S Canada - Essential Requirements Checklist for MDD 93/42/EEC Canada Medical Device Regulations 8
E Question on approval of the EU Essential Requirements Matrix - MDD Requirements EU Medical Device Regulations 1
5 Completed Medical Device Essential Requirements Matrix CE Marking (Conformité Européene) / CB Scheme 1
AnaMariaVR2 The Essential Guide to Combination Products cGMPs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Essential Design Output - Still a problem 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Essential Gap Analysis Checklist Components for ISO Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Essential Performance in IEC 3rd edition of the 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Q Japanese Pharmaceutical Affairs Law (PAL) doc and "Essential Principle Checklist" Japan Medical Device Regulations 2

Similar threads

Top Bottom