Question about the element 11.4 of VDA6.1

M

Mayala

#1
Hello,

I have a question about the element 11.4. Does the company provide procedure for the regular evaluation of its suppliers?
The Definition says that a regular Evaluation includes the periodic evaluation of the quality of delivered products and SERVICES.
We have here procedures to evaluate suppliers of delivered products but we don´t have a procedure to evaluate suppliers of services... it is necessary to have an special procedure to evaluate suppliers of services? if it is, what type of suppliers should I include?

Thanks in advance
Mayala
 
Elsmar Forum Sponsor
A

Andy Bassett

#2
I dont actually know what the standard says (and i keep getting into trouble for this) but if i applied common sense i guess it relates to companies that supply goods or services that can influence the quality of the final product.

So now you are left with the problem of defining which of your supplied goods or products can influence the quality of your product, and this is down to;
A. Your own judgement
B. Your auditors judgement on the day.
C. The type of business you are in.

If we take c first, an example maybe a supplier that supplies advertising. If you are manufacturing parts then only a very pedantic reading of the standard would connect your advertising to the quality of your product. If however you are a recruitment agency then your advertising is critical to your product, and you should almost certainly be evaluating your suppliers.

Suppliers of services that are quite commonly forgotten to be evaluated are
A. Your QMS consultant
B. Your certification Registrar.

Hope that helps.

Andy
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
I can't see why 1 procedure could not address both services and product. There is no requirement for separate procedures.
 
R

Roger Eastin

#4
I agree with Marc. There is no requirement fo r a separate procedure for suppliers of services. As Andy said, take a look at your business and determine who supplies a service that could affect product quality (whatever your "product" is). The standard does require you, at that point, that you evaluate the products or services periodically and assess (through audits - see note 1) the supplier at some frequency that you establish based on the complexity and technical nature of their product. Be sure to keep records of these evaluations.
 
M

Mayala

#5
I want to say Thanks!!! to all of you for you help, the information that you gave me was very important to us.

Mayala
 
G

George Baker

#6
Our QS-9000 procedures have always included both purchased goods and purchased services such as calibration and training, which could affect quality. We treat such service providers exactly the same as material suppliers, including supplier ratings and supplier development. The title of the applicable procedure is "Purchased Goods, Services, and Raw Materials"
 
Thread starter Similar threads Forum Replies Date
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
A Quality engineering positions in US - question Job Openings, Consulting and Employment Opportunities 1
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 6
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Company Moving - Relabelling Question Medical Device and FDA Regulations and Standards News 0
Ronen E Tolerance intervals (?) question - Flow Rate Probability Range Statistical Analysis Tools, Techniques and SPC 6
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
E Question on GD&T added to print - Positional callout for the small holes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J IEC 60601-1, ed 3.1 - Blue icon question IEC 60601 - Medical Electrical Equipment Safety Standards Series 4

Similar threads

Top Bottom