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

Fully vaccinated are you?
Leader
#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
Sam.F Question about granite surface plates out of spec AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
B GD&T Question, True Position Confusion Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
D Initial Importer question Other US Medical Device Regulations 0
Ed Panek Calibration question Manufacturing and Related Processes 4
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
sonflowerinwales Metric or Imperial; that is the question... After Work and Weekend Discussion Topics 6
M Can someone help me with this CMM programming question? Manufacturing and Related Processes 2
A A strange question about predicate device selected in 510(k) submission Medical Device and FDA Regulations and Standards News 8
S Question regarding AQL - ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
JoeRandom11 Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485: 2016 Lot numbering question ISO 13485:2016 - Medical Device Quality Management Systems 4
S Nadcap - Heat Treatment Proof of Verification question for Digital results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
JoeRandom11 Question of Calibration Cycles AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
B 8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
C Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Question regarding PCR workstation Fume Hood upon first use ISO 13485:2016 - Medical Device Quality Management Systems 0
Moncia ISO 9001 calibration question please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Quality Specialist Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
D ISO 13485--Question regarding performing calibrations in house. ISO 13485:2016 - Medical Device Quality Management Systems 13
S Document numbering question? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Has the facility been inspected? question in Certificate to Foreign Government application Other US Medical Device Regulations 0
M ESTAR 510(k) submission question Medical Device and FDA Regulations and Standards News 0
J Question on clause 5.2.2 IEC 62304 - Medical Device Software Life Cycle Processes 2
Ed Panek ISO 15223 Question EU Medical Device Regulations 2
R Question: Cg/Cgk formula Capability, Accuracy and Stability - Processes, Machines, etc. 2
J Quick question on responsible person's experience requirements UK Medical Device Regulations 3
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Question regarding "Customer Property" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
T Noob question regarding sample size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K 510(k) Manufacturer question (private label and manufacture under another persons 510(k)) US Food and Drug Administration (FDA) 1
M Question About Rolled Throughput Yield Manufacturing and Related Processes 5
M Quick Gage R&R Question Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
S Question: Best alternatives to audits for ensuring compliance Quality Tools, Improvement and Analysis 5
Ed Panek Question from 13485 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 2
C Question on KAFO (Knee Ankle Foot Orthosis device) classification CE Marking (Conformité Européene) / CB Scheme 0
T BMW GS 93010-2 Question Various Other Specifications, Standards, and related Requirements 1
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
Ron Rompen Question regarding CMM probe damage General Measurement Device and Calibration Topics 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
C Complaint Return Sample Size Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
8 Drawing Feature Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
D Question: How to analyze numerical and attribute data Reliability Analysis - Predictions, Testing and Standards 11
D Question on electronic signatures and initials on batch records ISO 13485:2016 - Medical Device Quality Management Systems 4
A Special Characteristic question from Automotive CSR Customer and Company Specific Requirements 9
Ron Rompen GDT Question - is this even correct? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A PPAP question for audit APQP and PPAP 17

Similar threads

Top Bottom