Subcontracting Inspections and Tests - ISO 17020:1998 clause 14.2

A

amanbhai

Though we subcontract certain inspections & tests related to inspections but don't like to mention that to our customers (our company policy). All we say is that we don't have the capability to do the tests so we have may have to subcontract that one. We do not specify any subcontractor nor we take any approval from the customer.
How do we address this particular clause of ISO 17020:1998 clause 14.2
:thanks:
 

Hershal

Metrologist-Auditor
Trusted Information Resource
The Clause specifically states "The sub-contractor shall be acceptable to the client." so there are several ways to address the requirement. The one that seems to be directed here is to inform your customer of the sub, but alternate approaches such as finding out if the customer specifically does NOT want any organization(s) to sub for you is another approach. There are many ways possible to fulfill this requirement, but make sure you document any acceptance or challenge to the subs that you may use, as you can rest assured the accrediting body will want to see evidence of compliance.
 
A

amanbhai

We have an internal audit CAR regarding subcontracting register. Again we do subcontracting but don't mention it to our customers. Also, in some cases we do not have the capability to judge the subcontracted jobs. What do we do? :confused:
Any help is appriciated. :thanks:
 

DietCokeofEvil

Trusted Information Resource
What do you mean that you don't have the capability to judge subcontracted jobs? I'm not understanding that.

Any subcontracter you use either has to be 17025 accredited or shown to be the only source for a specific service, even if they are not accredited. (E.G. the manufacturer of some of our equipment calibrates and services our machines every year because its proprietary- but they aren't accredited).

17025 states that the customer has be be informed of any subcontracting. To me, its straightforward- if you can't do the job and you need to send it out, the customer has to be informed first. Part of this is liability. Part of it is giving the customer a chance to deny the service. I had a customer who denied a subcontract- we had to send her fixtures out for rework and only one place could do it- and she wouldn't do business with them.

JMO
 

Hershal

Metrologist-Auditor
Trusted Information Resource
For a sub-contractor for inspection, the sub must be able to support an organization's ISO/IEC 17020 accreditation.....and the evaluation of an inspection sub is radically different than a lab sub.....so this means potentially field observations and related activities.....but this MUST be done in order to establish the competence of the sub.....or the AB may and should investigate the sub-contracting.....
 
S

siawo

We are an inspection company going for ISO/IEC 17020:1998, previously we are ISO 9001 certified for last 10 years. We have problem dealing with Clause 14.2 Subcontracting. Usually we do not subcontract, but for one of the specialized service we do subcontract, after getting approval from client. I would like to know the procedure for the same as following:

"If we hire the services of a person (not a company) for specialized services for execution of a part of inspection contract, Shall we describe it in subcontracting clause. If yes, What is the procedure for that."
 

Hershal

Metrologist-Auditor
Trusted Information Resource
Yes, it must be described in your sub-contracting caluse in your manual. Additionally, the sub-contractor must be acceptable to the client.

The specific procedures need to describe how you actually do the sub-contracting.

Hope this helps.
 
A

amanbhai

We are an inspection company going for ISO/IEC 17020:1998, previously we are ISO 9001 certified for last 10 years. We have problem dealing with Clause 14.2 Subcontracting. Usually we do not subcontract, but for one of the specialized service we do subcontract, after getting approval from client. I would like to know the procedure for the same as following:

"If we hire the services of a person (not a company) for specialized services for execution of a part of inspection contract, Shall we describe it in subcontracting clause. If yes, What is the procedure for that."

As long as my knowldge is concerned free lancers are not subcontractors! correct me if i am wrong. thanks.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
As long as my knowldge is concerned free lancers are not subcontractors! correct me if i am wrong. thanks.

You are correct, and this is how.

Under the accepted interpretations of ISO/IEC 17020 and also under ILAC/IAF A4, an individual is not considered a sub-contractor. However, a company is.

There may be some interpretive room if the individual has his own company and is the sole employee, but the generally accepted interpretation there would still be that it is sub-contracting.

Hope this helps.
 
Z

zamclachia

For me 17025 is very clear - The customer must be informed of any subcontracted work. If you are not informing the client I believe you are misrepresenting yourself. By not informing the customer, do you not open a can of worms should a legal challenge to 'your' submitted results arise? :argue:
 
Thread starter Similar threads Forum Replies Date
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
D Subcontracting specification developer duties US Food and Drug Administration (FDA) 5
D Subcontracting Clinical Evaluations EU Medical Device Regulations 1
T Is Testing in a Third Party Facility Subcontracting? General Measurement Device and Calibration Topics 2
G Subcontracting work (manufacturing) to another company location EASA and JAA Aviation Standards and Requirements 4
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Subcontracting of Tests and Calibration - ISO 17025 Clause 4.5 ISO 17025 related Discussions 1
C Establishment Register Question - Subcontracting - Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Subcontracting and Control Issues - Class I Medical Devices with Measuring Function ISO 13485:2016 - Medical Device Quality Management Systems 5
Q FAI Help - Subcontracting out all manufactured items (PCB & machined parts) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Definition Subcontracting vs. Outsourcing - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
J Class IIa Medical Device and Subcontracting questions ISO 13485:2016 - Medical Device Quality Management Systems 3
A Definition Outsourcing vs. Subcontracting - The Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 11
K Subcontracting of Tests and Calibrations - ISO 17025 Sec: 4.5 ISO 17025 related Discussions 11
J ISO 9001 procedures content - Subcontracting electrical and instrumentation Document Control Systems, Procedures, Forms and Templates 6
T Supplier subcontracting requirements and Distributor requirements Supplier Quality Assurance and other Supplier Issues 5
S Definition Outsource - Outsourcing - Subcontracting - Definition - TS 16949 and ISO 9001 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
R Subcontracting Finished Product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V External Processes - Subcontracting - Control Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
U How should we build the FDA inspection preparedness team for FDA inspections at factories? General Auditing Discussions 0
Q Health Authority Inspections Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Performing Additional Inspections IATF 16949 - Automotive Quality Systems Standard 10
Watchcat De novo Final Rule Pending - Inspections 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C First Article Inspections - 'how to measure' General Measurement Device and Calibration Topics 11
P FDA inspections and electronic signatures Other US Medical Device Regulations 2
E South Korea, MFDS - GMP inspections Other Medical Device Regulations World-Wide 4
S Gage R & R for large amount of inspections IATF 16949 - Automotive Quality Systems Standard 10
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Good Clinical Practice Inspections Program Medical Device and FDA Regulations and Standards News 0
S FDA Inspections and Pest Control - Pallets too close to walls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
C How to Control Temporary Inspections Manufacturing and Related Processes 5
G What to Check - Set Up vs. In Process Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
S Setting up the process - First piece inspections Statistical Analysis Tools, Techniques and SPC 3
T Difference betwee General vs. Follow-up Inspections US Food and Drug Administration (FDA) 3
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
A Infusion Pump - Pre-Clearance Inspections Learnings US Food and Drug Administration (FDA) 4
Q Please suggest how to improve Cosmetic Visual Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
T Raw Parts Inspections for NPI (New Product Introduction) Phase Supplier Quality Assurance and other Supplier Issues 1
M Validating a Product through Tool Control and Tool Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A Can Internal Audit Observations be kept confidential from State FDA inspections ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
G Do Inspections need to be performed by QA/QC Personnel 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Marc Guide To Inspections Of Medical Device Manufacturers - 1997 (06/08/2010) US Food and Drug Administration (FDA) 3
S FDA Enforcements for 2011 - RAPS article on FDA Inspections and Enforcements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A Is taking Photos by the Auditor during FDA Inspections allowed? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M Requirements for Site Inspections for Legal Compliance Miscellaneous Environmental Standards and EMS Related Discussions 7
C Microscope Power to use for Visual Inspections in an Aerospace Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Q Current Process Controls (Prevention) and Incoming Raw Material Inspections FMEA and Control Plans 8
Roberticus Blacklight Cosmetic Inspections of Stainless Steel Parts ISO 13485:2016 - Medical Device Quality Management Systems 5
R FDA Inspections - Questions from a Device Manufacturer Submitting 510k Other US Medical Device Regulations 3
J During Production Inspections (DUPROs) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2

Similar threads

Top Bottom