UK Conformity Assessment Bodies: using a subcontractor
This guidance is for UK Conformity Assessment Bodies (CABs) who are intending to subcontract tasks such as testing, certification or inspection.
This guidance applies to any conformity assessment activities that a UK Conformity Assessment Body (UK CAB) subcontracts.
It’s for all UK CABs, including:
- UK Approved Bodies
- UK Notified Bodies (for the Northern Ireland market)
- GB Appointed Bodies (for transportable pressure equipment)
- User Inspectorates
- Recognised Third Party Organisations (pressure equipment)
This is general guidance on subcontracting. There are specific requirements detailed in the product-specific regulations.
For medical devices, contact the Medicines and Healthcare products Regulatory Agency info@mhra.gov.uk with any questions.
Overview
Subcontracting is the act of contracting another body to do a task, which you have been appointed to perform, as part of the conformity assessment process. This is also commonly referred to as ‘outsourcing’.
You can subcontract most tasks within the UKCA conformity assessment process, such as testing, certification or inspections. However, the decision on conformity itself must be made by a UK CAB.
You’re responsible for ensuring that the activities you subcontract comply with the requirements of the conformity assessment standard for which you’re accredited. See UKAS publication GEN 5 for more information.
If you have an overseas subsidiary, you can use the subsidiary to carry out the conformity assessment activities subject to the same conditions as using sub-contractors.
Subcontracting does not include when individuals are contracted-in as employees of a UK CAB (regardless of where they are employed). These individuals fall under the quality management system of that body.
There may be different conditions for products approved under the terms of a mutual recognition agreement (MRA) with the UK. The requirements for CABs are detailed within these agreements.
Before subcontracting
Before subcontracting you will need to:
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Identify an organisation with the competence and skills needed to carry out the relevant testing or inspection activities on your behalf.
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Assess the organisation’s competence and qualifications to ensure that the subcontracted work will be carried out competently, and in line with the criteria in the relevant regulations and any conformity assessment standard. This can be reviewed through monitoring of activity.
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Have a contract under UK law with any subcontractors to ensure their responsibilities are fulfilled.
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Get agreement to use a subcontractor from the economic operator or business on whose behalf they will be carrying out conformity assessment activity.
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Where a specific regulation requires it, you must inform the Secretary of State that you intend to use a subcontractor, and that you’re satisfied that the subcontractor meets the relevant quality assurance requirements. The Secretary of State can amend your approval or notification if they do not feel that the approval requirements are met. To inform the Secretary of State for DBT regulated goods, you can contact OPSS on approvedbodies@businessandtrade.gov.uk. For other areas check the relevant regulations.
Subcontractor requirements
You can subcontract specific activities to other competent bodies based in the UK or overseas. For example:
- certification bodies
- inspection bodies
- testing laboratories
Subcontractors need to fulfil the same requirements as the UK CAB in relation to the performance of conformity assessment tasks. This means that the subcontractor must be technically competent and display independence, impartiality, and objectivity according to the same criteria as the UK CAB.
One way of demonstrating competence is by using a subcontractor that is accredited (for the scope concerned) by an internationally recognised accreditation body. You can check if the accreditation body is a signatory of an MRA operated by one of the following:
- International Laboratory Accreditation Cooperation
- International Accreditation Forum
- European Co-operation for Accreditation
As the subcontracting UK CAB you will still need to satisfy yourself of the integrity of all data used.
Pyrotechnic articles
A UKAS accredited CAB established overseas can subcontract to other overseas pyrotechnic CABs or test houses.
For pyrotechnics, you can meet your requirements through more use of subcontractors and subsidiaries than allowed in other regulations. Contact opss.enquiries@businessandtrade.gov.uk for more information.
Tasks which can be subcontracted
You can subcontract for any specific activities, such as:
- product testing
- factory production control audits
You cannot subcontract:
- contract review
- planning of the overall evaluation activity
- final conformity assessment decisions
As the UK CAB, you are responsible for issuing the certificate of conformity.
For example, a conformity assessment procedure may involve a specific technical operation, such as heat combustion testing. You could subcontract this specific testing but would need to analyse how the results were obtained and the test results before issuing certification.
You can only subcontract a task for which you have the competence to ensure the task is competently undertaken. You should not subcontract parts of the conformity assessment procedure because you do not have the required competence or knowledge in-house.
In practice, this means your staff must be technically competent to assess the test results and review the work of subcontractors.
UK CAB responsibilities
As the UK CAB you’re ultimately responsible for all conformity assessment decisions.
Keeping records
When subcontracting you must keep records, including:
- documentation of the procedures
- a list of facilities
- relevant information on the qualification and competence of the subcontractor and the work they carry out (as detailed in the relevant regulation)
This data must be made available to UKAS and the relevant Secretary of State on request. The period you need to keep records may be determined by the regulation specific to the product being assessed.
Monitoring
You must monitor the competence of any subcontractor, for example through monitoring their accreditation status, direct oversight, or review of submitted results.
Certification
All certificates relating to the conformity of the product must be issued in the name of, and under the responsibility of the UK CAB.
You’re responsible for maintaining a complete record of the certification process, including those activities which have been subcontracted. This record will include a complete technical file for the products which must be made available to enforcement authorities on request. For example local trading standards authorities, the Health and Safety Executive or the relevant Secretary of State.
Examples
Pressure Equipment (Safety) Regulations 2016
An Approved Body for pressure equipment in the GB market may have a formal, legally binding agreement with a competent non-UK conformity assessment body (where staff are employed by the non-UK entity) to perform work on certain conformity assessment tasks on their behalf, for example product testing or inspection.
The UK Approved Body, having consulted the relevant regulation and applicable accreditation standard, will need to:
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Ensure that they are satisfied the non-UK CAB meets the same requirements as themselves which are detailed in the relevant standard and product regulation.
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Ensure that the non-UK CAB and the personnel that it uses are impartial, and not under any undue influence.
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Get consent from the business who has requested the conformity assessment for some of this activity to be undertaken by the non-UK CAB.
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Inform the Secretary of State that they are using the subcontractor and that they are satisfied that the subcontractor meets the relevant requirements by emailing approvedbodies@businessandtrade.gov.uk.
The UK Approved Body needs evidence to support their assessment of the competence of the non-UK CAB and must keep this available for inspection by the Secretary of State or UKAS.
The UK Approved Body remains responsible for the proper performance of any subcontracted tasks or activity and is responsible for the final certification of any product.
If requested by the Secretary of State at any point, the UK Approved Body must provide any relevant documents concerning the assessment of the qualifications of the subcontractor and the tasks or activities carried out by the subcontractor.