–If the inspection body uses results from testing (from a laboratory) within its report, is that considered to be subcontracting in any way? (1)
–What if the laboratory and the inspection body are different departments performing different activities within the same entity/ organization? (2)
-Does it matter whether the two departments are implementing the same management system (integrated) or not? (3)
-Does it matter if the required tests/analyses influence the outcome of the inspection results or the interpretation of the results, or are just tests required by the client? (4)
STANDARD: ISO/IEC 17020 · CLAUSE: 6.3 · TOPIC: Subcontracting
Answer:
1.ISO/IEC 17020 makes reference to ISO/IEC 17000 for definition of terms. ISO/IEC 17000 makes reference to ISO 9000 for related terminology. ISO CASCO standards, see e.g. ISO/IEC 17065 clause 6.2.2.1, refers to “outsourcing” and “subcontracting” as synonyms. The definition of outsource in ISO 9000 is “make an arrangement where an external organization performs part of an organization’s function or process”. If an inspection scheme or contract calls for the performance of a test to provide input to the inspection, then performance of this test is part of an inspection body’s process and clause 6.3.1 of ISO/IEC 17020 is applicable. If an inspection scheme or contract calls for the review of test results provided by e.g. a manufacturer or supplier, then performance of this test is not part of an inspection body’s process and clause 7.1.6 is applicable. This holds true even where the manufacturer/supplier is not the performer of the test, but is commissioning this service.
2. It is the responsibility of the accreditation body to define the accredited body, see 17011:2017, clause 7.8.1. According to clause 5.1.1 of ISO/IEC 17020 the inspection body can be a legal entity or a defined part of a legal entity. If the laboratory is within the organisation thus defined as the inspection body, then it is not a subcontractor. If it is not within the defined organisation, then it is a subcontractor. However, if the two parts of the organization work according to the same management system, it would be expected that the accredited body is defined to include both entities, limiting the extent of subcontracting.
3. Yes. ISO/IEC 17020 does not allow for the inspection body to have multiple non-integrated management systems. See clause 8.1.1. If the inspection body and the laboratory have the same management system, or if the two systems are integrated, the answer to question 2 still applies.
4. The important consideration is; what has the inspection body contracted to deliver? In particular, does the client require all of the work to be covered by accreditation, and if not, which parts do they require the accreditation to cover? Many clients want a one-stop-shop for a variety of inspections and may contract an inspection body to provide a range of work under one contract that may include:
1. Inspections within the inspection body’s scope of accreditation, defined by an inspection scheme
2. Inspections within the inspection body’s scope of accreditation, not defined by an inspection scheme
3. Inspections outside of the inspection body’s scope of accreditation
4. Tests outside of the inspection body’s scope of accreditation but which are required to support an inspection decision that is covered by the inspection body’s scope of accreditation
5. Standalone tests (not supporting an inspection) outside of the inspection body’s scope of accreditation.
For the work in (1) the inspection body may do the work themselves or, in unusual circumstances, may subcontract the work. [clause 6.3.1 applies]
For the work in (2) the inspection body may do the work themselves or, in unusual circumstances, may subcontract the work. [clause 6.3.1 applies]
For the work in (3) the inspection body may do the work themselves (but cannot claim endorsement)
For the work in (4) the inspection body may do the work themselves or may subcontract the work [clause 6.3.1 applies] or may accept information (test results) provided by a third party [clause 7.1.6 applies]. In this case the inspection body may claim endorsement, but will have to put a disclaimer to test results not produced under accreditation or to the outcome of the inspection if individual test results are not included in the inspection report.
For the work in (5) the inspection body may do the work themselves or subcontract it to an organisation that is or is not accredited for the tests, in neither case can the inspection body claim endorsement.