Question

During a routine surveillance visit, the organization you are auditing informs you that they no longer carry out any design and development work. This activity is now outsourced to an external provider (contractor).
Give four examples of audit evidence you would look for to determine the conformance of the current system with ISO 9001:2015, given the information you have just received

Answer 1

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Explanation:

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Answer 2

Answer:

Typical solution

 Evidence that the organisation has carried out the transfer to an external provider

(contractor) in a planned manner[6.3].

 Evidence that the organisation retains, or has engaged, persons competent in design and

development to the degree necessary to place adequate controls on the external

provider (contractor) and to analyse and evaluate appropriate data and information

arising from monitoring and measurement [7.2].

 Evidence that the organisation has ensured that the design and development process

conforms to requirements [8.4.1].

 Evidence that the organisation has ensured that the design and development process is

controlled [8.4.1].

 Evidence of the criteria for the evaluation, selection, monitoring of performance, and reevaluation

of the external provider (contractor). [8.4.1].

 Documented information (records) addressing the evaluation, selection, monitoring of

performance, and re-evaluation of the external provider (contractor) [8.4.1].

 Evidence of controls applied to the external provider (contractor) [8.4.2].

 Evidence of controls applied to the resulting design and development process output

[8.4.2].

 Evidence of the verification, or other activities, necessary to ensure that the design and

development process meets requirements [8.4.2].

 Evidence that the organisation has communicated to the external provider (contractor)

the requirements for:

- design and development;

- the approval of design and development outputs (designs), as well as methods and

processes;

- competence, including any required qualification of persons;

- the external providers’ interactions with the organisation;

- control and monitoring of the external providers’ performance to be applied by the

organisation;

- verification or validation activities that the organisation, or its customer, intends to

perform at the external providers’ premises [8.4.3].

 Evidence that the decision to externally provide (outsource) design and development

was aligned to the strategic direction of the organisation [9.3.1].

 Evidence that trends in the performance of the external provider (contractor) have been

considered in management review [9.3.2 c) 7)].

 Documented information (records) from management review about this change to the external and internal issues [9.3.2 b)].

Explanation: