ISO-9001-Lead-Auditor Exam Dumps : QMS ISO 9001:2015 Lead Auditor Exam

The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.

Table

Audit evidence

ISO 9001 Clause 8 extract

Four of the 10 pallets of stock sampled in the warehouse were not labelled.

“8.5.2 … shall use suitable means to identify outputs …”

A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.

“8.7.1 … shall ensure that outputs that do not conform to their requirements are identified and controlled …”

One of the fork-lift truck drivers had no fork-lift truck driving licence.

“8.5.1 e … shall include, as applicable … the appointment of competent persons …”

There was no pest control provision in the warehouse.

“8.5.4 … shall preserve the outputs during production and service provision …”

Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.

“8.1 … shall plan, implement and control the processes …”

A Stage 1 audit is a preliminary assessment to evaluate the readiness of the organisation for the Stage 2 certification audit. The audit scope is defined by the audit client and the certification body based on the application and the contract. If the organisation wants to include a new work area that was not part of the original scope, the auditor should advise the Quality Manager that an extension of the scope is possible but will have to go through established procedures, such as submitting a formal request, providing relevant information, and paying additional fees. The auditor should also suggest that the Quality Manager will advise the programme manager, who is responsible for managing the audit programme, that the audit scope should be revised to include the new work area. The programme manager will then decide whether to approve or reject the request, and communicate the decision to the auditor and the Quality Manager. The auditor should not proceed with the audit of the new work area without the approval of the programme manager and the confirmation of the audit scope. 1234 References:

1: ISO 19011:2018 - Guidelines for auditing management systems

2: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified

3: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update

4: Getting Certified to ISO 9001 - the Stage 1 Audit

The action that the auditor would have accepted is:

•Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO 9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and updating the actions as necessary.

The following options are not correct:

•Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to implement actions to address risks and opportunities, as required by ISO 9001:2015 clause 8.1.