PECB ISO-9001-Lead-Auditor Dumps Questions Answers

Comprehensive and Detailed In-Depth Explanation:

Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:

Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.

Areas needing improvement, such as missing documented information or unclear process definitions.

While understanding the auditee’s main processes is important, documenting interviews is not a requirement at Stage 1.

According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization’s own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.

Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd’s own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd.

Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause 8.4. The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.

Non-Conformity Report:

ISO 9001 Clause Number

Nature of Problem

ISO 9001 Requirement That Has Not Been Fulfilled

6.1.1

Several risks and opportunities have not been determined.

"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."

6.1.2 (a)

Actions to address risks and opportunities not planned.

"The organization shall plan actions to address risks and opportunities."

Step-by-Step Reasoning:

Clause 6.1.1 - Determining Risks and Opportunities:

Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.

Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).

Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:

Requirement: The organization must plan actions to address identified risks and opportunities. These actions should be integrated into the QMS processes to ensure continuous improvement.

Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.

Correct Options Selected:

Clause 6.1.1 with the nature of the problem as: "Several risks and opportunities have not been determined."

Clause 6.1.2 (a) with the nature of the problem as: "Actions to address risks and opportunities not planned."

ISO 9001 Requirements Not Fulfilled:

For 6.1.1:"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."

For 6.1.2 (a):"The organization shall plan actions to address risks and opportunities."