You are carrying out an audit at an organisation seeking certification to ISO 9001 for...

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."