ISO 9001 Clause 6 deals with planning for the quality management system (QMS). It includes requirements for addressing risks and opportunities, setting quality objectives, and planning to achieve them. Here are the key steps to implement Clause 6 effectively:
Step 1: Plan Actions to Address Risks and Opportunities
- Identify Risks and Opportunities: Analyze the internal and external issues and the requirements of relevant interested parties to determine risks and opportunities that need to be addressed to assure the QMS can achieve its intended results.
- Plan Actions: Develop actions to address these risks and opportunities. These actions should be proportionate to the potential impact on the conformity of products and services.
Step 2: Set Quality Objectives and Planning to Achieve Them
- Establish Quality Objectives: Set measurable quality objectives at relevant functions, levels, and processes. The objectives should be consistent with the quality policy, relevant to the conformity of products and services, and focus on enhancing customer satisfaction.
- Detailed Planning: Define what will be done, the resources required, who will be responsible, when it will be completed, and how the results will be evaluated.
Step 3: Plan Changes to the Quality Management System
- Identify Needs for Changes: When changes to the QMS are necessary, carefully plan these changes to ensure continuity of conformity to requirements.
- Control the Changes: Implement a controlled process for changes, including the timing and transition processes. Ensure the integrity of the QMS is maintained and the desired results are achieved through these changes.
Implementing Clause 6 requires a systematic approach to determine and address the risks and opportunities that could affect the organization’s ability to consistently provide products and services that meet customer and regulatory requirements. Proper planning ensures that the QMS remains effective over time, adaptable to changes, and continuously improving.