ISO9001 GAP Analysis Question 21 Planned Activities to address Risks and Opportunities

To determine if your quality system meets the requirements of ISO 9001 section 6.2, you’ll need to carefully evaluate your quality objectives and the planning around them. This section is designed to ensure that your quality objectives are effectively established, managed, and aligned with your overall quality policy. Here’s how to assess your current system for compliance:

1. Confirm Alignment with Quality Policy (6.2.1a):

First, check if your quality objectives are consistent with your quality policy. The objectives should reflect the organization’s commitment to quality and continuous improvement as outlined in your policy. Review your objectives to ensure they align with strategic priorities such as customer satisfaction and product/service quality. If the objectives are not clearly linked to your quality policy, this could indicate a gap.

2. Verify Measurability and Relevance (6.2.1b, 6.2.1d):

Quality objectives must be measurable, meaning there should be specific criteria or metrics to assess performance. Confirm that each objective has associated targets that can be quantitatively or qualitatively measured. Additionally, the objectives should focus on aspects directly tied to product/service conformity and customer satisfaction. If your objectives are vague or lack measurable targets, you may need to refine them to ensure they are both practical and meaningful.

3. Assess Monitoring and Communication (6.2.1e, 6.2.1f):

Evaluate if you have mechanisms in place to monitor each objective. This can include performance dashboards, regular reports, or periodic reviews. You should also ensure that these objectives are communicated throughout the relevant levels of the organization, so employees understand their role in meeting these targets. If monitoring or communication is inconsistent or lacks formal documentation, you may need to implement more structured processes in these areas.

4. Review Documentation (6.2.1g):

Check if your quality objectives are documented and kept up-to-date as your organization evolves. Documented information should include any changes to the objectives, as well as ongoing performance metrics. If your objectives are not well-documented or updated regularly, it may indicate that this part of your quality system needs reinforcement.

5. Evaluate the Planning Process (6.2.2):

For each quality objective, assess if there is a defined plan outlining how it will be achieved. This includes clearly documenting what actions will be taken (6.2.2a), identifying the resources needed (6.2.2b), assigning responsibilities (6.2.2c), setting completion timelines (6.2.2d), and determining how success will be evaluated (6.2.2e). If any of these elements are missing or inadequately addressed in your plans, it could indicate a compliance gap. Look for any action plans, timelines, or resource allocations associated with each objective.

By thoroughly evaluating these aspects, you can determine if your system meets ISO 9001 section 6.2 requirements for setting and planning quality objectives. Identifying any gaps in these areas will allow you to make targeted improvements to ensure your objectives drive meaningful progress and align with ISO 9001 standards.