To evaluate whether your quality management system (QMS) complies with ISO 9001:2015 section 5.2.1, you'll need to focus on how your quality policy is established, implemented, and maintained by top management. This involves ensuring that the policy aligns with the purpose, context, and strategic direction of your organization, as well as providing a framework for setting quality objectives.

1. Appropriateness to Purpose and Context (Part a):

Begin by reviewing your current quality policy to determine if it is appropriate for your organization’s purpose and context. The policy should reflect the nature of your business, the needs and expectations of your customers, and the competitive and regulatory environment in which you operate. Ask yourself if your policy articulates your organization's unique mission and values and how it intends to meet its stakeholders’ needs.

Evaluate how well the quality policy aligns with your strategic direction. This requires assessing whether the goals stated in your policy are in harmony with your business objectives and long-term strategy. You should be able to see a direct connection between the quality policy and the strategic initiatives your company is pursuing. If this alignment is unclear, consider revising the policy to better integrate with your overall strategy.

2. Framework for Setting Quality Objectives (Part b):

Next, determine if your quality policy provides a clear framework for setting quality objectives. This means that your policy should contain commitments or guidelines that inform how specific, measurable, achievable, relevant, and time-bound (SMART) quality objectives are developed. Review the documented quality objectives in your QMS to see if they can be traced back to statements or commitments in your quality policy.

Check if there is a process in place for regularly reviewing and updating these objectives based on changes in your organization’s context or strategic direction. This process should involve input from various levels of your organization to ensure objectives are realistic and supported by all parts of the business. The ability of your quality policy to guide the formulation and reassessment of these objectives is crucial to maintaining a dynamic and responsive QMS.

By thoroughly evaluating these aspects, you can ensure that your quality policy not only meets the requirements of ISO 9001:2015 but also effectively supports your organization’s strategic direction and objectives. Any gaps identified during this process should be addressed through collaborative efforts to refine and enhance the policy and its implementation.