Why is a quality policy needed?
- CTU’s quality policy plays an important role in how its QMS functions and thus its overall operations. It provides the highest-level objective for a system’s function and thus the direction for each action and decision made by team members.
- In accordance with requirements set out in the SCTO’s Guidelines for Good Operational Practice (GGOP), each CTU needs to ensure that a quality policy is established, implemented, and maintained.
Audit observations: What was missing?
- There was no evidence that the commitments stated in an organisation’s quality policy are addressed by its existing QMS.
Recommendations
- A quality policy needs to consider all legal, ethical, and customer/service requirements.
- Define objectives that are appropriate to a CTU’s purpose and context and that support its strategic direction.
- Formulate the policy precisely to reflect the commitments that can be made based on the processes defined in the QMS.
- Example: If regulatory compliance is a stated objective, do the following:
- define a process to review and document regulatory changes in order to assess any impact before changes are made.
- evaluate all QMS processes against listed regulations, policies, etc.