Quality system and policy
- Define a clear quality policy and objectives.
- Identify the standards and regulations that apply.Align with applicable standards such as ISO 9001 and your procedures.
- Map the key processes that affect quality.
- Assign quality roles, responsibilities and authority.
- Communicate the policy and objectives to all staff.
- Set measurable quality targets to track performance.
Procedures and documentation
- Document procedures and work instructions for key processes.
- Ensure documents are clear, current and version controlled.
- Make approved documents available where work is done.
- Control changes and remove obsolete documents.
- Define which records must be created and retained.
- Review documents regularly and update as processes change.
Training and competence
- Define the skills and qualifications each role requires.
- Assess staff competence against those requirements.
- Provide training on procedures, standards and equipment.
- Keep training records and certifications up to date.
- Verify training is effective before staff work unsupervised.
- Plan refresher training and cover for skills gaps.
Supplier and material control
- Maintain a list of approved suppliers.
- Assess and qualify new suppliers before use.
- Define quality requirements in purchase orders.
- Require certificates of conformity for key materials.
- Monitor supplier performance and quality over time.
- Address supplier nonconformances and corrective actions.
Process control and prevention
- Define acceptance criteria and process parameters.
- Control equipment, calibration and process settings.
- Use error-proofing to prevent common mistakes.
- Monitor processes for variation and trends.
- Standardize how work is set up and handed over.
- Capture and act on improvement opportunities.
Internal audits and improvement
- Plan a schedule of internal audits across processes.
- Use trained, independent auditors where possible.
- Record findings, observations and nonconformities.
- Assign corrective actions with owners and due dates.
- Verify corrective actions are effective.
- Review quality performance and drive continuous improvement.
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