Sample and assessment method

Summary

This report is based solely on the answers Muster AG gave in the ISO 9001:2015 self-assessment. The answers were not verified on site by an auditor. This report is not an accredited audit.

Muster AG answered 33 of 36 questions with yes. All 11 mandatory requirements are met (11 of 11). The quality management system is well covered in leadership, operation and improvement.

Gaps remain in planning how to achieve the quality objectives, in evaluating external providers and in keeping organisational knowledge.

Assessment by chapter

Context of the organization (4/4)

• Has your organization determined the internal and external issues relevant to its purpose? Yes
• Are the requirements of interested parties (customers, suppliers, authorities) identified on a regular basis? Yes
• Is the scope of your quality management system documented and justified? Yes
• Are your business processes managed as an interrelated system? Yes

Leadership (5/5)

• Does top management take accountability for the effectiveness of the quality management system? Yes
• Is there a documented quality policy that is communicated? Yes
• Are responsibilities and authorities clearly assigned and communicated? Yes
• Does leadership actively promote customer focus? Yes
• Are quality objectives reviewed regularly and adjusted where necessary? Yes

Planning (3/4)

• Are risks and opportunities identified and addressed systematically? Yes
• Are there measurable quality objectives for relevant functions and processes? Yes
• Are changes to the quality management system planned and carried out in a controlled manner? Yes
• Is there an action plan for achieving the quality objectives? No

Support (7/8)

• Are sufficient resources available for the quality management system? Yes
• Is the competence of employees determined and ensured? Yes
• Are all employees aware of their role in the quality management system? Yes
• Are there defined internal and external communication channels? Yes
• Is documented information appropriately controlled and protected? Yes
• Is the infrastructure (buildings, equipment, IT) maintained? Yes
• Are measuring and test instruments calibrated or verified where the results are critical for quality? Yes
• Is the knowledge needed for your processes determined, maintained and shared where needed? No

Operation (6/7)

• Are production and service delivery processes planned and controlled? Yes
• Are customer requirements reviewed and confirmed before an order is accepted? Yes
• Is there a controlled process for design and development? Yes
• Are external providers (suppliers) evaluated and monitored? No
• Are nonconforming products and services identified and controlled? Yes
• Are products and services checked against defined criteria before release to the customer? Yes
• Is traceability of products and services ensured where it is required? Yes

Performance evaluation (4/4)

• Is customer satisfaction measured and analyzed regularly? Yes
• Are internal audits carried out according to a planned programme? Yes
• Does management conduct regular management reviews? Yes
• Are process indicators and the performance of external providers analysed and used for decisions? Yes

Improvement (4/4)

• Are nonconformities handled systematically and corrective actions taken? Yes
• Is there a process for continual improvement? Yes
• Are improvement opportunities identified and implemented proactively? Yes
• Are customer complaints recorded, investigated for causes and turned into improvements? Yes

Strengths

• Top management takes responsibility for the system, and the quality policy is documented and communicated.
• Customer requirements are reviewed before an order is accepted, and outputs are checked against defined criteria before release.
• Nonconformities and customer complaints are recorded systematically and turned into improvements.
• Internal audits and management reviews take place as planned.

Recommended actions

1. Create an action plan for the quality objectives. The question on an action plan was answered no. Without a plan with owners and dates, the measurable objectives have no effect.
2. Evaluate and monitor external providers. According to the answers, suppliers are not evaluated. Define criteria and evaluate the main suppliers at least once a year.
3. Identify and keep organisational knowledge. According to the answers, the knowledge the processes need is not identified or kept. Write down core workflows and define deputies.

Next steps

• Assign owners and dates to the three recommended actions.
• Check their implementation in the next internal audit.
• Include the results in the next management review.