Key Elements ISO 9001:2015

KEY ELEMENTS ISO 9001:2015

Bayu Nurwinanto

1. Context of the organization

• Understanding the organisation & its context.
• Understanding the needs & expectations of interested parties.
• Determining the scope of the quality management system.
• The quality management System.
• Process approach.

2. Leadership

• Leadership & Commitment.
• Quality Policy.
• Organizational roles, responsibilities & authorities.

3. Planning

• Action to address risks & Opportunities.
• Quality objectives & planning to achieve them.
• Planning of changes.

4. Support

• Resources.
• Competence.
• Awareness.
• Communication.
• Documented information.

5. Operation

• Operational planning & control.
• Determination of market needs & Interactions with customers.
• Operational planning process.
• Control of external provision of goods & services.
• Development of goods & services.
• Production of goods & service.
• Release of goods & services.
• Nonconforming goods & services.

6. Performance evaluation

• Monitoring, measurement analysis & evaluation.
• Internal Audit.
• Management Review.

7. Improvement

• Nonconformity & corrective action.
• Improvement.