ISO 9001:2015 Clauses Interpretation And Implementation Strategy

Course Objectives

Upon completion of this program, participants will be able to:

• Identify and understand the requirements of ISO 9001:2015 QMS principles and clauses
• Identify the new structure, terminology and concepts of ISO 9001:2015 compared to its previous version and the key changes
• Getting ready for the transition plan to ISO 9001:2015
• Develop a strategy for effective implementation of the changes at their organization

Key Content

Module 1: Overview of ISO 9001:2015 Changes

• Why ISO 9001 change
• What are the ISO 9001 change
• ISO 9001:2015 upgrading timeline
• ISO 9001:2015 structure and terminology change
• Risk based thinking

Module 2: Requirements of ISO 9001:2015 QMS Principles and Clauses

• Clause 1: Scope
• Clause 2: Normative references
• Clause 3: Terms and definitions
• Clause 4: Context of the organization
  • Understanding the organization and its context; needs and expectations of interested parties, scope of the system; processes of the quality management system
• Practical workshop: Identification of external and internal issues of organization
• Practical workshop: Determining the needs and expectations of interested parties
• Clause 5: Leadership
  • Leadership and commitment, quality policy; organizational roles, responsibilties and authorities
• Clause 6: Planning
• Actions to address risks and opportunities; qualitiy objectives and planning to achieve them; planning of changes
• Practical workshop: SWOT analysis
• Practical workshop: Risk approach and action plan using risk register
• Clause 7: Support
  • Resources; competence; awareness; communication; documented information
• Clause 8: Operation
  • Operational planning and control; requirements for products and services; design and development; control of externally provided processes, products and services; control of nonconforming outputs
  • Monitoring, measurement, analysis and evaluation; internal audit; management review
  • Nonconformity and corrective action; continual improvement
• Clause 9: Performance evaluation
  Clause 10: Improvement

Module 3: Implementation Strategy in Compliance

• Implementing strategy in achieving compliance
• Setup a quality management system that conforms to the ISO 9001:2015 Standard