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

• Explain and interpret the seven quality management principles and the structure of **ISO 9001:2015**.
• Understand and define the **Context of the Organization** (Clause 4) and stakeholder needs.
• Apply the **Process Approach** and the Plan-Do-Check-Act (PDCA) cycle to organizational processes.
• Determine and manage the risks and opportunities relevant to the QMS and its objectives.
• Design, implement, and maintain the necessary documentation (documented information) required by the standard.
• Plan and conduct effective internal audits to assess QMS conformance and effectiveness.
• Identify and implement nonconformity management and corrective action processes.
• Understand the role of top management in driving the **Leadership** and commitment (Clause 5).

• Quality Managers and Engineers
• Internal QMS Auditors and Lead Auditors
• Process Improvement and Continuous Improvement Specialists
• Operations and Production Managers
• Managers responsible for implementing or maintaining ISO standards
• Management Representatives for Quality Systems
• Consultants specializing in QMS implementation

• In-depth interpretation and analysis of the ISO 9001:2015 standard clauses.
• Group activity: mapping an organizational process and applying the PDCA cycle and risk-based thinking.
• Role-playing an internal audit interview and conducting a nonconformity investigation.
• Individual exercise: drafting a Quality Policy statement and quality objectives.
• Case studies of companies implementing a QMS for the first time.

Unit 1: The Foundations of Quality and ISO 9001

• The seven quality management principles (e.g., Customer Focus, Leadership, Process Approach)
• Understanding the history and evolution of the **ISO 9001** standard
• The High-Level Structure (HLS) and its relevance across ISO standards

• Defining, mapping, and managing interdependent organizational processes
• Applying the **Plan-Do-Check-Act (PDCA)** cycle to all QMS activities

Unit 2: Context, Leadership, and Planning (Clauses 4, 5, 6)

• Identifying internal and external issues relevant to the organization's purpose
• Determining the needs and expectations of interested parties (customers, regulators)

• The role of top management in accountability, policy, and promoting the QMS culture
• Setting quality objectives that are measurable, consistent, and monitored
• Applying **Risk-Based Thinking** to identify risks and opportunities for the QMS

Unit 3: Support and Operation (Clauses 7, 8)

• Determining and providing the necessary resources (people, infrastructure, environment)
• Ensuring competence, awareness, and internal communication within the QMS
• Controlling documented information (creation, update, control, retention)

• Requirements for operational planning and control (planning, review, monitoring)
• Management of external provision of goods and services (supplier quality)

Unit 4: Performance Evaluation and Improvement (Clauses 9, 10)

• Requirements for monitoring, measurement, analysis, and evaluation of QMS performance
• Planning and executing the **Internal Audit Program** (scope, criteria, reporting)
• Conducting effective Management Review meetings (inputs, outputs, decisions)

• Handling nonconformities, implementing containment, and correction
• Applying **Corrective Action** to eliminate the root cause of nonconformities
• Driving continuous improvement of the QMS suitability, adequacy, and effectiveness

Unit 5: Implementation Case Studies

• Case studies of successful and challenging ISO 9001 implementation projects
• Techniques for transitioning from older ISO standards to the 2015 version
• Preparing for and managing the external certification audit process