ISO 9001:2015 Foundation and Internal Audit

ISO 9001:2015 Foundation and Internal Audit

PROGRAM TOPICS:

Module1: Introduction to ISO 9001

• Introduction & suggested reading
• What is ISO 9001?
• The structure of ISO 9001
• Quality management principles in ISO 9001
• Introduction to the Quality Management System
• Implementing ISO 9001 requirements
• Implementing ISO 9001 as a project
• Documenting ISO 9001 requirements
• ISO 9001 Benefits
• Related documentation
• Practice exam

Module 2 - The planning phase

• Introduction & suggested reading
• Understanding your organization and its context [clause 4.1]
• Understanding the needs and expectations of interested parties [clause 4.2]
• Determining the scope of the QMS [clause 4.3]
• Leadership and commitment [clause 5.1]
• Quality Policy [clause 5.2]
• Organizational roles, responsibilities and authorities [clause 5.3]
• Addressing risks and opportunities [clause 6.1]
• Quality objectives [clause 6.2]
• Resources [clause 7.1]
• Competence [clause 7.2]
• Awareness [clause 7.3]
• Communication [clause 7.4]
• Documented information [clause 7.5]
• Related documentation
• Practice exam

Module 3 - Operation

• Introduction & suggested reading
• Operational planning and control [clause 8.1]
• Requirements for products and services [clause 8.2]
• Design and development of planning and inputs [clause 8.3]
• Design and development controls, outputs and changes [clause 8.3]
• Control of externally provided processes, products and services [clause 8.4]
• Control of production and service provision [clauses 8.5 ]
• Post production activities [clauses 8.5 and 8.6]
• Control of nonconforming outputs [clause 8.7]
• Operating the QMS [clause 8]
• Related documentation
• Practice exam

Module 4 - The Check and Act phases

• Introduction & suggested reading
• Monitoring, measurement, analysis and evaluation [clause 9.1]
• Internal audit [clause 9.2]
• Management review [clause 9.3]
• Nonconformities and corrective actions [clause 10.1]
• Continual improvement [clause 10.2]
• Related documentation
• Practice exam
• Instructions for taking the exam and obtaining the certificate

LESSON PLAN

• This interactive course contains 5 lessons, short exams to check understanding, and summaries.

Lesson 1: ISO 9001:2015 Basics

• Introduction to the ISO 9001 Standard
• Major Changes in ISO 9001:2015
• Benefits of ISO 9001 certification
• The Quality Management Principles
• The Process Approach
• The Plan-Do-Check-Act Cycle
• Practical Application of the Plan-Do-Check-Act Cycle

Lesson 2: The Structure and Requirements of ISO 9001:2015

• ISO 9001:2015 Terminology and Concepts
• ISO 9001:2015 Requirements:

•  Context of the Organization 
• Leadership 
• Planning 
• Support 
• Operation 
• Performance Evaluation 
• Improvement

Lesson 3: ISO 9001:2015 Documentation

• Documented Information
• Records
• Contents of the Quality Manual

Lesson 4: ISO 9001:2015 Implementation

• Implementing an ISO 9001 System
• Updating an ISO 9001 System

Lesson 5: ISO 9001 Audits

• Implementation of an Internal Audit Program
• Collection and Verification of Information
• Non-compliances
• Recommendations
• Audit Reports