ISO 17020 Lead Implementer Training Course Outline
Module 1: Introduction to ISO 17020
- Scope
- Normative References
- Terms and Definitions
Module 2: Inspection Bodies
- What is Inspection?
- Introduction to Inspection Bodies
- Goals and Requirements of Inspection Bodies
- Inspection According to ISO
- Important Functions of Inspection
- Types of Inspection Bodies
- Inspection Body Accreditation
Module 3: Inspection Procedure
- Select and Prepare
- Conduct Intelligence Led Inspection
- Report, Record, Follow Up, Close Out, and Evaluate
Module 4: Quality Management and Improvement Overview
- What is Quality Management?
- Introduction to Quality Improvement
- Basics of Quality Improvement
- Quality Improvement Process
- Methods of Quality Improvement Management
- Benefits of Improving Quality
Module 5: General Requirements
- Impartiality and Independence
- Confidentiality
Module 6: Structural Requirements
- Administrative Requirements
- Organization and Management
Module 7: Resource Requirements
- Personnel
- Facilities and Equipment
- Subcontracting
Module 8: Plan-Do-Check-Act
- PDCA Cycle
- PDCA Approach
- Planning
- Support
- Operation
- Performance Analysis
- Improvement
Module 9: Planning Individual Internal Audits
- Internal Audit Approach
- Risk Assurance Mapping
- Audit Plan
- Research the Audit Area
- Conduct Process Walk-Throughs
- Map Risks to the Organization, Process, or Function
- Obtain Data Prior to Fieldwork
Module 10: Audit Procedure
- Considerations During the Auditing Process
- Auditing Methods
- Requirements for Auditors
- Conformity Assessment Audit Procedure
- Conducting the Audit
Module 11: Auditing Roles and Principles
- Auditing Roles
- Audit Team
- Maintaining Confidentiality
- Independence
- Evidence-Based Approach
- Integrity
- Fair Presentation of Audit Reports
Module 12: Skills and Competencies of an Internal Auditor
- Personal Attributes
- Skills
- Education and Experience
- Knowledge
Module 13: Responsibilities of the Auditor
- Management of Personnel
- Preparing Checklist
- Scope of Work
- Managing an Audit Program
- Communication at All Levels of Organization
Module 14: Conducting the Internal Audit and Handling the Interview Process
- Decide What You Want to Achieve
- Identify Risks
- Plan and Audit Activities
- Validate the Facts and Complete the Work
- Develop a Deliverable or Report That will Drive Action
- Follow Up
Module 15: Audit Program
- Reviewing and Improving Audit Program
Module 16: Closing an ISO 17020 Audit
- Prepare Audit Report
- Distribute Audit Report
- Conduct Audit Follow-Up
Module 17: Managing an ISO 17020 Audit Program
- Know What and When to Audit
- Create an Audit Schedule
- Pre-Planning the Scheduled Audit
- Conducting the Audit
- Record the Findings
- Report Findings
Module 18: Roles and Responsibilities of a Lead Implementer
- Roles and Responsibilities
Module 19: Difference Between Compliance and Conformity
- What Does Compliance and Conformity Mean?
- Compliance Vs Conformity
Module 20: Importance of Inspections for Compliance
- Several Specific Functions in Inspections
- Importance of Regulatory Inspections
Module 21: Reforming Inspections
- Recognizing the Inspections Problem and Mobilizing Support
- Drivers of Reform
- Role of Public Opinion
- Defining Goals and Approach of Reform
- Driving Implementation Successfully
Module 22: Improve the Inspection
- How Does Inspection and Review Support Improvement?
- Ways to Improve the Effectiveness of Inspections
- Standardize Inspection Procedure
- Eliminate the Need for Manual Data Entry
- Use Mobile Assessment Apps to Your Advantage
- Determine the Best Inspection Frequency
- Assign Facility-Level Inspections
- Make Corrective Actions More Automated