ISO 17020 Lead Implementer Training - Malawi

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
• Organisation 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 Organisation, 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 Programme 
• Communication at All Levels of Organisation

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

• Recognising the Inspections Problem and Mobilising 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
  • Standardise 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