Duration
ISO 9001 :2015 QUALITY MANAGEMENT SYSTEMS (QMS) AUDITOR / LEAD AUDITOR
5 days
Overview
This course is certificated by the Chartered Quality Institute (CQI) and International Register of Certificated Auditors (IRCA). CQI / IRCA Course Certification Number 17977-PR 328.
The objective of this course is to equip learners with the knowledge and skills required to perform audits of QMS against ISO 9001:2015 in accordance with ISO 19011.
Objective
The programme aims to provide delegates with learning how to:
- Describe the purpose of a QMS, of QMS standards, of QMS audit and of third-party certification;
- Explain the role of an auditor to plan, conduct, report and follow-up a QMS audit in accordance with ISO 19011 and ISO/IEC 17021 where appropriate;
- Plan, conduct, report and follow-up an audit of a QMS to establish conformity (or otherwise) with ISO 9001 and in accordance with ISO 19011 and ISO/IEC 17021 where appropriate.
Who Should Attend
This programme is suitable to develop and enhance the audit knowledge and auditing skills of quality management system practitioners or professionals, who may conduct first, second or third party audits.
Prior Knowledge
Before starting this course, leaners are expected to have the following prior knowledge:
- Knowledge of the following quality management principles and concepts :
- the relationship between quality management and customer satisfaction;
- commonly used quality management terms and definitions and the seven quality principles as given in ISO 9000;
- the process approach used in quality management;
- the model of a process-based QMS, the structure and content of ISO 9001.
- Knowledge of the requirements of ISO 9001:2015, which may be gained by completing an IRCA certified QMS Foundation Training Course or equivalent
DAY 1
08.45Course Registration
09.00-09.30Course introduction
Objectives, activities, team-work, continuous assessment, examination structure, administration; learner introductions
09.30-10.00Session 1 Quality Management Systems and the ISO 9000 Series of Standards
◼ The need for and benefits of a QMS
◼ The ISO 9000 series of standards
◼ ISO 9001:2015 fundamentals and vocabulary
◼ Compatibility with other Standards
◼ Legal compliance – ISO Standards
◼ The process approach
◼ The seven quality management principles
10.00-10.30Activity 1
Quality Management Principles
10.30-10.45Break
10.45-11.15Activity 1
Feedback
11.15-13.00Session 2 Process-Based Quality Management Systems
◼ The application of PDCA Cycle
◼ Quality system documented information
◼ Electronic data systems
◼ Control of documents and records
◼ Monitoring and measurement
◼ Infrastructure
◼ Work environment
◼ Product realisation
◼ Monitoring and measurement
◼ Continual improvement
14.00Lunch
14.00-14.35Activity 2
Context of the Organisation
14.35-15.00Feedback
15.00-15.15Activity 3
Risk and Opportunities
15.15-15.25Feedback
15.25-15.40Break
15.40-15.55Activity 4
Organisational Knowledge
15.55-16.05Feedback
16.05-16.50Session 3 Registration, Certification and Auditor Competence
◼ Certification and registration of organisations
◼ Certification of auditors
◼ Competence of auditors
◼ Personal characteristics of auditors
16.50-17.35Activity 5
Audit Evidence / Audit Trail
17.35-18.20Feedback
18.20-18.35Review of Day 1
18.35End of Day 1
There will be a break of 15 minutes mid-morning and mid-afternoon.
DAY 209.00-09.30 Recapitulation
09.30-10.00 Session 4 Audits: Definition, Principles and Types
◼ Audit definition
◼ Principles of auditing
◼ Types of audits
10.00-10.45Activity 6
Continual Improvement
10.45-11.00Break
11.00-11.45Activity 6
Feedback
11.45-13.00Session 5 The Audit Process
◼ Certification process
◼ Planning the audit
◼ Audit roles and responsibilities
◼ Good practice at meetings
13.00-14.00Lunch
14.00-14.45Activity 7
QMS Questionnaire
14.45-15.15Feedback
15.15-15.30Break
15.30-16.45Session 6 Preparing for the On-Site Audit (Audit Stage 1)
◼ Initial contact with the auditee
◼ Stage 1 audit
◼ Document review
◼ The audit plan
◼ Work documents
16.45-17.45Activity 8
Stage 1 Audit: Document Review
17.45-18.15Feedback
18.15-18.30Review of Day 2
18.30End of Day 2
There will be a break of 15 minutes mid-morning and mid-afternoon
DAY 3
09.00-09.30Recapitulation
09.30-10.15Activity 9
Planning the Audit
10.15-10.30Break
10.30-11.15Activity 9
Feedback
11.15-11.45Session 7 Developing a Checklist
◼ The audit checklist
◼ Process review
◼ The “Turtle Diagram”
11.45-13.00Activity 10
Audit Role Play
◼ Part 1: Preparing for the audit
◼ Development of working documents
13.00-14.00Lunch
14.00-14.45Session 8 Conducting the On-Site Audit (Audit Stage 2)
◼ Collecting and verifying information
◼ Opening meeting
◼ Roles and responsibilities of guides
◼ Conducting the audit
◼ Questioning techniques
◼ Controlling the audit
◼ Communication with the audit client and auditee
14.45-15.30Session 9 Audit Review
◼ Audit review meeting
◼ Audit findings
◼ Finding statements
◼ Corrective Action Requests (CARs)
◼ Classification of CARs
◼ Opportunities for improvement
15.30-15.45Break
15.45-17.45Activity 11
Interpretation of the Standard; Classification of Findings / Finding Statements / CARs
17.45-18.30Session 10 Audit Reporting and Follow-Up
◼ Presenting the findings
◼ Reporting on the audit
◼ Audit completion
◼ Corrective action
◼ Management review
◼ Follow-up and close out
18.30Role Play
Demonstration of Closing Meeting
Activities 10 &11
18.45Review of Day 3
19.00End of Day 3
There will be a break of 15 minutes mid-morning and mid-afternoon.
DAY 4
09.00-09.30Recapitulation
09.30-10.15Activity 11
Feedback
10.15-10.45Activity 12
Case Study
◼ Briefing and distribution of final case studies
◼ Case study: team preparation for formal presentations
10.45-11.00Break
11.00-13.00Activity 10
Audit Role Play: Part 2
◼ Conducting the audit
◼ Feedback and group discussions
13.00-14.00Lunch
14.00-15.00Activity 10
Audit Role Play: Part 2, continued
15.00-16.00Examination Review
16.00-16.15Break
16.15-17.15Examination Review
17.15-18.00Activity 12
Case Study, continued
18.00-18.15Review of Day 4: Key Elements of the Course Learning Objectives
18.15End of Day 4
There will be a break of 15 minutes mid-morning and mid-afternoon.
DAY 5
09.00-09.30Recapitulation
09.30-11.00Activity 12
Case Study Presentations
Presentations in accordance with the formal closing meeting format and content
Each team member has a shared responsibility in presenting the results of an analysis of assigned QMS
11.00-11.15Break
11.15-11.45Activity 12
Case Study Presentations
11.45-14.00Q&A, Examination Revision
13.00-14.00Lunch
14.00-14.30Course Review and Summary
17.00End of Course
There will be a break of 15 minutes mid-morning and mid-afternoon.
**Learners will have 30 days from the last day of their course to take their CQI and IRCA online exam.
Programme scope, delivery arrangements and suitability are confirmed during enquiry.