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EIEIO / BUSINESS, FINANCE & QUALITY

ISO9001 2015 Quality Management Systems Auditor Lead Auditor

Course outline

ISO90015 days

Duration

5 days

Overview

This course is designed for those who have a general background in Quality Management and have a basic knowledge of the requirements of the ISO 9001.

The objective of each Course is to equip delegates with the knowledge and skills required to perform audits of quality management systems against ISO 9001:2015 in accordance with ISO 19011.

This is not intended to be an implementer’s course, or one that will create an expert in Quality legislation, or one that will train to an acceptable level a delegate with no prior knowledge of the standard or of quality. Therefore, prior to attending this training course, we recommend that participants in this course demonstrate competence in the items below:

a) 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 principles as given in ISO 9000
  • the process approach used in quality management
  • the model of a process-based Quality Management System, the structure and content of ISO 9001.

b) ISO 9001

  • Knowledge of the requirements of ISO 9001 and the commonly used quality management terms and definitions, as given in ISO 9001, which may be gained by completing an IRCA certified QMS Foundation Training course or the equivalent.

The course duration is 40 hours including a two-hour written examination. Participants may need to work late days over the week. Participants will be graded on the basis of:

  • a continuous assessment of their performance against the Course learning objectives;
  • their marks obtained in the written examination.

To successfully complete the Course, delegates must obtain at least:

  • a pass grade in the continuous assessment;
  • 70% of the total marks available in the examination.

Objective

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

  • Knowledge
  • Explain the purpose and business benefits of:
  • A QMS;
  • QMS standards,
  • Management system audit; and
  • Third-party certification.
  • Explain the role of an auditor to plan, conduct, report and follow-up on a QMS to establish conformity (or otherwise) against ISO 9001 in accordance with ISO 19011 and ISO/IEC 17021, as applicable.
  • Skills
  • Plan, conduct, report and follow-up an audit of a QMS to establish conformity (or otherwise) against ISO 9001 in accordance with ISO 19011 and ISO/IEC 17021, as applicable.

Who Should Attend

This programme is suitable to develop and enhance the audit knowledge and auditing skills of quality practitioners or professionals, who may conduct first, second or third party audits.

Course Programme

DAY 1

08.45 COURSE REGISTRATION

09.00 COURSE Introduction: Objectives, workshops, team-work, continuous assessment, examination structure, administration. Delegate introductions

Session 1: Quality Management Systems and the ISO 9000 series of Standards

Workshop 1: Quality management principles

Workshop 1: Feedback

Session 2: Process-based Quality Management Systems

13.00-14.00Lunch

Workshop 2: Context of the Organisation

Workshop 2: Feedback

Workshop 3: QMS Questionnaire

Workshop 3: Feedback

Workshop 4: Organisational Knowledge

Workshop 4: Feedback

Session 3: Registration, Certification and Auditor Competence

Workshop 5: Audit Evidence / Audit Trail

Workshop 5: Feedback

18.40 End of Day 1

There will be a break of 15 minutes mid-morning and mid-afternoon.

DAY 2

09.00 Recapitulation

Session 4: Audits: Definition, Principles and Types

Workshop 6: Continual Improvement

Workshop 6: Feedback

Session 5: The Audit Process

13.00-14.00 Lunch

Workshop 7: QMS Questionnaire

Workshop 7: Feedback

Session 6: Preparing for the on-site audit (Audit Stage 1)

Workshop 8: Stage 1 Audit: Document Review

Workshop 8: Feedback

Session 8: Audit planning

18.30 End of Day 2

There will be a break of 15 minutes mid-morning and mid-afternoon.

DAY 3

09.00 Recapitulation

Workshop 9: Planning the Audit

Workshop 9: Feedback

Session 7: Developing a Checklist

Workshop 10: Part 1: Audit Role Play

Preparing for the audit; development of working documents

13.00-14.00 Lunch

Session 9: Audit Review

Workshop 11: Interpretation of the Standard; Classification of findings/ finding statements/CARs

Session 10: Audit reporting and Follow-Up

Role Play: Demonstration of closing meeting

Workshop 10 & 11: Part 1: Audit Role Play, continued

18.30 End of Day 3

There will be a break of 15 minutes mid-morning and mid-afternoon.

DAY 4

09.00 Recapitulation

Workshop 11: Audit Role Play: Feedback

Workshop 12: Case study;

Briefing and distribution of final case studies. Case study team preparation for formal presentations

Workshop 10: Part 2 : Audit Role Play

Conducting the audit, feedback and group discussion.

13.00-14.00 Lunch

Workshop 10: Part 2 : Audit Role Play, continued

Examination review

Specimen Exam Paper; Key elements of Course Learning Objectives

Workshop 12: Case Study, continued

18.30 End of Day 4

There will be a break of 15 minutes mid-morning.

DAY 5

09.00 Workshop 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.

11.45 Recapitulation

13.00-14.00 Lunch

14.00 Course Review and Summary

14.30 WRITTEN EXAMINATION

16.30 End of Course

There will be a break of 15 minutes mid-morning.

NB: All Course times are approximate

Programme scope, delivery arrangements and suitability are confirmed during enquiry.