irca 2180 - qms internal auditor feb 2013

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Certification criteria for

Internal QMS Auditor

Training Course


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CERTIFICATION CRITERIA FOR INTERNAL QUALITY MANAGEMENT SYSTEMS (QMS)AUDITOR TRAINING COURSE

IRCA/2180 13/2

CONTENTS

1. INTRODUCTION2. LEARNING OBJECTIVES3. ENABLING OBJECTIVES KNOWLEDGE &SKILLS4. TRAINING METHODS5. COURSE CONTENT6. COURSE DURATION7. TUTORS &STUDENTS8. VARIATIONS9. STUDENT ASSESSMENT &EXAMINATION10. COURSE PUBLICITY&ADVERTISING

APPENDIX 1:AUDIT PART OF AQUALITYMANAGEMENT SYSTEMBASED ON ISO9001(NORMATIVE)

APPENDIX 2: GUIDANCE (INFORMATIVE)

Copyright IRCA 2013

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted inany form or by any means electronic, mechanical, photocopying, recording or otherwise without priorpermission of the CQI International Register of Certificated Auditors (IRCA).


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1. INTRODUCTION1.1 We, the International Register of Certificated Auditors (IRCA), have prepared these criteria to

help you, the approved training organisation, to achieve certification of an InternalQualityManagement Systems(QMS) Auditor training course. All references in this document toISO standards are to the current versions unless otherwise stated.

1.2 Before designing an Internal QMS Auditortraining course to meet the requirements of thisdocument, you should consider the following:

1.2.1 Aim of this courseThe aim of this course is to provide students with the knowledge and skills requiredto perform an internal audit of part of a quality management system based on ISO9001 (or equivalent) and report on the effective implementation and maintenance ofthe management system in accordance with ISO 19011. (Note: this documentreferences ISO 9001 as the management system standard that provides the contextfor the internal audit. However, this course does not address ISO 9001 in detail, anddoes not aim to equip students with the knowledge and skills to determineconformity, or otherwise, with ISO 9001. Students requiring the knowledge and skills

to conduct entire quality management system audits against ISO 9001 should bedirected to attend a QMS Auditor/Lead Auditor training course.)

1.2.2 Auditor certificationStudents who successfully complete this Internal QMS Auditorcourse will satisfy partof the training requirements for initial certification as an IRCA Internal QMS Auditor.In addition to this course, students must also complete an IRCA-certified QMSFoundation training course (or equivalent) to meet the full training requirements forinitial certification as an IRCA Internal QMS Auditor.

1.2.3 Prior knowledgeBefore starting this course, you must inform students that the IRCA recommends allstudents have the following prior knowledge:

Management systems

Understand the Plan-Do-Check-Act (PDCA) cycle

Quality management

A basic knowledge of the concepts of quality management and the relationshipbetween quality management and customer satisfaction

Understand commonly used quality management terms and definitions, as givenin ISO 9000

ISO 9001

An understanding of the requirements of ISO 9001, which may be gained bycompleting an IRCA-certified QMS Foundation training course or equivalent.

1.2.4 Flexibility in course designThese criteria specify the requirements for training courses, including the knowledgeand skills to be covered during the course. Your training course must be designedand delivered in accordance with these criteria, although you may exercise flexibilityin the inclusion of additional material, and in the structure and selection of specifictraining methods used during the course. Many of the certification requirementscommon to the management and control of courses are detailed in IRCA/2000,Requirements for Training Organisation Approval. These requirements are in additionto the requirements of this document and are mandatory. It is essential, therefore,that you are familiar with the requirements of IRCA/2000.


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1.2.5 Training vs assessmentThere must be two distinct aspects to courses based on these criteria:

a) Effective training to help students develop the knowledge and skills defined inthis document

b) Effective assessment of each individual students achievement of the knowledgeand skills learning objectives through objective testing based on defined outputs.

1.2.6 Training methodsThis course may be designed to be presented in a variety of ways:

a) Classroom-based as a single, complete learning event over two days full-time(ie two consecutive working days)

b) Classroom-based as a series of part-time modules over a longer periodc) Blended as a combination of self-study (ie e-learning course, correspondence

course etc) and classroom-based learning.

However it is designed, students must complete the whole course of study with yourorganisation. (Note: we will not accept courses wholly based on self-study learning.)

2. LEARNING OBJECTIVES2.1 Learning objectives describe in outline what students will know and be able to do by the end of

the course. On completion, successful students will have the knowledge and skills to:

Knowledge

2.1.1 With reference to the Plan, Do, Check, Act cycle, explain the process-based qualitymanagement system model for ISO 9001, and the role of internal audit in themaintenance and improvement of quality management systems (see 3.1).

2.1.2 Explain the role and responsibilities of an auditor to plan, conduct, report andfollow up an internal quality management system audit, in accordance with ISO19011 (see 3.2).

Skills

2.1.3 Plan, conduct, report and follow up an internal audit of part of a quality managementsystem based on ISO 9001, and in accordance with ISO 19011 (see 3.3).

3. ENABLING OBJECTIVES KNOWLEDGE &SKILLSIn order for students to achieve the overall learning objectives, they will need to acquire and developspecific knowledge and skills. These are specified below as enabling objectivesand can beconsidered as steps towards the achievement of learning objectives.

3.1 With reference to the Plan, Do, Check, Act cycle, explain the process-based qualitymanagement system model for ISO 9001, and the role of internal audit in themaintenance and improvement of quality management systems

Knowledge

3.1.1 Explain the purpose of a quality management system and the business benefits ofimproving the effectiveness of a quality management system.

3.1.2 With reference to ISO 9001 (or equivalent):


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a) Outline the model of a process-based quality management system and thestructure and content of ISO 9001, referring to the PDCA cycle as appropriate

b) Describe (in outline) the relationship between management responsibility, qualitypolicy, quality planning and objectives, resource management, productrealization, measurement analysis and improvement, and the significance ofthese for QMS auditors

c) Describe typical product realisation processes and process controls that may beapplied to these processes in order to achieve customer satisfaction andconformity of product to statutory and regulatory requirements, and thesignificance of these for QMS auditors

d) Outline the requirements for internal audit, as described in ISO 9001 clause8.2.2.

3.1.3 Define an internal quality management system audit, including:a) The terms and definitions used in auditing, referencing ISO 19011 and ISO 9001

as appropriate

b) Typical objectives for internal quality management system audits, includingdetermination of conformance, evaluation of capability, evaluation ofeffectiveness and identification of potential improvement, and suggest how thesedifferent types of audit can contribute to the maintenance and improvement ofquality management systems.

3.2 Explain the role and responsibilities of an auditor to plan, conduct, report andfollow up an internal quality management system audit, in accordance with ISO19011

Knowledge

3.2.1 Audit processa) Outline the process for performing an audit, from its initiation through to

conducting audit follow-up

b) Explain the purpose and significance of the audit objectives, scope and criteriac) Describe audit preparation activities including preparing the audit plan, assigning

work to the audit team and preparing work documents

d) Outline the process for conducting audit activities, from conducting the openingmeeting through to preparing audit conclusions and closing the audit

e) Explain the evidence-based approach to audit and describe in outline the processfor collecting and verifying information, including different sources of informationand use of sampling methods

f) Explain how audit findings are determined by evaluating audit evidence againstthe audit criteria

g) Outline different audit methods, including on-site and remote audits, and auditactivities requiring human interaction or no human interaction

h) Explain the purpose and typical content of an internal audit report, includingrecording nonconformity

i) Explain the corrective action process and audit follow-up activities.3.2.2 Auditor responsibilities

a) Describe the role and responsibilities of the auditor at each stage of the auditprocess

b) Explain the need for effective communication with the auditee throughout theprocess

c) Explain the principle of confidentialityd) Outline the content and intent of the IRCA code of conduct.


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3.3 Plan, conduct, report and follow up an internal audit of part of a qualitymanagement system based on ISO 9001, and in accordance with ISO 19011

Skills (to be practised and tested through tasks and in real or simulated auditsituations see Appendix 1)

3.3.1 Planning the audita) Establish that the scope, objectives, criteria, duration and resources for an audit

are appropriate

b) Prepare an on-site audit plan that is appropriate to the abovec) Prepare the necessary work documents, such as an audit checklist, sampling plan

and forms.

3.3.2 Conducting the audita) Demonstrate the ability to conduct opening meetings effectivelyb) Demonstrate the ability to build a rapport with the auditee during the audit,

including sensitivity to the needs and expectations of the auditee

c) Demonstrate the ability to manage audit interviews effectively, including theability to formulate effective audit questions

d) Demonstrate the ability to implement the audit plan, to use work documents andto follow audit trails

e) Demonstrate the ability to collect and verify audit evidence by means ofappropriate sampling

f) Evaluate audit evidence and generate audit findings appropriate to the auditobjectives, scope and criteria.

3.3.3 Report and close the audita) Give feedback to the auditee on the audit findings and resolve any issues arisingb) Prepare and present the audit report, including reporting conformity and

nonconformity.

3.3.4 Follow up the auditConduct audit follow-up activities, including gathering audit evidence to verify thecompletion and effectiveness of actions taken.

4. TRAINING METHODS4.1 Your course may be presented as a wholly classroom-based course, or as a blended course

where self-study is used to supplement classroom training. The course may be presented as asingle, complete learning event, or can be broken into discrete elements which collectivelycover all the learning and enabling objectives.

4.2 Where the course is not delivered as a single, complete learning event, you must makeappropriate arrangements to ensure continuity of learning, including use of summaries andlearning reviews.

4.3 Regardless of media and method of delivery, training must be highly participative and shouldinvolve and engage students throughout the duration of the course.

4.4 Classroom-based training4.4.1 You must provide students with an environment conducive to effective

learning. At the beginning of the course you must provide the students with a


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description of the learning objectives, course structure, format and programme,student responsibilities, the assessment processes and assessment criteria, andyou must also deal with any concerns or worries that the students may have.

4.4.2 Your course must be based on the learning cycle (see guidance in Appendix 2)and include opportunities for students to:

a) Experience new ideas and skills. (Note: tutor-led slide presentations as a solemethod to help students gain new knowledge is not acceptable.)

b) Reflect on their learning and identify strengths and weaknesses. (Note: yourcourse must include methods for monitoring and providing time for tutorsand students to review tasks and activities, and each students achievementof the learning objectives.)

c) Address and improve on areas of weakness. (Note: your course must includeprovision for review and remedial work, and individual coaching wherenecessary.)

4.4.3 Your course must include a variety of learning methods to suit the range oflearning styles (see guidance in Appendix 2).

4.4.4 Your course must not rely on tutor presentations and tutor-led discussions toachieve knowledge-based learning objectives. We expect to see studentslearning these elements mostly through a process that requires them to completea task or activity, often in teams, and to produce a defined output.

4.4.5 All students must practise the skills-based learning objectives of the course(learning objective 2.1.3) through participation in appropriate tasks and activities(role play, simulation etc).

4.4.6 Timekeeping, planning and programme management are essential elements in theperformance of an audit and, although we recognise that effective training isresponsive to students needs, deviations from the timetable must be managed sothat all learning objectives are adequately covered and students are kept informed

of significant changes to the programme.

4.4.7 You shall provide tutors with the materials needed to deliver the courseconsistently and in accordance with planned arrangements. Tutor materials shallcontain sufficient information to ensure:

a) Tutors apply a clearly structured learning processb) Consistency in the delivery of training by tutors to meet the learning

objectives and enabling objectives, including tutors from any subcontractorand branch that you permit to deliver IRCA-certified courses on your behalf,and courses presented in other countries and languages.

4.4.8 You must submit session plans or tutor notes for each individual training session.Session plans must specify:

a) Learning objectives and duration of the sessionb) An outline of, or reference to, the content of the session sufficient to achieve

the learning objectives and consistency between tutors

c) Descriptions of the training method(s) sufficient to ensure tutors apply aclearly structured learning process

d) Training aids, exercises, case studies and other activities designed to involveand engage students and enhance participation, or make reference to them

e) A description of any activities, their purpose and intended output, orreference to other documents containing this information, eg exercise briefs

f) Where training methods or use of exercises etc are optional, this must beclearly indicated in session plans

g) Student evaluation methods that specify how each learning objective will beassessed and, where applicable, include documented criteria with


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performance standards for successful completion of the course, or makereference to them.

4.5 Blended courses (a combination of self-study, including electronic media and classroom-based learning)

4.5.1 Only knowledge-based learning objectives 2.1.1 and 2.1.2 may be covered by self-study methods.

4.5.2 Learning objective 2.1.3 (auditing skills) must be completed in a classroomenvironment in terms of practice and student assessment. See clause 4.4 of thisdocument for requirements for the classroom element of blended learning courses.

4.5.3 Training methods selected should seek to involve and engage students throughoutthe duration of the course. Simply providing students with a set of readingmaterials will not be acceptable. Your self-study materials must be designedaround a clearly structured learning process, with:

a) Theoryb) Examples (scenarios, case studies etc)c) Practice (activities, case studies, progress tests, etc)d) Feedback/self-assessment on activities and tests where relevant, to ensure

students can self-assess their understanding and achievement of the learningobjectives, and identify any areas requiring further work.

4.5.4 Evaluation of achievement of the learning and enabling objectives shall beincorporated into self-study elements where self-study is used to supplementclassroom training.

4.5.5 Self-study course materials must be clearly presented and structured for ease ofuse, with appropriate navigational aids. You must make the following clear tostudents to help them manage their learning:

a) The learning objectives for the overall self-study element of the courseb) The learning objectives for each section within the coursec) How the self-study element of the course links with the classroom componentd) The structure and suggested or intended sequence of the materialse) Instructions for the students use of the materials, including realistic

timescales

f) Examples of typical documents, reports, forms, etcg) How, when and how often students may contact tutors for help, guidance and

feedback

h) Methods for students to assess their learning and to seek timely feedback andcoaching from the tutor(s).

4.5.6 You must ensure that each student has timely access to a course tutor to answerquestions and queries. (Note: as a guide, a response to communications fromstudents within 24 hours would be acceptable.)

5. COURSE CONTENT5.1 At the beginning of the course presentation, you must provide the students with a description

of the learning objectives, course format and programme, student responsibilities, and studentevaluation processes and criteria.

5.2 The course must cover all the aspects defined in clause 2 learning objectives, and amplified inclause 3 enabling objectives.


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5.3 The course must include outline information on the role of the IRCA, the benefits ofcertification as an IRCA Internal QMS Auditor, including brief details of the IRCA QMS auditorcertification scheme, and provide students with details of how to contact the IRCA and applyfor certification (you must use IRCA/190 and IRCA/118, or equivalent, for this purpose).

6. COURSE DURATION6.1 Classroom-based learning

6.1.1 Where the course is wholly classroom-based, it must be at least 14 hours in total,calculated as detailed in IRCA/2000.

6.1.2 This course may be presented over a minimum of two consecutive days full-time, orover a maximum of four weeks on a part-time (modular) basis. (Note: although notmandatory, we recommend that this course be residential if presented over twoconsecutive days.)

6.2 Blended learning6.2.1

Elements of the courses that are delivered through self-study will allow studentsthree times longer than classroom training (ie approximately 18 hours for learningobjectives 2.1.1 and 2.1.2).

6.2.2 The classroom element (ie the skills-learning objective 2.1.3 as a minimum) must betimed to allow each student to practise and be assessed on the skills-learningobjective. The amount of time given to this classroom element will depend on thelearning objectives being covered, normally however, 50% (or one day, or sevenhours gross as calculated in IRCA/2000) duration will be devoted to classroom-basedlearning and assessment. Courses with a reduction in classroom time may be allowedif agreed in advance with the IRCA. See Appendix 2 for guidance on instances wherereduced classroom time may be allowed.

6.2.3 Each student must complete both the self-study and the classroom part of thetraining course in no more than 90 days.

6.2.4 Students must complete each element of blended courses in the correct sequence.For example, on courses where a self-study element is followed by a classroomelement, the training organisation must ensure that students who do not completethe self-study element of the course are not accepted onto the classroom-basedelement. You must have a process for recording and validating each studentscompletion of each element of blended courses, to ensure the course is completed inthe correct order.

6.3 TranslatorsIf the course is given through translators, the time must be increased as necessary to satisfythe learning objectives.

7. TUTORS &STUDENTS7.1 Classroom-based learning

7.1.1 The maximum number of students per course is 20.7.1.2 The minimum number of students per course is four.7.1.3 You must specify the tutor resource for all parts of your course, and be able to

demonstrate that this is adequate for the effective delivery of the course content(clause 5) and the effective implementation of the student assessment (clause 9).(Note: we have not prescribed student/tutor ratios. However, for elements of yourcourse where students audit skills are assessed/tested see clause 9 we consider itunlikely that one tutor would be able to effectively assess the performance of morethan 12 students. Therefore, for groups larger than 12 you are advised to provide


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additional tutor resource during elements of your course where audit skills areassessed. We will review the effectiveness of the tutor resource specified during theapplication process, and review its effective implementation during the surveillanceprocess.)

7.1.4 The course must be run with at least one tutor who is present throughout the fullduration of the course.

7.1.5 Where additional tutors, including trainee tutors and specialists, are used the maincourse tutor(s) remains responsible for the entire presentation.

7.2 Self-study learningTutors who provide educational support on self-study elements of blended learning must becompetent to operate any media required.

7.3 All coursesTutors for this course must demonstrate the following key attributes:

7.3.1 Competence in training, by satisfying the tutor or lead tutor requirements asappropriate (see IRCA/2000).

7.3.2 Competence in auditing against ISO 9001 by demonstrating auditing competence as acurrently-certificated IRCA QMS Lead Auditor (or Principal Auditor) for lead tutors (orQMS Auditor for tutors), as described in IRCA/1000, or meeting the requirements forsuch certification and maintaining audit logs and evidence of continual professionaldevelopment (CPD).

7.3.3 Competence to deliver training and student assessment on your specific course.

8. VARIATIONS8.1 Requests for variations to any of these criteria, or in respect of any special circumstances, will

be considered for approval on written submission to the IRCA by the approved trainingorganisation. Any such request shall be made immediately upon the reason for the variationrequest becoming apparent.

8.2 We will consider the following when evaluating any request for variation:8.2.1 Reasons for the requested variation.8.2.2 Proposed modifications to the training.8.2.3 The impact on the learning and assessment processes, and how this will be

managed.

9. STUDENT ASSESSMENT &EXAMINATIONWe regard the assessment and examination of students to be a very important part of this course.

9.1 Successful completionIn order to satisfactorily complete the course, each student must:

9.1.1 Complete/attend all elements of the course.9.1.2 Pass the continuous assessment (focused on the three learning objectives).

9.2 Conduct and management of continuous assessment9.2.1 Students must demonstrate acceptable levels of performance in the three learning

objectives (clause 2.1) to successfully complete the course.


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9.2.2 You must provide each student with feedback on his or her achievement of theselearning objectives, as described in IRCA/2000.

9.2.3 You must specify how each learning objective will be assessed within the followingminimum requirements:

a) Objectives 2.1.1 and 2.1.2 must be assessed through a short, written quiz(zes)or examination(s), for which each student is awarded an individual mark.

b) Objective 2.1.3 must be assessed through each students individual performancein a practical audit situation and, where possible, through written outputs.

10. COURSE PUBLICITY&ADVERTISING10.1 Course advertising and promotional material shall clearly state that, prior to the

commencement of the course, the IRCA recommends all students have the prior knowledgedefined in clause 1.2.3.

10.2 Course advertising and promotional literature shall clearly state that in order to satisfy thetraining requirements to become an IRCA-certificated Internal Quality Management Systems

Auditor, students will also need to complete an IRCA-certificated, one-day Quality ManagementSystems (QMS) Foundation training course (or acceptable alternative).

10.3 Course advertising and promotional literature shall not state or imply that this course satisfiesmore than part of the requirements for certification as an IRCA QMS Auditor.


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APPENDIX1:AUDIT PART OF A QUALITY MANAGEMENT SYSTEM BASED ON ISO 9001

(NORMATIVE)

1. Coverage of ISO 9001

This course is designed for students who have prior knowledge of quality management systems, and knowledge

of quality management principles and concepts, and the requirements of ISO 9001. Its purpose is to providestudents with skills-based training that will enable them to perform an internal audit of part of a QualityManagement System based on ISO 9001, and report on the effective implementation and maintenance of themanagement system in accordance with ISO 19011.

Learning objective 2.1.1 and enabling objective 3.1 require students to apply and extend this prior knowledge incontext with performing an internal audit. We will accept training courses that include some coverage of thespecific quality management-related elements of ISO 9001, sufficient to enable students to refresh their priorknowledge. We will not accept training courses designed to impart this knowledge. Training organisations maychoose to provide students with this prior knowledge through such means as pre-course learning, or combiningfoundation training with internal auditor training.

2. Perform an internal audit of part of a quality management system based on ISO 9001

You will need to demonstrate that your course gives students the opportunity to audit part of a quality

management system based on ISO 9001. We require the majority of the time available to be spent on theseactivities.

The IRCA require audit skills to be practised and tested through tasks, and in real or simulated audit situations.Tasks and simulated audits must make use of quality management system materials and information (documentsand records, etc) representative of those that auditors can expect to find in real audits of quality managementsystems based on ISO 9001. We will not accept courses where tasks and real or simulated audits rely on genericmanagement system elements (ie documentation, document control, records, competence and training,management review, etc), although we will accept some aspects of these provided they are set in a qualitymanagement system context.

The IRCA do not mandate which parts of a quality management system you shall include in tasks and in real orsimulated audit situations. However, it is unlikely we will accept a course that does not focus on the specificquality management-related elements of ISO 9001:

Determination of customer requirements, and statutory and regulatory requirements applicable to theproduct

Quality policy Quality objectives Planning, control, monitoring and measurement of product realisation processes, including sales, and

product design, purchasing, product and service provision such as manufacturing, installation, servicedelivery, etc

Control of any outsourced process that affects product conformity to requirements Quality performance monitoring, measurement and reporting, and continual improvement of the

effectiveness of the quality management system

Quality management review.We require tasks and real or simulated audit situations to be realistic, and of sufficient complexity and duration

to allow students to demonstrate, and for tutors to evaluate, achievement or otherwise of the audit skillsspecified in enabling objective 3.3.


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APPENDIX2:GUIDANCE

(INFORMATIVE)

1. Meeting the learning and enabling objectives

The IRCA do not expect courses to be designed in the same chronological order as the learning and enablingobjectives in this document. We recognise that individual sessions within a training course can cover more thanone learning or enabling objective at the same time.

2. Helping students learn new knowledge & skills

We promote the use of participative learning approaches because they are more efficient in terms of speed anddepth of comprehension, and more effective in terms of long-term retention of new knowledge. Therefore, youshould employ practical tasks and activities to help students to understand new concepts and ideas. You shouldnot rely on tutor-focused lecture/presentation to transfer new ideas and concepts.

The IRCA promote a variety of training methods in your course design. Different people learn in different ways,so your sessions should follow the learning cycle and your course should include a variety of different learningactivities to cater for all needs, as far as possible. Honey and Mumford (TheLearning Styles Questionnaire, PeterHoney Publications, ISBN 1 902899 07 5)provide one model for describing different learning styles that you mayfind useful as a basis.

Continuous assessment should have a clear link between the following: session plans (for tutors), cleartask/activity instructions with defined and measurable outputs (for students and tutors), activity markingschemes/model answers (for tutors), model answers (for students), and individual student continuousassessment record (for recording student performance).

3. Blended learning: course duration & tutor/student ratios

The IRCA will consider courses designed with less than 60% of the course duration devoted to classroom activity(as calculated in IRCA/2000) in circumstances where, for example, there is a smaller tutor/student ratio, eg twotutors and a maximum of six students.

4. Self-study

The IRCA recommend that you consider the following documents when developing training based on information

technology solutions:BS 7988:2002 A code of practice for the use of information technology for the delivery of assessments

BS 8426:2003 A code of practice for e-support in e-learning systems

irca 2180 - qms internal auditor feb 2013

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