ISO 9001:2015 Internal Auditing

If you need to conduct effective ISO 9001:2015 internal audits and understand the requirements of ISO 9001:2015 – then this is the course for you!

TEC have packaged everything needed into a 1-day practical course & workshop to ensure that participants will have the knowledge and skills to understand and implement ISO 9001:2015 and plan, undertake and report on internal audits using the ‘process approach’.

Participants obtain an understanding of the ISO 9001:2015 requirements by mapping them to their organization’s processes and activities, and then devising audit questions to evaluate the extent of conformity.

Particular attention is given to creating these ‘evaluation questions’ in situations where there may be no documented procedures! In addition, participants will learn how to assess the ‘active’ management of customer satisfaction, QMS and suppliers’ performance and process-level effectiveness – and how to audit their organization's Top Management.

This practical course contains Team Exercises and Individual role-play scenarios that are structured to follow the key steps in preparing for, undertaking, reporting on and closing-off process-based internal audits. This is how participants gain an in-depth understanding of requirements – it’s learn-by-doing or accelerated learning.

The course timings are – 08:30 to 17:00.We can also run the course on-site, and add an additional day for ‘audit coaching’ at cost.


PREAMBLE

Course objectives & Introductions

ISO 9001:2015 terminology definitions

UNDERSTANDING QMS EFFECTIVENESS, AUDITING AND REQUIREMENTS

Understanding different types of ‘quality requirements’

Interpreting & auditing ISO 9001:2015 requirements (audit criteria)

Elements of the ISO 9001:2015 international standard

Identifying the P-D-C-A structure of ISO 9001:2015 clauses

Class quiz – common names for OPERATION processes

Describing OPERATION processes and their interactions

Class quiz – description of QMS processes –

  • sequence of operation processes
  • interaction of operation processes

Understanding ISO 9001:2015 standards requirements –

  • ‘mandatory’ requirements
  • ‘appropriate’ requirements
  • ‘applicable’ requirements

UNDERSTANDING THE QUALITY MANAGEMENT SYSTEM AUDIT

Guidelines and Standards relating to auditing –

  • ISO 19011:2018
  • ISO/IEC 17021

Team exercise – audit-related terminology –

  • audit objectives
  • audit scope
  • audit criteria

Understanding audit elements and methods

AUDITING THE ‘CONTEXT’ OF THE ORGANIZATION

Team quiz – organization, interested parties, scope and processes

Key elements of the QMS and their relationships

AUDITING EXTERNAL AND INTERNAL ISSUES

Understanding external and internal issues

Mock audit – external and internal issues

Example of the company’s SWOT analysis

AUDITING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

Relevant interested parties and their relevant requirements

Mock audit – interested parties and their requirements

AUDITING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM

Understanding the ‘scope’ of the QMS

Mock audit – QMS scope and applicability of requirements

IDENTIFYING QMS OPERATION PROCESSES

Strengthened focus on the ‘process approach’

Class quiz – common names for OPERATION processes –

  • mapping OPERATION processes to ISO 9001:2015 clauses

Identifying OPERATION processes tasks/activities

Relating audit questions to audit criteria (ISO 9001:2015)

Team exercise – audit questions for an OPERATION process

Auditing QMS ‘controlled conditions’ for OPERATION processes

Using a ‘turtle diagram’ to identify controlled conditions

Team exercise – audit questions for support and related processes

Relating audit questions to audit trails (i.e. activities ‘flows’)

Relating audit questions to audit trails (i.e. activities ‘flows’) –

  • closed questions
  • open questions

Class quiz – identifying other ancillary processes

Other key ancillary processes and resources

AUDITING AND ORGANIZATION’S LEADERSHIP

Leadership – not just management!

Leadership (QMP #2 & ISO 9000:2015)

Demonstrable leadership and commitment (involvement!)

Team exercise – auditing leadership and top management

AUDITING QUALITY POLICY

Understanding quality policy

Team exercise – auditing and evaluating quality policy

AUDITING QMS PLANNING AND OBJECTIVES

Requirements for planning for the quality management system –

  • actions to address risks and opportunities
  • quality objectives and planning to achieve them
  • planning of changes

Team exercise – auditing planning for the QMS

Sources of an organization’s (quality-related) objectives

Team mock audit – evaluating customer-focused quality objectives

Understanding ‘planned activities’ and ‘planned results’ –

  • effectiveness = planned activities achieved + planned results obtained

Team mock audit – auditing process effectiveness

AUDITING PERFORMANCE EVALUATION AND IMPROVEMENT

Active management of all quality objectives –

  • understanding the P-D-C-A cycle

Understanding the link between clauses 9 and 10

Team exercise – auditing performance evaluation

PLANNING THE ON-SITE AUDIT

Understanding different types of on-site audit (audit trails) –

  • project based
  • inter-process based
  • value-stream based
  • actual situations based

Example – preparing the audit plan

CONDUCTING THE ON-SITE AUDIT

Sequence of audit activities

Delivering an effective opening meeting

Team role-play exercise – performing an Opening Meeting

Collecting, verifying and recording audit evidence

Audit sampling methods and sample size determination –

  • haphazard sampling
  • judgmental sampling

Building rapport with the auditee –

  • phrasing audit questions
  • relaxed and conversational style

Determining conformity and nonconformity

Recording audit evidence and making your decision –

  • okay
  • nonconformity

Writing an effective NCR (the NCR template)

Team mock audits – simulated audit situations –

  • tutor evaluation of team decisions
  • tutor evaluation of team NCRs

Agreeing on audit conclusions

Team exercise – preparing audit conclusions

Delivering an effective Closing Meeting

Role-play exercise – delivering an effective Closing Meeting

PREPARING AND PRESENTING THE AUDIT REPORT

Suggested ‘generic’ format –

  • sections of the audit report
  • audit recommendations
  • auditee required actions

CONDUCTING AUDIT FOLLOW-UP

Presenting the audit findings (NCRs) –

  • understanding by the auditee
  • responsibilities for Presenting the audit findings (NCRs)

Individual/Team quiz – simulated audit situation –

  • evaluation of proposed corrective actions
  • reasons for auditor rejection of corrective actions

EXTENDED QUESTION & ANSWER SESSION


Public course

Our public courses are run at the Woodland Grange Conference Centre in Warwickshire

The course fee includes a 3-course lunch and refreshments on each training day

Course dates
On-site course

In-company courses may be organised at any time and are extremely cost-effective on a ‘cost-per-student’ basis. The host company is responsible for the venue costs.

We can accommodate up to 10 (maximum) delegates per session.

Details/quote

The course is primarily aimed at individuals who are required to conduct internal audits covering conformity and compliance against ISO 9001:2015 requirements.

Participants are not required to have any previous experience of auditing or a detailed understanding of the ISO 9001:2015 clauses – it’s learn-by-doing or accelerated learning.


Individuals who successfully complete the course will –

  • be better equipped to maintain conformity with ISO 9001:2015
  • be able to undertake an in-depth 'gap analysis' of an existing ISO 9001:2015 QMS
  • be confident in knowing that their audit questions address all important issues
  • identify weaknesses in QMS performance (e.g. quality and delivery) and process-level effectiveness
  • conduct effective evaluations of 'Leadership' by auditing Top Management
  • identify risks and opportunities within the QMS

All students successfully completing the 1-day course will receive an individual training certificate containing the TEC Transnational logo.

The organization will –

  • be confident that their auditors are empowered to undertake effective ISO 9001:2015 internal audits
  • know that the outcomes of the audits will meet the expectations of Certification Bodies and Customers
  • ensure conformity, maintenance and ongoing improvement of the QMS

Larger teams might benefit from our in-house courses. Fill out the form below and we will contact you with further details.

We will only ever user your information to process your enquiry in accordance with our privacy policy. If you join our mailing list your name email will processed by Mailchimp.