Quality Management Systems

(QMS) Internal Auditor Course

as per ISO 9001:2015
Management Systems

Global Training Services

Business Assurance
2021
Together we will cover
 What is quality?
 What is the purpose and structure of a management system?
 What is a “process-based” system?
 What is the purpose and structure of ISO 9001?

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“Quality”
what is Quality?

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Exercise, 15 minutes
• What does “Quality” mean to you?
Group
Activity
• Consider you are going to buy a new television set for your home.
• In pairs, discuss what you feel would make your new television a quality product.

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Quality definitions…

Degree to which a set of inherent characteristics of an object fulfils

requirements
ISO 9000

 Requirement covers both need and expectation

 Customer satisfaction includes stated as well as implied needs/expectations
 Satisfying customers and other interested parties (e.g. regulators)
 A product, system or service, or any combination thereof
 The organisation will have to observe and understand the needs and expectations of its
customers

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Management System
What is a Management System?

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You are in charge! 15 minutes
 What are your aims & objectives?
 How would you express these so that everyone in the organisation is aware of them and understands them?
 What would you do to try and help your organisation meet your aims & objectives?
 How would you know if the organisation was meeting your aims & objectives?

Group
Activity

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Management System

Management System – “..set of interrelated or interacting elements of an

organization to establish policies and objectives, and processes to achieve
those objectives”

Quality Management System – part of management with regard to quality

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Policy & Objectives

Quality Policy – overall intentions and directions of an organisation related to

quality as formally expressed by top management

ISO 9000, 3.2.4

Quality Objectives – something sought, or aimed for, related to quality

ISO 9000, 3.2.3

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Quality Management System
Policy

Management Processes
Objectives

Sales Design Production Inspection Despatc

h

Purchasin Stores
g

Realisation Processes

What other processes?

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PDCA Cycle

performance
improvement

Check Do

Act Plan

QMS

time

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A broader set of challenges…
Globalized supply chain and expectations of social
responsibility.

Rapid changes in competitive business landscape as well as in

geo-political & environmental conditions.

Sustainable business performance expected by investors,

regulators, consumers and broader stakeholders (e.g.
NGOs).

Transparency, accountability and independent assurance

Intangible assets as primary source of value (e.g.

brand/reputation)

…demands a broader view.

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Prioritizing

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Modern view of Management systems
 Management tool
 Process owner´s tool
 Linked to requirements, strategies, objectives and
significant aspects

Risk based and leads to

improvement
opportunities!

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5. Leadership

5 Leadership

5.1 Leadership and commitment

5.2 Policy

5.3 Roles, Responsibility & Authority.

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Managers vs Leaders
Manager Leader
Planning and budgeting Creating vision and strategy
Organizing and staffing Communicating and setting direction
Controlling and problem solving Motivating action
Taking complex systems of people and Aligning people
technology and making them run Creating systems that managers can
efficiently and effectively, hour after manage and transforming them when
hour, day after day needed to allow for growth, evolution,
opportunities, and hazard avoidance

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Leadership

Leadership issues are addressed in several clauses. Clearly new or clarified issues are:
 Connection of MS to strategy and business processes (5.1)
 Aim and intended output of MS (4.1, 5.1, 5.3, 6.1)
 Principles of “result based management / management by objectives” (5.1, 6.2)
 Systematic change management (8.1)

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Aim of MS and intended output
Top management needs to have a clear view on what is the aim;
intended outcome(s) of the management system and ensure its achievement.

The policy and objectives should be connected to the defined intended outcome and the strategy of the organization.

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Leadership & commitment
 Top management is responsible for the effective implementation of the management system.
 The concept of MR from previous releases are not reflected in the new.
 There must be a clear link between the Business Plan / Strategy and the management system (policy, goals,
etc..).
 Management system to be coupled to the business processes and its expected outcome.

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6. Planning

6 Planning 6.1 Actions to address risks and opportunity

6.2 XXX objectives and planning to achieve them

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6.2. Objectives and planning to achieve them
This clause indicates “result based management / management by objectives” on a general level,
but also a strengthened approach for objectives as a driver for improvements.

What will be done

What resources are required

Who is responsible

When it will be completed

How will the results be evaluated

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Internal Audits to address Risk based thinking – Why?
 To avoid unforeseen situations, events, occurrences or incidents
 To reduce impact and consequences in case of……
 To reduce or mitigate liabilities
 To improve or maintain service delivery
 To protect our business and manage reputation
 To achieve our strategy and goals
 and many more……..

The benefits of risk management are the benefits of better

decisions; fewer surprises, improved planning, performance and
effectiveness and improved relationships with stakeholders.

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Process

Set of interrelated or interacting activities which transforms inputs into outputs

ISO 9000, 3.4.1

What are the factors that can affect

the successful performance of an activity?

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Process Model
people

method

materials
input output

equipment

environment

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High Level Structure (HLS)

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Focus on effective process based audits!

5.1 Business strategy 5.1 Aim and intended

outcome of MS
Holistic understanding of what is
4.1 Internal & external 4.2 Expectations of
important including support
business context interested parties
functions
6.1 Risk & opportunity
assessment

5.1, 8.1 Embedding into business

processes & 6.2 objective
Connection into operations
including support functions 9 Monitoring & evaluation of
performance

10 Improvement

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Procedure

Specified way to carry out an activity or a process

ISO 9000, 3.4.5

What are the factors that affect

how much information
should be contained
in a documented procedure?

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ISO 9001, 5 minutes

 Review clause 1 of ISO 9001 and identify what you consider to be the
fundamental aims/objectives of the standard (the text is in your
manual).

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Structure of the ISO 9001:2015

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High Level Structure coupled to the ISO 9001 standard
Not to imply uniformity
0.1 General
Risk based thinking and PDCA cycle
0.2 Quality Management principles
PDCA Cycle
Section 0
0.3 Process Approach
Risk based Thinking

0.4 Relationship with other management systems

Meeting requirements
Section 1 Scope
Enhance customer satisfaction

Section 2 Normative references ISO 9000:2015

Section 3 Terms and definitions None

4. Context of an organization
5. Leadership
Section 4 -10 Requirements 6. Planning
7. Support
8. Operations
9. Performance evaluation
10.Improvement

Annex A Clarification of new structure, terminology and concepts

Annex
Annex B Provides a list of QMS related standards developed by ISO TC 176

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An Appreciation of ISO9001

 Review the clause allocated to you (text

in your manual)
 Discuss the requirements
 Produce a simple set of prompts which
would help you remember items during
the performance of an internal audit of
these requirements
 Space in workbooks for recording your
notes
 30 minutes

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Reflection - we have covered…
 What is quality?
 What is the purpose and structure of a management system?
 What is a “process-based” system?
 What is the purpose and structure of ISO 9001?

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Our Audit
Statistics
General overview of
QMS audit performance

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Overview

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Chapter Focus
Clause Level

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Top 10

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End of module 1

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