Module 3:

lntroduction, Scope, Normative

References and Terms &
Defi nitions

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 Module 3: Introduction,
Scope, Normative Management
Quality
References and Terms &
l

Systems - An lntroduction r

Definitions An ISO 9001:2015 Based

Quality Management System

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References and Terms and

Leadership

Planning

Support

Duration: 45 minutes including Activity 4

Objectives:
. Understand the introductory clauses in the Standard (lntroduction and
Clauses 1 to 3)
. Understand the concept of the Process Approach
. Understand the PDCA Model

Slides: 31 - 3z

Activities:
Activity 4 - Process Approach and PDCA, page 35

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ISO 9001: 2015 INTRODUCTION

lntroduction 0.1 General clarifies the intent of the Standard, and explains that
it does not prescribe uniformity in different management systems or their
documentation, nor does it require specific terminology to be used. lt can,
however, be used by internal and external parties, to assess the
organisation's ability to consistently meet customer, statutory and regulatory
requirements.

lntroduction 0.2 simply lists the seven principles on which quality management
systems are based, as already discussed.

0.2 Quality Management Principles ------ i

This lnternational Standard is based on the quality i

management principles described in ISO 9000. The i

descriptions include a statement of each principle, a i

rationale of why the principle is important for the i

organisation, some examples of benefits associated with the principle and i

e><amples of typical actions to improve the organisation's performance when i

applying the principle.

The quality management principles are:
customer focus;
-
Ieadership;
-
engagement of people;
-
process approach;
-
improvement;
-
evidence-based decision making;
-

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 PROCESS APPROACH
Consistent and predictable results are achieved more effectively and
efficiently when activities are understood and managed as inter-related
processes that function as a coherent system. The Process Approach applies
systematic definition and management of processes and their interactions.

When used within a quality management system, the process approach

CNSUTCS:

a) Understanding and consistently meeting requirements

b) Consideration of processes in terms of added value
c) The achievement of effective process performance
d) lmprovement of processes based on evaluation of data and information
lntroduction 0.3.1

lntroduction 0.3.1 is Process Approach and defines what this means and its
importance. The 2015 Standard retains and strengthens the requirement for a
process approach when implementing a quality management system. lt also
retains the recommendation to use the PDCA cycle and this is explained in
lntroduction 0.3.2 and the associated graphics.

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0.3 Process approach

0.3.1 General
This lnternational Standard promotes the adoption of a
process approach when developing, implementing and
improving the effectiveness of a quality management
system, to enhance customer satisfaction by meeting customer
requirements. Specific requirements considered essential to the adoption
of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system
contributes to the organisation's effectiveness and efficiency in achieving
its intended results. This approach enables the organisation to control the
interrelationships and interdependencies among the processes of the
system, so that the overall performance of the organisation can be
enhanced,
The process approach involves the systematic definition and
management of processes, and their interactions, so as to achieve the
intended results in accordance with the quality policy and strategic
direction of the organisation. Management of the processes and the
system as a whole can be achieved using the PDCA cycle (see 0.3.2)
with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system
enables:
a) understanding and consistency in meeting requirements:
b) the consideration of processes in terms of added value:
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and
information.
Figure 1 gives a schematic representation of any process and shows the
interaction of its elements. The monitoring and measuring checkpoints,
which are necessary for control, are specific to each process and will vary
depending on the related risks.

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 Figure 1 shows a schematic diagram for a single process.

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PLAN.DO.CH ECK.ACT CYCLE
The basis for the approach underlying a quality management system is
founded on the Shewhart concept of Plan, Do, Check and Act (PDCA) made
popular by Deming.

The PDCA model demonstrates an iterative process used by organisations to

achieve continual improvement. lt can be applied to a management system
and to each of its individual elements. lt can be briefly described as follows.

Plan - this means establish the objectives of the sysfem and its component
processes and resou rces
Do - this means implementing what was planned
Check- this means monitoing and measuring processes, product and
servrces against policies, objectives and requirements, and report the results

Act- this means taking action to improve process performance as necessary

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 The Standard incorporates the PDCA concept into a new framework, as shown in Figure 2 below.

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Objective:

The process approach and PDCA cycle are critical concepts of the ISO 9001
Quality Management Standard.

An organisation needs to understands all aspects of their processes (inputs,

outputs, resources, and control methods) and enable them to determine what
planning, operational, evaluation, improvement (PDCA) protocols are needed
to produce a consistent, reliable result that meet requirements.

Task:

Part A: Process Approach

ln your teams, review the Process Approach template provided and identify at
least two examples for each component (input; controls; resources; outputs).

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 Part B PDGA

Under each heading of the Plan Do Check Act Cycle identify:

. What sections of ISO 9001:2015 relates to each step of the cycle; and
. ldentify at least two clauses that you believe supports your selection.

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RISK BASED THINKING
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Introduction 0.3.3

lntroduction 0.3.3 makes it clear that, although the concept of Risk-based

thinking has always been present in the ISO 9001 Standard, this is much
more explicit in the 2015 version, which incorporates it in the requirements.

0.3.3 Risk-based thinking

Risk-based thinking (see Clause A.4) is essential for
achieving an effective quality management system.
The concept of risk-based thinking has been implicit in
previous editions of this lnternational Standard including,
for example, carrying out preventive action to eliminate potential
nonconformities, analysing any nonconformities that do occur, and taking
action to prevent recurrence that is appropriate for the effects of the
nonconformity.
To conform to the requirements of this lnternational Standard, an
organisation needs to plan and implement actions to address risks and
opportunities. Addressing both risks and opportunities establishes a basis for
increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
i Opporlunities can arise as a result of a situation favourable to achieving an
I intended result, for example, a set of circumstances that allow the
organisation to attract customers, develop new products and services,
reduce waste or improve productivity. Actions to address opportunlties can
also include consideration of associated risks. Risk is the effect of
i uncertainty and any such uncertainty can have positive or negative effects. A
i positive deviation arising from a risk can provide an opportunity, but not all
i positive effects of risk result in opportunities.

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 ln the lntroduction of the standard, the concept of risk-based thinking is
explained. The risk-based approach requires risks in QMS processes to be
identified and appropriate action to be taken, as well as identifying additional
opportunities for risk. Besides identifying the risks, the ISO standard expects
organisations to address opportunities for improvement based on risk
analysis. lt does not, however, require you to create a formal risk
management system.

Organisations will have to identify the factors in each process that could have
a negative impact on the desired result, and develop counter-measures for
them, taking criteria such as shortage of resources, process instability and
other influencing factors into consideration, ldeally, organisations should
therefore analyse their processes to evaluate the extent to which risk factors
have previously been addressed.

ln Section 4 the organisation is required to determine the risks which can

affect its ability to meet the system objectives. lt recognises that the
consequences of risk are not the same for all organisations. For some, the
consequences of delivering a nonconforming product are minor; for others the
consequence can be fatal.

ln Section 6 the organisation is required to take action to identify risks and

opportunities, and plan how to address the identified risks and opportunities.

So risk-based thinking means considering risk quantitatively as well as

qualitatively, depending on the business context.

Risk-based thinking therefore:

. Establishes a proactive culture of improvement
. Assures consistency of quality of goods or services
. lmproves customer confidence and satisfaction
. Builds a strong knowledge base
. Proactively improves operational efficiency and governance
. Builds stakeholder confidence in the use of risk techniques
. Enables organisations to apply management system controls to analyse
risk and minimise losses
. lmproves management system performance and resilience
. Enables organisations to respond to change effectively and protect their
business as they grow
. Allows an organisation to make informed decisions

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RELATIONSHIP TO OTHER MANAGEMENT SYSTEM
STANDARDS
Lastly in lntroduction 0.4 as previously discussed, there is a confirmation of
the objective to align all international standards, with a common framework.
Other standards may specify additional requirements relative to a particular
sector.

0.4 Relationship with other management system standards

4.4 Relationship with other management system

standards
This lnternational Standard applies the framework
developed by ISO to improve alignment among its
lnternational Standards for management systems
(see Clause A.1).
This lnternational Standard enables an organisation to use the process
approach, coupled with the PDCA cycle and risk-based thinking, to align or
integrate its quality management system with the requirements of other
management system standards.
This lnternational Stardard relates to ISO 9000 and ISO 9004 as follows:
ISO 9000 Quality management sysfems
- Fundamentals and
vocabulary provides essential background for the proper understanding
and implementation of this lnternational Standard;
ISO 9004 Managing for the sustained success of an organisation
-quality - A
management approach provides guidance for organisations that
choose to progress beyond the requirements of this lnternational Standard.
Annex B provides details of other lnternational Standards on quality
management and quality management systems that have been developed
by ISO/TC 176.
This lnternational Standard does not include requirements specific to other
management systems, such as those for environmental management,
occupational health and safety management, or financial management.
Sector-specific quality management system standards based on the
requirements of this lnternational Standard have been developed for a
number of sectors. Some of these standards specify additional quality
management system requirements, while others are limited to providing
guidance to the application of this lnternational Standard within the
particular sector.

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 SECTION 1: SCOPE
The purpose of the Scope section is to define the boundaries of the standard,
which are to specify the requirements for a generic quality management
system.

I Scope
;&
;s 1 Scope
This International Standard specifies requirements for a
quality management system when an organisation:
a) needs to demonstrate its abilitv to consistently provide
qroducts and serviees thrt Tg$_-"q"tgpcr and applicable statutory and
regulatory requirements, and
b) aims to enhance
SlqreL5dtreciloqthrough the effective application of
the system, including processes for improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.
All the requirements of this lnternational Standard are generic and are
intended to be applicable to any organisation, regardless of its type or size, or
the products and services it provides.

NOTE 1 ln this lnternational Standard, the terms "product" or "service" only

apply to products and services intended for, or required by, a customer.

I ruOff 2 Statutory and regulatory requirements can be expressed as legal

, requirements.

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SECTION 2: NORMATIVE REFERENCES
The reader is referred to ISO 9000 for a complete list of definitions of
fundamentals and vocabulary used in quality management systems.

2 Normative references

2 Normative references
The following documents, in whole or in part, are
normatively referenced in this document and are
indispensable for its application. For dated references, only
the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments) applies
ISO 9000:2015, Quality management systems Fundamentals and
vocabulary
-

SECTION 3: TERMS AND DEFINITIONS

The reader is again referred to ISO 9000 for a complete list of terms
definitions, they are not given in this standard.

3 Terms and Definitions

3 Terms and Definitions

For the purposes of this document, the following terms
and definitions given in ISO 9000:2015 apply.

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 NOTES

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