QMS Auditor/ Lead Auditor: Pre-Course Notes

QMS Auditor/ Lead Auditor
Pre-Course Notes
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Introduction a
Welcome to the Quality Management Systems Auditor/Lead Auditor training course.
Thank you for choosing LRQA.
We have designed the course to give you the knowledge and skills to perform audits of
management systems against ISO 9001 effectively and with confidence.
• It meets the requirements of the International Register of Certificated Auditors

(IRCA) www.irca.org
Complete the course successfully and you will satisfy the formal training requirements
for IRCA certification to all grades of Quality Management System auditor.
Course hours
• The course duration is 40 hours over 4½ days
• 100% attendance is required.
• You will be asked to complete evening work each day, which will take approximately
1 hour.
Delegate assessment
• We will fully explain at the start of the course the assessment criteria and
performance standards you need to achieve.
• We will give you written feedback each day, and guidance on any improvements
needed.
• You will complete a 2 hour written examination at the end of the course.
What is this pre-course work for?

• You must have some understanding of the ISO 9000 series of standards before
starting the course. Complete this pre-course work and you will gain essential
knowledge, which you will use and build on during the course.
• We are giving you this information in advance so we can make the course practical
and activity-based. This will help you to learn and make the course enjoyable.
• This pack is part of your course notes.
How long will it take?

• Plan on taking approximately two hours in total to complete it.
What happens if I do not complete this?

• You will have missed a valuable opportunity to start building your knowledge.
• You will almost certainly find it difficult to participate in some of the course exercises
and you will need to complete it in your own time in addition to your evening work.
• You may well reduce your chance of successfully completing the course.
QMS Auditor/Lead Auditor Page 1 of 25
Version 3 - Revision 0.0
Precourse Notes
© LRQA Training 2009
Introduction a
Am I expected to remember all of the information in this pack?
• No, the course is not a test of memory. But to be successful you will need to apply
this information during the course.
• The examination is open book. Which means you can refer to this pack, your
course notes, any personal notes you make during the course and to your personal
copy of ISO 9001.
Important
• Please complete Section G – Verification of pre-course work. This is very important.
It will help you prepare for the course.
• Please be sure you bring the completed pack and your personal copy of ISO 9001
with you when you attend the course.
• Please complete your personal course objectives at the end of the pack. We will ask
you to present these at the start of the course.

Precourse Notes
Introduction a
Contents
Page
Introduction 1
SECTION A The ISO 9000 Series of Documents 4
SECTION B ISO Terms and Definitions 5
ISO 9000 Quality Management Principles

• The Eight Quality Management Principles
SECTION C 7
• Matching ISO 9001 Requirements to the Quality
Management Principles
SECTION D Understanding Processes 9

• The Process-improvement model
• The process model
• Process conformance and effectiveness
SECTION E ISO 9001 Structure and Contents 13

• ISO 9001 - Model of a process-based quality
management system
• ISO 9001 Contents and layout
SECTION F Introduction to Auditing 18

• Audit terms and definitions
• Audit types and purpose
• Certification and accreditation
SECTION G Verification of pre-course work 21
SECTION H Defining Personal Course Objectives 24
Note: The following spellings are used throughout for consistency with the
ISO 9000 series of documents: - Organization. Realization. Realized

Precourse Notes
Section A – ISO 9000 Series of Documents a
Purpose
This section contains information on the ISO 9000 series of documents.
The ISO 9000 Series of Documents

The ISO 9000 series of documents comprise:
• ISO 9000 - Quality management systems – Fundamentals and vocabulary

ISO 9000 explains the fundamentals of quality management. It defines terms used in
ISO 9001 and ISO 9004.
• ISO 9001 - Quality management systems – Requirements

ISO 9001 specifies requirements for a quality management system that aims to
enhance customer satisfaction by meeting customer and applicable statutory and
regulatory requirements. It can be used for internal application by organizations, for
certification and for contractual purposes.
ISO 9001 is an auditable standard. The others are not.
• ISO 9004 – Quality management systems – Guidelines for performance

improvements
ISO 9004 is a guide for organizations that wish to move beyond the requirements of
ISO 9001, in pursuit of continual improvement. ISO 9004 considers the needs of
stakeholders as well as customers and addresses efficiency as well as effectiveness.
ISO 9001 and ISO 9004 are designed to complement each other, but can also be used
independently.
Most standards require periodic revision. Several factors combine to render a standard
out of date: technological evolution, new methods and materials, new quality and safety
requirements. To take account of these factors, ISO has established the general rule that
all ISO standards should be reviewed at intervals of not more than five years.

Precourse Notes
Section B – ISO Terms and Definitions a
Purpose
This section introduces some essential quality terms and definitions. These will help you
interpret and audit ISO 9001 requirements. You may want to refer back to these
definitions as you read through the other sections of this pack.
Definitions
The following terms and definitions are quoted from ISO9000 Quality management
systems - Fundamentals and vocabulary.
To help your understanding, we have grouped related terms together and separated
groups using this bullet symbol.
Quality
Degree to which a set of inherent characteristics fulfils requirements
System
Set of interrelated or interacting elements
Management system
System to establish policy and objectives and to achieve those objectives
Quality management system

Management System to direct and control an organization with regard to quality

Process
Set of interrelated or interacting activities which transforms inputs into outputs
Product
Result of a process
• The term Product is used as a generic term for:
- services (for example transport)
- software (for example computer programme or information,)
- hardware (for example engine mechanical part)
- processed materials (for example lubricant)
Procedure
Specified way to carry out an activity or a process
• Where the procedure is documented the term ‘written procedure’ or ‘documented
procedure’ is frequently used. For clarity, auditors should not use the term procedure
when in fact they are referring to a written or documented procedure.

Precourse Notes
Section B – ISO Terms and Definitions a
Requirement
Need or expectation that is stated, generally implied or obligatory
Nonconformity
Non-fulfilment of a requirement
Correction
Action to eliminate a detected nonconformity
• for example rework
Corrective action
Action to eliminate the cause of a detected nonconformity or other undesirable situation
Preventive action
Action to eliminate the cause of a potential nonconformity or other undesirable
situation

Document
Information and its supporting medium
Record
Document stating results achieved or providing evidence of activities performed

Precourse Notes
Section C - ISO 9000 Quality Management Principles a
Purpose
ISO 9000 introduces eight Quality Management Principles that can be used to lead an
organization towards improvement. ISO 9001 includes requirements that can be traced
back to these principles.
During the course you will be asked to match requirements of ISO 9001 to some of the
quality management principles. By reading this section and working through an
example of how requirements of ISO 9001 can be linked back to the principles you will
be giving yourself a head-start. You will also start to familiarise yourself with ISO
9001.
The Eight Quality Management Principles

The eight quality management principles given in ISO 9000 are:
1. Customer focus
Organizations depend on their customers and therefore should understand current
and future needs, should meet customer requirements and strive to exceed customer
expectations.
2. Leadership
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the internal environment in which people can become fully
involved in achieving the organization's objectives.
3. Involvement of people
People at all levels are the essence of an organization and their full involvement
enables their abilities to be used for the organization’s benefit.
4. Process approach
A desired result is achieved more efficiently when activities and related resources are
managed as a process.
5. Systems approach to management

Identifying, understanding and managing interrelated processes as a system
contributes to the organization's effectiveness and efficiency in achieving its
objectives.
6. Continual improvement
Continual improvement of the organization's overall performance should be a
permanent objective of the organization.
7. Factual approach to decision making

Effective decisions are based on the analysis of data and information.
8. Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial
relationship enhances the ability of both to create value.
(Reproduced from ISO 9000)
Precourse Notes
Section C - ISO 9000 Quality Management Principles a
Please note - Suppliers are stakeholders not customers. Stakeholder needs are
considered in ISO 9004 but are outside the scope of ISO 9001. Consequently there
is no direct traceability from ISO 9001 to the quality management principle of
mutually beneficial supplier relationships.
Matching ISO 9001 requirements to the quality management

principles
With the exception of “mutually beneficial supplier relationships” requirements that
support each of the principles can be found in ISO 9001. An example of this is shown
below.
Use this example to start to familiarise yourself with ISO 9001.
Principle ISO 9001 requirements that support the principle
Process approach 4.1a) identify the processes needed for the quality management system….
4.1b) determine the sequence and interaction of these processes
4.1c) determine criteria and methods needed to ensure that both the
operation and control of these processes are effective
Now refer to ISO 9001. Read what it says in the sections listed below and
see how these requirements support the process approach principle.
4.1 e)
4.1 f)
7.1 – refer to the first paragraph
8.2.3
Complete the “Quality Management Principle and ISO 9001 cross reference
section” that is part of the “Verification of pre-course work” section.

Precourse Notes
Section D – Understanding Processes a
Purpose
ISO 9001 promotes a process approach to quality management. We introduce in this
section the Process Improvement Model, the Process Model and process conformance
and effectiveness.
The Process-improvement model
This is the “Plan-Do-Check-Act” improvement cycle. You may hear it called the PDCA
cycle or the Deming cycle. You can apply it to all processes and you can use it to plan
and implement process change.
• Plan – Plan the improvement and plan how you will know if it has worked.
• Do - Do what you planned to do and measure it as planned.
• Check - Check the results against expectations.
• Act – Act to maintain the improvement, address any shortfall and learn from
experience.
ISO 9001 aims to bring about continual improvement through the Plan-Do-Check-Act
cycle, which is embedded into ISO 9001 requirements.

Precourse Notes
The Process model
The ISO 9000 series of documents make frequent reference to processes and process-
base quality management systems. It will be useful if you understand the relevant ISO
terms, what is meant by a process and how any process can be represented by a simple
model. We will use this process model during the course.
• Process - set of interrelated or interacting activities which transforms inputs into

outputs.
• Product -result of a process.
• Procedure - specified way to carry out an activity or process.

You can describe a business or organization as a collection of processes. Processes use
resources to transform the inputs into the outputs. People and equipment are examples
of resources.
The purpose of a quality management system based on ISO 9001 is to ensure the
product of the organization meets customer, statutory and regulatory requirements, and
the organization’s own requirements. Using the PDCA approach, ISO 9001 requires
processes to be designed, monitored and improved so they consistently deliver product
that meets these requirements.
When the way in which an activity or process is carried out can affect the product’s
ability to meet requirements a procedure (a specified way to carry out the process) is
needed. The procedure may be implemented by training the process operator or by
automating the process.
It is useful to be able to represent a process by a simple diagram. The Process model

shown below is one recognised way of doing this and it will be used in the course.
Controls
Input Activities Output
Resources

Precourse Notes
For example, consider the enquiry handling part of a sales process.
Controls - controls or constraints applied to the

process or output
E.g. Company pricing and discount policy
Input – materials or Output - the result of

information that is changed transforming the input.
in some way to become the Process E.g. A quotation to the
output.
Activities customer
E.g. Customer enquiry
Resources - resources to enable the process

to be carried out.
E.g. Sales person and database
Process Interaction
Individual processes rarely operate in isolation and processes can often be broken down
into sub-processes. Outputs from one process are often inputs into later processes.
Some times the output from one process will become a control to another process. For
example, consider two parts of a purchasing process.
Supplier
Performance
standards
Potential
Approved
Suppliers Supplier Approval Suppliers
Competent
Personnel
Approved
Suppliers
Purchase Purchase
Purchasing
Requirements Order
Competent
Personnel

Precourse Notes
Process conformance and effectiveness
• Conformance – fulfillment of a requirement
The term conformance is used when discussing ISO management system standards in
preference to the term compliant, which is used when discussing statutory and
regulatory standards.
• Effectiveness – extent to which planned activities are realized and planned results
achieved.
A process is conforming when carried out in accordance with planned arrangements.

The planned inputs, resources and controls have been used to produce the planned
output. But a conforming process is not automatically an effective process. For
example, the planned output may not meet requirements of the customer.
Checking a process has been carried out in accordance with planned arrangements is a
conformance audit. Checking the results of a process meet requirements is an
effectiveness audit. Auditors must consider the purpose of a process to determine its
effectiveness.
For example, consider a purchasing process. The purpose of a purchasing process is to

have the right product, in the right quantities, at the right time, in the right place, to the
right specification and at the right price. An effective purchasing process will achieve
these results. So for example, the procedure for purchasing should take account of how
much lead time suppliers need. If specified lead times are too short it is possible to have
a conforming, but ineffective purchasing process. This could result in late delivery.

Precourse Notes
Section E - ISO 9001 Structure and Contents a
Purpose
Read this section and start to familiarise yourself with ISO 9001. It will help you during
the course, the exam and later as an auditor if you can navigate your way around ISO
9001 requirements quickly and accurately.
ISO 9001 – Model of a process-based quality management system

ISO 9001 includes the diagram below. It illustrates in simple terms how a business
works following the principles of ISO 9001 and it provides a framework around which
ISO 9001 is structured.
Continual
Continualimprovement
improvementof
of
the quality management system
the quality management system
Management
Management
Responsibility
Responsibility
Customers Customers
Measurement,
Resource Measurement, Satisfaction
Resource analysis and
management analysis and
management improvement
improvement
Input Output
Requirements Product
Product Product
Realisation Product
Realisation
The diagram illustrates the relationship between customers and the supplying
organization. On the left-hand we have customer requirements. In the middle we have
the organisation supplying the customer. On the right-hand we have the customer’s
perception as to whether the organization has met their requirements.
Customers Requirements - consider customers at two levels, as shown on the left-

hand side. Firstly there is the collective customer, or market place that the organization
operates within. And there is the individual customer and individual order. The
enclosed “requirements” box in the diagram represents the individual customer. The
same principle applies in the illustration of customers’ satisfaction on the right-hand
side. There is the perception of whether the organization has met the needs of an
individual customer for an individual order, and there is the overall perception of the
collection of customers.

Precourse Notes
Management Responsibility - Businesses generally operate within a market sector.
For example one airline may choose to concentrate on the business traveller whilst
another targets the low cost part of the market. The organization needs to fully
understand the market it is operating in and what customers want now and in the
future. This is the role of Top management, who direct and control the organization.
Top management need to establish effective two-way communication between the
organization and customers and understand their requirements. This is shown in the
diagram by the two-way dotted line from “management responsibility” to the
“customer”. Of course some businesses have only a low number of customers, possibly
only one. Never the less the same principle applies.
Through this communication with customers top management will be in a position to

make informed decisions and give direction and leadership to the business. Of course
there are many other factors that top management need to take account of, such as
what competitors are offering, new technology, new legislation, stakeholder
expectations and new business opportunities. For top management quality
management is just another part of business management. Top management rarely
uses quality terminology. Auditors need to recognise this and use appropriate business
language when interviewing top management.
• Quality policy – overall intentions of an organization with regard to quality
The organization’s quality policy should reflect what is important to the organization
and its customers. Top management may formulate and review the quality policy as part
of other business planning activities. In practice an organization’s policies tend to
remain fairly constant from one year to the next whilst objectives change to meet
emerging needs.
• Quality objectives – something sought, or aimed for, relating to quality
Having set policy and established objectives for quality as well as other business
requirements such as profitability, the role of top management is to communicate these
and establish a unity of purpose throughout the organization.
Resource Management - All businesses need resources. Within the context of ISO
9001 these comprise:
• Human resources - including competence, training and awareness.
• Infrastructure - including buildings, workspace and associated utilities, process
equipment (hardware and software) and supporting services (such as transport,
communication or information systems).
• Work environment - including physical, environmental and other factors under which
work is performed.
Resources need to be planned, implemented and checked for adequacy and

effectiveness in meeting customer, statutory and regulatory requirements applicable to
the product, and the organization’s own requirements as set out in the quality policy
and quality objectives.
Precourse Notes
In addition to the three resource types given, organizations will need also to plan and
manage other resources such as financial resources and supplier partnerships. These are
outside of the scope of ISO 9001 but are referred to in ISO 9004.
Product Realization - is a term used to refer to the collection of processes that go to

identify and deliver customer requirements at an individual customer order level.
Typically these are the every-day operational processes of an organization. An example
would be all of the individual processes undertaken by an airline; from selling a ticket to
a customer through to delivery of the passenger and their baggage to their destination.
Examples of realization processes that apply to most companies are sales, purchasing,
delivery and invoicing. For a manufacturing company, realization processes could also
include production processes, inspection and test, calibration and installation. For a
service company such as a hotel, examples of realization processes would be guest
reception, restaurant and room services.
ISO 9001 applies the PDCA cycle to these realization processes
Measurement, Analysis and Improvement - is the fourth set of processes in the

model of a process-based quality management system. There is a requirement to plan
and implement monitoring, measurement, analysis and improvement processes. These
are the check and act parts the PDCA cycle.
The aim is to:

• make sure customer requirements are being met
• make sure product conforms to requirements
• make sure processes are capable and effective
• make sure the quality management system is being followed
• analyse data to determine the effectiveness of the management system and enable
fact based decision making
• continually improve the effectiveness of the management system
That is, continually improve the probability that customer, statutory and regulatory
requirements applicable to the product, and the organization’s own requirements
will be met.
Continual improvement – is the last part of the model of a process-based quality

management system. The aim of the measurement processes is to gather factual data
that can be used to correct any deficiencies in the planned arrangements and identify
improvement opportunities.
Continual improvement acts at two levels.

1. At product realization level - through monitoring and measurement of product and
processes.

Precourse Notes
The aim is to:
• correct anything that is wrong and then take corrective action to eliminate cause and
stop it recurring in the future
• improve process capability so the probability that customer, statutory and regulatory
requirements applicable to the product, and the organization’s own requirements
will be met is increased
• make sure the quality management system is being followed
And:
2. At organization level – through use of the quality policy, quality objectives, audit
results, analysis of data, corrective and preventive actions and management review.
The aim is to:
• review what has been achieved against the quality policy and quality objectives and
act to address any shortfalls
• plan for the future, taking account of changes in requirements and other changes
that could affect the quality management system such as development of
technology
This activity is part of what ISO 9001 calls “management review” and is the process
by which new quality objectives and targets are established.
ISO 9001 Contents and layout

Look now at your copy of ISO 9001.
• Clause 1 – Scope. This section defines the scope and purpose of ISO 9001
• Clause 2 – Normative references. This section identifies reference documents that
should be used with ISO 9001
• Clause 3 - Terms and definitions. This clause refers to ISO 9000
• Clause 4 – Quality management system. This section describes general requirements
for developing and implementing a quality management system using ISO 9001. It
specifies documentation requirements and requirements for a Quality manual,
Control of documents and Control of records.
Look now at clauses 5 through to 8. The main body of the Standard is organised in the
same way as the model of a process-based quality management system. That is:
• Clause 5 – Management responsibility
• Clause 6 – Resource management
• Clause 7 – Product realization
• Clause 8 – Measurement, analysis and improvement
Exclusions – Clause 7 only

Where any requirement(s) of ISO 9001 cannot be applied due to the nature of an
organization and its product, this can be considered for exclusion. Exclusions are limited
to requirements within clause 7. For example, where an organization does not use

Precourse Notes
monitoring and measuring equipment the requirements of clause 7.6 can be excluded.
The quality manual shall include details of, and justification for, any exclusion.
Pre-course preparation
During the course you will look in detail at some of the specific requirements of ISO
9001. Ideally you will start familiarise yourself with ISO 9001 requirements before
attending the course.

Precourse Notes
Section F – Introduction to Auditing a
Purpose
This section introduces some basic concepts of auditing. It contains essential
information, which you should know and understand before attending the course.
Read this section carefully. You will have an opportunity during the course to clarify any
points with the trainer.
Audit terms and definitions

The following terms and definitions are quoted from ISO 19011 – Guidelines for quality
and/or environmental management systems auditing, which is referred to in ISO 9001
• ISO 19011 is a guidance document, not a set of requirements.

Audit
Systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled
Audit evidence
Records, statements of fact or other information, which are relevant to the audit criteria
and verifiable
Audit criteria
Set of policies, procedures, standards or requirements

Auditor
Person with competence to conduct an audit
Audit team
One or more auditors conducting an audit, supported if needed by technical experts
Note – one auditor of the audit team is appointed as the audit team leader
Technical expert
Person who provides specific knowledge or expertise to the audit team
Audit client
Organization or person requesting an audit
Auditee
Organization being audited

Audit programme
Set of one or more audits planned to a specific time frame and directed towards a
specific purpose
Precourse Notes
Audit plan
Description of the activities and arrangements for an audit
Audit scope
Extent and boundaries of an audit
Audit types and purpose

Audits are done for a variety of reasons. For example to check a process is carried out in
accordance with the planned arrangements.
Quality management system audits may be used to:

• verify conformance to planned arrangements
• identify opportunities for improvement
• assess the effectiveness of quality management systems
• assist with selection and monitoring of suppliers
• verify compliance with contractual requirements
• determine conformity with ISO 9001 requirements
1st, 2nd and 3rd Party audits.

These terms describe the relationship the auditor has with the organization being
audited.
• 1st party or internal audit is the term used when the auditor works for the
organization being audited. 1st party audits are used for internal purposes. The
person managing the audit programme will decide the scope of the audit.
• 2nd party or supplier audit is the term used when the auditor works for the client
buying from the auditee. 2nd party audits are used to help select and monitor
suppliers. The audit client will decide the scope of the audit.
•
rd
3 party or independent audit is the term used when the auditor works for an
independent auditing organization. For example those carrying out certification
audits. The auditee organization may include all of its products within the audit, or
it may want to limit the audit to a selected range. The independent audit body will
audit all applicable parts of the organizations quality management system and
evaluate conformance with all applicable requirements of ISO 9001.
Note – determining conformity with ISO 9001 or other recognised standard is the
rd
primary purpose of a 3 party audit.

Precourse Notes
Certification and accreditation
At some stage you will almost certainly need to explain the terms certification and
accreditation to people who do not understand them.
In overview the system works like this.
Accreditation bodies, for example the United Kingdom Accreditation Service (UKAS):
Audit and award accreditation to:
ªCertification bodies, for example LRQA
Who audit and award certification to:
ªOrganizations

Precourse Notes
Section G – Verification of Pre-course Work a
The purpose of this section is to check your understanding of the information given in
this pre-course work.
1. Match the definition to the term and write the letter of the correct definition against
the term. There are two definitions for which there is no term listed.
No TERM Def. DEFINITION

1 Management A Set of interrelated or interacting activities which
system transform inputs into outputs
2 Procedure B Action taken on a nonconforming product to

make it conform to requirements
3 Corrective action C Specified way to carry out an activity or a

process
4 Nonconformity D System to establish policy and objectives and to

achieve those objectives
5 Process E Co-ordinated activities to direct and control an

organization with regard to quality
F Action to eliminate the cause of a detected

nonconformity or other undesirable situation
G Non-fulfilment of a requirement
2. In the space below, describe the difference between corrective action and preventive
action and give an example of each.
3. Which of the following are guidance documents?

a) ISO 9000
b) ISO 19011
c) ISO 9004
d) none of the above
e) all of the above

Precourse Notes
4. Complete this cross-reference guide by identifying 5 specific requirements in ISO
9001 that support each of the quality management principles listed below.
Quality Management ISO 9001 requirements that support the principle

Principle
Customer focus
Leadership
Involvement of people
Continual
improvement
Factual approach to
decision making

Precourse Notes
5. With reference to this pre-course work and ISO 9001, who has overall responsibility
for the organization’s quality policy and quality objectives?
6. With reference to this pre-course work and ISO 9001 describe in the space below
the purpose of “Management review”
-----------------------------------------------------------------------------------------------------------------

Precourse Notes
Section H – Personal Course Objectives a
Purpose
Each delegate will have their own reason for coming on the course. For example you
may be an internal auditor (1st party audits) who wants now to audit against ISO 9001.
Or you may be coming on the course as part of your personal development. It will help
you and the trainer if before you arrive you think about and plan what you want to get
from the course. We have designed this section to help you with this. It forms a bridge
between the pre-course pack and the course itself.
In thinking about your objectives for the course you also want to consider:
• What you need to do to meet the IRCA requirements for Auditors. You may find it
beneficial to visit the IRCA web site for more details of the requirements for
becoming an IRCA certificated auditor. www.irca.org
• Your familiarity with ISO 9001 and quality management systems
• Any other expectations which you or your employer have from the course.
Please now write your personal objectives using the form on the next page and bring it
with you to the course.

Precourse Notes
Section H – Personal Course Objectives a
Personal Course Objective
Name: Company:
Course Name: QMS Auditor/ Lead Auditor
My current auditing experience is: (please give a brief description of your auditing
experience including the type of audits you have completed or been involved in)
My future auditing role will be: (please give a brief description of how you see your role as
an auditor developing in the future and include also the type of audits you expect to be
involved in)
My objectives for the course are: (please list between three and five specific things that you
want to be able to do as a result of completing the course)
Do you intend to apply to become an IRCA certificated auditor or lead auditor?

Yes No Don’t know
Please take a copy of this page and bring it with you to the course. You will be asked to
discuss and present your course objectives to your group and LRQA trainer.

Precourse Notes
a
T: 0800 328 6543
LRQA F: 024 7651 1116
Measure the Difference E: lrqatraining@lrqa.com
W: www.lrqa.co.uk/training
Lloyd’s Register Quality Assurance Limited is a member of the Lloyd’s Register Group.

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QMS Auditor/ Lead Auditor

• It meets the requirements of the International Register of Certificated Auditors

What is this pre-course work for?

How long will it take?

What happens if I do not complete this?

QMS Auditor/Lead Auditor Page 2 of 25

SECTION A The ISO 9000 Series of Documents 4

SECTION B ISO Terms and Definitions 5

ISO 9000 Quality Management Principles

SECTION D Understanding Processes 9

SECTION E ISO 9001 Structure and Contents 13

SECTION F Introduction to Auditing 18

SECTION G Verification of pre-course work 21

SECTION H Defining Personal Course Objectives 24

QMS Auditor/Lead Auditor Page 3 of 25

The ISO 9000 Series of Documents

• ISO 9000 - Quality management systems – Fundamentals and vocabulary

• ISO 9001 - Quality management systems – Requirements

• ISO 9004 – Quality management systems – Guidelines for performance

QMS Auditor/Lead Auditor Page 4 of 25

Quality management system

QMS Auditor/Lead Auditor Page 5 of 25

QMS Auditor/Lead Auditor Page 6 of 25

The Eight Quality Management Principles

5. Systems approach to management

7. Factual approach to decision making

8. Mutually beneficial supplier relationships

Matching ISO 9001 requirements to the quality management

Use this example to start to familiarise yourself with ISO 9001.

Principle ISO 9001 requirements that support the principle

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The Process-improvement model

• Do - Do what you planned to do and measure it as planned.

• Check - Check the results against expectations.

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• Process - set of interrelated or interacting activities which transforms inputs into

• Product -result of a process.

• Procedure - specified way to carry out an activity or process.

It is useful to be able to represent a process by a simple diagram. The Process model

 Input Activities  Output

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Controls - controls or constraints applied to the

Input – materials or Output - the result of

Resources - resources to enable the process

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A process is conforming when carried out in accordance with planned arrangements.

For example, consider a purchasing process. The purpose of a purchasing process is to

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ISO 9001 – Model of a process-based quality management system

Customers Requirements - consider customers at two levels, as shown on the left-

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Through this communication with customers top management will be in a position to

• Quality policy – overall intentions of an organization with regard to quality

• Quality objectives – something sought, or aimed for, relating to quality

Resources need to be planned, implemented and checked for adequacy and

Product Realization - is a term used to refer to the collection of processes that go to

ISO 9001 applies the PDCA cycle to these realization processes

Measurement, Analysis and Improvement - is the fourth set of processes in the

The aim is to:

Continual improvement – is the last part of the model of a process-based quality

Continual improvement acts at two levels.

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ISO 9001 Contents and layout

Input Activities Output