IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM ACCORDING TO
ISO 9001:2008 IN SME-S
Note: The length of the classroom training is approximately 12 hours. This can be
extended to 16 hours using additional exercises and examples available in all
educational materials both on paper and in electronic format.
Time Section 1. Introduction: GOALS AND CONTENT OF THE
Min. Time 15 -20 minutes
Resources Ensure you have each of the following:
Flipchart and marker pens;
Projector and screen;
Paper and pens for the participants
5 Presentation If the participants do not know each other every participant
min of presents him/herself and tells the group what he/she expect
participants from this training. Write these expectations on a flipchart
Present the first slide and tell the participants the subject of
IMPLEMENTATION OF A
SYSTEM ACCORDING TO
ISO 9001:2008 IN SME-S
10 Exercise: Present slide 2, the title of the introductory part.
GOALS AND CONTENT OF
Give each participant a post it paper. Ask them to define
individually what quality means for them and write it on a post
it. Each participant puts its definition on the flipchart table.
Read loudly the definitions and group them according to their
content. Make notes on the flipchart of the elements
mentioned for the definition of Quality. Discuss the elements
of the definition with the group. Based on these the group
gives the definition of quality. Present them other definitions
using slide 3.
DEFINITION OF “QUALITY”
There are numerous different definitions:
„An essential and distinguishable attribute of a person or a
thing" or „a feature defining the individual nature of
Those product features which cover the needs of the
customer and determine his/her satisfaction
Absence of defects and faults which require repair
measures and usually imply market share losses, customer
ISO 9001:2008 "Degree to which a set of inherent
characteristics fulfils requirements"
5 Aims of the Present slide 4. Training goals and explain the goals to be
min training achieved during the training:
Ensuring the understanding of the ISO 9001:2008
requirements and implementation process.
Providing owners and quality managers of SMEs with
knowledge, skills, tools and examples needed to
implement a quality management system according to
Relate to each individual expectation and explain how it is
going to be satisfied.
Explain the structure of the training using slide 5: Content of
CONTENT OF THE
Definition of quality
Basic information on ISO 9001:2008
Benefits and advantages
Content of ISO 9001:2008
QMS – general considerations and requirements
Measurement, analysis and improvement
Steps for implementing a QMS
Present the educational material available for self-study and
to support implementation in practice (slide 6):
Contains the necessary theoretical background
Present practical examples for ISO requirements
Working or final documents ready to use in a QMS
CD-ROM with tools, examples and case studies
E-learning with explanations, guidelines, case studies, exercises
Educational materials are also suitable for self-study
Time Section 2. INTRODUCTION TO ISO 9001:2008
Min. Time 40-45 minutes
Resources Ensure you have each of the following:
Flipchart and marker pens;
Projector and screen;
Paper and pens for the participants
Handouts containing slides 7-23
5 Presentation The second part of the training presents the general
min background of ISO (slide 7)
INTRODUCTION TO ISO
Explain what ISO is and using slide 8
THE ISO 9001:2008
Set of international standards (for the first time
Result of an international agreement regarding "good
management practices" to guarantee products or
services in line with the customers’ quality
expectations by means of processes, management
Set of guidelines and requirements to implement and
maintain a quality management system which is
applicable to any kind of a public or private
organisation, regardless of its activity and size
Present the evolution and improvements of ISO 9001
emphasising the improvements to the new version in
comparison to the version from 2004. Use slides 9 and 10.
CHARACTERISTICS AND IMPROVEMENTS IN ISO
CONTENTS ISO 9001:2008 9001:2008
An international standard for quality management Focus on risk management
systems, issued by ISO in 1987 Wider interpretation of the regulatory environment
Revisions in 1994, 2000 and 2008 Widening the meaning of the term „product”, including not only
the final product but also the supplied and intermediate
Aims of the last revision: Handling outsourced processes
Clarification of the text and terms used Infrastructure content extended to include the information
Increased compatibility with ISO 14001 system
Definition of after delivery requirements
New ideas for customer satisfaction input
Highlighting the importance of measuring the results and
effectiveness of the preventive and improvement measure.
5 Evolution of quality management
min Make a short presentation of the development of Quality
Management using slides 11-15 describing the overall
development process, respectively its phases.
DEVELOPMENT PHASES OF
“QUALITY MANAGEMENT" QUALITY GUARANTEE
Big difference Developed in the 60s
between quantity and
quality An integrated quality management approach which is
Quantity regarded as
primary objective Development of Total Quality in services regarded as a part of the system and controlled by
Quality is one of Quality (TQM) “Internal" quality the entire organisation and primarily by the
many success factors approach in the USA “External" quality
Immediate applicability to services
1935 - 1945 60s 1990 - today
Before 50s 70s - 80s
Attention on planning and activity recording
World War 1
Expansion of the planning and test concept from
production to design
Development of so- Development of Quality
called Quality Control Guarantee Satisfaction of
activities Concept of quality once consumers, citizens
Services are not again modified; now and users
included yet systematically operates Primary objective
on both on the improvement of
production process and quality of life
on the product itself
MANAGEMENT QUALITY IN SERVICES
Puts quality on top of the business values Traditional approach
Aim improving customer relations Identifying customers’ needs and expectations and
subsequent product/service design
Improvement of quality as a continuing process
Quality programme is based on a change of culture, values
Improvement by defined policies and aims and attitudes of the staff
Education of the whole organisation to quality as a Most important points staff management and customer
REQUIREMENTS OF INTERNAL
AND EXTERNAL QUALITY
Everything in connection with staff satisfaction and with
parameters such as shift-work, information distribution,
time management, feedback on accomplished tasks, etc.
Awareness with regard to the customers’ needs
Customers’ attitudes and expectations
Considering the customers’ wishes
Problem solving skills
Good relations with suppliers, media, etc.
10 Quality management system
min Explain what the quality management system means (slide
DEFINITION OF THE
“QUALITY MANAGEMENT SYSTEM"
Systemic set of management procedures used to
monitor, check and improve the operative and
financial performance of the organisation, aiming at
offering the best product or service at lower costs
The management procedures that constitute the
“quality management system” include groups of
activities, which are indicated as “quality assurance”,
“quality control” and “quality improvement”
Present the advantages of using a QMS (slide 17)
IMPLEMENTING A QMS
Systematic way to settle quality related matters within one’s
Knowledge that an organisation which meets the criteria of an
accepted QMS (certified according to an international
standard) stands for high-quality products and services
Establishes minimum requirements in some areas (e.g.
Present in brief the 3 elements of a QMS: quality assurance,
quality control and quality improvement, using slides 18-20.
QUALITY ASSURANCE (QA) QUALITY CONTROL (QC)
Guarantees that all process changes are clearly Also known as " statistical quality control"
identified and evaluated Permits to evaluate the performance of the current
Also guarantees that all product or service organisational processes and to adapt and undertake
specifications which are necessary to satisfy the the measures necessary to eliminate unwanted
demands of both the customers and the product or performances
service producers are clearly fixed and respected Makes it possible to fully take into account the
quality improvement standards
A systematic and continuing activity that includes
business processes and aims at higher performance
and quality levels as obtained previously.
Ask examples for each process.
10 Exercise Ask participants to give reasons why they would implement a
min QMS. Write them on a flipchart paper. Group the reasons in
internal and external reasons and discuss the right ones with
the group. As a summary, present slide 21.
IMPLEMENTING A QMS
Internal quality improvement (e.g. reduction of rework or
Have a holistic approach over the processes enabling the
Create a formalised structure to activate and maintain a
continuous improvement process
A guarantee for expected quality level
Increased costumer satisfaction
A proof and quaranty of quality in the eyes of the customer
Differentiation by means of a long-term quality strategy
10 Presentation Explain what internal and external factors influence the QMS
min (slide 22)
FACTORS INFLUENCING THE
The structure and implementation of the QMS is
influenced by the following elements:
Risks connected to the activities
Present a usual QMS using slide 23.
TYPICAL QMS PROCESSES
- Establishing the quality policies and quality objectives
- Conducting management reviews
- Communicating customer, statutory and other requirements
within the organization
- Ensuring the availability of resources
Resource management Measurement, analysis and
Determination and allocation of improvement processes
- Human resources QMS - To demonstrate conformity of the
product and QMS
Processes - To continually improve the
- Work environment
effectiveness of the QMS
Product realisation processes
- Planning of the product realisation
- Customer-related processes
- Design and development
- Purchasing and production and service provision
- Control of monitoring and measuring devices
Time Section 3. The Content of ISO 9001: 2008
Resources Ensure you have each of the following:
Flipchart and marker pens;
Overhead projector and screen;
Documents: flowchart.pdf; job analysis sheet template.doc;
job description template.doc; job specification
template.doc; job description senior trainer.doc; job
specification senior trainer.doc; supplier evaluation
Handout containing slides 24-91;
Paper and pens for the participants
Cards with the names of process groups
Job analysis sheets, job description and specification
templates, evaluation sheets, one set for each participant.
5 Presentation The third part presents the content of the standard. (slide 24)
CONTENT OF ISO
Present the content of ISO 9001:2008 using slide 25.
CONTENT OF THE
0 Introduction 6 Resource management
0.1 General 6.1 Provision of resources
0.2 Process Approach 6.2 Human resources
0.3 Relation hip with ISO 9004 6.3 Infrastructure
0.4 Compatibility with other management 6.4 Work environment
Systems 7 Product realisation
1 Scope 7.1 Planning of product realisation
1.1 General 7.2 Customer-related processes
1.2 Application 7.3 Design and development
2 Normative Reference 7.4 Purchasing
3 Terms and definitions 7.5 Production and service provision
4 Quality management system 7.6 Control of monitoring and measuring
4.1 General requirements
4.2 Documentation requirements 8 Measurement, analysis and
5 Management Responsibility 8.1 General
5.1 Management commitment 8.2 Monitoring and measurement
5.2 Customer Focus
8.3 Control of nonconforming products
5.3 Quality policy
8.4 Analysis of data
5.5 Responsibility, authority and
5.6 Management review
Clause 4 Quality Management System
Time 130 min
10 Presentation General requirements (4.1.)
min This clause refers to the process approach of the company’s
activities. (slide 26)
"The organisation shall establish, document,
implement and maintain a quality management
system and continually improve its effectiveness in
accordance with this international standard."
Functioning management system directs and controls an
organisation with regard to quality
Analysis of customer requirements
Definition of processes
Level of documentation can be determined by the company
Processes are the basis of all business activities. Explain the
content, structure and components of a process using slide
A process is a logically coherent, repeatable sequence of
activities; its input and output and, therefore, its creation of
value can be measured.
Input Activity 1 Activity 2 Activity 3 Output
Transformation (creation of value)
Start of process End of process
A process must be delimited by a definable
A process must be delimited by a definable
process start and process ending.
process start and process ending.
The definition of a process: “a set of interrelated or interacting
activities that transforms inputs to outputs”
A process must be capable of achieving desired outputs.
Each process has a supplier and a customer. There are also
requirements, controls and feedbacks from the process itself
and also from the customer and to the supplier. All these are
part of the control of the process.
10 Example Present an example of process using slide 28. This is a
min winery process with 3 main sub-processes.
PROCESS EXAMPLE: WINERY
grapes wine Right quantity
Alcohol degrees etc
Discuss the elements of these processes: inputs, outputs,
Give example of measurement criteria for different processes,
Concrete production – durability
Clothing – fashion, defects
Hotel services – overbooking, mistakes, delays in services
Food preparation – temperature, taste
20 Presentation The ISO standard categorizes the processes in 4 categories
min (slide 29)
PROCESSES IN THE
The norm subdivides company processes into four
Management of resources
Measurement, analysis and improvement
An important aspect from quality management point of view
are outsourced processes (slide 30).
In search of higher efficiency and greater
productivity many companies outsource their
secondary or functional processes to companies
specialised in that field able to perform those
processes at better standards and lower costs.
According to ISO 9001:2008 an outsourced
process is a process that the organisation
needs for its quality management system and
which the organisation chooses to have
performed by an external party.
Outsourced processes, if they have important
contribution to the final output, must be taken into
consideration in the QMS.
Ask participants to give examples of processes which could
be outsourced. Discuss 1 or 2 processes in detail: reasons
and advantages of outsourcing them.
This process is essential for managing human resources but it
is a mainly routine functional process suitable for a high level
of IT support. This process can be performed more effectively
by a specialised company equipped with suitable qualified
people and modern software base.
However, the communication process and the flow of
information between the company and the contractor must be
established in detail and well organised.
This is a process needed to ensure a comfortable, hygienic
and safe working place but requires a high amount of routine
tasks performed by low qualification persons and the
organisation of the cleaning activity. The process can be
entirely outsourced to be performed by a company having the
needed equipment and personnel. A contact person must be
named from the company to keep in touch with the
responsible person from the contracting company.
In order to improve the quality processes must be
continuously improved, thus these activities form an
Presentation improvement circle, having 4 activities (slide 31)
In order to improve the quality we have to
change the operation method of each company
process in a systematic way, following the cycle
A NEW METHOD
IMPROVE THE IMPLEMENT THE
NEW METHOD NEW METHOD
20 Presentation The process of analysing company processes
min In order to improve the processes, we first must define and
analyse them and make for each process a comprehensive
graphic representation. Present the steps of the analysis
process using slide 32.
THE PROCESS OF ANALYSING
ANALYSIS OF REPRESENTATION
PROCESSES OF PROCESSES
PROCESSES AND STEPS
1st Step: Definition of company processes
Processes are defined by the manager together with his/her
team. Present the steps of defining processes using slide 33.
DEFINITION OF COMPANY
Each manager together with his/her collaborators has to
define the processes they participate in to have a clear picture
of their starting and ending points, the inputs and outputs, the
participants and their connections to other company processes.
To collect information they can use brainstorming.
The steps to follow:
Delimit the processes. Each process has a starting and an
Define the inputs and outputs of each process. Each process
has one main output = the reason for existing of that
process. It can also have collateral outputs (e.g. information,
Define the phases/steps of each process. Each step has
intermediary inputs and outputs.
Define the jobs participating in each process, their tasks
Explain in detail the technique of brainstorming used for
gathering information. This is a creative technique used for
gathering as much information and ideas as possible to solve
a particular problem by focusing the thinking on this problem.
It can be used in group but also individually. It has 2 steps:
a.) Gathering information
In this phase, the stress is on the amount of information and
ideas, not on their quality. This will be analysed later. Use
slide 34 to present the content of the step.
BRAINSTORMING STEP 1:
The leader of the group asks a question relevant to the problem
they want to solve.
The members of the group tell their ideas one by one until the
group runs out of ideas.
The leader of the group writes down all the answers on a
flipchart paper without analysing them.
Examples of questions for determining the steps and
activities in a process:
What steps / activities does the process/phase consist of?
What decisions have to be made in the process / phase?
What has to be controlled and when?
What has to be approved and when?
When are there interruptions in the process?
What type of problems do usually occur in the process?
b.) Analysing information
In this phase the gathered information is analysed by the
group using relevant criteria and it is prepared to be used in
answering the initial question, e.g. solving a problem,
designing a process. Use slide 35 to present the content of
BRAINSTORMING STEP 2:
Systematise information according to criteria
relevant for the questions (e.g. succession in time,
risks, inputs, outputs, participants, complexity,
Eliminate redundant information.
Analyse each group of information considering their
content of reality, their feasibility, their potential
Eliminate information which are not useful to answer
the initial question. The remaining information helps
to answer the question.
2nd Step: Analysis of company processes
Based on the information gathered in brainstorming and from
company documents, processes are analysed from different
point of views. This step corresponds to the second step of
3rd Step: Representation of company processes
Processes can be represented by flowcharts. Use slide 36 to
explain what a flowchart is and why it is useful.
REPRESENTATION OF COMPANY
The representation of company processes is done by
A flowchart is the map of a process, the graphic
representation of what happens in that process in a logical
The steps of a process are represented by geometrical forms
symbolising different activities, arrows connecting the
symbols and showing the direction of the process.
Aditionally, it can contain inputs, outputs, responsible
A flowchart can be used for
analysing the process to improve its effectiveness and
setting up information database, etc.
Show an example of flowchart: fabrication of tailor made
clothing (file: Flowchart.pdf) and present the symbols used to
represent different activities. The main symbols are presented
on slide 37:
transportation the process
4th Step: Establishing processes and steps with risks
Processes and their steps should be analysed especially from
point of view of risks putting in danger the achievement of
quality requirements. The major risks must be identified and a
list of possible actions to avoid or diminish them drawn. Each
process comporting a major risk has to be documented.
Present the main sources of risk in processes using slide 38.
ESTABLISHING PROCESSES AND
STEPS COMPORTING RISKS
Risks in a process could refer to:
human resources, e.g. lack of personnel, lack of qualification
Raw materials, e.g. law quality, delay in supplies, insufficient
Technical equipment, e.g. machines out of order, lack of spare
pieces, failure and mistakes in maintenance, bottle necks
Organisation, e.g. redundant activities, waiting time, long
transportation routes, long information channels
Management: delay in management decisions, lack of
consistency of decisions taken at different level, too complex
jobs, lack of information at lower levels
50 Exercise Representation of a process
min Form groups of 3-5 participants, depending on the total
number of participants. Each group names a representative.
Each representative chooses a card with a process group for
The group has to think of a process belonging to that process
group, they were assigned, and draw its flowchart naming the
measurement criteria / indicators for each control point. Leave
20 minutes for this activity. Then each representative presents
on a flipchart their flowchart. Discuss the flowcharts and the
possible measurements with the entire group.
20 Presentation Documentation requirements (4.2.)
min Present the different levels and types of documentation
required by ISO 9001 using slide 39.
Information and its supporting medium
Record, specification, procedure, instruction, drawing,
Contents of a QM documentation
Statements on quality policy and quality objectives
Documents for the effective planning, operation and control
The general, minimum level of documentation is presented on
The necessary and minimum level of documentation
A quality policy
A Quality Manual
A minimum of Six Documented Procedures
Documents required by the company for the
effectiveness of the QMS
Quality Records, as required by the ISO 9001
The Quality manual is a basic document presenting the quality
management system of the company and must include:
- The scope of the QMS
- Documented procedures
- Interaction among the processes
All documents and records produced in the QMS must be
controlled using the activities presented on slide 41.
Printed or electronic document
Adapted to the purpose of an organisation
The quality manual states the quality management
system of the organisation
Evidence for meeting all requirements of ISO
There are a number of procedures which must be
documented in all cases. Present these procedures using
1. Control of documents
Approval and updating of documents
Storing and protecting of documents (backup copy, safe deposits,
retention time, etc.)
Control and update of external documents (standards, customer drawings,
2. Control of quality records
3. Internal audit
Conducting internal audits (frequency, areas, etc.)
4. Control of nonconforming products
5. Corrective action
Review of nonconformities
Determining causes of nonconformities
Implementing corrective action
6. Preventive action
Detecting causes for nonconformities
Taking action to avoid nonconformities
Other documents which can be parts of the Quality
Management documentation are presented on slide 43.
Process maps, process models, process descriptions
Work and/or test instructions
Documents containing internal communication
Lists stating approved suppliers
Test and inspection plans
Quality plans (ISO/TC 176/SC2: 4)
The documentation of the quality management requires
keeping certain records concerning the activities and
processes. Present the compulsory records using slide 44.
Records from management reviews
Records with regard to education, training, skills and
Evidence for meeting the product requirements
Design and development (input, review, verification of results,
validation prior to delivery)
Results of supplier evaluation
Demonstration of the validation of processes
Record of the identification of the product
Reports on lost or damaged customer property
Records on calibration and verification of measuring equipment
Results of internal audits
Nature of product nonconformities
Results of corrective action
Results of preventive action
Control of documents and records is an important activity in
the quality management. Both control activities are among the
six processes which must be documented according the ISO
9001:2008. Use slide 45 to present this topic.
CONTROL OF DOCUMENTS
Control of documents is one of Control of records is another
the six required documented required documented procedure
procedures prescribing: and must ensure that records are
The approval of documents maintained in a way that they
The review and updating of remain “legible, readily identifiable
The identification of their
current revision status
The availability of the
documents to all relevant
positions, always in their latest
The legibility and identification
of both internal and external
Management responsibility (5)
Time 90 min
40 Presentation Present the content of the fifth clause using slide 46
min RESPONSIBILITY (5)
The Management Responsibility clause consists of 6
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.5 Responsibility, authority and communication
5.6 Management review
Explain that management commitment means that the
company’s top management must be totally committed to and
involved into the development, implementation and supporting
of the QMS and demonstrate active participation in the
development of the quality policy, quality objectives, carrying
out the management reviews and provision of resources. Use
“Top management shall provide evidence of its commitment to
the development and implementation of the quality
management system and continually improving its
a) communicating to the organisation the importance of meeting
customeras well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.”
Regarding customer focus, top Management must set as
priority to ensure that all customer requirements and
expectations are understood and fulfilled, resulting in
enhanced customer satisfaction. Use slide 48.
“Top management shall ensure that customer
requirements are determined and are met with the
aim of enhancing customer satisfaction.”
Management must have an active and leading role to
The customer requirements
Good customer communication
Good internal communication
Top Management must issue the Quality Policy declaring the
company’s commitment to the continuous improvement of the
QMS, for the benefit of all interested parties (customers,
employees, sub-contactors, the society, etc).
Quality policy represents the “overall intentions and direction
of an organisation related to quality as formally expressed by
top management.” Explain the content of the Quality policy
and the basis for devising it using slide 49.
A Quality Policy needs to satisfy The Quality Policy should take
the following requirements: into consideration two major
It is appropriate to the elements:
purpose of the organisation. The overall strategy of the
It includes a commitment to organisation: e.g. How do you
comply with requirements and position your organisation on
continually improve the the market? Do you aim to
effectiveness of the QMS. high quality and adequate
It provides a framework for
pricing or low quality and low
establishing and reviewing prices?
quality objectives. The expectations of the
It is communicated and
customers: e.g. What your
understood within the customers expect in terms
organisation. of quality? What is your
It is reviewed periodically for
Present an example of Quality Policy using slide 50. Discuss
its content with the group.
QUALITY POLICY EXAMPLE
A hardware provider and service company
The company aims to provide a properly resourced, high
quality, modern, customer focused service appropriate
to the clients’ needs in a timely manner. We take all
possible steps to reduce the risk of error and ensure
that the services we provide are inclusive and
accessible to all our clients. Our company takes an
innovative, proactive approach to the delivery and
installation of a wide range of products and to ensure
that the correct maintenance and client information is
provided at the correct time in the appropriate format.
Quality objectives must be established in order to enable the
organisation to comply with requirements and continually
improve the effectiveness of the quality management system.
They must be consistent with the Quality Policy. Present the
content and aims of quality objectives using slide 51.
Definitions: Quality objectives must achieve
“Something sought, or aimed four things:
for, related to quality.” Enable the organisation to meet
“Top management shall ensure customer requirements.
that quality objectives, Enable the organisation to
including those needed to meet enhance customer satisfaction.
requirements for products, are Enable the organisation to
established at relevant comply with all legal
functions and levels within the requirements applicable to the
organisation. The quality product.
objectives shall be measurable
Continually contribute to the
and consistent with the quality effectiveness of the quality
policy.” management system.
QUALITY OBJECTIVES MUST BE
Planning involves both setting the quality objectives and
planning the QMS. (slide 52). The planning of the QMS must
ensure that both the minimum requirements of the ISO 9001
standard are fulfilled and the quality objectives are met. The
QMS must be planned so as to keep its integrity even when
Establishing quality objectives
Planning the quality management system
Responsibility of the top management
When there are changes to the QMS, their effect on
present procedures and conflicts with the system has to be
taken into account
Example of table to be used in quality planning
Chapter of the Used documents Competence Rev./ Scope
QM Handbook & forms Issue
Setting quality objectives requires team work. It is very
important that all objectives should be measurable. Use slide
53 to explain the process of setting quality objectives.
Involve several persons in setting the quality objectives of your team:
e.g. the Quality Manager, members of the Quality Management Team,
members of your team.
Ask your customers what they expect from you and take that into
account. Customers can be:
Internal: other teams or departments using your product/service.
External: other organisations to whom you sell products/services.
Make sure your objectives are measurable so that you can assess
Set achievable and realistic objectives, stretching but achievable
under the existing circumstances. „Mission impossible” type objectives
Quality objectives are different from financial or productivity
objectives. Generally quality objectives are expressed in terms of
conformity to certain characteristics or requirements, not in terms of
saving money or being more productive.
Present 1-2 examples for quality objectives (slide 54)
EXAMPLES OF QUALITY
Example 1: Example 2:
In order to meet customer needs To enhance Customer
we have established the Satisfaction by 3% through
following quality objectives to strict adherence to Quality
be accomplished by the end of Standards.
year 2010: Increasing productivity by 5%
To improve our ability to deliver through employee training,
product on time by increasing motivation and involvement.
the on-time delivery from 95% To be Market Leader in our
to 98%. Industry by following the motto
To reduce design defects with of "Quality at a Competitive
To reduce manufacturing Adopting safe & environment
defects with 12%. friendly manufacturing systems
and recycling all materials
suitable to recycling.
The responsibilities and authority are defined in the job
descriptions. Top Management must ensure that the
responsibilities and authorities of the personnel have been
clarified and communicated to all job holders. Communication
channels must be established and their hierarchy must be
cleared out. Job description and specification, respectively
organisational charts are among the tools that can be used.
“Top management shall ensure that responsibilities
and authorities are defined and communicated within
Persons responsible for critical activities must know
exactly their work
Assignment contracts, organisational charts, process maps,
Appointment of one management representative to
be in charge of QMS affairs (= representative of
the top management)
Responsibility also covers the appointment of a management
representative as Quality Manager. Explain his/her tasks and
responsibilities using slide 56.
REPRESENTATIVE OF THE
The Quality Manager is Tasks
responsible for: Organisation of internal
Design, implementation and audits
maintenance of processes Report on the performance
required by the QMS. of the management system
Reports to the Management
on the operation of QMS complaints
and its the development Monitoring the effect of
needs. corrective and preventive
Ensures raising and
developing the consciousness
concerning customer Regular member of
requirements among the the management team
Another important issue is the communication within the
company. Communication refers both to guidance and
feedback on the effectiveness of the established QMS. (Slide
Communication refers both to guidance and
feedback on the effectiveness of the
A good internal communication system must
ensure the flow of information vertically up
and down, respectively horizontally between
departments and jobs at the same level.
It is essential that the Top Management is informed on all
elements and activities concerning quality. Formally this is
achieved by the management audit held not less than once a
year. (slide 58)
“Top management shall review Contents
the organisation’s quality Information from the audit
management system, at planned results
intervals, to ensure its Corrective and preventive
continuing suitability, adequacy actions
and effectiveness. This review Customer complaints
shall include assessing Process capabilities and product
opportunities for improvement conformance
and the need for changes to the Improvement activities
quality management system,
including the quality policy and
Consequence update of the
Review is usually done once per
ISO 9001:2008 requires a
year documented record of the
Present the outputs and inputs of a management review using
REVIEW INPUT AND OUTPUT
Reviewed data are: Management reviews come out
Audit data with decisions concerning:
Customer data Improvements on the total
Process and product data QMS
Preventive – corrective Improvements on the
actions data product
Data concerning follow-up Resources
actions from past reviews
Data concerning changes
related to the QMS
Data from improvement
50 Exercise Quality policy, objectives and indicators / measurements
min Form 3 groups of participants representing 3 three different
SME-s. Each group can choose their own field of activity and
description of the company (profile, target group, markets they
operate in, products/services, number of employees, strategic
goals). After defining their own company, each group
develops the quality policy and establishes 5 quality
objectives, explaining also the methods they will use to
measure the achievement of these objectives. Leave the
groups 20 minutes for this activity. Then each group presents
to the participants their company, quality policy and
objectives. (5 minutes/ each presentation). Discuss the quality
policy and objectives presented with the entire group.
Resource management (6)
Time 110 min
50 Presentation The main resources needed for the activities can be grouped
min in human resources, infrastructure and work environment. The
company has to define the resources needed from each
group. (slide 60)
RESOURCE MANAGEMENT (6)
Identification of resources needed to support and
improve the quality system processes, and to achieve
Main resource management processes concern:
Job holders must fit the requirements of the jobs regarding
competences, knowledge and experience. This is especially
important in jobs with considerable influence on complying
with the quality requirements of the products.
The selection, as well as the training must ensure achieving
these competence requirements.
The basic tools for achieving these are the job descriptions
and job specification (requirements) as well as the
performance reviews and personal development plans
Present the documentation requirements using slide 61.
Definition of jobs: tasks, responsibilities and accountabilities,
communication needs, organisational relations
Definition of minimal competence requirements with regard to
education, training, skills and experience
Trainings in the case of competence gaps
Job descriptions and specifications
Records with regard to education, training, skills and experience
Performance review forms, personal development plan
Curriculum vitae, certificates, attendance lists from trainings,
course materials, etc.
Present the content and importance of job descriptions and
“The job description presents the content of the job, its place
in the organisation, its main tasks and duties, accountabilities
and responsibilities and other specific features of it. It makes
the job clear to the employee and the manager.”
“The job specification concerns the person who can hold a
certain job. It answers to the question what kind of
qualifications, experience, skills, personal characteristics, etc.
are needed to do the job.”
The company must define the required competencies for each
job with significant influence on complying with the quality
requirements of the products. Where possible, in order to
achieve required competency levels, training must be
provided. This is ensured devising a Personal Development
Plan for each employee. Present the process of elaborating
job descriptions and specifications using slide 62.
THE PROCESS OF PREPARING
Defining the Document job analysis
content of job analysis sheet
Determining key Using critical
Filling in job
Step 1. Definition of the structure of job descriptions.
The manager and his team decide together on the structure
and general content of job descriptions. They should take into
account the nature of their activity and the HR strategy.
Present the most important elements of a job description
using slide 63.
DEFINING THE CONTENT OF
Aim of the job
Location of the job
Position in the hierarchy
Responsibilities and accountabilities
Communication and cooperation (internal and
Challenges and motivation factors
Key performance areas
Step 2: Document analysis
The manager or the person performing job analysis (e.g. HR
manager or specialist) gathers all available documentation
about the work processes to have a more objective general
view of the needs for performing certain tasks. Present the list
of document which could be used in document analysis using
DOCUMENTS USED IN
work flow charts
organisational strategy and goals
descriptions of training programmes attended by the
project proposals prepared for clients
project meeting minutes
training evaluations provided by the client
Step 3: Elaboration of the Job Analysis Sheet
Based on the information gathered the manager and his/her
team devise a job analysis sheet to help them gathering the
same type of information in a systematic way for all the jobs of
the organisation. Present the possible content of a job
analysis sheet using slide 65.
ELEMENTS OF THE JOB
Elements defining the job: title, place in the organisation
(organisational chart), immediate superior, job titles directly
responsible to it, location.
A definition of the overall purpose of the job.
A list of the main tasks and duties that the job holder carries out.
Accountabilities and responsibilities
Relationships within the work team, within the organisation and outside
Physical and mental load arising from work environment, from the work
itself and from dealing with people.
Key performance areas (quantitative and qualitative indicators)
Motivational factors: challenges, novelty of work, variety of tasks,
human relations, work climate, development opportunities.
Special equipment and tools used.
Special circumstances: travelling, the likelihood of being transferred
to another location, unsocial hours, unpleasant and dangerous working
Knowledge, qualifications, experience, skills, abilities.
Step 4: Conducting Job Analysis Interviews
Job analysis interviews are conducted by the manager or the
HR specialist, if the company has one. Their aim is to gather
information on each job. Interviews are conducted at least
with 2 persons connected to the job: the job holder and the
direct manager/supervisor of the job. Additional interviews can
be conducted with other persons connected to the job, like
colleagues with whom the collaboration is frequent, service
providers, clients, etc. depending on the content of the job.
In case of several people holding the same job, group
interviews can be conducted. This is also a good opportunity
to check information and to eliminate contradiction. The
interviewer lets the participant to discuss for a while their
answers to each question. It is very important that the
interviewer never looses control and does not let arguments
go on too long.
Step 5: Filling in Job Analysis Sheets
Based on the information collected during the previous steps,
the person who performs the job analysis fills in a job analysis
sheet for each job. Show an example of job analysis sheet for
a trainer position. (Job analysis sheet template.doc)
Step 6: Using Critical Incident Technique
Allows gathering information on the critical elements of each
job, and on this basis determining the key competencies. The
person who conducts the analysis asks job holders to
describe and analyse critical incidents, events that have
occurred during work and were extremely challenging,
respectively led to excellent results, in order to get an insight
into particular processes or events which can reveal the most
difficult parts of the job or key elements of the high
performance. Use slide 66 to present the most used questions
for discovering critical elements of the job.
QUESTIONS FOR ANALYSING
What event was the most important in achieving the
goal / in preventing you from achieving the goal?
In what conditions did this event occur?
How did you act?
How did you feel?
How did the other persons involved feel?
What competencies did you employ?
What was the result?
Present an example of a critical incident (slide 67) and explain
the elements of its description.
EXAMPLE OF CRITICAL
1. Description of the event:
A participant asks a question concerning a topic not included in the
2. Presentation of the background and circumstances:
The group was solving a case study. They prepared a very unexpected
solution which raised questions connected to another functional process
and field of activity.
3. The moment when it occurred:
The question was raised after the presentation of the solution to the
case study by the second working group having a very unorthodox
4. What the person actually did
The person made a short comment but avoided to enter into details on
this matter as it was not in the scope of the training. As a result the
participant asking the question was unsatisfied for not receiving a
Explain that in a similar situation other trainer can react
differently, for example answering the question in detail. This
could satisfy of the person asking the question but would bore
other participants if they are not particularly interested in the
topic. This shows that in case of a trainer it is critical to
possess the skills to satisfy at a time different expectations
and to keep a balance between satisfying them.
Step 7: Observation
This is a simple technique for job analysis, but highly time-
consuming. It is task orientated, thus very appropriate for
manual and repetitive tasks, but also for jobs where behaviour
is very important. It involves completing a time-sampling
checklist. Everything the job holder is carrying out (if it is
orientated towards tasks) or his/her behaviour in the activities
and situations occurred (if it is orientated towards behaviour)
must be recorded. This technique can be used for gathering
information, but also for checking the coverage of reality of job
descriptions for the newly created jobs.
Step 8: Determining critical competencies
Critical or key competencies are those skills, abilities,
personal characteristics which determine the performance in
that task. For each task key competencies can be established
based on the job analysis sheet and with participative
application of critical incident technique. The work team
guided by the manager or the analyst tries to reveal the most
difficult areas of the interconnected jobs and the key
competencies necessary to carry out these tasks at the
required performance level.
Using the previous example of the critical incident, ask the
group to establish 1 or 2 critical competencies for the trainer.
Step 9: Preparation of job descriptions and
Show and explain briefly the examples of job description and
specification for the trainer position. (Use the documents: “job
description senior trainer.doc” and “job specification senior
50 Exercise Preparation of job description and specification
min Ask participants to work in pairs. Each participant receives a
blank job analysis sheet, a job description form and a job
One of the participants is the manager who has to prepare the
job description and specification. Using the job analysis form
the “manager” asks questions concerning the other person’s
job and completes the job analysis form. They also have to
discuss two critical incidents relevant to the job. On this basis
they prepare together the job description and specification.
Leave for the preparation 25 minutes. Then each group hands
over the documents to the group next to them. The task is
now to analyse the job description and specification and make
comments on the strengths and weaknesses of the job
description and specification. Give them in advance some
examples: clear, concise, easy to understand, using action
verbs in formulating tasks, etc.) The time available for this
task is 10 minutes.
Write the positive and negative elements the participants
found in the job descriptions and specifications on two
different flipchart papers, and discuss them with the group.
10 Presentation Infrastructure
The second main resource is infrastructure including facilities,
equipment, transportation, communication and information
systems. Use slide 68 to present the main tasks concerning
“System of facilities, equipment and services needed
for the operation of an organisation”
Workspace including associated utilities
Supporting services such as transport, communication
Determining the need for facilities
Providing and maintaining the required facilities
Performance on two levels
As a part of the top management’s consideration
On an individual contract basis
Work environment includes the conditions under which work
is performed. Physical, environmental and other factors must
be taken into consideration.
E.g.: level of noise, humidity, temperature, lighting, weather.
All necessary infrastructures, including establishments,
hardware, software and supporting services must be
determined, provided and controlled, in order for the company
to be able to fulfil requirements. (slide 69)
“Set of conditions under which work is performed”
Physical, social, psychological and environmental
Product Realisation (7)
Time 120 min
Resources In addition to the resources presented at the beginning of the
3rd part, you need two flipchart papers on which you have
written questions to be answered when choosing a supplier,
respectively criteria to evaluate suppliers.
10 Presentation The Product realisation clause concerns all activities and
processes aimed to obtain the product or deliver the service at
the expected quality level. Present the content of this clause
using slide 70.
PRODUCT REALISATION (7)
Planning of product realisation
Customer related processes
Design and development
Production and service provision
Control of monitoring and measuring devices
Planning of product realisation means that the organisation
should plan and develop processes for the realisation of the
product. Use slide 71 to present the main planning activities.
PLANNING OF PRODUCT
During this process the followings must be
defined, if they are relevant for the processes:
• Quality objectives and requirements concerning
• Needs for process design
• Needs for document design
• Verification, validation, monitoring, control,
analysis and measurement activities concerning
• Records required to prove the conformity of the
processes and products
Customer related processes refer to determining requirements
stated or not stated by the customer, statutory and regulatory
requirements and additional requirements determined by the
organisation using methods and techniques presented in slide
The organisation shall determine:
1. requirements specified by the customer, including the
requirements for delivery and post-delivery activities
Depth analysis of customer satisfaction questionnaires
Participation in joint development projects with customers
2. requirements not stated by the customer but necessary for
specified or intended use, where known
Regulatory rules and standards
3. statutory and regulatory requirements related to the product
Statutory and regulatory requirements during design,
manufacture, delivery and servicing
4. any additional requirements determined by the organisation.
Expectations that are hidden and not mentioned by the customer
Idea of the organisation of what the customer appreciates
It is necessary to review the requirements related to the
product before the product is delivered and to provide correct
information to the customers, respectively effective handling
of enquiries, orders, customer complaints, and other
15 Exercise Post-delivery activities
min Ask participants to give examples from their own field of
activity for post-delivery activities. Write them on a flipchart
paper as they are told. Then make 3 columns on a blank
flipchart paper and on the top of each column write a post-
delivery activity type:
• Activities in the guaranty period
• Contractual obligations
• Supplementary services
Ask participants to group the examples they have given.
Discuss the nature and importance of these activities.
45 Presentation “With regard to design and development planning, the
min organisation shall determine
- the design and development stages,
- the review, verification and validation that are appropriate to
each design and development stage, and
- the responsibilities and authorities for design and
Use slide 73 to present the records required for this process.
DESIGN AND DEVELOPMENT
The following records are required by the standard
Records on inputs with regard to product requirements
e.g. a technical drawing
Records on the design and development review
e.g. authorised signature on a drawing
Records on the verification
e.g. authorised signature on a drawing
Records on the validation
Records on changes in design and development
e.g. authorised signature on a drawing
Present the inputs and outputs of the design and development
planning process using slide 74.
DESIGN AND DEVELOPMENT
INPUTS AND OUTPUTS
Inputs required include Outputs resulting from the process must be in
technical requirements, a form that allows the certification based
regulatory requirements, on comparison with the inputs. The outputs
data from similar designs of the design and development processes
must be approved before they are further
If the product is custom-
These outputs have to:
made, inputs must be
• satisfy the input requirements of the
collected by the customer.
design and development,
But even in any other case,
• provide suitable information for purchasing,
a market research may production and service processes,
provide very useful inputs.
• specify acceptance criteria of the product
• define the characteristics for the safe and
proper use of the product.
Ask examples for inputs and outputs.
Input examples: market analysis data, customer
expectations, laboratory equipment
Output examples: Features of raw materials to produce the
product, safety criteria for using the product, equipment
needed to produce the product.
To ensure the quality of design and development planning
several activities must be carried out (slide 75).
ENSURING THE QUALITY OF
DESIGN AND DEVELOPMENT
DESIGN AND DEVELOPMENT REVIEW
At planned intervals the design and development process and its outputs
must me reviewed, in order to evaluate whether the process tends to meet
requirements or corrective actions and amendments are necessary.
DESIGN AND DEVELOPMENT VERIFICATION
Verification is the process step that intends to control whether the design
and development outputs meet the relevant output requirements.
DESIGN AND DEVELOPMENT VALIDATION
Validation is the process step that intends to control whether the resulting
product meets the intended use requirements, according to the initial
If applicable, validation should be performed before massive or final
production (a sample could be validated) or before delivery to the customer
(validation could be performed by the customer).
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Any changes implemented during the process must be controlled and
recorded (who, when, what, why?).
Control means that changes must be approved and validated before their
Another process of the product realisation is purchasing. The
organisation has to ensure that the purchased products
conform to specified purchase requirements. The type and
extent of the control applied to the supplier and the purchased
products shall be dependent based on the effect of the
product on subsequent product realisation or the final product.
The control will be different if the purchased product is critical
or not the processes and products. Present examples using
If the purchased products are not critical to the
quality of the final product
Checking quantities and possible transit damages
If the purchased products are critical to the quality
of the final product
Inspection of the items at supplier’s premises prior to
Monitoring customer satisfaction
Providing a full specification of the process parameters to
A very important activity for ensuring the quality of purchased
products is the evaluation of the suppliers. Present the
suppliers’ evaluation using slide 77.
APPROVAL OF SUPPLIERS
Suppliers must be evaluated and selected
Existence of selection and evaluation criteria
Supplier’s performance in the past
Existence of a certified quality management system
Reviewing the records of performance history
Visiting the supplier’s premises
Evaluating product samples
Conducting a survey (questionnaire with some critical points)
Records on evaluation results
Production and service provision must be planned and
carried out under controlled conditions, with focus lying on
prevention of nonconformities, production under controlled
conditions, availability of adequate product information and
suitable equipment, preventive maintenance and methods and
procedures for the product release. (slide 78)
Controlled conditions for planning and carrying out
the production and service provision:
Focus lies on the prevention of nonconformities
Production under controlled conditions
Adequate product information available
Methods and procedures for the product release
If there are special processes where the results cannot be
verified by means of monitoring and measuring and where
deficiencies can be revealed only after the product is in use or
the service has been delivered, it has to be proved that these
processes are controlled and the personnel are qualified. E.g.
food preparation or air traffic control services.
Identification and traceability of products means that the
organisation shall identify, where appropriate, the product by
suitable means throughout product realization. The product
must be identified in all phases of production, as well as the
condition of the product from point of view of monitoring and
measurement requirements. If the traceability is a
requirement, then it must be kept under control and the
identification must be recorded. The means for identification
and traceability are presented on slide 79.
TRACEABILITY OF PRODUCTS
“The organisation shall identify, where appropriate,
the product by suitable means throughout product
Marking and labelling
Connection to a particular batch, work order, raw material,
and any other source of origin
Controlling and recording the unique identification of the
product (if required by the customer)
In case that the company maintains any customer property
to use it for the production of the requested product, that must
be handled respectively and must be recorded. This might
also include intellectual property and personal data.
The company has to identify, verify and protect the customer’s
property. Any deterioration must be reported to the customer
and documented. (slide 80)
“The organisation shall identify, verify and protect
customer property provided for use or incorporation
into the product.”
Material and components
In case of damage report to customer and record
Control of monitoring and measuring devices concerns
the fact that the company should, when necessary, measure
the product and monitor process performance with applicable
devices in order to be convinced that the product will meet all
These devices must be verified that they function normally,
with the required accuracy, they must be calibrated or
validated, or both, if it is the case.
In case of software verification and configuration is the
guarantee that they are suitable to be used according to their
purpose. (slide 81)
CONTROL OF MONITORING
AND MEASURING DEVICES
Measuring instrument, software, measurement standard,
reference material or auxiliary apparatus or combination
thereof necessary to realise a measurement process
Calibration of measuring equipment (or otherwise
Measurement standards, traceable to international or
national measurement standards
Records of calibration and verification results
List of devices to be calibrated at certain time intervals
50 Exercise Split the participants into 2 groups. One group will work on
min establishing the criteria for choosing a supplier, the other on
establishing the criteria for evaluating the suppliers of a
They should establish the criteria for selection or evaluation
and the factors they take into account, respectively the
methods and indicators for measurement when it is the case.
E.g. An important criterion in both cases would be the product
delivery measured by the quantity delivered at a time for
selection, respectively by the delays in delivery for evaluation.
Each group presents the results on a flipchart paper. Discuss
with the group the results.
To help the participants, present the two flipchart papers with
the questions and criteria concerning supplier selection and
evaluation. Discuss briefly each element.
a.) Questions to be answered when selecting suppliers:
- Do they have the ability to do the work?
Ask for details of similar jobs they have done in the past
and get in contact with past customers to see of they did a
good job. Request a tour of their facilities to see if they
appear organised. Ask them for evidence of their ability to
deliver the quantities you require.
- Do they have a Quality Management System?
Ask for evidence of a QMS in action. You may choose to
deal only with suppliers certified under ISO 9001, for
- Do they understand what you want?
Make sure they have seen and understood the
specification. It is often a good sign if a supplier explains
to you their understanding of the terms of the
- Are they easy to deal with?
You can get an idea of this through your initial contacts
with them. Do they return your calls promptly? Do they
seem organised? Do you like the attitude of their staff?
These questions will all be very important in the context of
a long-term commercial relationship.
- Are they financially stable?
Are they well established or might they go bust before
delivering? Depending on the country in question, you can
request copies of financial accounts, or you can read
documents like annual reports.
- Is their price competitive?
How are their prices in comparison to the prices of other
similar or substitute products on the market?
b.) Criteria that might be used to evaluate suppliers:
• Quality of the product or service
- Has it met consistently with the specification?
- What was the percentage of faulty products?
- Has it caused other incidents or problems in the
production or service provision process?
- Have the specified delivery times and modalities been
- Percentage of delayed deliveries
- Average length of delay
• Flexibility of the supplier
- Has the supplier been able to adjust to urgent, large-
• Reliability of Information
- Is the information that the supplier provides you always
- Is the supplier’s price competitive?
- Have market conditions changed and has the supplier
- Changes in prices during the last year
Measurement, analysis and improvement (8)
Time 60 min
30 Presentation The company has the responsibility to establish a system for
min monitoring, measuring, analyzing and improving processes.
Measurement, analysis and improvement chapter of the
standard covers 4 main topics (slide 82)
AND IMPROVEMENT (8)
Covers four main chapters:
1. Monitoring and measurement
2. Control of nonconforming products
3. Analysis of data
4. Continuous improvement
For monitoring and measurement purposes information has to
be collected on customer satisfaction, internal audit,
performance of processes and products. (slide 83)
Information has to be collected on
Conformity of the product and the quality
Continuous improvement of the effectiveness of the
quality management system
The organisation must collect information concerning the
clients’ satisfaction using a variety of methods. Present the
methods and the sources of information on customers’ opinion
using slide 84
The company must set a mechanism to obtain, process and
analyse customer satisfaction level. The data must be used in
order to take decisions for potential modifications on the
company’s QMS. The methods of gathering and using these
information must be defined.
Methods for obtaining information:
Collecting information on customer satisfaction and dissatisfaction
(customer satisfaction questionnaires)
Visits to customers’ premises
Communication with the customer
Information may result from the following sources:
Customer satisfaction surveys
Customer information concerning the delivered goods
Analysis of lost businesses
Customer opinion surveys
Internal audit is one of the six documented procedures,
required by the standard. It must be planned and implemented
periodically, in order to check if the established QMS is well
implemented according to the initial arrangements and the
ISO 9001 standard’s requirements and if it is effective. (slide
“The organisation shall conduct internal audits at
Internal audit systematic evaluation within the
Employing the principles of the standard’s requirements
Processes according to the standard and one’s own
Time interval: at least once in twelve months
The organisation must devise an audit programme. Auditors
must be trained in auditing and they must be independent
from the audited field or activities. Present the main rules for
carrying out an internal audit using slide 86.
CARRYING OUT AN
Planning an audit program
What activities and areas to be audited in what kind of time
Considering the results of previous audits
At least two auditors in the organisation
Auditor cannot audit his/her own work
Documented procedure for internal audits
Defines scope, frequency and methods of audits to be
carried out and the records to be generated
An organisation is a set of interrelated processes that must be
monitored and measured, so as to be able to set targets for
each process and measure performance and improvement. In
establishing the methods for monitoring and measurement
of processes, suitable methods must be considered
according to the nature of each process so that the process
influences positively the observation of the requirements
concerning the products and the quality management system.
MEASUREMENT OF PROCESSES
“The organisation shall apply suitable methods for
monitoring and, where applicable, measurement of
the quality management system process.”
“The organisation shall monitor and measure the
characteristics of the product to verify that product
requirements have been met.”
Examples of records indicating acceptance criteria and
authorised persons: work orders or records in the operation
Monitoring and measurement of the product’s
characteristics is done in order to satisfy the requirements
regarding the product. Quality controls of the product must be
planned and documented. The records have to name the
person(s) responsible for transmitting the product or releasing
it to the customer.
In case that a nonconforming product is identified, the
company must take all the necessary measures to eliminate
the detected problem. Moreover, if the product is to be
released or reworked, that must be under concession of the
company or the customer. Control of nonconforming
product is one of the required documented procedures.
When applicable, companies should choose one or more
measures to deal with non-conforming products. (Slide 88)
“The organisation shall ensure that a product which does not
conform to product requirements is identified and controlled
to prevent its unintended use or delivery...”
Measures to be taken in case of non-conforming products:
Measure to eliminate non-conformities
Approval for use, transmission or acceptance by the department
having the authority for this, based on a deviation permit.
Measure for excluding the planned use of the product.
The handling of non-conforming products must be recorded.
Analysis of collected data allows evaluation of the
effectiveness of QMS. The data are related to:
- Customer satisfaction
- The product
- The processes
- The suppliers
The organisation shall continually improve the effectiveness
of the quality management system through the use of the
quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management
review. The improvements carried out may have 3 forms:
continuous improvement, corrective actions and preventive
The tools of continuous improvement are presented on
1. Quality policy and quality objectives steer the organisation
towards the targets
2. Audits, to find out whether processes perform according to
the principles of the standard and the targets set by the
3. Analysis of data to have a real picture on the present situation
and on the trends.
4. Corrective and preventive actions are tools that guide the
improvements. Their aim is the elimination of the cause of the
problem and not of the symptoms.
Corrective actions are the tool to take immediate action for
an occurring problem and to prevent any potential future
similar problem. It is among the six required documented
procedure of the standard. Corrective actions should
correspond to the effects of the non-conformities. Not only
corrective actions must be verified, but also their
Preventive actions are the measures taken to eliminate the
occurrence of a potential problem, meaning a problem that is
more or less likely to occur. It is the last of the six required
documented procedures of the standard.
Use slide 90 to present the corrective and preventive actions.
Preventive actions Corrective actions
Try to eliminate the underlying The problem has already appeared and
cause of the problem before the the actions are taken to prevent its
problem occures recurrence in the future
Documented procedure for both corrective and preventive
review of nonconformities (not concerning preventive actions);
determination of the causes of nonconformities;
evaluation of the need for action to prevent occurrence /
recurrence of nonconformities;
determination and implementation of needed actions;
record of the results of the actions taken;
review of the corrective or preventive actions taken.
Present the steps of a preventive action using slide 91.
STEPS OF A PREVENTIVE
The procedure must establish requirements
concerning the followings:
Analysis of potential non-conformities and their
Assessment of the necessity of preventive actions to
avoid occurrence of non-conformities
Establishment and implementation of necessary
activities and recording of their results
Verification of preventive actions
30 Exercise Ask the participants to form groups of 3-4 persons and put
min forward suggestions for 2 examples of corrective, respectively
of preventive actions. Leave them 10 minutes to think.
Write the suggestions on a flipchart paper, separately for
preventive and corrective actions. Discuss each action. Ask
the participants what preventive actions could reduce the
need for the corrective actions given as examples.
4. Implementation of QMS
Time 40 min
Resources Ensure you have each of the following:
Flipchart and marker pens;
Projector and screen;
Paper and pens for the participants
Handouts containing slides 92-120
STEPS TO IMPLEMENT
The implementation of a QMS is preceded by discussion
within the organisation and a communication process at all
levels. Present the functions involved in this process and their
roles using slide 93.
DECISION TO IMPLEMENT A
Discussions in the organisation are necessary
Managing director: takes the decision from a strategic
point of view
Quality manager: is in charge of QMS details (necessary
resources, costs, etc.)
Marketing manager: Experience from day to day business
Technician: Experience from day to day business
External training for the quality manager?!
Information for all employees
Present the phases of the implementation of a QMS using
slide 94. Use the links from the title of each phase to go
directly to the slide describing that phase.
1 Top Management Decision
2 External Consultant
3 First Section Plan
4 First Self Assessment
5 Implementation Plan
6 Quality Manual
7 Design and Cheek Up Processes
9 Internal Audit
10 External Audit
11 Continuous Improvement 94
1. Top management must take the decision of implementing
a QMS system in the organisation (slide 95)
1. TOP MANAGEMENT
Top management decision to implement a QMS
derives from the general manager. A preliminary
meeting of the general manager, the quality manager,
the marketing sales manager and the technical
manager is necessary.
The general manager has to assign a management
representative for the QMS implementation (usually
the quality manager)
2. QMS implementation could vary from a totally home made
system to a complete outsourcing of all implementation
activities. Using external consultants presents the
advantage of bringing into the organisation specialised
knowledge and experience in the implementation of quality
management systems. (slide 96)
2. EXTERNAL CONSULTANTS
The advantage is a far-reaching implementation
The top management decision in this topic
Level of internal knowledge of how a QMS is
implemented and how it is operated.
Available internal human recourses.
3. Elaboration of the first section plan aims the plan the
phases of the implementation process (slide 97)
3. FIRST SECTION PLAN
QMS implementation is a long process so it could be divided
into the following phases:
Start up phase: collection of information about QMS, decision
making process, training on QM, support of consultants,
Assessment phase: identification of actual strengths and
System building phase: management handbook, creation of
documents, identification and description of key processes and
quality relevant issues.
Training phase: training of staff in all areas of the
Auditing phase: first review of the system (internal audit) and
Auditing phase: external certification audit.
4. The first self assessment aims to figure out which is the
company’s actual level of QMS maturity and how different
relevant activities and processes are performed. (slide 98)
4. FIRST SELF-ASSESSMENT
Actual level of QMS maturity
Areas of highest potentials
Requirements for the company
Formalisation of the way things are done
Demonstrating assurance that things are done in the
Monitoring the effectiveness of what is done
Useful tools for the self assessment are, cheek lists, strength
weakness analysis and forced field analysis. (slide 99)
TOOLS FOR SELF-
Questions on every single ISO element
Easily to be found in ISO literature
Areas of high ISO maturity are highlighted against areas of
extremely low maturity in a kind of balance sheet
Force field analysis
Takes into consideration human aspects and the
organisational change process
Present an example of each tool using slides 100-102
EXAMPLE OF CHECK LIST ANALYSIS
Level of Maturity
Chapter 5: INPUT OUTPUT
Management Question: Yes No Remarks
Definition of ISO Elements weak average strong
responsibility ISO elements in
columns. strengths and
Assessment of weaknesses.
maturity levels Continual Definition of
5.1.1 Does a quality policy exist? X
of the elements. improvement
Identification of Supplier
critical elements Development
Do management reviews exist There is no systematic (low level).
5.1.2 and do they include all essential X customer satisfaction
aspects? analysis. ---
5.1.3 .... ? X
OF FORCE FIELD ANALYSIS
INPUT Which forces are effecting the goal? OUTPUT
The goal has to Visualisation of
be defined (e.g.
efficient project forces.
implementation Determination of
Identification of activities.
constraining Reinforcing Constraining
forces aspects aspects
5. A detailed implementation plan includes the system
building phase, the training phase, the improvement phase
and the audit phase of the implementation. The plan sets the
milestones of each phase and defines the project
organisations. Using slide 103 present an example of an
5. IMPLEMENTATION PLAN -
Phase 1 Phase 2 Phase 3
Self assessment System building Improvement
Start: 10/03 01/04
09/03 First self System draft
Data analysis Generating the QM handbook
◗ What has to be done?
Strengths - weaknesses Identification of processes ◗ Until when should it
Force field Analysis Definition of documentation be done?
... Design of records ◗ Who should do it?
Management commitment and ◗ With what resources?
6. The Quality Manual generally describes how the QMS is
operated and could be divided in the following chapters as the
ISO 9001 paragraphs. Use slide 104 to present the content of
the Quality Manual.
6. DEVELOPMENT OF A QM
Structure of the documentation
Usually following the original structure of DIN ISO
Quality management system
Remedial requirements - measurement, analysis and
The quality documentation has a hierarchical structure. This is
presented on slide 105.
Q-Policy and Objectives
Work Instructions, Forms
7. In the design and check-up phase organisational
processes must be analysed and interaction between them
has to be defined. Use slide 106 to present the elements of a
process, respectively its flowchart.
7. DESIGN AND CHECK-UP
Process logical and sequential flow of activities
that are repeatable and fulfil the following criteria:
Clear starting point and end (process boarders)
Well defined input factors (material, information, human
resources, etc.) and a clear output (result)
Suppliers and customers
Methods of control
Necessary information (documents)
Processes can be classified in 3 categories. (slide 107)
Three types of processes can be distinguished
Core or key processes
Value adding processes
Defined by a certain customer need
E.g. maintenance process
Planning, steering and development activities
E.g. strategic planning or controlling
Besides the flowchart, SIPOC is another method of
representing processes. (slide 108)
INPUT OUTPUT S = Supplier
Name the process Consistent
understanding of the
I = Input
Define start and end
process P = Process
Specify the output and
the customers of the Clear boundary of the O = Output
C = Customer
Identify the necessary
input factors Start End
Name the supplier of
Supplier Process Customer
8. Training for QMS implementation can be divided in 4
categories as presented on slide 109.
Overview of the ISO standard, the requirements and
consequences for the upper and middle management
Introduction to QMS for all employees
Information on certain procedures and work instructions
Work instruction training
Training of employees with regard to the documentation
describing their tasks
9. Internal audits are performed at planed intervals and
concentrate on controlling conformity to the ISO 9001
requirements, respectively the effective implementation and
maintenance of the QMS. It has 3 steps as presented on slide
9. INTERNAL AUDIT
Conducted in planned intervals
Proving conformity with the planned arrangements, with the
requirements of the international standard and with - one’s
own - quality management system requirements
Proving the effective implementation and maintenance of
Three major steps
Prearrangement, information and scheduling
Controlling the QMS documents
Internal audit (introduction, analysing and testing, variation
description, final report, and documentation)
The behaviour of the internal auditor is a key element of the
success and it has to comply with a set of rules as presented
on slide 111.
BEHAVIOUR OF AN
Act target oriented.
Determine employee motivation.
Define the minimum standards of acceptance.
Consider benefit and work relationship.
Count only facts and no assumptions.
If you find a nonconformity, do not criticise, look for the
reasons, record all details, try to assess whether the
nonconformity is a single case or whether it is "normality".
Understand yourself as a partner of the auditees.
Communicate honestly (explanations, open ended questions,
An audit report has the content presented on slide 112.
CONTENT OF THE AUDIT
Scope and target of the audit
Date and signature of the auditor
Members of the audit team
Referring documents (ISO 9001:2008, QMS
Assessment of ISO standard conformity
Capability of the QMS to achieve the defined quality
10. External audit is performed by a certification body.
Present its steps using slide 113.
10. EXTERNAL AUDIT
External auditing is done by a certification body
and could be divided into the following phases:
Internal meeting of the external auditor with the
top management in the company.
Pre-audit (making documentation for auditing)
Surveillance audit for visits.
The most important element of this step is the certification
process. Present the content, the criteria and the steps of this
process using slides 114-116.
THE CERTIFICATION AUDIT CERTIFICATION BODY
Size of the company determines the number of audit Criteria for choosing a certification institute
days and the number of auditors
Procedure Official approval of the certification body (national
Tour through the facilities and observing ongoing operations accreditation body)
Interviewing the employees The cheapest certification body could prove to be the most
Reviewing the documentation and evaluating the quality- expensive one if its audit does not comply with the standard
related records or if its certification is not recognised by the customers of
Closing meeting (reviewing the identified problems)
Auditors with experience in the business sector of the
Defining necessary follow-up actions for nonconformities organisation
identified during the audit
Time table of the certification phase
Kind of cooperation
Information of management and employees with regard to
Effectiveness of the system and the implementation
11. Continuous improvement is a cornerstone of the ISO
9001 and can be subdivided into the following levels:
• Top management improvement
• Process owner improvement
• Employee improvement
ISO 9001 demands permanent activities for the continuous
improvement. (Slide 117)
Three main levels
Top management improvement (instrument: management
Process owner improvement (instrument: the use of process-
oriented performance indicators)
Employee improvement (continual improvement process such
as proposal systems or quality circles)
The quality management process is based on 8 management
principles presented on slide 118.
QM Process According S H
U E F U Process – Resources
to the 8 Management
P N I M - Conditions
P V S A N A 2-3
I A R A
I R K N
E O C R
N T T E management
M Y I S 1-8
R E N O Commitment
N R G
1 Customer focus L
T E Ability of 1-8
I S managers,
3 Involvement of the people N
4 Process approach
5 System approach with regard 5
6 Continual improvement
7 Factual approach with regard
to decision making
8 Supplier approach based on MANAGEMENT MANAGEMENT
mutual benefit 6 7
CONTINUOUS IMPROVEMENT USING FACTS
systems, processes, resources information, data, knowledge 118
Present the most important management activities linked to
these principles using slide 119.
LINKED TO THE PRINCIPLES
Ensuring credible information
Setting annual quality objectives
Concluding clear contracts with regard to products
Controlling one’s own activity (processes)
Meeting customer requirements increasing
Program for continuous improvement
To apply these principles in practice, certain pre-requisites are
needed in the organisation (slide 120).
PRE-REQUISITES FOR APPLYING
THE MANAGEMENT PRINCIPLES
The pre-requisite of all management activities and
applying the management principles are:
having a sound mission and vision
established strategic goals
developed strategy for achieving goals.