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1. 15.10.2003 Version 10.0
The High Performance Organisation LtdISO9001:2000 Foundation Workshop
1
ISO9001:2000
Foundation Workshop
Welcome

2. 15.10.2003 Version 10.0
The High Performance Organisation LtdISO9001:2000 Foundation Workshop
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Objectives of the day
The objectives are to:
•introduce the concepts of Standardisation
•introduce ‘system thinking’
•review ISO9001:2000 as a management tool
•identify the requirements of ISO9001:2000
•selling the benefits of ISO9001:2000
•create an implementation plan.

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Session 1
Standards
‘the big picture’
Learning points:
•To understand how a standard is created
•To understand the history of quality standards
•To understand that process based systems are the start point.

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Standards
•Background
–Standards & measurement
–Standardising the standards
–Standards for industries
•The future
–Standards for continuous improvement and
change.

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How are standards created?
Country
Standards
Body
Industry
requirements
International
Standards
Body
Produce
Standards
Implemented by
industry

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How are they implemented?
Standards are implemented by:
•Identify the correct standard based on your
organisations needs
•Understanding what is required
•Understanding how to implement
•Carry out a gap analysis against your current
management system
•Carry out improvement activity to address any gaps
•Apply and maintain registration.
‘ISO9001:2000 is about your management
system’

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History of quality
management systems
BS5750 – Quality Control
ISO9000:1994 – Quality Assurance
ISO9001:2000 – Quality Management
??

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The rationale for
management systems
The quality management system approach
encourages:
–Analysis of customer requirements
–Defining processes that meet these requirements
–The control and management of these processes
–Provision of a framework for continuous
improvement
–Confidence in the products and services being
offered

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The big picture
‘setting off in the right direction is critical’
ISO 9001:2000
Systems & process
thinking
Management systems development
Management skills development
Learn
ing
an
d
ch
an
g
e
Corporate Social
Responsibility /
Corporate Governance
Based on

10. 15.10.2003 Version 10.0
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Session 2
Systems thinking
Learning points:
•To understand systems thinking
•To understand how standards are used to enhance systems thinking.

11. 15.10.2003 Version 10.0
The High Performance Organisation LtdISO9001:2000 Foundation Workshop
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Management system &
continuous improvement
Plan
Do
Check
Act
Plan 1
Do1
Check 1
Act 1
The aim: Continuous business improvement
The
future

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System / process management
Understanding
the
market
Monitor &
measure
performance
Communicate
services
Design
/ enhance
services
Business
planning
Bringing about
change
Deliver
services
Managing
assets
Managing
people
Managing
finance
‘a business is made up of one system, not
many & follows PDCA’

13. 15.10.2003 Version 10.0
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What is a system?
A management system:
•Incorporates all components of an organisation into one system
•It is not about putting quality, environment etc in one book
•Buying a software package that incorporates environment,
Heath & safety and quality documentation is not a system
•Merging disciplines such as quality manager, health & safety
manager and environment manager into one is not a system.

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System thinking & standards
Inputs Outcomes / results
LearnChange
Risk Mgt
Excellence Model
15001
8800
BS7799
14001
CSR
‘many standards, only one business system’

15. 15.10.2003 Version 10.0
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Exercise 1
In groups:
•Select a standard / framework you are familiar
and identify where you would find the requirements
in the generic system shown?
•What is the impact of systems thinking on organisation’s
performance?

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Session 3
ISO9001:2000
quality management systems
Learning points:
•To understand the ISO9001:2000 model as a management tool
•To understand the details of the clauses that make up the standard.

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Quality (business) principles
•Customer focus
•Leadership
•Involvement of people
•Process approach
•System approach to management
•Continual improvement
•Factual approach to decision making
•Mutually beneficial supplier relationships.

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Based on a process approach
Emphasizes the importance of:
•understanding and meeting requirements
•the need to consider processes in terms of
added value
•obtaining results of process performance
and effectiveness
•continual improvement of processes based
on objective measurement.

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Clauses 1, 2 and 3
•Scope
•Normative reference
•Terms & definitions

20. Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management
responsibility
Resource
Management
Measurement,
analysis and
improvement
Product
realisation
Product
output
input

21. 15.10.2003 Version 10.0
The High Performance Organisation LtdISO9001:2000 Foundation Workshop
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Clause 4 – Quality management systems
‘The Critical Elements’
•Identify processes
•Determine sequence
•Operate & control
•Ensure resources & information to support
operation & monitoring
•Measure
•Improve based on fact.

22. 15.10.2003 Version 10.0
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Clause 4 – 4.2.1.General
‘Highlights’
•Documented quality policy, quality
objectives & quality manual
•Note 2.
–The extent of the quality management system
documentation can differ from one organisation
to another due to:
•Size & Type of Organisation
•Complexity of processes and their interactions
•Competence of personnel

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Clause 4 – 4.2.2. quality manual
•Scope (of management system)
–coverage and exclusions
•Reference to documented procedures
•Interaction between the processes.
‘what it looks like is up to you – show examples’

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Clause 4 – 4.2.3. control of documents
‘Documents shall be controlled’
Approve/
Review
Documents
Version 2.0
Revision
Status
Available at
Point of use
Documents
Remain
Legible
External Documents
Controlled
BIN
Obsolete
Documents

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Clause 4 – 4.2.4. control of records
•Evidence of conformity
–“How do you do that?”
–“Can you show me?”
•Legible, identifiable & retrievable
•Documented procedure to define
controls.

26. Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management
responsibility
Resource
Management
Measurement,
analysis and
improvement
Product
realisation
Product
output
input

27. 15.10.2003 Version 10.0
The High Performance Organisation LtdISO9001:2000 Foundation Workshop
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Clause 5 – management responsibility
What clause 5 really means:
•Management commitment
•Understanding customer focus shapes
•The design of the quality policy
•Which is delivered by objectives & plans
•Responsibilities & authorities are defined &
communication
•Management review results at the management review
and take required action
•Results are internally communicated on a regular basis.

28. Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management
responsibility
Resource
Management
Measurement,
analysis and
improvement
Product
realisation
Product
output
input

29. 15.10.2003 Version 10.0
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Exercise 2
Clause 6 - resource management
All groups review clause 6:
•Group 1 – Provide overview of ‘Human Resources’
•Group 2 – Provide overview of ‘Infrastructure’
•Group 3 – Provide overview of ‘Work Environment’
All groups
•What is the link to quality objectives?

30. Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management
responsibility
Resource
Management
Measurement,
analysis and
improvement
Product
realisation
Product
output
input

31. 15.10.2003 Version 10.0
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Clause 7 – Product Realisation
•Planning
•Customer related processes
•Design and development
•Purchasing
•Production & service provision
•Control of monitoring & measuring
devices

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Clause 7
Clause 7.1
Planning for Product
Realisation

33. 15.10.2003 Version 10.0
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Clause 7
Clause 7.1
Planning for Product
Realisation
Clause 7.2
customer
related
processes

34. 15.10.2003 Version 10.0
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Clause 7
Clause 7.2
customer
related
processes C
l
a
u
s
e

7
.
3

7.3.1
Design
7.3.2
Design
Inputs
7.3.3
Design
Outputs
7.3.4
Design
Review
7.3.5
Verify
Design
7.3.6
Validate
Design
7.3.7 – Change Control
Clause 7.1
Planning for Product
Realisation

35. 15.10.2003 Version 10.0
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Clause 7.2
customer
related
processes
C
l
a
u
s
e

7
.
3

7.3.1
Design
7.3.2
Design
Inputs
7.3.3
Design
Outputs
7.3.4
Design
Review
7.3.5
Verify
Design
7.3.6
Validate
Design
7.3.7 – Change Control
Clause 7.4
purchasing
Clause 7.1
Planning for Product
Realisation
Clause 7

36. 15.10.2003 Version 10.0
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Clause 7
Clause 7.1
Planning
for Product
Realisation
Clause 7.2
customer
related
processes
C
l
a
u
s
e
7
.3

7.3.1
Design
7.3.2
Design
Inputs
7.3.3
Design
Outputs
7.3.4
Design
Review
7.3.5
Verify
Design
7.3.6
Validate
Design
7.3.7 – Change Control
Clause 7.1
Planning for Product
Realisation
Clause 7.5
Control of Product
Clause 7.4
Purchasing

37. 15.10.2003 Version 10.0
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Clause 7
Clause 7.1
Planning
for Product
Realisation
Clause 7.2
Customer
Related
Processes C
l
a
u
s
e
7
.3

7.3.1
Design
7.3.2
Design
Inputs
7.3.3
Design
Outputs
7.3.4
Design
Review
7.3.5
Verify
Design
7.3.6
Validate
Design
7.3.7 – Change Control
Clause 7.1
Planning for Product
Realisation
Clause 7.5
Control of Product
Clause 7.6 control of
monitoring & measuring
Product
Clause 7.4
Purchasing

38. Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management
responsibility
Resource
Management
Measurement,
analysis and
improvement
Product
realisation
Product
output
input

39. 15.10.2003 Version 10.0
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Exercise 3
Clause 8 – measurement analysis
& improvement
In groups review clause 8:
•Group 1 – Why must we measure and monitor performance?
•Group 2 – What do we need to measure and how?
•Group 3 – What should we do with the information collected?
All groups
•Provide an overview of the whole clause.
•How is the information prioritised to identify improvements?

40. 15.10.2003 Version 10.0
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Procedures
•Procedures are required for:
–Preventive action
–Corrective action
–Control of documents
–Control of non-conforming product
–Control of quality records
–Internal/External Auditing.

41. 15.10.2003 Version 10.0
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Session 4
Business process management
‘A practical approach’
Learning points:
•To understand a management system structure.

42. 15.10.2003 Version 10.0
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Scope – covers everyone
CEO
Directors
Managers
Staff
ISO9001:2000

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Management system structure
multi-level mapping
Owner – Head of scope
Management system
A process A process
Owner - Process Owner
‘the what’
A procedure / information
‘the how’
•measure efficiency and
effectiveness
•measure business performance
•finance, customer, process
Training
Guide
Photograph

44. 15.10.2003 Version 10.0
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An example management system
Understanding
the
market
Monitor &
measure
performance
Communicate
services
Design
/ enhance
services
Business
planning
Bringing about
change
Deliver
services
Managing
assets
Managing
people
Managing
finance
‘what your system looks like is up to you’

45. 15.10.2003 Version 10.0
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Example Process

Inititate the work
& outsource if
required
Produce timetable /
p rogramme to carry
o ut th e work
Identify t h e resources
required
Iden tify & ap p oint
exter nal resource
Do we have
sufficient
internal
resource?
Establish p roject /
work teams

Ca rry out &
complete the
work
Evalua te the success
of the job & take
action on any re sults
Any Staff M ember
Receive request for
work & direct to
ap p r op riate unit
All U nits & Contract Services
Project / Job Co-ordinator & T eams
Team M anagers
Yes
No

46. 15.10.2003 Version 10.0
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Links to other workshops
•‘ISO9001:2000 Foundation Workshop’ (today)
(to provide guidance on ISO9001:2000 and what needs to be achieved – the context)
•‘Creating a Process Based Management Systems’
(to provide guidance on how a management system is created)
•‘Effective Process Mapping for (Business) Performance & ISO9001:2000’
(to provide guidance on how to map business processes and identify
measures)
•‘Auditing Process Management’
(to help you audit process effectiveness and compliance & identify
Improvements).

47. 15.10.2003 Version 10.0
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Session 5
Selling
ISO9001:2000
Learning points:
•To identify the benefits of ISO9001:2000 to customers
and organisations.

48. 15.10.2003 Version 10.0
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Exercise 4
In groups:
•Group 1 – what are the benefits to customers?
•Group 2 – what are the benefits to the organisation?
•Group 3 – what are the benefits to managers & staff?
of introducing ISO9001:2000.
All groups
•What barriers could exist that prevent the introduction
of IS09001:2000.

49. 15.10.2003 Version 10.0
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Benefits to ‘real’ customers
•Focus on results
•Brought departments together into one process
•Highlighted areas of duplication
•Highlighted areas of weakness
•Promoted teamwork
•Reducing paperwork
•Addressing management issues not just standard issues
•Introducing ‘cross-functional’ measures
•Understanding of others roles in achieving process &
company objectives
•Movement towards one system instead of many.

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Benefits to ‘real’ customers
•Identified major gaps in operational activity
•Improved business planning
•Better understanding of processes that identify an
understanding of our market
•Senior Team working together
•Creating the right measures to manage the business
•Staff involvement
•Streamline existing paperwork (procedures only a few lines)
•Fill gaps
•Computerised, reduced paperwork
•Organisation transparent to all managers and staff.

51. 15.10.2003 Version 10.0
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Session 6
Project implementation
Learning points:
•To identify the component parts of an implementation
Plan.

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Implementation plan
- as the workshop summary
•Understand ISO9001:2000 – particularly clause 4
•Communicate overview and systems thinking to management
•Create quality management system
•Define processes and measures
•Create procedures
•Create quality manual
•Communicate system to all staff
•Audit process effectiveness
•Collect measurement information
•Identify & carry out improvement opportunities
•Obtain registration.

53. 15.10.2003 Version 10.0
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Any questions?

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Guidance, advice & support
In partnership with
The High Performance Organisation Ltd
01604 470837
[email protected]
www.the-hpo.com