1. Welcome
ISO9001:2000
Foundation Workshop

2. 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.

3. 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.

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

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

6. 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’

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

8. 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

9. The big picture ‘setting off in the right direction is critical’
Systems & process
thinking
Management systems development
Corporate Social Responsibility / Corporate Governance
Based on
ISO 9001:2000
Management skills development
Learning and change
‘setting off in the right direction is critical’

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

11. Management system & continuous improvement
The
future
Plan 1
Plan
Act Do
Act 1
Do1
Check
Check 1
The aim: Continuous business improvement

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

13. 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.

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

15. 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?

16. quality management systems
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.

17. 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.

18. 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.

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

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

21. 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. 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

23. 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’

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

25. 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
Continual improvement of the quality management system
Management
responsibility
Customer
Customer
Resource
Management
Measurement,
analysis and
improvement
Satisfaction
Requirements
output
input
Product
realisation
Product

27. 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
Continual improvement of the quality management system
Management
responsibility
Customer
Customer
Resource
Management
Measurement,
analysis and
improvement
Satisfaction
Requirements
output
input
Product
realisation
Product

29. 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
Continual improvement of the quality management system
Management
responsibility
Customer
Customer
Resource
Management
Measurement,
analysis and
improvement
Satisfaction
Requirements
output
input
Product
realisation
Product

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

32. Clause 7
Clause 7.1
Planning for Product
Realisation

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

34. Clause 7 Clause 7.2 customer Clause 7.3 related processes Clause 7.1
7.3.1
Design
7.3.2
Inputs
7.3.3
Outputs
7.3.4
Review
7.3.5
Verify
7.3.6
Validate
7.3.7 – Change Control
Clause 7.1
Planning for Product
Realisation

35. Clause 7 Clause 7.4 purchasing Clause 7.2 customer Clause 7.3 related
processes
Clause 7.3
7.3.1
Design
7.3.2
Inputs
7.3.3
Outputs
7.3.4
Review
7.3.5
Verify
7.3.6
Validate
7.3.7 – Change Control
Clause 7.4
purchasing
Clause 7.1
Planning for Product
Realisation

36. Clause 7 Clause 7.4 Purchasing Clause 7.2 Clause 7.1 customer
Planning
for Product
Realisation
Clause 7.2
customer
related
processes
Clause 7.3
7.3.1
Design
7.3.2
Inputs
7.3.3
Outputs
7.3.4
Review
7.3.5
Verify
7.3.6
Validate
7.3.7 – Change Control
Planning for Product
Clause 7.5
Control of Product
Clause 7.4
Purchasing

37. monitoring & measuring
Clause 7
Clause 7.1
Planning
for Product
Realisation
Clause 7.2
Customer
Related
Processes
Clause 7.3
7.3.1
Design
7.3.2
Inputs
7.3.3
Outputs
7.3.4
Review
7.3.5
Verify
7.3.6
Validate
7.3.7 – Change Control
Planning for Product
Clause 7.5
Control of Product
Clause 7.6 control of
monitoring & measuring
Product
Clause 7.4
Purchasing

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

39. 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. 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. Business process management ‘A practical approach’
Session 4
Business process management
‘A practical approach’
Learning points:
To understand a management system structure.

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

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

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

45. Example Process

46. 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. Session 5 Selling ISO9001:2000 Learning points:
To identify the benefits of ISO9001:2000 to customers
and organisations.

48. 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. 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.

50. 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. Session 6 Project implementation
Learning points:
To identify the component parts of an implementation
Plan.

52. 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. Any questions?

54. Guidance, advice & support
In partnership with
The High Performance Organisation Ltd