15.10.2003 version 10.0 the high performance organisation ltd iso9001:2000 foundation workshop 1...
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15.10.2003 Version 10.0The High Performance Organisation LtdISO9001:2000 Foundation Workshop 1
ISO9001:2000 Foundation Workshop
Welcome
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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?
CountryStandards
Body
Industryrequirements
InternationalStandards
Body
ProduceStandards
Implemented byindustry
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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 managementsystem’
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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 & processthinking
Management systems development
Management skills development
Learning and change
Corporate Social Responsibility / Corporate Governance
Based on
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Session 2
Systems thinking
Learning points:•To understand systems thinking •To understand how standards are used to enhance systems thinking.
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Management system & continuous improvement
Plan
Do
Check
Act
Plan 1
Do1
Check 1
Act 1
The aim: Continuous business improvement
Thefuture
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System / process managementUnderstanding
themarket
Monitor & measure
performance
Communicateservices
Design / enhanceservices
Businessplanning
Bringing aboutchange
Deliver services
Managingassets
Managingpeople
Managing finance
‘a business is made up of one system, not many & follows PDCA’
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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 & safetymanager and environment manager into one is not a system.
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System thinking & standards
Inputs Outcomes / results
LearnChange
Risk Mgt
Excellence Model
150018800
BS7799
14001
CSR
‘many standards, only one business system’
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Exercise 1
In groups:
•Select a standard / framework you are familiarand identify where you would find the requirementsin the generic system shown?
•What is the impact of systems thinking on organisation’sperformance?
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Session 3
ISO9001:2000quality 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 approachEmphasizes 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
Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management responsibility
ResourceManagement
Measurement,analysis andimprovement
Productrealisation Product
outputinput
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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.
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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.
Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management responsibility
ResourceManagement
Measurement,analysis andimprovement
Productrealisation Product
outputinput
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Clause 5 – management responsibilityWhat 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.
Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management responsibility
ResourceManagement
Measurement,analysis andimprovement
Productrealisation Product
outputinput
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Exercise 2Clause 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?
Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management responsibility
ResourceManagement
Measurement,analysis andimprovement
Productrealisation Product
outputinput
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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 7.1Planning for Product
Realisation
Clause 7.1Planning for Product
Realisation
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Clause 7
Clause 7.1Planning for Product
Realisation
Clause 7.1Planning for Product
Realisation
Clause 7.2customer relatedprocesses
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Clause 7
Clause 7.2customer relatedprocesses C
laus
e 7.
3
7.3.1Design
7.3.2DesignInputs
7.3.3DesignOutputs
7.3.4DesignReview
7.3.5VerifyDesign
7.3.6ValidateDesign
7.3.7 – Change Control
Clause 7.1Planning for Product
Realisation
Clause 7.1Planning for Product
Realisation
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Clause 7.2customer relatedprocesses C
laus
e 7.
3 7.3.1
Design7.3.2
DesignInputs
7.3.3DesignOutputs
7.3.4DesignReview
7.3.5VerifyDesign
7.3.6ValidateDesign
7.3.7 – Change Control
Clause 7.4purchasing
Clause 7.1Planning for Product
Realisation
Clause 7.1Planning for Product
Realisation
Clause 7
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Clause 7
Clause 7.1Planning
for Product Realisation
Clause 7.1Planning
for Product Realisation
Clause 7.2customer relatedprocesses C
laus
e 7.
3 7.3.1
Design7.3.2
DesignInputs
7.3.3DesignOutputs
7.3.4DesignReview
7.3.5VerifyDesign
7.3.6ValidateDesign
7.3.7 – Change Control
Clause 7.1Planning for Product
Realisation
Clause 7.1Planning for Product
RealisationClause 7.5
Control of ProductClause 7.5
Control of Product
Clause 7.4Purchasing
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Clause 7
Clause 7.1Planning
for Product Realisation
Clause 7.1Planning
for Product Realisation
Clause 7.2Customer RelatedProcesses C
laus
e 7.
3
7.3.1Design
7.3.2DesignInputs
7.3.3DesignOutputs
7.3.4DesignReview
7.3.5VerifyDesign
7.3.6ValidateDesign
7.3.7 – Change Control
Clause 7.1Planning for Product
Realisation
Clause 7.1Planning for Product
Realisation
Clause 7.5 Control of Product
Clause 7.5 Control of Product
Clause 7.6 control of monitoring & measuring
Product
Clause 7.4Purchasing
Quality management process model
Customer
Continual improvement of the quality management system
Customer
Requirements
Satisfaction
Management responsibility
ResourceManagement
Measurement,analysis andimprovement
Productrealisation Product
outputinput
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Exercise 3Clause 8 – measurement analysis
& improvementIn 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?
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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.
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Session 4
Business process management‘A practical approach’
Learning points:•To understand a management system structure.
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Scope – covers everyone
CEO
Directors
Managers
Staff
ISO9001:2000
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Management system structuremulti-level mapping
Owner – Head of scopeManagement system
A process A processOwner - Process Owner
‘the what’
A procedure / information
‘the how’
• measure efficiency and effectiveness
• measure business performance• finance, customer, process
Training Guide
Photograph
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An example management systemUnderstanding
themarket
Monitor & measure
performance
Communicateservices
Design / enhanceservices
Businessplanning
Bringing aboutchange
Deliver services
Managingassets
Managingpeople
Managing finance
‘what your system looks like is up to you’
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Example Process
Inititate the work & outsource if
required
Produce timetable / programme to carry
out the work
Identify t he resources required
Identify & appoint external resource
Do we have sufficient internal
resource?
Establish project / work teams
Carry out & complete the
work
Evaluate the success of the job & take
action on any results
Any Staff M ember
Receive request for work & direct to appropriate unit
All Units & Contract Services
Project / Job Co-ordinator & Teams
Team M anagers
Yes
No
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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 identifymeasures)
• ‘Auditing Process Management’(to help you audit process effectiveness and compliance & identifyImprovements).
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Session 5
Selling ISO9001:2000
Learning points:•To identify the benefits of ISO9001:2000 to customersand organisations.
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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.
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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 anunderstanding 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.
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Session 6
Project implementation
Learning points:•To identify the component parts of an implementationPlan.
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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.
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Any questions?
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