Effectively applying ISO9001:2000 clauses 5 and 8

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Effectively applying ISO90012000 clauses 5 and 8

ISO90012000 Clause 5 and 8 workshop
Version K.10.1-UK Oct 03 ?The High Performance
Organisation Ltd
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Outline of the day

• Process management for context
• Clause 5 requirements
• Examples of application
• Clause 8 requirements
• Examples of application

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Session one
What is a process management?

• Learning points
• To understand what is meant by the term
  management system
• To be able to put process management in context

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System management
Customer satisfaction
Products Services
Economic
Environmental
Outcomes / results
Inputs
Law
Regulations
Society
Learn
Change
system is a collection of processes that
delivers results
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A typical system?
Understanding the market
Business planning
Bringing about change
Monitor measure performance
Design / enhance services
Winning business
Deliver services
Managing after sales
Managing assets
Managing people
Managing finance
the system is the business
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Process Management
Competence
Budget
Asset use
HS
Culture
Process as a series of activities
Measure outcomes / results against targets
Inputs
Teamwork
Methods
Environment
Information sharing
Learn improve to Enhance performance
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ISO 90012000 process model
Continual improvement of the management system
Management responsibility
Customer
Customer
Measurement, analysis and improvement
Satisfaction
Resource management
output
Requirements
input
Product realisation
Product
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Generally, where the clauses fit?
Understanding the market
Clause 5
Business planning
Bringing about change
Clause 8
Monitor measure performance
Design / enhance services
Winning business
Deliver services
Managing after sales
Managing assets
Managing people
Managing finance
Supporting ?
Clause 5 is at the start, clause 8 the end
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Management system structure
Management system

• Clauses are seen at system level

the what
A process
A process

• With detailed requirements
• at process level and

A procedure

• Procedures where required

the how
Training Guide
Photograph
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The big picture
Systems process thinking
Management systems development
Corporate Social Responsibility / Corporate
Governance
Based on
Management skills development
ISO 90012000
Learning and change
setting off in the right direction is critical
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Session two
Clause 5 process management

• Learning points
• To understand the requirements of clause 5
• To identify processes activities that meet clause
  5 requirements.
• To understand how the sub-clauses link together.

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The joined up clause 5
Identify what customers require (5.2)
Build quality policy based on these wants (5.3)
Review performance of the business
(5.6.1) Communicate results (5.5.3)
Set business individual objectives to deliver
results (5.4.1)
Allocate responsibility communicate who does
what? (5.5)
Create processes to deliver objectives (5.4.2)
these activities should link together
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Management Commitment(5.1)

• Top management commitment to the development
• implementation of the quality management system
• continually improve its effectiveness by
• Communicating the importance of meeting customer
  requirements
• Establishing the quality policy
• Ensuring quality objectives are set.

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Customer Focus (5.2)
Establish customer requirements with aim of
enhancing customer satisfaction
Deliver products services (7.0)
Measure customer Satisfaction (8.2.1)
Identify customer Requirements (5.2)
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Quality Policy

• Needs to be appropriate to the purpose of the
  organisation
• Commitment to comply with requirements and
• continually improve the system
• Framework for establishing reviewing quality
  objectives
• Communicate understood within the organisation
• Is reviewed for suitability.

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Quality objectives (5.4.1)

• Requirements
• establish objectives at relevant functions and
  levels
• objectives need to measurable.

• consider / show how objectives are created in the
  process
• all objectives should lead / link to the overall
  objectives
• for quality objectives read business objectives
• objectives need to be SMART
• will objectives deliver the quality policy.

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Quality management system planning (5.4.2)

• Requirements
• system must meet objectives and cover clause 4.1
• maintain integrity when changes are planned
  implemented.

• Make sure these requirements are covered in the
  process
• After objectives are set, question if current
  processes will
• deliver the objectives
• If not show how changes to processes and / or
  system are
• carried out.

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Responsibility, authority (5.5.1)
Requirement define and communicate.

• Best shown on the processes themselves
• Dont forget control points, approvals and
  decisions
• Could be in other documents such as job
  descriptions
• Method is up to your organisation.

make sure everyone understands what they
are responsible for
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Management Representative (5.5.2)

• Requirement management member
• processes are established, implemented and
  maintained
• report on system performance
• promote awareness of customer requirements.

• you decide who this is but must be senior person
• doesnt mean that Management Representative has
  to do
• everything could delegate
• someone must be responsible for the system!!!

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Internal communication (5.5.3)
Requirement communicate effectiveness of the
system.

• Communicate results
• Define the method(s) in your process(es)
• The method is up to you
• Method based upon your organisations needs
  requirements
• Consider current methods
• Communicate results and other factors that impact
  on effectiveness.

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Management review (5.6)
Requirements Top management review performance
of the system identifying opportunities for
improvement and the need to change the system,
objectives or policy.

• Can call the review what you like it is your
  business
• Review can happen often as you like but must be
  planned
• Consider inputs in the Standard and other
  business needs
• Outputs are improvements and resource needs
• Review is often already happening e.g. Board
  meeting
• Show the review in the process
• Keep a record but format is up to you.

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Exercise 1
In groups consider the following processes and
identify where the clauses below are
covered 5.2 Customer focus 5.3 Quality
policy 5.4.1 Quality objectives 5.4.2 Quality
management system planning 5.5.1 Responsibility
authority 5.5.3 Internal communication 5.6
Management review.
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Exercise 2
Map a business planning process for your
organisation and show where the main elements of
clause 5 are covered
5.2 Customer focus 5.3 Quality policy 5.4.1
Quality objectives 5.4.2 Quality management
system planning 5.5.1 Responsibility
authority 5.5.3 Internal communication 5.6
Management review.
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Session three
Clause 8 process management

• Learning points
• To understand the requirements of clause 8
• To identify processes activities that meet clause
  8 requirements
• To understand how the sub-clauses link together.

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Generally, where the clauses fit?
Understanding the market
Clause 5
Business planning
Bringing about change
Clause 8
Monitor measure performance
Design / enhance services
Winning business
Deliver services
Managing after sales
Managing assets
Managing people
Managing finance
Supporting ?
Clause 5 is at the start, clause 8 the end
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The joined up clause 8
Customer Satisfaction
8.2.1
Internal Audit
8.2.2
8.4
5.6
8.5
Measure Processes
Analyse data
Review data
Improve performance
8.2.3
Measure Products
8.2.4
Other factors
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Customer satisfaction (8.2.1)

• Requirements
• monitor information relating to customer
  perception
• relates to whether or not customer requirements
  have been met
• determine methods for collecting using
  information.

• the method for collecting information is up to
  you
• consider using methods / resources already in
  place
• show the method in the process
• link the analysis / information collected back to
  requirements.

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Customer Satisfaction (8.2.1)
Establish customer requirements with aim of
enhancing customer satisfaction
Deliver products services (7.0)
Measure customer Satisfaction (8.2.1)
Identify customer Requirements (5.2)
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Internal audits (8.2.2)

• Requirements
• planned intervals check compliance
  effectiveness
• programme is planned based on importance of
  processes
• select auditors who are independent objective
• need a documented procedure
• take timely actions.

• need to audit compliance and effectiveness
• schedule is based on risk to the business
• auditor competence is key
• can report areas for improvement as well as
  non-conformances
• dont have to call them audits
• make sure results are fed into Management Review
• reports can be free format.

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Compliance auditing
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Assessing effectiveness
Knowledge
Risks
etc.
Inputs
Outputs
Resources
Budget
Competence
Tar Act Var
Com.
Com.
Com.
Com.
Teamwork Ownership
Learn
Change
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Monitor measure processes (8.2.3)

• Requirements
• measure processes to demonstrate planned results
  are achieved
• take correction and corrective action when
  results are not achieved.

• not all processes need measures, key ones do
• use targets and trends to show performance
• feed results into Management Review
• use the results to stimulate improvement activity
• communicate results.

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Monitor measure products (8.2.4)

• Requirements
• measure the characteristics of the product, where
  applicable to show product
• requirements have been met
• keep records of acceptance criteria
• dont release products / services until planned
  arrangements have taken
• place unless authorised by the Customer or other
  relevant authority.

• measure performance against targets
• show trends that can identify improvements
• keep records of individual product acceptance
• report trends / results to Management Review
• make sure it is clear who has authorisation to
  release products / services.

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Non-conforming product (8.3)

• Requirements
• identify products / services so that they cant
  be used unintentionally
• need a documented procedure to show controls and
  responsibilities
• take appropriate action, record including any
  concessions
• re-verify after any product / services
  corrections
• if problem occurs after the product / service has
  been delivered
• take appropriate action.

• could take place in more than one process
• non-conforming product could be called anything
• write procedure and align with appropriate
  processes
• retest products services that have previously
  non-conformed
• include product / service recall in appropriate
  process.

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Analyse data (8.4)

• Requirements
• determine, collect and analyse appropriate data
  to demonstrate suitability
• and effectiveness
• evaluate where improvements can take place
• data shall include customer satisfaction,
  conformity to product requirements,
• process and product measures and suppliers.

• review information collected from all
  measurement
• activity, not just above
• show clearly where improvement could take place
• feed information into management review
• managers need to know the critical areas to work
  on
• not necessarily lots of detail.

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Continual improvement (8.5.1)

• Requirements
• the organisation shall continually improve the
  effectiveness of the system
• do this by using results, corrective actions,
  data etc.

• formal / large improvements use a process as part
  of
• the system
• smaller improvement could take place in more than
  one process
• use business process improvement etc. methodology
  as a base.

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Corrective Action (8.5.2)

• Requirements
• eliminate the causes of non-conformities to
  prevent recurrence
• need a documented procedure
• make sure areas in Standard are covered,
  including a record of action taken.

• corrective action take place after something has
  happened that
• has gone wrong
• happens through out the system
• doesnt have to be called corrective action
• identify where in other processes corrective
  action takes place
• write a procedure(s) and add to relevant
  activit(ies) in processes.

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Preventive Action (8.5.3)

• Requirements
• eliminate the causes of potential nonconformities
  to prevent occurrence
• actions are appropriate to the effect of the
  potential problem.

• preventive action take place before activity
  takes place
• happens through out the system
• doesnt have to be called preventive action
  could be trials, tests
• risk assessments
• identify where in other processes preventive
  action takes place
• write a procedure(s) and add to relevant
  activit(ies) in processes.

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Exercise 3
In groups consider the following processes and
identify where the clauses below are
covered 8.2.1 Customer satisfaction 8.2.2
Internal audit 8.2.3 Monitoring and measurement
of processes 8.2.4 Monitoring and measurement of
product 8.3 Control of nonconforming
product 8.4 Analysis of data 8.5.1 Continual
improvement 8.5.2 8.5.3 Corrective Preventive
action.
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Exercise 4
Map a monitoring performance and / or a business
improvement process for your organisation and
show where the main elements of clause 8 are
covered
8.2.1 Customer satisfaction 8.2.2 Internal
audit 8.2.3 Monitoring and measurement of
processes 8.2.4 Monitoring and measurement of
product 8.3 Control of nonconforming
product 8.4 Analysis of data 8.5.1 Continual
improvement 8.5.2 8.5.3 Corrective Preventive
action.
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Session four
Activities first, clauses second

• Learning points
• To understand that process requirements depend
  upon the organisation
• To understand that demonstration to meeting each
  clause will be
• different for different organisations.

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Exercise 5
Given the following management systems, where
would expect to find the sub clauses For clauses
5 8.