Effectively applying ISO9001:2000 clauses 6 and 7.

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Effectively applying ISO90012000 clauses 6 and
7.
Version JP.10.1-UK Oct 03 ?The High Performance
Organisation Ltd
ISO90012000 Clause 6 and 7 workshop
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Outline of the day

• Process management for context
• Clauses that support process management
• Examples of application
• Clauses that can be processes
• Examples of processes

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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
Supporting ?
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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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
Clauses that support process management

• Learning points
• To understand the requirements of clauses
• 6.1 Provision of resources
• 6.2 Human resources
• 6.3 Infrastructure
• 6.4 Work environment
• To identify processes activities that meet each
  clause requirements.
• To understand how the sub-clauses link together.

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Resources support core process activity
Core Process 1
Core Process 2
Core Process 4
Core Process 3
6.3 Infrastructure
6.2 Human Resources
6.4 Work Environment
along with other resources!!
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Provision of resources (6.1)
Requirements Provide the resources required to
implement, maintain and continually improve the
effectiveness of the management system, to
enhance customer satisfaction.

• The organisation must provide the resources for
• A management representative, to coordinate
• Training, for people in understanding process
  management
• Time, for people to be involved in developing
  maintaining
• the management system

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Human resources (6.2)
Requirements Determine what competences are
required by individuals in order to perform
their assigned duties and provide training in
order to achieve the competences required.

• Identify the competencies required for each role
• Consider using job descriptions to include these
  competencies
• Determine the current competencies of staff
• Consider a formal appraisal process / competency
  matrix
• Close competency gap with training
• Check training has been effective
• Keep records of training

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Example process
Refer to laminate of an example Managing
Developing Our People process shows how an
organisation can comply with clause 6.2 human
resources.
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Infrastructure (6.3)
Requirements Determine, provide and maintain the
infrastructure required to meet product /
customer requirements.

• Buildings and workspace must be suitable for the
  product being made or the service being provided
• Equipment (hardware software) used in processes
  must be capable of doing what is being asked of
  it
• Support services (such as transport) are
  appropriate

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Work environment (6.4)
Requirements Determine and manage the work
environment required to meet product / customer
requirements.

• Being aware of complying with health safety
  law
• Providing adequate lighting, protective clothing,
  atmospheric conditions, etc., etc., etc.

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Exercise 1
For your organisation map either A managing
people process covering clause 6.2 Or A managing
physical assets process clause 6.3 Show where
the main elements of clauses are covered.
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Session three
Clause 7

• Learning points
• To understand the requirements of clauses
• 7.1 Planning of product realization
• 7.2 Customer-related processes
• 7.3 Design and development
• 7.4 Purchasing
• 7.5 Production and service provision
• 7.6 Control of monitoring and measuring devices
• To identify processes activities that meet each
  clause requirements.
• To understand how the sub-clauses link together.

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The joined up clause 7
Customer related processes 7.2.1 7.2.2
Design and development 7.3
Purchasing 7.4
Product service provision 7.5
Control of measuring devices 7.6
Customer related processes 7.2.3
what about exclusions
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Planning product realisation (7.1)
Requirements Identify and map the processes
required to directly produce the product or
deliver the service and to be consistent with
other management system processes.

• Identify map the Key processes
• Establish the objectives for each process linked
  to
• The product or service
• The overall business objective
• Develop support documents to support process
  activities, consider risks
• Consider what records should be maintained as
  evidence of meeting requirements

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Customer-related processes (7.2)
Requirements Determine what the customer
requirements are and review them to ensure they
can be met. Any differences in perceived
requirements Or amendments to an order must be
highlighted and agreed with the customer.

• Be clear up-front what the customer wants
• Product or service specification
• Delivery and after sales service
• Statutory or regulatory requirements of the
  product
• Be sure the organisation can deliver what the
  customer wants
• Agree any difference or amendments with the
  customer
• Provide the customer with
• Clear product information
• Organisation contact information for enquiries,
  etc.
• A complaints process

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Design and development (7.3)
Requirements
Design and Development Planning
Design and Development Input
Design and Development Output
Design and Development Review
Design and Development Verification
Design and Development Validation
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Example process
Refer to laminate of an example Designing New
Products Services process shows how an
organisation can comply with clause 7.3 design
and development
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Purchasing (7.4)
Requirements Clearly specify what you want to
purchase, provide the supplier with all the
information they need to supply you correctly.
Select suppliers based on our purchasing needs
and evaluate their performance, maintaining only
the best suppliers.

• Select suppliers based on ability to supply
• Establish supplier evaluation criteria
• Keep records of supplier evaluation
• Describe fully what you want to purchase, usually
  on a purchase order
• Reference any specific standards, product
  approval requirements, etc.
• Review order prior to communicating to the
  supplier

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Example process
Refer to laminate of an example Managing
Purchasing Suppliers process shows how an
organisation can comply with clause 7.4 purchasing
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Production service provision (7.5)
Requirements Carry out operational process
activities in a controlled manner using suitable
information and equipment, ensuring that, where
appropriate, product is identified and
traceable, particularly customer property.

• Define the process determine the controls
  required to reduce risks of failure
• Provide the right information- product
  specification, procedures, work instructions,
  etc.
• Provide the right equipment
• Implement monitoring checking methods
• Ensure the product or service is identified can
  be traced using records
• Look after customers property report problems
  to them

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Production service provision (7.5)
Requirements Validate any processes where the
output of the process cannot be subsequently
tested.

• Usually manufacturing processes such as welding
• Validation / testing can be of the person
  carrying out the activity rather than the product
  itself
• Need to define validation / test criteria
• Need to keep records of validation / tests
• Need to re-test / validate at defined intervals

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Control of monitoring measuring devices (7.6)
Requirements Determine what monitoring and
measuring is to be undertaken needed to provide
evidence of product conformity to specified
requirements. Provide the most appropriate
devices and maintain them to the appropriate
level to ensure they provide consistent results.

• Understand what needs to be monitored or measured
• Select most appropriate devices for task
• Calibrate device to ensure it can be trusted
• Maintain device re-calibrate at appropriate
  intervals
• Prevent devices from being tampered with
• Determine action to be taken if device fails
  calibration
• Maintain calibration records

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Example process
Refer to laminate of an example Calibrating
Measuring Equipment Process to show how an
organisation can comply With clause 7.6 control
of monitoring measuring devices
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Exercise 2
For your organisation map either a Sales
Order process or a Design and Development
process Show where the main elements of
clauses are covered
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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 3
Given the following management systems, where
would expect to find clauses 6.2 Human
resources 6.3 Infrastructure 6.4 Work
environment 7.2 Customer-related processes 7.3
Design and development 7.4 Purchasing 7.5
Production and service realisation 7.6 Control of
measuring devices.