1. Effectively applying ISO9001:2000 clauses 6 and 7.
Version K.10.1-UK Oct 03
The High Performance Organisation Ltd
ISO9001:2000 Clause 6 and 7 workshop

2. Outline of the day Process management for context
Clauses that support process management
Examples of application
Clauses that can be processes
Examples of processes

3. What is a process management?
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

4. System management Customer satisfaction Products & Economic Services
Environmental
Inputs
Outcomes / results
Law
Regulations
Society
Change
Learn
‘system is a collection of processes
that delivers results’

5. A typical system? Supporting ? ‘the system is the business’
Understanding
the
market
Bringing about
change
Business
planning
Monitor &
measure
performance
Design
/ enhance
services
Managing
after
sales
Deliver
services
Winning
business
Managing
people
Managing
assets
Managing
finance
Supporting ?
‘the system is the business’

6. Process management Competence Budget Asset use H&S Culture
Process as a
series of activities
Measure outcomes
/ results against
targets
Inputs
Teamwork
Methods
Environment
Information
sharing
Learn & improve to
Enhance performance

7. Continual improvement of the management system
ISO 9001:2000 process model
Continual improvement of the management system
Management
responsibility
Customer
Customer
Resource
management
Measurement,
analysis and
improvement
Satisfaction
Requirements
input
output
Product
realisation
Product

8. Management system structure
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

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. Clauses that support process management
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.

11. Resources support core process activity
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
‘along with other resources!!’

12. 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

13. Human resources (6.2) Identify the competencies required for each role
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

14. 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.

15. 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

16. 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.

17. 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.

18. 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.

19. The ‘joined up’ clause 7 ‘what about exclusions’
Customer related processes & 7.2.2
Design and development 7.3
Control of measuring devices 7.6
Product & service provision 7.5
Purchasing 7.4
Customer related processes 7.2.3
‘what about exclusions’

20. 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

21. 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

22. 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

23. 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

24. Purchasing (7.4) Select suppliers based on ability to supply
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

25. Example process Refer to laminate of an example
‘Managing Purchasing & Suppliers’
process shows how an organisation can comply
with clause 7.4 purchasing

26. 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

27. 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

28. 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

29. 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

30. 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

31. Activities first, clauses second
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.

32. 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.