Effectively applying ISO9001:2000 clauses 6 and 7. Version K.10.1-UK Oct 03 The High Performance...

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Effectively applying ISO9001:2000 clauses 6 and 7.

Version K.10.1-UK Oct 03The High Performance Organisation LtdISO9001:2000 Clause 6 and 7 workshop

Version K.10.1-UK Oct 03The High Performance Organisation Ltd

2ISO9001:2000 Clause 6 and 7 workshop

Outline of the day

• Process management for context

• Clauses that support process management

• Examples of application

• Clauses that can be processes

• Examples of processes

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

System management

Inputs Outcomes / results

LearnChange

Society

Economic Products &Services

Customersatisfaction

Environmental

Regulations

‘system is a collection of processes that delivers results’

A typical system?Understanding

themarket

Monitor & measure

performance

Winning business

Design / enhanceservices

Businessplanning

Bringing aboutchange

Deliver services

Managingassets

Managingpeople

Managing finance Supporting ?

Managing after sales

‘the system is the business’

Process management

InputsMeasure outcomes

/ results against targets

Process as aseries of activities

Learn & improve toEnhance performance

Budget Competence Asset use

Methods

Teamwork

Environment

CultureH&S

Information sharing

ISO 9001:2000 process model

Continual improvement of the management system

Customer Customer

Requirements

Satisfaction

Management responsibility

Resourcemanagement

Measurement,analysis andimprovement

Productrealisation

Product

outputinput

Management system structureManagement system

A process A process

‘the what’

A procedure

‘the how’

• Clauses are seen at system level

Training Guide

Photograph

•With detailed requirementsat process level and

•Procedures where required

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

Session two

Clauses that support process management

Learning points:•To understand the requirements of clauses

6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment

•To identify processes activities that meet each clause requirements.•To understand how the sub-clauses link together.

Resources support core process activity

Core Process 1

Core Process 3

Core Process 2Core Process 4

6.3 Infrastructure

6.2 Human Resources

6.4 Work Environment

‘along with other resources!!’

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

Human resources (6.2)

• 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

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.

Example process

Refer to laminate of an example ‘Managing & Developing Our People’

process shows how an organisation can complywith clause 6.2 human resources.

Infrastructure (6.3)

• 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

Requirements: Determine, provide and maintain the infrastructure required to meet product / customer requirements.

Work environment (6.4)

• Being aware of & complying with health & safety law

• Providing adequate lighting, protective clothing, atmospheric conditions, etc., etc., etc.

Requirements: Determine and manage the work environment required to meet product / customer requirements.

Exercise 1

For your organisation map either:

A managing people process covering clause 6.2Or

A managing physical assets process clause 6.3

Show where the main elements of clauses are covered.

Session three

Clause 7Learning points:•To understand the requirements of clauses

7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision7.6 Control of monitoring and measuring devices

•To identify processes activities that meet each clause requirements.•To understand how the sub-clauses link together.

The ‘joined up’ clause 7

Purchasing 7.4Product & service

provision 7.5

Design and development 7.3

Control of measuring devices 7.6

‘what about exclusions’

Customer related processes 7.2.1 & 7.2.2

Customer related processes 7.2.3

Planning & product realisation (7.1)

• 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

Requirements: Identify and map the processes required to directly producethe product or deliver the service and to be consistent with other managementsystem processes.

Customer-related processes (7.2)

• 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

Requirements: Determine what the customer requirements are and reviewthem to ensure they can be met. Any differences in perceived requirementsOr amendments to an order must be highlighted and agreed with the customer.

Design and development (7.3)Requirements:

Design and Development Planning

Design and Development Input

Design and Development Output

Design and Development ReviewDesign and Development

Verification

Design and Development Validation

Example process

Refer to laminate of an example ‘Designing New Products & Services’

process shows how an organisation can complywith clause 7.3 design and development

Purchasing (7.4)

• 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

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.

Example process

Refer to laminate of an example ‘Managing Purchasing & Suppliers’

process shows how an organisation can complywith clause 7.4 purchasing

Production & service provision (7.5)

• 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

Requirements: Carry out operational process activities in a controlled mannerusing suitable information and equipment, ensuring that, where appropriate, product is identified and traceable, particularly customer property.

Production & service provision (7.5)

• 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

Requirements: Validate any processes where the output of the process cannotbe subsequently tested.

Control of monitoring & measuring devices (7.6)

• 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

Requirements: Determine what monitoring and measuring is to be undertakenneeded to provide evidence of product conformity to specified requirements. Provide the most appropriate devices and maintain them to the appropriate levelto ensure they provide consistent results.

Example process

Refer to laminate of an example ‘Calibrating Measuring Equipment’

Process to show how an organisation can complyWith clause 7.6

control of monitoring & measuring devices

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

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 bedifferent for different organisations.

Exercise 3Given the following management systems,where would expect to find clauses:

6.2 Human resources6.3 Infrastructure6.4 Work environment7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service realisation7.6 Control of measuring devices.

Effectively applying ISO9001:2000 clauses 6 and 7. Version K.10.1-UK Oct 03 The High Performance...

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