Effectively applying ISO9001:2000 clauses 5 and 8 ISO9001:2000 Clause 5 and 8 workshop Version...

Effectively applying ISO9001:2000 clauses 5 and 8

ISO9001:2000 Clause 5 and 8 workshop Version JP.10.1-UK Oct 03The High Performance Organisation Ltd

Version JP.10.1-UK Oct 03

The High Performance Organisation Ltd2

ISO9001:2000 Clause 5 and 8 workshop

Outline of the day

• Process management for context

• Clause 5 requirements

• Examples of application

• Clause 8 requirements

• Examples of application




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

Law

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

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




Generally, where the clauses fit?Understanding

themarket

Monitor & measure

performance

Winning business


Businessplanning


Deliver services

Managingassets

Managingpeople

Managing finance Supporting ?


‘Clause 5 is at the start, clause 8 the end’

Clause 5

Clause 8




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

Clause 5 & processmanagement

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.




The ‘joined up’ clause 5Identify what customers

require (5.2)

Build quality policybased on these

wants (5.3)

Set business & individual objectives to deliver results

(5.4.1)

Create processes to deliver

objectives (5.4.2)

Allocate responsibility &communicate whodoes what? (5.5)

Review performanceof the business (5.6.1)

Communicate results (5.5.3)

‘these activities should link together’




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.




Customer Focus (5.2)

Establish customer requirements with aim of enhancingcustomer satisfaction:

Identify customer Requirements

(5.2)

Deliver products& services (7.0)

Measure customerSatisfaction (8.2.1)




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.




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.




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 willdeliver the objectives•If not show how changes to processes and / or system arecarried out.




Responsibility, authority (5.5.1)

Requirement: define and communicate.

•Best shown on the processes themselves•Don’t 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 areresponsible for’




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•doesn’t mean that Management Representative has to doeverything – could delegate•someone must be responsible for the system!!!




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 organisation’s needs & requirements•Consider current methods•Communicate results and other factors that impact on effectiveness.




Management review (5.6)

Requirements: Top management review performance of the system identifying opportunities for improvement and the need to changethe 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.




Exercise 1

In groups consider the following processes and identifywhere the clauses below are covered:

5.2 Customer focus5.3 Quality policy5.4.1 Quality objectives5.4.2 Quality management system planning5.5.1 Responsibility & authority5.5.3 Internal communication5.6 Management review.




Exercise 2

Map a business planning process for your organisationand show where the main elements of clause 5 are covered:

5.2 Customer focus5.3 Quality policy5.4.1 Quality objectives5.4.2 Quality management system planning5.5.1 Responsibility & authority5.5.3 Internal communication5.6 Management review.




Session three

Clause 8 & processmanagement

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.




Generally, where the clauses fit?Understanding

themarket

Monitor & measure

performance

Winning business


Businessplanning


Deliver services

Managingassets

Managingpeople

Managing finance Supporting ?


‘Clause 5 is at the start, clause 8 the end’

Clause 5

Clause 8




The ‘joined up’ clause 8

Internal Audit

CustomerSatisfaction

MeasureProcesses

MeasureProducts

Otherfactors

Analysedata

Reviewdata

Improveperformance

8.2.1

8.2.2

8.2.3

8.2.4

8.4 5.6 8.5




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.




Customer Satisfaction (8.2.1)

Establish customer requirements with aim of enhancingcustomer satisfaction:

Identify customer Requirements

(5.2)

Deliver products& services (7.0)

Measure customerSatisfaction (8.2.1)




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•don’t have to call them ‘audits’•make sure results are fed into Management Review•reports can be ‘free format’.




Compliance auditing

Com.Com. Com. Com.

Training Guide

Photograph




Assessing effectiveness

Com.Com. Com. Com.

Tar Act Var

Inputs Outputs

Knowledge

ResourcesCompetence

Teamwork + Ownership

Budget

LearnChange

Risks etc.




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.




Monitor & measure products (8.2.4)Requirements:•measure the characteristics of the product, where applicable to show productrequirements have been met•keep records of acceptance criteria•don’t 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.




Non-conforming product (8.3)Requirements:•identify products / services so that they can’t 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 deliveredtake 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.




Analyse data (8.4)Requirements:•determine, collect and analyse appropriate data to demonstrate suitabilityand 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 measurementactivity, not just above•show clearly where improvement could take place•feed information into management review•manager’s need to know the critical areas to work on•not necessarily lots of detail.




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 ofthe system•smaller improvement could take place in more than one process•use business process improvement etc. methodology as a base.




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 thathas gone wrong•happens through out the system•doesn’t 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.




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•doesn’t have to be called ‘preventive action’ – could be trials, testsrisk assessments•identify where in other processes ‘preventive action’ takes place•write a procedure(s) and add to relevant activit(ies) in processes.




Exercise 3

In groups consider the following processes and identifywhere the clauses below are covered:

8.2.1 Customer satisfaction8.2.2 Internal audit8.2.3 Monitoring and measurement of processes8.2.4 Monitoring and measurement of product8.3 Control of nonconforming product8.4 Analysis of data8.5.1 Continual improvement8.5.2 & 8.5.3 Corrective & Preventive action.




Exercise 4

Map a monitoring performance and / or a business improvementprocess for your organisation and show where the main elements of clause 8 are covered:

8.2.1 Customer satisfaction8.2.2 Internal audit8.2.3 Monitoring and measurement of processes8.2.4 Monitoring and measurement of product8.3 Control of nonconforming product8.4 Analysis of data8.5.1 Continual improvement8.5.2 & 8.5.3 Corrective & Preventive action.




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 5

Given the following management systems,where would expect to find the sub clauses

For clauses 5 & 8.

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Effectively applying ISO9001:2000 clauses 5 and 8 ISO9001:2000 Clause 5 and 8 workshop Version...

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