Welcome ISO9001:2000 Foundation Workshop

Objectives of the day The objectives are to: introduce the concepts of Standardisation introduce ‘system thinking’ review ISO9001:2000 as a management tool identify the requirements of ISO9001:2000 selling the benefits of ISO9001:2000 create an implementation plan.

Session 1 Standards ‘the big picture’ Learning points: To understand how a standard is created To understand the history of quality standards To understand that process based systems are the start point.

Standards Background The future Standards & measurement Standardising the standards Standards for industries The future Standards for continuous improvement and change.

How are standards created? Industry requirements Country Standards Body International Standards Body Implemented by industry Produce Standards

How are they implemented? Standards are implemented by: Identify the correct standard based on your organisations needs Understanding what is required Understanding how to implement Carry out a gap analysis against your current management system Carry out improvement activity to address any gaps Apply and maintain registration. ‘ISO9001:2000 is about your management system’

History of quality management systems ?? ISO9001:2000 – Quality Management ISO9000:1994 – Quality Assurance BS5750 – Quality Control

The rationale for management systems The quality management system approach encourages: Analysis of customer requirements Defining processes that meet these requirements The control and management of these processes Provision of a framework for continuous improvement Confidence in the products and services being offered

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’

Session 2 Systems thinking Learning points: To understand systems thinking To understand how standards are used to enhance systems thinking.

Management system & continuous improvement The future Plan 1 Plan Act Do Act 1 Do1 Check Check 1 The aim: Continuous business improvement

System / process management Understanding the market Bringing about change Business planning Monitor & measure performance Design / enhance services Deliver services Communicate services Managing people Managing assets Managing finance ‘a business is made up of one system, not many & follows PDCA’

What is a system? A management system: Incorporates all components of an organisation into one system It is not about putting quality, environment etc in one book Buying a software package that incorporates environment, Heath & safety and quality documentation is not a system Merging disciplines such as quality manager, health & safety manager and environment manager into one is not a system.

System thinking & standards BS7799 15001 8800 14001 Inputs Outcomes / results Risk Mgt CSR Excellence Model Change Learn ‘many standards, only one business system’

Exercise 1 In groups: Select a standard / framework you are familiar and identify where you would find the requirements in the generic system shown? What is the impact of systems thinking on organisation’s performance?

quality management systems Session 3 ISO9001:2000 quality management systems Learning points: To understand the ISO9001:2000 model as a management tool To understand the details of the clauses that make up the standard.

Quality (business) principles Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships.

Based on a process approach Emphasizes the importance of: understanding and meeting requirements the need to consider processes in terms of added value obtaining results of process performance and effectiveness continual improvement of processes based on objective measurement.

Clauses 1, 2 and 3 Scope Normative reference Terms & definitions

Quality management process model Continual improvement of the quality management system Management responsibility Customer Customer Resource Management Measurement, analysis and improvement Satisfaction Requirements output input Product realisation Product

Clause 4 – Quality management systems ‘The Critical Elements’ Identify processes Determine sequence Operate & control Ensure resources & information to support operation & monitoring Measure Improve based on fact.

Clause 4 – 4.2.1.General ‘Highlights’ Documented quality policy, quality objectives & quality manual Note 2. The extent of the quality management system documentation can differ from one organisation to another due to: Size & Type of Organisation Complexity of processes and their interactions Competence of personnel

Clause 4 – 4.2.2. quality manual Scope (of management system) coverage and exclusions Reference to documented procedures Interaction between the processes. ‘what it looks like is up to you – show examples’

Clause 4 – 4.2.3. control of documents ‘Documents shall be controlled’ External Documents Controlled Approve/ Review Documents Available at Point of use Version 2.0 Obsolete Documents Revision Status Documents Remain Legible BIN

Clause 4 – 4.2.4. control of records Evidence of conformity “How do you do that?” “Can you show me?” Legible, identifiable & retrievable Documented procedure to define controls.

Quality management process model Continual improvement of the quality management system Management responsibility Customer Customer Resource Management Measurement, analysis and improvement Satisfaction Requirements output input Product realisation Product

Clause 5 – management responsibility What clause 5 really means: Management commitment Understanding customer focus shapes The design of the quality policy Which is delivered by objectives & plans Responsibilities & authorities are defined & communication Management review results at the management review and take required action Results are internally communicated on a regular basis.

Quality management process model Continual improvement of the quality management system Management responsibility Customer Customer Resource Management Measurement, analysis and improvement Satisfaction Requirements output input Product realisation Product

Exercise 2 Clause 6 - resource management All groups review clause 6: Group 1 – Provide overview of ‘Human Resources’ Group 2 – Provide overview of ‘Infrastructure’ Group 3 – Provide overview of ‘Work Environment’ All groups What is the link to quality objectives?

Quality management process model Continual improvement of the quality management system Management responsibility Customer Customer Resource Management Measurement, analysis and improvement Satisfaction Requirements output input Product realisation Product

Clause 7 – Product Realisation Planning Customer related processes Design and development Purchasing Production & service provision Control of monitoring & measuring devices

Clause 7 Clause 7.1 Planning for Product Realisation

Clause 7 Clause 7.2 customer related processes Clause 7.1 Planning for Product Realisation

Clause 7 Clause 7.2 customer Clause 7.3 related processes Clause 7.1 7.3.1 Design 7.3.2 Inputs 7.3.3 Outputs 7.3.4 Review 7.3.5 Verify 7.3.6 Validate 7.3.7 – Change Control Clause 7.1 Planning for Product Realisation

Clause 7 Clause 7.4 purchasing Clause 7.2 customer Clause 7.3 related processes Clause 7.3 7.3.1 Design 7.3.2 Inputs 7.3.3 Outputs 7.3.4 Review 7.3.5 Verify 7.3.6 Validate 7.3.7 – Change Control Clause 7.4 purchasing Clause 7.1 Planning for Product Realisation

Clause 7 Clause 7.4 Purchasing Clause 7.2 Clause 7.1 customer Planning for Product Realisation Clause 7.2 customer related processes Clause 7.3 7.3.1 Design 7.3.2 Inputs 7.3.3 Outputs 7.3.4 Review 7.3.5 Verify 7.3.6 Validate 7.3.7 – Change Control Planning for Product Clause 7.5 Control of Product Clause 7.4 Purchasing

monitoring & measuring Clause 7 Clause 7.1 Planning for Product Realisation Clause 7.2 Customer Related Processes Clause 7.3 7.3.1 Design 7.3.2 Inputs 7.3.3 Outputs 7.3.4 Review 7.3.5 Verify 7.3.6 Validate 7.3.7 – Change Control Planning for Product Clause 7.5 Control of Product Clause 7.6 control of monitoring & measuring Product Clause 7.4 Purchasing

Quality management process model Continual improvement of the quality management system Management responsibility Customer Customer Resource Management Measurement, analysis and improvement Satisfaction Requirements output input Product realisation Product

Exercise 3 Clause 8 – measurement analysis & improvement In groups review clause 8: Group 1 – Why must we measure and monitor performance? Group 2 – What do we need to measure and how? Group 3 – What should we do with the information collected? All groups Provide an overview of the whole clause. How is the information prioritised to identify improvements?

Procedures Procedures are required for: Preventive action Corrective action Control of documents Control of non-conforming product Control of quality records Internal/External Auditing.

Business process management ‘A practical approach’ Session 4 Business process management ‘A practical approach’ Learning points: To understand a management system structure.

Scope – covers everyone CEO Directors Managers Staff ISO9001:2000

Management system structure multi-level mapping Owner – Head of scope measure business performance finance, customer, process ‘the what’ A process A process Owner - Process Owner measure efficiency and effectiveness A procedure / information ‘the how’ Training Guide Photograph

An example management system Understanding the market Bringing about change Business planning Monitor & measure performance Design / enhance services Deliver services Communicate services Managing people Managing assets Managing finance ‘what your system looks like is up to you’

Example Process

Links to other workshops ‘ISO9001:2000 Foundation Workshop’ (today) (to provide guidance on ISO9001:2000 and what needs to be achieved – the context) ‘Creating a Process Based Management Systems’ (to provide guidance on how a management system is created) ‘Effective Process Mapping for (Business) Performance & ISO9001:2000’ (to provide guidance on how to map business processes and identify measures) ‘Auditing Process Management’ (to help you audit process effectiveness and compliance & identify Improvements).

Session 5 Selling ISO9001:2000 Learning points: To identify the benefits of ISO9001:2000 to customers and organisations.

Exercise 4 In groups: Group 1 – what are the benefits to customers? Group 2 – what are the benefits to the organisation? Group 3 – what are the benefits to managers & staff? of introducing ISO9001:2000. All groups What barriers could exist that prevent the introduction of IS09001:2000.

Benefits to ‘real’ customers Focus on results Brought departments together into one process Highlighted areas of duplication Highlighted areas of weakness Promoted teamwork Reducing paperwork Addressing management issues not just standard issues Introducing ‘cross-functional’ measures Understanding of others roles in achieving process & company objectives Movement towards one system instead of many.

Benefits to ‘real’ customers Identified major gaps in operational activity Improved business planning Better understanding of processes that identify an understanding of our market Senior Team working together Creating the right measures to manage the business Staff involvement Streamline existing paperwork (procedures only a few lines) Fill gaps Computerised, reduced paperwork Organisation transparent to all managers and staff.

Session 6 Project implementation Learning points: To identify the component parts of an implementation Plan.

Implementation plan - as the workshop summary Understand ISO9001:2000 – particularly clause 4 Communicate overview and systems thinking to management Create quality management system Define processes and measures Create procedures Create quality manual Communicate system to all staff Audit process effectiveness Collect measurement information Identify & carry out improvement opportunities Obtain registration.

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