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

Outline of the day Process management for context Clause 5 requirements Examples of application Clause 8 requirements

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

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’

A typical system? ‘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 ‘the system is the business’

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

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

Generally, where the clauses fit? Understanding the market Clause 5 Bringing about change Business planning Clause 8 Monitor & measure performance Design / enhance services Managing after sales Deliver services Winning business Managing people Managing assets Managing finance Supporting ? ‘Clause 5 is at the start, clause 8 the end’

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

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 two Clause 5 & process management 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 5 ‘these activities should link together’ Identify what customers require (5.2) Review performance of the business (5.6.1) Communicate results (5.5.3) Build quality policy based on these wants (5.3) Set business & individual objectives to deliver results (5.4.1) Allocate responsibility & communicate who does what? (5.5) Create processes to deliver objectives (5.4.2) ‘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 enhancing customer satisfaction: Identify customer Requirements (5.2) Deliver products & services (7.0) Measure customer Satisfaction (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 will deliver the objectives If not show how changes to processes and / or system are carried 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 are responsible 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 do everything – 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 change the 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 identify where the clauses below are covered: 5.2 Customer focus 5.3 Quality policy 5.4.1 Quality objectives 5.4.2 Quality management system planning 5.5.1 Responsibility & authority 5.5.3 Internal communication 5.6 Management review.

Exercise 2 Map a business planning process for your organisation and show where the main elements of clause 5 are covered: 5.2 Customer focus 5.3 Quality policy 5.4.1 Quality objectives 5.4.2 Quality management system planning 5.5.1 Responsibility & authority 5.5.3 Internal communication 5.6 Management review.

Session three Clause 8 & process management 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 the market Clause 5 Bringing about change Business planning Clause 8 Monitor & measure performance Design / enhance services Managing after sales Deliver services Winning business Managing people Managing assets Managing finance Supporting ? ‘Clause 5 is at the start, clause 8 the end’

The ‘joined up’ clause 8 Customer Satisfaction 8.2.1 Internal Audit 8.2.2 8.4 5.6 8.5 Measure Processes Analyse data Review data Improve performance 8.2.3 Measure Products 8.2.4 Other factors

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 enhancing customer satisfaction: Identify customer Requirements (5.2) Deliver products & services (7.0) Measure customer Satisfaction (8.2.1)

Internal audits (8.2.2) need to audit compliance and effectiveness 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. Training Guide Photograph

Assessing effectiveness Knowledge Risks etc. Inputs Resources Budget Outputs Competence Tar Act Var Com. Com. Com. Com. Teamwork + Ownership Change Learn

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 product requirements 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 delivered take 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) review information collected from all measurement Requirements: determine, collect and analyse appropriate data to demonstrate suitability and 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 measurement activity, 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 of the 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 that has 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, tests risk 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 identify where the clauses below are covered: 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5.1 Continual improvement 8.5.2 & 8.5.3 Corrective & Preventive action.

Exercise 4 Map a monitoring performance and / or a business improvement process for your organisation and show where the main elements of clause 8 are covered: 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5.1 Continual improvement 8.5.2 & 8.5.3 Corrective & Preventive action.

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.

Exercise 5 Given the following management systems, where would expect to find the sub clauses For clauses 5 & 8.