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

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

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? 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’

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

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’

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.

Resources support core process activity 6.2 Human Resources 6.3 Infrastructure 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 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

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.

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

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.

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.

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.

The ‘joined up’ clause 7 ‘what about exclusions’ Customer related processes 7.2.1 & 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’

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

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

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

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

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

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

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

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

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

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

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

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 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.