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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

2 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 2 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

3 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 3 ISO9001:2000 Clause 6 and 7 workshop 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

4 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 4 ISO9001:2000 Clause 6 and 7 workshop System management Inputs Outcomes / results Learn Change Law Society Economic Products & Services Customer satisfaction Environmental Regulations system is a collection of processes that delivers results

5 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 5 ISO9001:2000 Clause 6 and 7 workshop A typical system? Understanding the market Monitor & measure performance Winning business Design / enhance services Business planning Bringing about change Deliver services Managing assets Managing people Managing finance Supporting ? Managing after sales the system is the business

6 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 6 ISO9001:2000 Clause 6 and 7 workshop Process management Inputs Measure outcomes / results against targets Process as a series of activities Learn & improve to Enhance performance Budget Competence Asset use Methods Teamwork Environment Culture H&S Information sharing

7 ISO 9001:2000 process model Continual improvement of the management system Customer Requirements Satisfaction Management responsibility Resource management Measurement, analysis and improvement Product realisation Product output input

8 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 8 ISO9001:2000 Clause 6 and 7 workshop Management system structure Management system A process the what A procedure the how Clauses are seen at system level Training Guide Photograph With detailed requirements at process level and Procedures where required

9 The big picture setting off in the right direction is critical ISO 9001:2000 Systems & process thinking Management systems development Management skills development Learning and change Corporate Social Responsibility / Corporate Governance Based on

10 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 10 ISO9001:2000 Clause 6 and 7 workshop 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.

11 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 11 ISO9001:2000 Clause 6 and 7 workshop Resources support core process activity Core Process 1 Core Process 3 Core Process 2Core Process Infrastructure 6.2 Human Resources 6.4 Work Environment along with other resources!!

12 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 12 ISO9001:2000 Clause 6 and 7 workshop 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

13 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 13 ISO9001:2000 Clause 6 and 7 workshop 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.

14 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 14 ISO9001:2000 Clause 6 and 7 workshop 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.

15 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 15 ISO9001:2000 Clause 6 and 7 workshop 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.

16 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 16 ISO9001:2000 Clause 6 and 7 workshop 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.

17 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 17 ISO9001:2000 Clause 6 and 7 workshop 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.

18 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 18 ISO9001:2000 Clause 6 and 7 workshop 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.

19 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 19 ISO9001:2000 Clause 6 and 7 workshop 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 & Customer related processes 7.2.3

20 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 20 ISO9001:2000 Clause 6 and 7 workshop 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 produce the product or deliver the service and to be consistent with other management system processes.

21 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 21 ISO9001:2000 Clause 6 and 7 workshop 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 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.

22 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 22 ISO9001:2000 Clause 6 and 7 workshop 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

23 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 23 ISO9001:2000 Clause 6 and 7 workshop 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

24 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 24 ISO9001:2000 Clause 6 and 7 workshop 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.

25 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 25 ISO9001:2000 Clause 6 and 7 workshop Example process Refer to laminate of an example Managing Purchasing & Suppliers process shows how an organisation can comply with clause 7.4 purchasing

26 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 26 ISO9001:2000 Clause 6 and 7 workshop 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 manner using suitable information and equipment, ensuring that, where appropriate, product is identified and traceable, particularly customer property.

27 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 27 ISO9001:2000 Clause 6 and 7 workshop 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 cannot be subsequently tested.

28 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 28 ISO9001:2000 Clause 6 and 7 workshop 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 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.

29 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 29 ISO9001:2000 Clause 6 and 7 workshop 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

30 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 30 ISO9001:2000 Clause 6 and 7 workshop 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

31 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 31 ISO9001:2000 Clause 6 and 7 workshop 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.

32 Version K.10.1-UK Oct 03 The High Performance Organisation Ltd 32 ISO9001:2000 Clause 6 and 7 workshop 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.


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