Employee Overview of ISO 9001:2008

Transcription

1 Your Organization Presents an: Employee Overview of ISO 9001:2008 Presented by: 1

2 Today you will learn... What ISO 9001 is all about Why your organization wants to implement it How you can help develop and improve the quality system prepare for the quality system audit 2

3 ISO adopts a process approach for: Implementing an effective quality management system, and Enhancing customer satisfaction through continual improvement 3

4 C U S T O M E R Continual Improvement of the Quality Management System Management Responsibility C U S T O M E R R E Q U I R E M E N T S Resource Management Input Product Realization Measurement Analysis & Improvement The Process-Based Quality Management System Output Product S A T I S F A C T I O N 4

5 the ISO 9000 family of standards include... ISO 9000:2005 Quality Management Systems - Fundamentals and Vocabulary ISO 9001:2008 Quality Management Systems - Requirements ISO 9004:2009 Managing for the sustained success of an organization A quality management approach 5

6 Goals for ISO 9001 Achieve quality by managing the processes that create products and services with an emphasis on: preventing problems reducing variation Give the customer confidence that products and services will consistently meet requirements Give the organization confidence that it can achieve its objectives 6

7 Your Organization is Adopting ISO 9001 to COMPLY: Your key customers have said your organization must demonstrate compliance to ISO 9001 to keep its status as a preferred supplier SELL: Many future customers will require compliance before considering your organization as a possible supplier COMPETE: Most of your organization s competitors will seek ISO 9001 registration as a means of getting more business IMPROVE: All companies adopting ISO 9001 have reported that it has provided many benefits and improvements 7

8 A Quality System must be Suitable Effective Documented Auditable Words of wisdom from Victor Schur (Sears) 8

9 The Basis of a Quality System is to... say what you do, do what you say, record what you did, check the results, and act on the difference Words of wisdom from Ian Durand (US Technical Advisory Group to ISO TC 176) 9

10 ISO 9001:2008 Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships 10

11 Customer Focus Organizations depend on their customers and therefore should: understand current and future customer needs; meet customer requirements; and strive to exceed customer expectations. 11

12 Customer related processes are vital to business success... Advertising and Inquiry Handling Offer, Quote and Contract Processing Customer Complaint Handling Customer Feedback = Customer Satisfaction? 12

13 Leaders should: Leadership establish unity of purpose and direction of the organization, and create and maintain the internal environment in which people can become fully involved in achieving the organization s objectives. 13

14 Your Organization s Goals are Captured in its Quality Policy The quality policy was developed by top management to: tell customers what your quality goals are, and tell all employees what they should strive for Do you know your organization s quality policy? Insert Quality Policy Statement Here 14

15 Your Organization s Goals are Achieved through Corporate Objectives and Management Actions Our key corporate objectives are to: CI Objective #1: CI Objective #2: CI Objective #3: Do you know you contribute to achievement of your organization s key corporate objectives? (discuss and/or give examples) 15

16 Performance Against Desired Results Actions are taken when management or customer objectives are NOT achieved: defect targets/goals (PPM) process capability (Cpk, Ppk) process efficiency (scrap, waste) On-Time Delivery (schedule adherence) Expediting Costs (premium freight) 16

17 Process Approach INPUT ACTIVITY OUTPUT Monitor more than process output: (typically through inspection activities) Monitor inputs and transformation activities as well: (i.e. define/control input, develop controls and mechanisms to manage the activity, and define/measure output in terms of desired results that are linked to established the organization s performance and improvement objectives) 17

18 a simple process model 18

19 Production and Service processes must be... Capable Effective Efficient Continually Improved 19

20 Product/Service Quality must be Planned Verified Validated Monitored 20

21 System Approach Identify, understand, and manage interrelated processes (system) the output of one process is the input to one or more subsequent processes in the system these interfaces must be managed to ensure the outputs of a process meet the input requirements of related processes that follow 21

22 Involvement of People People at all levels are the essence of an organization, and their full involvement enables... their abilities to be used... for the organization s benefit 22

23 Continual Improvement Continual Continuous Continual improvement of the organization s overall performance should be a permanent objective: improvement activities must be planned (to take action to achieve a desired result) and monitored for effectiveness (to make sure desired results are sustained) 23

24 Root Causes of Problems must be identified and eliminated Process Monitoring Internal Audits Complaint Processing Nonconforming Product Control Corrective/Preventive Action 24

25 The QMS must be used for continual improvement... Improve Process through PDCA Cycle Plan Do Act Check QMS Results Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results Improvement Objective Baseline Performance 25

26 Factual Approach to Decision Making Effective decisions are: based on the analysis of data and information. 26

27 Mutually Beneficial Supplier Relationships An organization and its suppliers are inter-dependent so: a mutually beneficial relationship enhances the ability of both to create value. 27

28 Purchased materials and services must be what s needed... Purchase Document and Data Control Supplier Evaluation and Monitoring 28

29 An ISO 9001 QMS Benefits You You get good materials and correct data and information to work with The equipment and tools you use are suitable and in good condition You receive the necessary instructions and training to do your job You are able to quickly find things and obtain the information you need Should there be anything that prevents you from doing a good job, you are able to report the problem and get help to do something about it 29

30 An ISO 9001 QMS Benefits the Whole Organization The customer s needs and requirements are well understood Suppliers and subcontractors provide high quality materials and services All activities, from taking orders to shipping finished goods, are planned and coordinated Rejects and rework rates are decreased, saving materials and time while improving efficiency and productivity All functions and personnel can identify problems affecting quality and find and implement solutions The organization supplies better quality products and wins new customers and markets 30

31 You can help implement an effective QMS... Learn how the quality system works Help define and implement your portion of the quality system (i.e. YOUR PROCESSES): Say what you do (document) Do what you say (implement) Prove it (keep records) Improve it (communicate and participate in quality audits) Help maintain document control Report problems 31

32 You can help prepare for the ISO 9001 audit... Know the organization s quality policy Check your documents and records Clean up your work area Prepare to demonstrate to the auditors how you use the QMS to manage YOUR PROCESSES: Say what you do Do what you say Prove it Improve it 32

33 Employee Handout for today s Overview of ISO 9001:2008 ISO 9001 Benefits the Organization The customer s needs and requirements are well understood Suppliers provide high quality materials and services All activities, from taking orders to shipping finished goods, are planned and coordinated Rejects and rework are decreased Everyone gets involved in improvement The organization supplies higher quality products and wins new customers ISO 9001 Benefits You... You get good materials and correct data and information to work with The equipment and tools you use are suitable and in good condition You receive the necessary instructions and training to do your job You are able to quickly find things and obtain the information you need Should there be anything that prevents you from doing a good job, you are able to report the problem and get help to do something about it You Can Help Implement it... Learn how the quality system works Help develop procedures and work instructions for your portion of the system i.e. your processes... Say what you do Do what you say Prove it Improve it Help maintain document control Report problems Participate in internal audits and process 33 improvement activities