AGENDA
1. 2. 3. 4. 5. 6. 7. 8. ISO 9001 Structure Eight Quality Management Principles Soon-to-be-Famous Circle Chart Implementing a Quality Management System 3rd Party Registration Possible Project Plan Summary References
From
Customer Focus Leadership Involvement of People Process approach Systems approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships
HOMES
Theres no air conditioning, so the only break from the heat is a small fan.
Now, one bit of technical lingo. Air being blown by a fan is measured in cubic feet per minute, or CFM for short. So now, put it all together..the hot sunthe little kid..the fanhair clippings being blown all over the placeand you get
10
CLIPS CFM
ISO Clause Number 0 0.1 0.2 0.3 0.4 1 1.1 1.2 2 3 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 5 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 6 6.1 6.2 6.2.1 6.2.2 6.3 6.4
ISO Clause Name INTRODUCTION General Process Approach Relationship with ISO 9004 Compatibility with Other Management Systems SCOPE General Application NORMATIVE REFERENCES TERMS AND DEFINITIONS QUALITY MANAGEMENT SYSTEM General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records MANAGEMENT RESPONSIBILITY Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority, and Communication Responsibility and Authority Management Representative Internal Communications Management Review General Review Input Review Output RESOURCE MANAGEMENT Provision of Resources Human Resources General Competence, Training, and Awareness Infrastructure Work Environment
ISO ISO Clause Name Clause Number 7 PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer-related Processes 7.2.1 Determination of Requirements Related to the Product 7.2.2 Review of Requirements Related to the Product 7.2.3 Customer Communication 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Product Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measuring Equipment 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audits 8.2.3 Monitor 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 Improvement 8.5.1 Continual Improvement
CUSTOMERS
8.3 Control of Nonconforming Product 8.4 Analysis of Data (Suppliers, Process, Product, Customer)
7.6 Monitoring & Measuring Devices 7.5 Production Control 7.4 Purchasing & Receiving 7.3 Design 7.1 Planning
5.6 Management Review 5.4 Quality Objectives 5.3 Quality Policy 5.1 Management Commitment
CUSTOMER REQUIREMENTS
CUSTOMERS
Embrace the Eight Quality Management Principles Engage Top Managers Answer the question Why do we need a formal
Quality Management System? Conduct a gap analysis Determine where you are compared to where you want to be Identify areas for improvement
Create QMS performance metrics Begin Management Review Meetings Conduct Internal Auditor training Perform internal audits Respond to internal audits and fill gaps Focus on document control, recordkeeping, continual improvement and management review
5. 3 Party Certification
rd
Research and select a 3rd party registrar Optional Pre-assessment meeting (you actually get some consulting) Will need at least two Management Review meetings Will need a full cycle of internal audits Practice certification Respond to gaps Formal certification
7. Quality Management System Summary 1. Say what you do 2. Write it down in standard format 3. Do what you say 4. Keep excellent records 5. Audit to verify 6. React to gaps 7. Review at Top Management
8. References
ANSI/ISO/ASQ Q9001-2008: Quality management systems Requirements List price $105 ASQ member discount $84
Cianfrani, Tsiakais, West, ISO 9001:2008 Explained, 3rd Edition, ASQ Quality Press, 2009 List price $105 ASQ member discount $63
Thank you!