ISO 9001:2008

1. ISO 9001:2008 Actually, How to Implement a Quality Management System December 15, 2010

2. AGENDA • 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

3. Why the initials “ISO” • organización internacional de normalización • internasyonal na organisasyon ng istandardisasyon • Διεθνής Οργανισμός Τυποποίησης • “iso” is the Greek root for “equal”

4. 1. ISO 9001 Structure • Quick History • Original Standard in 1987 • 20 clauses • Procedure-based • Revision in 1994 • A “tweak” • Revision in 2000 • Major overhaul • 8 sections • Focus on the Customer • Focus on Business Results • Revision in 2008 • A “tweak” http://www.iso.org/iso/about.htm

5. The 2008 “Tweak” • ISO 9001:2008 did not introduce additional requirements • Nor did it change the intent of the ISO 9001:2000 standard. • ISO 9001:2008 was developed in order to: • Introduce clarifications to the existing requirements of ISO 9001:2000 and • Introduce changes that are intended to improve compatibility with ISO 14001:2004, Environmental Management Systems.

6. Some Simple Clarifying Examples

7. Some More Substantial Clarifying Examples • Clause 4.2.3, Control of Documents • Expanded to clarify documents of external origin • Clause 6.2.2, Competence, Training and Awareness • Determination of needed competencies, emphasizing taking whatever action is needed to close competency gaps, and requiring evaluation of the effectiveness of the actions taken to close those gaps. • Clause 8.3, Control of Nonconforming Product • The addition of “Where applicable…” to recognize that it is not always possible to deal with nonconforming products or services.

8. 2. Eight Quality Management Principles Customer Focus Leadership Involvement of People Process approach Systems approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships

9. Who remembers Mnemonics? Every Good Boy Deserves Fudge HOMES My Very Educated Mother Just Served Us Nine Pickles

10. Real hot, maybe 100 degrees. It’s a hot day A cute little boy is getting his first haircut. At an old style barber shop 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 sun……the little kid……..the fan……hair clippings being blown all over the place…………and you get There’s no air conditioning, so the only break from the heat is a small fan. CLIPSCFM

11. Eight Quality Management Principles Customer Focus Leadership Involvement of People Process approach Systems approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships

12. 3. The soon-to-be-Famous Circle Chart

14. Quality Management System CUSTOMERS Feedback 8.2 Monitoring Customer Satisfaction 8.2 Internal Audits Covering the entire QMS is: 4.2.3 DOCUMENT CONTROL AND 4.2.4 RECORDS CONTROL Shipping & Delivery 8.3 Control of Nonconforming Product 8.4 Analysis of Data (Suppliers, Process, Product, Customer) 7.6 Monitoring & Measuring Devices 8.5 Corrective & Preventive Action 8.5 CONTINUAL IMPROVEMENT 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 7.5 Production Control 5.6 Management Review 5.4 Quality Objectives 7.4 Purchasing & Receiving 7.0 PRODUCT REALIZATION 5.0 MANAGEMENT RESPONSIBILITY 5.3 Quality Policy 7.3 Design 5.1 Management Commitment 6.0 RESOURCE MANAGEMENT 7.1 Planning 6.2 Human Resources (Training) 6.3 Infrastructure 6.4 Work Environment Bids, Quotations, Orders, and Contracts CUSTOMERS CUSTOMER REQUIREMENTS

15. 4. Implementing a Quality Management System • 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 Adapted from: Cianfrani, Tsiakais, West, ISO 9001:2008 Explained, 3rd edition, ASQ Quality Press, 2009

16. 4. Implementing a Quality Management System (cont) • Review or create: • Quality objectives that align with business objectives • Quality Policy • Quality Manual (Level I document) • SOPs (Level II documents) • Need to address a minimum of 6 areas • Work Instructions (Level III documents) • Forms (Level IV documents) • 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

17. 5. 3rd Party Certification • 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

18. Some questions to ask 3rd Party Registrars • Are you accredited by a signatory to the International Accreditation Forum? • Are you qualified to audit in our industrial class? • Can you accommodate our expected registration date? • May I speak to some of your current customers to get a feel for your customer service? Adapted from: “Registrar Search Simplified”, Craig Cochran, Quality Digest, February 2006

19. More questions to ask 3rd Party Registrars • Ask to interview the lead auditor who will be assigned: • Can you tell me about your experiences working in our industry? • How are major nonconformities handled? • How do you feel about disagreements when they arise between you and the customer? • Can you tell me about an audit situation when you and a customer had a disagreement on interpretations and how the disagreement was resolved? • What are the three most important things I should know about you?

20. Still more questions to ask 3rd Party Registrars • Understand all the costs: • What is the fee per auditor day? • Will we be billed for travel time? • (Of course you will be charged for actual travel, lodging and meals) • Get a list of all other fees: • Application fee • Admin fee • Report writing fee • Maintenance fee • Use of logo fee

21. 6. Possible Project Plan You have already embraced the 8 Quality Management Principles and You have already engaged the Top Managers

22. Typical 3rd Party Certification Costs • Assume $1300 per auditor day • 1st year certification • Admin fee $ 500 • Pre-Assessment fee (2 days) $2600 • Pre-Assessment travel $1000 • Practice certification fee (3 days) $3900 • Practice certification travel $1200 • Formal certification fee (5 days) $6500 • Formal certification travel $1600 • 2nd year surveillance • Admin fee $ 500 • Surveillance fee (2 days) $2600 • Surveillance travel $1000 • 3rd year recertification • Admin fee $ 500 • Recertification (5 days) $6500 • Recertification travel $1600 • THREE YEAR TOTAL $30000

23. 7. Quality Management System Summary • Say what you do • Write it down in standard format • Do what you say • Keep excellent records • Audit to verify • React to gaps • Review at Top Management level • Build in continual improvement

24. 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

25. Thank you!