ISO 9001:2008Actually,

How to Implement a Quality Management System

December 15, 2010

AGENDA

1. ISO 9001 Structure2. Eight Quality Management Principles3. Soon-to-be-Famous Circle Chart4. Implementing a Quality Management System5. 3rd Party Registration6. Possible Project Plan7. Summary8. References

• organización internacional de normalización• internasyonal na organisasyon ng

istandardisasyon• Διεθνής Οργανισμός Τυποποίησης• “iso” is the Greek root for “equal”

Why the initials “ISO”

1. ISO 9001 Structurea. Quick History

i. Original Standard in 1987a) 20 clausesb) Procedure-based

ii. Revision in 1994a) A “tweak”

iii. Revision in 2000a) Major overhaulb) 8 sectionsc) Focus on the Customerd) Focus on Business Results

iv. Revision in 2008a) A “tweak”

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.

Some Simple Clarifying ExamplesFrom ToRegulatory Requirements Statutory and regulatory

requirementsEquipment DevicesConformity of the product Conformity of the product to

requirements

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.

2. Eight Quality Management Principles

8

1. Customer Focus 2. Leadership 3. Involvement of People 4. Process approach 5. Systems approach to management 6. Continual Improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships

Who remembers Mnemonics?

My Very Educated Mother Just Served Us Nine Pickles

HOMES

Every Good Boy Deserves Fudge

10

A cute little boy is getting his first haircut.

At an old style barber shop

CLIPS CFM

It’s a hot day Real hot, maybe 100 degrees.

There’s 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

sun……the little kid……..the fan……hair clippings being blown all over the

place…………and you get

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

3. The soon-to-be-FamousCircle Chart

ISO Clause Number ISO Clause Name

0 INTRODUCTION0.1 General0.2 Process Approach0.3 Relationship with ISO 90040.4 Compatibility with Other Management Systems1 SCOPE

1.1 General1.2 Application2 NORMATIVE REFERENCES3 TERMS AND DEFINITIONS4 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements4.2 Documentation Requirements

4.2.1 General4.2.2 Quality Manual4.2.3 Control of Documents4.2.4 Control of Records

5 MANAGEMENT RESPONSIBILITY5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning

5.4.1 Quality Objectives5.4.2 Quality Management System Planning5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority5.5.2 Management Representative5.5.3 Internal Communications5.6 Management Review

5.6.1 General5.6.2 Review Input5.6.3 Review Output

6 RESOURCE MANAGEMENT6.1 Provision of Resources6.2 Human Resources

6.2.1 General6.2.2 Competence, Training, and Awareness6.3 Infrastructure6.4 Work Environment

ISO Clause Number ISO Clause Name

7 PRODUCT REALIZATION7.1 Planning of Product Realization7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the Product7.2.2 Review of Requirements Related to the Product7.2.3 Customer Communication7.3 Design and Development

7.3.1 Design and Development Planning7.3.2 Design and Development Inputs7.3.3 Design and Development Outputs7.3.4 Design and Development Review7.3.5 Design and Development Verification7.3.6 Design and Development Validation7.3.7 Design and Development Changes7.4 Purchasing

7.4.1 Purchasing Process7.4.2 Purchasing Information7.4.3 Verification of Purchased Product7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

7.5.2Validation of Processes for Production and Service Provision

7.5.3 Product Identification and Traceability7.5.4 Customer Property7.5.5 Preservation of Product7.6 Control of Monitoring and Measuring Equipment8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction8.2.2 Internal Audits8.2.3 Monitor and Measurement of Processes8.2.4 Monitoring and Measurement of Product8.3 Control of Nonconforming Product8.4 Analysis of Data8.5 Improvement

8.5.1 Continual Improvement8.5.2 Corrective Actions8.5.3 Preventive Actions

CUSTOMERS

CUSTOMERS

5.6 Management Review

5.3 Quality Policy

5.1 Management Commitment

6.4 Work Environment

6.3 Infrastructure

6.2 Human Resources(Training)

7.1 Planning

8.5 Corrective &Preventive Action

8.4 Analysis of Data(Suppliers, Process,Product, Customer)

8.3 Control of Nonconforming Product

8.2 Monitoring CustomerSatisfaction

8.2 Internal Audits

Bids, Quotations,Orders, and Contracts

CUSTOMER REQUIREMENTS

Shipping &Delivery

Feedback

8.5 CONTINUALIMPROVEMENT

5.0 MA

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6.0 RESOURCEMANAGEMENT

7.0

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8.0 MEASUREMENT,ANALYSIS ANDIMPROVEMENT

Covering the entire QMS is:4.2.3 DOCUMENT CONTROL AND 4.2.4 RECORDS

CONTROL

Quality Management System

7.6 Monitoring &Measuring Devices

7.5 Production Control

7.4 Purchasing &Receiving

7.3 Design

5.4 Quality Objectives

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

• 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

4. Implementing a Quality Management System (cont)

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

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?

• 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?

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

Still more questions to ask 3rd Party Registrars

Description Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov DecKickoff meeting Select 3rd party registrar Gap Analysis Document review Create QMS metrics Mgt Review Meetings Pre-Assessment meeting Internal Auditor training Internal Audits Round 1 Practice certification Internal Audits Round 2 Formal certification

6. Possible Project PlanYou have already embraced the 8 Quality Management Principles

andYou have already engaged the Top Managers

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

7. Quality Management System Summary

1. Say what you do2. Write it down in standard format3. Do what you say4. Keep excellent records5. Audit to verify6. React to gaps7. Review at Top Management level8. Build in continual improvement

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!