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ISO 9001:2008

Actually, How to Implement a Quality Management System December 15, 2010

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

Why the initials ISO


organizacin internacional de normalizacin internasyonal na organisasyon ng istandardisasyon iso is the Greek root for equal

1. ISO 9001 Structure


a. Quick History
i. Original Standard in 1987
a) 20 clauses b) Procedure-based

ii. Revision in 1994


a) A tweak

iii. Revision in 2000


a) b) c) d) Major overhaul 8 sections Focus on the Customer Focus on Business Results

iv. Revision in 2008


a) 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.

From

Some Simple Clarifying Examples


To Statutory and regulatory requirements Devices Conformity of the product to requirements

Regulatory Requirements Equipment Conformity of the product

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

2. Eight Quality Management Principles


1. 2. 3. 4. 5. 6. 7. 8.
8

Customer Focus Leadership Involvement of People Process approach Systems approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships

Who remembers Mnemonics?


Every Good Boy Deserves Fudge

HOMES

My Very Educated Mother Just Served Us Nine Pickles

Its a hot day

Real hot, maybe 100 degrees.

A cute little boy is getting his first haircut.

At an old style barber shop

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

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-Famous Circle Chart

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

Quality Management System


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 7.5 Production Control 7.4 Purchasing & Receiving 7.3 Design 7.1 Planning

8.5 Corrective & Preventive Action

8.5 CONTINUAL IMPROVEMENT

7.0 PRODUCT REALIZATION

8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

5.0 MANAGEMENT RESPONSIBILITY

5.6 Management Review 5.4 Quality Objectives 5.3 Quality Policy 5.1 Management Commitment

6.0 RESOURCE MANAGEMENT


6.2 Human Resources (Training) 6.3 Infrastructure 6.4 Work Environment

Bids, Quotations, Orders, and Contracts

CUSTOMER REQUIREMENTS

CUSTOMERS

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

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

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

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?

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?

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

6. Possible Project Plan


You have already embraced the 8 Quality Management Principles and You have already engaged the Top Managers
Description Jan Kickoff 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 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Typical 3 Party Certification Assume $1300 per auditor day Costs


rd
1st year certification
Admin fee Pre-Assessment fee (2 days) Pre-Assessment travel Practice certification fee (3 days) Practice certification travel Formal certification fee (5 days) Formal certification travel $ 500 $2600 $1000 $3900 $1200 $6500 $1600 $ 500 $2600 $1000 $ 500 $6500 $1600 $30000

2nd year surveillance


Admin fee Surveillance fee (2 days) Surveillance travel

3rd year recertification


Admin fee Recertification (5 days) Recertification travel

THREE YEAR TOTAL

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!

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