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ISO 9001:2008 Actually, How to Implement a Quality Management System

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

1. ISO 9001 Structure a. Quick History i.

Original Standard in 1987 a) b)

20 clauses 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.

Some Simple Clarifying Examples From Regulatory Requirements Equipment Conformity of the product

To Statutory and regulatory requirements Devices 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 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


My Very Educated Mother Just Served Us Nine Pickles

It’s a hot day

Real hot, maybe 100 degrees.

A cute little boy is getting his first haircut.

At an old style barber shop

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-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 Clause Number 7 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3

ISO Clause Name PRODUCT REALIZATION Planning of Product Realization Customer-related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product Customer Communication Design and Development Design and Development Planning Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Design and Development Changes Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Product Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Equipment MEASUREMENT, ANALYSIS AND IMPROVEMENT General Monitoring and Measurement Customer Satisfaction Internal Audits Monitor and Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Actions Preventive Actions


Quality Management System Feedback

8.2 Monitoring Customer Satisfaction 8.2 Internal Audits

Shipping & Delivery

8.3 Control of Nonconforming Product 8.4 Analysis of Data (Suppliers, Process, Product, Customer)

7.4 Purchasing & Receiving 7.3 Design 7.1 Planning





7.5 Production Control

8.5 Corrective & Preventive Action


7.6 Monitoring & Measuring Devices

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

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

6.2 Human Resources (Training) 6.3 Infrastructure 6.4 Work Environment Bids, Quotations, Orders, and Contracts



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

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? Adapted from: “Registrar Search Simplified”, Craig Cochran, Quality Digest, February 2006

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 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













Typical 3rd Party Certification Costs •

Assume $1300 per auditor day

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

2nd year surveillance

$ 500 $2600 $1000 $3900 $1200 $6500 $1600

– Admin fee – Surveillance fee (2 days) – Surveillance travel

$ 500 $2600 $1000

– Admin fee – Recertification (5 days) – Recertification travel

$ 500 $6500 $1600

3rd year recertification



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 level 8. 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!

How to Implement ISO 9001  
How to Implement ISO 9001  

How to Implement ISO 9001