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

http://www.iso.org/iso/about.htm

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

To
Statutory and regulatory
requirements

Equipment

Devices

Conformity 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
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

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

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
ISO Clause Name
7
PRODUCT REALIZATION
7.1
Planning of Product Realization
7.2
Customer-related Processes
Determination of Requirements Related to
7.2.1 the Product
Review of Requirements Related to the
7.2.2 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
Validation of Processes for Production and
7.5.2 Service Provision
7.5.3 Product Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
Control of Monitoring and Measuring
7.6
Equipment
MEASUREMENT, ANALYSIS AND
8
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
8.5.2 Corrective Actions

CUSTOMERS

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

8.0 MEASUREMENT,
ANALYSIS AND
IMPROVEMENT

6.0 RESOURCE
MANAGEMENT

8.5 CONTINUAL
IMPROVEMENT

5.0 MANAGEMENT
RESPONSIBILITY

7.5 Production Control

8.5 Corrective &

Preventive Action

7.0 PRODUCT
REALIZATION

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

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 forma
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, 3 edition, ASQ Quality Press,
rd

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

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
Feb Mar Apr May
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

Jun

Jul

Aug

Sep

Oct

Nov

Dec

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

Thank you!
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