Standardized the • way things are done, reducing variability and making it easier to solve problemsFostered continual • improvement as an institutionalized core value, and provided a pla
Trang 1Cracking the Case of ISO 9001:2008 for Service
Trang 3ISO 9001:2008 Explained, Third Edition
Charles A Cianfrani, John E (Jack) West, and Joseph J Tsiakals
ISO 9001:2008 Explained, Third Edition (Spanish)
Charles A Cianfrani, John E (Jack) West, and Joseph J Tsiakals
Cracking the Case of ISO 9001:2008 for Manufacturing
John E (Jack) West and Charles A Cianfrani
The ASQ ISO 9000:2000 Handbook
Charles A Cianfrani, John E (Jack) West, and Joseph J Tsiakals
ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step
Guidelines for Successful Internal Audits, Second Edition
Ann W Phillips
How to Audit the Process-Based QMS
Dennis R Arter, John E (Jack) West, and Charles A Cianfrani
Unlocking the Power of Your QMS: Keys to Business Performance Improvement
John E (Jack) West and Charles A Cianfrani
The ASQ Auditing Handbook, Third Edition
J.P Russell, editing director
Quality Audits for Improved Performance, Third Edition
Dennis R Arter
The Quality Toolbox, Second Edition
Nancy R Tague
Mapping Work Processes, Second Edition
Bjørn Andersen, Tom Fagerhaug, Bjørnar Henriksen, and Lars E Onsøyen
Lean Kaizen: A Simplified Approach to Process Improvements
George Alukal and Anthony Manos
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition
Russell T Westcott, editor
To request a complimentary catalog of ASQ Quality Press publications, call
800-248-1946, or visit our Web site at http://www.asq.org/quality-press.
Trang 5Cracking the Case of ISO 9001:2008 for Service
A Simple Guide to Implementing Quality Management in Service Organizations Second Edition
Charles A Cianfrani and John E (Jack) West
ASQ Quality PressMilwaukee, Wisconsin
Trang 6© 2010 by American Society for Quality
All rights reserved Published 2009
Printed in the United States of America
12 11 10 09 08 07 06 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Cianfrani, Charles A.
Cracking the case of ISO 9001:2008 for service : a simple guide to implementing
quality management in service organizations / Charles A Cianfrani and John E
(Jack) West — 2nd ed.
p cm.
Originally published under title: Cracking the case of ISO 9001:2000 for service.
Includes bibliographical references and index.
ISBN 978-0-87389-762-4 (alk paper)
1 Quality control—Standards 2 ISO 9001 Standard I West, Jack, 1944– II
Cianfrani, Charles A Cracking the case of ISO 9001:2000 for service III Title.
TS156.C73 2009
658.4’013—dc22
2009043600
No part of this book may be reproduced in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without the prior written permission
of the publisher.
Publisher: William A Tony Acquisitions Editor: Matt Meinholz
Project Editor: Paul O’Mara Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and
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Printed on acid-free paper
Trang 7Contents
Chapter 1 Why Do ISO 9001:2008? 1
Chapter 2 Principles and Key Concepts 5
Quality Management Principles 5
Customers—Customer Focus and Measuring Satisfaction 7
Process Approach—Activities, Process Management, and the System Approach to Management 9
Alignment—Quality Objectives, Process Measurement, and Communications 12
Continual Improvement 13
Process Control to Facilitate Learning, Innovation, and Improvement 14
Leadership and Involvement at All Levels 15
Chapter 3 Implementing ISO 9001:2008 17
Introduction 17
Changes in ISO 9001:2008 from ISO 9001:2000 18
1 Scope 21
1.1 General 21
1.2 Application 21
2 Normative Reference 23
3 Terms and Definitions 23
Trang 84.1 General Requirements 24
4.2 Documentation Requirements 27
4.2.1 General 27
4.2.2 Quality Manual 29
4.2.3 Control of Documents 30
4.2.4 Control of Records 32
5.1 Management Commitment 35
5.2 Customer Focus 38
5.3 Quality Policy 39
5.4.1 Quality Objectives 41
5.4.2 Quality Management System Planning 43
5.5.1 Responsibility and Authority 45
5.5.2 Management Representative 46
5.5.3 Internal Communication 48
5.6 Management Review 50
5.6.1 General 50
5.6.2 Review Input 52
5.6.3 Review Output 54
6.1 Provision of Resources 56
6.2 Human Resources 58
6.2.1 General 58
6.2.2 Competence, Awareness and Training 60
6.3 Infrastructure 62
6.4 Work Environment 63
7.1 Planning of Product Realization 65
7.2.1 Determination of Requirements Related to the Product 68
7.2.2 Review of Requirements Related to the Product 70
7.2.3 Customer Communication 73
7.3 Design and Development 74
7.3.1 Design and Development Planning 74
7.3.2 Design and Development Inputs 76
7.3.3 Design and Development Outputs 79
Trang 97.3.4 Design and Development Review 81
7.3.5 Design and Development Verification 83
7.3.6 Design and Development Validation 85
7.3.7 Control of Design and Development Changes 87
7.4.1 Purchasing Process 88
7.4.2 Purchasing Information 90
7.4.3 Verification of Purchased Product 92
7.5.1 Control of Production and Service Provision 94
7.5.2 Validation of Processes for Production and Service Provision 98
7.5.3 Identification and Traceability 100
7.5.4 Customer Property 102
7.5.5 Preservation of Product 104
7.6 Control of Monitoring and Measuring Devices 106
8 Measurement, Analysis and Improvement 111
8.1 General 111
8.2 Monitoring and Measurement 114
8.2.1 Customer Satisfaction 114
8.2.2 Internal Audit 117
8.2.3 Monitoring and Measurement of Processes 121
8.2.4 Monitoring and Measurement of Product 123
8.3 Control of Nonconforming Product 126
8.4 Analysis of Data 129
8.5 Improvement 132
8.5.1 Continual Improvement 132
8.5.2 Corrective Action 133
8.5.3 Preventive Action 136
Chapter 4 Tools 139
Tools Discussed in This Section 139
Tool 1: Flowchart 140
Tool 2: Process Mapping 144
Tool 3: Brainstorming 148
Trang 10Tool 4: Gantt Chart 150
Tool 5: Run or Trend Chart 153
Tool 6: Histogram 156
Tool 7: Pareto Chart 160
Tool 8: Failure Modes and Effects Analysis 162
Tool 9: Sampling Inspection 165
Tool 10: Cause-and-Effect Diagram (Fishbone/Ishikawa Diagram) 172
Tool 11: Problem Solving 176
Tool 12: How to Conduct an Improvement Project 178
Glossary 183
Additional Reading 199
Index 201
Trang 11ISO 9001:2008 provides a model for quality management
While no such model is perfect, this one has proven to be applicable to virtually all sizes of organizations, in every marketplace, and for every product category throughout the
world for over 20 years
Why has ISO 9001 become the world’s most used dard? Why has it achieved such widespread acceptance and
stan-use? Certainly not because of the elegance of the text in the
standard, for this writing is among the dullest, most boring
prose the human mind and hand have ever crafted The ISO
9001 standard has survived and flourished because it adds
value to how organizations are managed, from the viewpoint
of both managers and workers
Workers like ISO 9001 because it makes life simpler In an ISO 9001 system, workers have:
A better understanding of what to do and how to do it
• The ability to ensure that their work meets
• requirements
Chapter 1
Why Do ISO 9001:2008?
Trang 12The ability to adjust processes when results are not
nonthreatening manner by focusing on process issues
An environment where they are not blamed for issues
•
that can be resolved only by managersMiddle managers have embraced ISO 9001 because it has
contributed to better control of processes and has resulted
in a higher level of consistency throughout the organization
Middle managers find that ISO 9001 has:
Made it easier to manage using facts and data rather
•
than opinionsEnhanced communication throughout the organization
Trang 13Standardized the
• way things are done, reducing variability and making it easier
to solve problemsFostered continual
• improvement as an institutionalized core value, and provided a platform for mov-ing to performance excellenceTop managers find that adopting a formal ISO 9001 quality
management system (QMS) helps the organization focus on
meeting objectives Top managers find that ISO 9001 has:
Improved their organization’s ability to fully understand
• and meet customer requirements in a consistent manner
Brought greater clarity to the goals and objectives of
• the organizationHelped align all employees and processes to meet
• objectivesImproved bottom-line performance by enhancing
• revenue and reducing costs, created a competi-tive advantage in some markets, and enabled their organizations to compete in markets where most other potential suppliers are registered
Trang 14Perhaps the most important reason for doing ISO 9001 is
survival In these times of uncertainty, people are concerned
about protecting their jobs
All of these reasons for embracing ISO 9001:2008 can
be reduced to a single effect: It facilitates quality
improve-ment And quality improvement has two positive impacts on
If an organization does not have a foundation of
uncompro-mising integrity, adventures into the world of performance
excellence or attempts to sustain improvement programs are
futile exercises The requirements of ISO 9001 can be used to
create a foundation upon which a successful organization can
be built They may not be sexy or exciting, but unless they are
performed consistently and well, an organization will not
pros-per and may not survive in the contemporary marketplace
This guide is intended to help everyone in an organization
participate in creating and sustaining a foundation of integrity,
and meeting requirements and customer expectations to the
advantage of everyone in the organization and to each of its
customers
Charlie Cianfranicianfranic@aol.comJack Westjwest92144@aol.com
Trang 15This chapter describes the eight quality management
principles that were used as the basis for the ment of ISO 9001:2008 It also discusses several key concepts that are important to fully understand
develop-QUALITY MANAGEMENT PRINCIPLES
The eight quality management principles were a key input in the
development of ISO 9001:2008 The principles may be found in
clause 0.2 of ISO 9000:2005, which is quoted as follows:
To lead and operate an organization fully, it is necessary to direct and control it in a systematic and transparent manner Success can result from implementing and maintaining a man- agement system that is designed to continually improve performance while addressing the needs
success-of all interested parties Managing an tion encompasses quality management amongst other management disciplines.
organiza-Chapter 2
Principles and Key Concepts
Trang 16Eight quality management principles have been identified that can be used by top management in order to lead the organization towards improved performance.
a Customer focus Organizations depend
on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
b Leadership Leaders establish unity of purpose and direction of the organization They should create and maintain the internal environment
in which people can become fully involved in achieving the organization’s objectives.
c Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
d Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process.
e System approach to management ing, understanding and managing inter- related processes as a system contributes
Identify-to the organization’s effectiveness and efficiency in achieving its objectives.
f Continual improvement Continual ment of the organization’s overall perfor-
Trang 17improve-mance should be a permanent objective of the organization.
g Factual approach to decision making tive decisions are based on the analysis of data and information.
Effec-h Mutually beneficial supplier relationships An organization and its suppliers are interdepen- dent and a mutually beneficial relationship enhances the ability of both to create value.
These eight quality management principles form the basis for the quality management system stan- dards within the ISO 9000 family (Source: ANSI/
ISO/ASQ Q9000-2005)More details on using the principles and the benefits of using
each can be found on the ISO Web site at http://www.iso.ch/
iso/en/iso900014000/iso9000/qmp.html
CUSTOMERS—CUSTOMER FOCUS AND MEASURING SATISFACTION
The purpose of ISO 9001 is to achieve customer satisfaction by
meeting customer requirements While meeting requirements
Trang 18and preventing nonconformities have been fundamental to
ISO 9001 since its initial issue in 1987, ISO 9001:2008
contin-ues the enhanced emphasis on customers There are key things
an organization needs to understand and implement that are
related to customer focus:
Top management is required (clause 5.1) to
The quality policy is required (clause 5.3) to contain
Customer feedback is required (clause 5.6.2) as an input
•
to the management review process, and improvement
of services offered related to requirements is a required management review output (clause 5.6.3)
Resources are required (clause 6.1) to “ enhance
cus-•
tomer satisfaction by meeting customer requirements.”
Customer requirements are the key input to product
•
realization Processes are required to determine
Trang 19(clause 7.2.1) and review (clause 7.2.2) those tomer requirements.
cus-Processes are required (clause 7.2.3) for
communica-• tions with customers
Monitoring of information related to customer
percep-• tion is required (clause 8.2.1)
Understanding this focus on the customer is critical to
imple-mentation of an effective ISO 9001 quality management system
The organization needs to carefully think about the interrelated
processes that are needed to meet the ISO 9001 requirements
in a way that will enhance customer satisfaction
PROCESS APPROACH—ACTIVITIES, PROCESS MANAGEMENT, AND THE SYSTEM APPROACH TO MANAGEMENT
Of particular importance among the eight quality management
principles are “system approach to management” and
“pro-cess approach.” People in any organization perform
activi-ties These activities are interrelated The process approach
involves managing the interrelated activities and associated
resources together to achieve a particular output
Process
Activity Activity
Activity
Outputs Inputs
Trang 20The system approach to management is basic to ISO
9001:2008 It encourages organizations to link interrelated
value-adding processes This linked system of processes results
in the outputs that go to customers Thus, the quality
manage-ment system needs to be composed of interrelated processes
Clause 0.2 of ISO 9001:2008 describes this concept of a system
of processes within an organization
This approach is easy to implement and has many
It helps the organization focus on what is important to
It encourages continual improvement, since any gaps
•
between customer requirements and process mance are highlighted—quantitatively—and can be targeted for improvement efforts
perfor-It directly supports the principles of “leadership” and
Trang 22In summary, the process approach is very generic and applicable
to all sectors and sizes of organizations It helps create value by
managing horizontally across functional departments, thereby
reducing quality problems that typically occur between
depart-ments And by tying key indicators of process performance to
customer needs and supplier performance, it focuses on what
is important to customers It also strongly encourages continual
improvement since it helps identify gaps between customer
requirements and process performance Finally, it involves
everyone and every level of the organization in meeting
require-ments, customer satisfaction, and continual improvement
The ISO committee responsible for the ISO 9000 family of
standards has developed additional guidance on the process
approach As of July 2009, N 544R3—ISO 9000 Introduction and
Support Package: Guidance on the Concept and Use of the
Pro-cess Approach for management systems was available as a free
download at http://www.bsi.org.uk/iso-tc176-sc2
ALIGNMENT—QUALITY OBJECTIVES, PROCESS
MEASUREMENT, AND COMMUNICATIONS
ISO 9001:2008 requires that quality objectives be measurable
and aligned with the quality policy It also requires that the
measurable objectives be deployed
The intent of this requirement is to ensure that
respon-sibility and authority for key dimensions of the quality
man-agement system are understood and deployed throughout the
organization with the involvement of top management
Ensur-ing that objectives are measurable is intended to enhance
improvement
Trang 23Clause 5.4.2 requires that the quality management system
be planned so that it meets the quality objectives This means
that the processes of the organization need to be operated,
monitored, and measured with the organization’s objectives
in mind Clause 8.2.3 requires that processes be measured
where applicable It makes sense to measure the processes
that are key to achieving the organization’s quality objectives
Objectives should be related to monitoring and measurement
of the processes of the organization Developing and
imple-menting a process to address the establishment and
deploy-ment across the organization of measurable objectives that are
aligned with the quality policy and truly drive the effectiveness of
the quality management system is an ongoing and challenging
task, but it can be one of the major keys to success
Properly deployed objectives with aligned process sures are important Communication is also needed to
mea-ensure that the organization’s people understand
require-ments (clauses 5.1, 5.2, and 5.5.2) and receive input on the
effectiveness of the system (clause 5.5.3)
CONTINUAL IMPROVEMENT
ISO 9001:2008 has a clear requirement for continual
improve-ment of quality manageimprove-ment system effectiveness
Sustain-able improvement of system effectiveness is accomplished by
improving the processes of the system Clause 8.5.1 describes
an improvement system that includes at a minimum:
Setting a quality policy with a commitment to continual
• improvement of the effectiveness of the quality man-agement system (clause 5.3)
Trang 24Establishing and deploying measurable objectives at
•
the relevant levels and functions of the organization
The objectives must be set with the commitment to improvement in mind (clauses 5.1 and 5.4.1)
Collecting data (clause 8.4)
Taking corrective action by eliminating the causes of
PROCESS CONTROL TO FACILITATE LEARNING,
INNOVATION, AND IMPROVEMENT
Many of the requirements of ISO 9001 involve the concept
that work is to be performed under controlled conditions This
concept is found throughout clause 7 and is best described in
clause 7.5.1 Control of processes implies low variability,
con-sistency of process performance, and conformity of product
and process to customer and internal requirements
Designing process controls is critical to success of the
quality management system If done wrong, the controls can
stifle positive changes and continual improvement But if the
Trang 25controls are properly integrated into the organization’s
pro-cesses, they can become important facilitators of learning,
innovation, and improvement It is not a matter of “balancing”
control with learning, innovation, and change Rather, it is a
matter of developing controls so that they will promote
learn-ing, innovation, and improvement When a control is being
designed and implemented, always ask the question, how
will the control facilitate learning, innovation, and continual
ISO 9001:2008 continues to emphasize the role of top
man-agement There are specific activities in which top managers
need to be involved Top management is required to:
Communicate the importance of meeting customer
• requirementsCreate and maintain awareness of quality policy
• Ensure that there are processes to determine and meet
• customer requirementsEstablish measurable quality objectives at relevant
• levels in the organization
Trang 26Ensure that the quality management system is planned
Clause 5.5.2 requires appointment of a representative of the
organization’s management to spearhead the establishment,
implementation, and maintenance of the quality management
system The importance of this appointment cannot be
over-emphasized This person needs to be able to work well with
top managers as well as with people at all other levels in the
organization
All People in the Organization
Everyone has a role in the deployment of a quality
man-agement system that conforms to the requirements of ISO
9001:2008 Some people are involved every hour of every
day Others may have periodic involvement For a few people,
involvement may be indirect or infrequent A key role of top
managers, supervisors, and the management representative
is to find ways to get and keep everyone in the organization
involved in the efficient and effective implementation and
improvement of the quality management system
Trang 27INTRODUCTION
This chapter provides a simplified explanation of the
require-ments of each subclause of ISO 9001:2008, why it is required,
tips for implementation, and questions to ask The format for
the explanations is as follows:
What Is the Requirement? Provides a brief description
of each requirement of ISO 9001:2008
Why Do It? Gives a brief description from an
organiza-tional and management perspective of why the ment should be addressed
require-Implementation Tips Provides tips for your
consider-ation as you develop processes to meet the requirements
In some cases, tools are referenced by an icon in the margin These tools are described in Chapter 4
The number of the tool is given in the icon
Questions to Ask Yourself Asks questions that should
be answered during implementation and auditing to ISO 9001:2008
Chapter 3
Implementing ISO 9001:2008
1
Trang 28CHANGES IN ISO 9001:2008 FROM ISO 9001:2000
Before providing an explanation of the requirements of
each subclause of ISO 9001:2008, a brief summation of the
changes in ISO 9001 that occurred between the 2000
edi-tion and the 2008 ediedi-tion is presented The summaedi-tion is not
intended to be exhaustive, but rather to provide for those who
have worked with ISO 9001:2000 an overview of the kinds of
changes that were made
The 2008 edition of ISO 9001 was targeted to provide
clari-fications of the existing requirements of ISO 9001:2000 and to
improve consistency with the ISO 14001:2004
environmen-tal standard Several wording changes were made to clarify
the intent of the standard, and some text was restructured to
enhance ease of understanding It was not intended that the
changes in 2008 would create new requirements or expand
existing requirements
From a practical point of view, if an organization was
com-plying with the intent and spirit of ISO 9001:2000, then
dem-onstrating compliance with ISO 9001:2008 will require little or
no additional actions
A few of the kinds of changes that have been made in
clauses 4 through 8 that we consider of interest or significance
are indicated in the following table This is not a listing of all
the changes between ISO 9001:2000 and ISO 9001:2008 A
more comprehensive indication of the changes can be found
in our book ISO 9001:2008 Explained in the chapters that
explain the content of each clause
Trang 29Requirement to defi ne the type and extent of controls 4.1 note 2,
note 3
Added notes Clarifi es what is an
out-sourced process and the controls needed for such processes
5.5.2 Clarifi es who can be the
management tive for an organization
representa-It is now clear that the management representa- tive must be a member of the management of the organization 6.2.1 Clarifi es the applicability
of competence ments
require-A broader view that tence is required of person- nel who can indirectly affect conformity of product to requirements 7.5.4 To emphasize the
compe-requirement to report to
a customer if customer equipment is lost or other- wise unsuitable for use
Clarifi es the requirement
to communicate lost or damaged customer equip- ment to the customer
7.6 Note added regarding
software used in tion activities
calibra-Clearly states the need
to confi rm the ability of software to perform its intend function 8.2.2 Clearer requirement for
a procedure for planning and conducting audits and the requirement for audit records and for correction and corrective action
This change is a rewording
of the 2000 standard requirements with emphasis
on the need for records and the clarifi cation that both correction and corrective action are required
( Continued )
Trang 300 Introduction
ISO 9001:2008
1 Scope
2 Normative reference
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Clause
8.2.3 Note added to guide what
to consider when mining suitable methods
deter-The note clarifi es the cept of suitable methods
con-8.3 Wording change to more
clearly indicate the ment for a documented procedure, and words added to address taking action after delivery
require-It is now clear that a documented procedure is required, as well as taking action after delivery of nonconforming product
Trang 311 SCOPE 1.1 GENERAL 1.2 APPLICATION
What Is the Requirement?
Clause 1.1 describes the scope of ISO 9001 ISO 9001:2008
is comprehensive in that it applies to all quality management
system processes from the identification of requirements to
the delivery and addressing of customer satisfaction It is
use-ful for demonstrating the ability of an organization to
consis-tently meet customer requirements for services The scope
makes it clear that an ISO 9001:2008–compliant quality
man-agement system is aimed at achieving customer satisfaction
by meeting requirements
Clause 1.2 deals with limiting the scope of the tion’s quality management system It provides that where any
organiza-requirements of clause 7 in the standard cannot be applied
due to the nature of an organization and the services it
pro-vides, they can be considered for exclusion Where exclusions
are made, claims of conformity to this International Standard
are not acceptable unless these exclusions are limited to
requirements in clause 7 and such exclusions do not affect
the organization’s ability, or responsibility, to provide service
that meets customer and applicable regulatory
require-ments In ISO 9001:2008, “regulatory requirements” has
been changed to “statutory and regulatory requirements” to
Trang 32ensure understanding that written laws (“statutes”) must be
considered as well as regulations
Why Do It?
To have an effective quality management system
•
focused on meeting customer requirements
To demonstrate the quality management system
cation for each
Questions to Ask Yourself
Does the quality manual include the scope of the
•
quality management system, including details of and justification for all exclusions taken under clause 1.2?
Trang 33Are exclusions appropriate and do they meet the
• criteria described in clause 1.2?
Does your quality management system ensure that you
• consistently meet customer requirements for service?
2 NORMATIVE REFERENCE
3 TERMS AND DEFINITIONS
What Is the Requirement?
The only normative reference in ISO 9001:2008 is ISO
9000:2005 Clause 3 of ISO 9000 contains the terms and
defi-nitions used in the ISO 9000 family When a term defined in ISO
9000 is used in ISO 9001, the ISO 9000 definition becomes
part of the requirements Annex A of ISO 9000 provides concept
diagrams showing how the various terms relate to one another
Annex A is informative and not part of the requirements
ISO 9000:2005 defines a “product” as the “result of a cess.” Certainly by this definition a “service” can be consid-
pro-ered a “product.” Clause 3 of ISO 9001:2008 points out that
in the text of ISO 9001:2005, “wherever the term ‘product’
occurs, it can also mean ‘service.’” In this pocket guide, the
term “service” is normally used instead of “product.”
Why Do It?
Clause 2 of ISO 9000:2005 on the fundamentals of
• quality management systems provides understanding
of basic concepts
Trang 34Definitions help the ISO 9001 user better understand
Question to Ask Yourself
Have you obtained a copy of ISO 9000:2005
What Is the Requirement?
The organization must establish, implement, and document
a quality management system In order to do this, the
pro-cesses of the system must be identified and their sequence
and interaction understood The criteria to effectively
man-age, operate, monitor, measure where applicable, analyze,
Trang 35and control the processes must be determined “Where
applicable” was added in ISO 9001:2008 to recognize that
sometimes measurement may not apply Resources must be
made available to operate, monitor, measure, and improve
the processes It is also necessary to provide for control of
any processes that are outsourced
Why Do It?
To ensure that activities and necessary resources are
• managed effectively
To understand and control the processes so that they
• are managed effectively
To ensure that all requirements are met
•
To consistently provide products that meet
• requirements
To continually improve the effectiveness of the quality
• management system by improving its processes
Implementation Tips
Identify your processes
• Identify inputs and outputs for each process
• Decide how to measure inputs, outputs, and/or
• process parametersCreate process maps for key processes
• Use relationship diagrams to show the interactions
•
of the processes
3 2
Trang 36Develop a flowchart of the process
• Link process measures to your quality objectives
• Strive for simplicity
•
Questions to Ask Yourself
Have the processes needed for quality management
monitoring of the processes?
Are processes measured, monitored, and analyzed,
mented where appropriate?
Is the quality management system established,
the services being provided been identified?
Has provision been made to ensure control of quality
•
management system processes that are outsourced?
1
Trang 374.2 DOCUMENTATION REQUIREMENTS
4.2.1 GENERAL
What Is the Requirement?
Documentation of the quality management system must
include a quality manual, the quality policy, the quality
objec-tives, the six documented procedures specifically called out
in ISO 9001, and other documents needed to effectively plan,
operate, and control the organization’s processes The
docu-mentation also needs to include the records called out in the
various clauses of ISO 9001
Implementation Tips
Identify the processes and interactions first (see
• clause 4.1)Simple processes with competent workers
• and simple interactions may not need to be documented
Use process maps
•
2
Trang 38Questions to Ask Yourself
Have the processes needed for quality management
•
been identified?
Are the quality policy and quality objectives
docu-•
mented and controlled?
Are the procedures required by ISO 9001:2008
monitoring of the processes?
Are processes measured as appropriate, monitored,
management system processes that are outsourced?
In determining the extent of documentation, has
con-•
sideration been given to the size of the organization, the complexity of processes, and the skills, training, and competence of your personnel?
Trang 394.2.2 QUALITY MANUAL
What Is the Requirement?
The quality manual provides a basic description of the
qual-ity management system It must describe the scope of the
quality management system and include the justification for
exclusions from clause 7 that the organization has found
appropriate The quality manual either includes or references
the documented procedures established for the quality
man-agement system The manual must describe the interactions
among the processes of the system
Why Do It?
To ensure consistent understanding of the overall
• quality management system among members of the organization
To ensure consistent understanding of the overall
qual-• ity management system among customers and other interested parties
To describe the basic commitments of the organization
• that are related to the quality management system
To provide a baseline for auditing the quality
manage-• ment system
Implementation Tips
Use diagrams to show process interactions
• Keep the quality manual short, simple, and structured
•
in the same manner in which the organization works
Trang 40Describe basics of processes in the quality manual; put
•
details in documented procedures or work instructions
Questions to Ask Yourself
Does the quality manual describe the interaction of
•
processes in the quality management system?
Does the quality manual either include or reference the
What Is the Requirement?
Quality management system documents require control
Con-trol of documents is one of the six processes that require a
documented procedure Control of each document starts with
an approval process to ensure adequacy before it is issued
There is a requirement that relevant versions of applicable
documents be available where they need to be used and that
both changes and the current revision status of each
ment be identified The process must ensure that the
docu-ments remain legible and identifiable Docudocu-ments need to be
reviewed and updated as necessary In cases where obsolete