Umschl.QM ISO engl. komplett_Layout 1 21.11.

11 10:00 Seite 1

er

pt

Interpretation of ISO 9001:2008-12 Requirements

with Consideration of ISO 9004:2009
6th revised edition

-e

xc

ISO 9001:2008

More about the program under

www.tuev-media.de

ISBN 978-3-8249-1480-7

ISO 9001:2008 Interpretation of the Requirements

On the use of this publication

This publication is intended for auditors, management representatives, organizations and consultants as well as all
those involved in the establishment and maintenance of a quality management system.
It interprets and explains the requirements of ISO 9001:2008 in conjunction with ISO 9004:2009, the guideline for
managing for the sustained success of an or ganization. The objective of the publication is to improve the under standing of the requirements of the standard and provide reasonable suggestions for their direct implementation
based on numerous practical examples.
In Part A of this publication the reader is given an introduction to the objectives, structure and the most important
characteristics of ISO 9001:2008.
In Part B, the major part of this publication, the requirements of the standard are listed by keywords in a table and
interpreted with respect to its application in practice. Examples are provided with the intention to show the reader
how the fulfillment of requirements can be documented.

The recommendations of ISO 9004:2009 regarding sustained improvement of the overall performance of an or
ganization were summarized as key aspects, avoiding redundancies with requirements of the ISO 9001:2008 standard.
This provides the reader with a compact overview of compatibility between ISO 9001:2008 and ISO 9004:2009.

-e

xc

er

pt

The key indicators examples in the last column reflect the options for managing continual improvement and making the results evident and transparent for interested parties and employees.

TV Media GmbH

-e

xc

er

pt

ISO 9001:2008 Interpretation of the Requirements

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Table of contents
A

ISO 9001:2008 An introduction

1

General information
1.1 Development of the standard
1.2 Application of the standard
1.3 Exclusion of requirements
1.4 The importance of the standard for the organization

Process approach and interactions

Quality management principles

Practical hints for sustained success (ISO 9004)

Continual improvement via key indicators

Customer satisfaction

Adaptation of existing quality management systems

Required documentation for the management system

Compatibility with other standards

pt

ISO 9001:2008 Interpretation of the requirements of ISO 9001:2008 Table

er

Explanations of the table columns

Clause 4: Quality Management System

xc

Clause 5: Management responsibility

Clause 6: Resource management
Clause 7: Product realization

-e

Clause 8: Measurement, analysis, improvement

AnnexCorrespondence between ISO 9001:2008, ISO 9004:2009, ISO 14001:2004 and

OHSAS 18001:2007

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

ISO 9001:2008 An introduction

1 General
1.1

Development of the standard

The international standards organization (ISO) developed the ISO 9001:2008 standard in the technical committee
ISO/TC 176. It was implemented in December 2008, replacing the previous standard ISO 9001:2000.
ISO 9001:2008 has no new requirements. The intention of the previous standard ISO 9001:2000 was simply made
clearer with explanations and changes to the text. Some requirements were formulated more distinctly and strictly by additional notes; others were limited with wording such as where applicable. The majority of changes are
editorial or of a linguistic nature.

1.2

Application of the standard

er

pt

All the requirements defined in ISO 9001:2008 are of a general nature and are applicable to all organizations regardless of type and size and the nature of the products produced. Not to be overlooked, however, is that the wording in the standard is to some extent quite clearly oriented toward terms and expressions of production operations.
Clause 7 Product realization, 7.6 Control of monitoring and measuring equipment or 8.3 Control of nonconforming products are examples of this. Among other things, this led to the development of a series of sector-specific standards using ISO 9001 as a basis and adapting it to the particular sector with additional requirements and
specific explanations. Here are a few examples:
Automotive supply industry: ISO/TS 16949

Aerospace industry: EN 9100

Food industry: ISO 22000

Crop production: ISO 22006

Medical device manufacturers: ISO 13485

Medical device packaging: ISO 15378

Transport packaging for dangerous goods: ISO 16106

Software: ISO/IEC 90003

Health care: IWA 1

Educational organizations: IWA 2

Local government: IWA 4

Transportation: EN 12507 and 12798

1.3

-e

xc

Exclusion of requirements

If one or more requirements cannot be applied due to the nature of an or ganization and its products, these re quirements can be considered for exclusion. However, your visitation must exclude only those requirements from
quality management system which do not adversely af fect the capacity or responsibility of the organization to
make products which meet customer requirements and the relevant statutory and regulatory requirements. Such
exclusions are limited to requirements within Clause 7. Exclusions must be justified in quality manual (see also
Clause4.2.2). Here the following can be considered:

Product type

Customer requirements

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Statutory and regulatory requirements

Scope of responsibility

Consequently, all requirements of Clauses 4, 5, 6 and 8 must be met completely to verify conformity. This means,
for example, that development cannot be excluded if the organization bears full responsibility for the product.

1.4

The importance of the standard for the organization

The development, introduction and implementation of a quality management system is regarded as a strategic corporate decision to ensure competitiveness of the organization. This can be achieved in an effective and sustained
manner with the introduction and application of the management system based on this standard.
The design and implementation of an organizations quality management system is influenced by its environment,
its changes and the risks associated with this environment, by the requirements of the or ganization and the market, the strategic objectives, the products produced and the processes used as well as the size and structure of the
organization. The present standard explicitly demands no unification of the structures and documentation in the
organizations.

Compatibility with other standards

er

pt

After the revision of ISO 9004 in 2009, both standards are similar in structure but are not a consistent pair of standards as before. The standards complement each other but can also be applied independently. Whereas the focus
of ISO 9001 is primarily on customers, ISO 9004:2009 covers requirements and expectations of all relevant interested parties (customers, suppliers, employees, owners/shareholders, the public, etc.) and provides guidance to
systematic, sustained improvement of the organizations overall performance.

xc

ISO 9001:2008 is oriented with respect to the standard ISO 14001:2004 Environmental management systems
Requirements with guidance for use to increase the compatibility of both standards in favor of the user community.

-e

The table in the annex of this publication provides an overview of how the requirements of ISO 9001:2008
correspond to the requirements of other management system standards such as ISO 14001 and OHSAS 18001 (occupational safety management).

Process approach and interactions

Each activity in which input can be converted to the desired output can be regarded as a process. In order to operate effectively, organizations must identify, define and control the interactions of processes associated with one
another. Often, the result of one process constitutes the direct input of the next one. The systematic identification,
analysis and control of these various processes in an organization and particularly their mutual interactions are referred to as a process approach and must be implemented by the organization. ISO 9001:2008 supports this process approach to quality management. Figure 1 shows the ISO 9001:2008 process model.
The organizations top management defines the requirements and takes responsibility for implementation and application of the requirement (Clause 5 of the standard); the means necessary are defined and deployed under a
Resource management (Clause 6 of the standard); processes with their interactions are developed and applied
according to the Product realization (Clause 7 of the standard); the results are determined and analyzed under
Measurement, analysis and improvement (Clause 8 of the standard). The systematic review of the QM system
(Clause 5.6 of the standard), causes a feed-back of informations to the top management, which is responsible for
approving changes to the QM system or initiating improvements.
For Product realization, it is very importat that customers and other interested parties clearly define their requirements for the product. Process management handles all processes required for implementing the product and verifies or validates the process results. Measuring of the satisfaction of customers and other interested parties pro vides the basis for reviewing product quality.

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Cointinual measurement of customer satisfaction reinforces the trust of customers in the or ganizations ability to
deliver quality. It is an importan t condition for documenting continual improvement. Efforts regarding these requirements must be verified.
Regarding process interactions, the provision of resources such as

material, machines, energy, environment

and necessary information such as

methods, requirements, data, facts, analyses and timetables

must be considered. Displaying the processes and their interactions by a process flow chart can be helpful. Examples of this are shown in Figures 2 to 4.

Quality management principles

Clear definitions of processes and easy-to-understand visual workflows, focussed on the value chain, are some
of the mayor benefits of a process-based QM system. They make it easy for each employee to recognize his own
processes and lead to a better understanding and more acceptance in carrying out committed duties. Moreover, the
potentially motivated employees are tending to support a process of continual improvement for increasing customer satisfaction.

er

pt

Each organization pursues an adequate purpose. Accordingly, the requirements and expectations of customers and
other interested parties (employees, suppliers, owners and shareholders) play a decisive role. Moreover, gaining
competitive advantages preferably in an effective and efficient manner as well as achieving, maintaining and
improving organizational performance and capabilities are extremely important.

xc

In ISO 9000:2005 and 9004:2009, Annex B, eight principles of quality management for achieving the named objectives are defined. The application of these principles not only provides direct advantages for increasing the capability to deliver quality, but also makes an important contribution to the management of cost and risk; considering the benefits, costs and risks is decisive for the success of the organization.

-e

These principles are summarized as follows:

1) Customer focus

Organizations depend on their customers and should therefore understand the present and future needs of
their customers, meet the requirements and strive to exceed their expectations.

2) Leadership

Leaders bring the purpose and direction of the organization together. They should create and maintain the
internal environment in which people can become fully involved in achieving the or ganizations objectives.

3) Involvement of employees

Employees at all levels are the essence of an or ganization, and their complete involvement enables their
abilities to be used for the organizations benefit.

4) Process approach

A desired result can be achieved more efficiently if the activities and associated resources are managed as
a process.

5) System approach to management

Identifiying, understanding and managing interrelated processes as a system contribute to the organizations effectiveness and efficiency in achieving its objectives.

6) Continual improvement

Continual improvement of the organizations overall performance schould be a permanent objective of the
organization.
TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Continual improvement of the quality management system

Management
responsibility

Customers
Resource
management

Customers

Requirements

Measurement,
analysis and
improvement

Satisfaction

Output

Input

Productrealization

Product

Value-adding activities

pt

Information flow

Key

xc

er

Fig. 1: ISO 9001:2008 process model

-e

Management processes

Key processes

Supporting processes

Fig 2: Example of a process flow chart

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Human Resources
Planning

Agreement
on Objectives

Financial
Planning

Design and
Development
Production
Planning

Purchasing

Production

Sales

Customer
Service

Maintenance

Information
Management

Customer Needs

xc

er

Fig 3: Example of interactions between the processes

pt

Quality
Assurance

-e

Marketing

Design and
Development

Purchasing

Assignment
Trainer

Program Planning

Servicing/
Maintenance

Registration/
Invitation

Planning/Realization Trainings

Customer
Satisfaction

Proposals, Improvement System, Complaints

Fig 4: Excerpt of a flow chart for work processes

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

7) Factual approach to decision making

Effective decisions are based on the analysis of data and information.
8) Mutually benefitial supplier relationships

An organization and its suppliers are dependent on each other. A mutually beneficial relationship increases the ability of both to create value.

Practical hints for sustained success

Basically, the objectives of ISO 9001 are improving the quality of products and processes as well as increasing customer satisfaction, whereas ISO 9004:2009 provides a wider framework on quality management and addresses the
needs and expectations of all interested parties. In this respect, ISO 9004:2009 provides guidance to systematic, continual improvement of the organizations overall performance aiming towards the organizations sustained success.
This objective explicitly includes efficiency and increased profits and thus the economic success of the organization. Quality management is thus a primary concern for top management. The customer does not only benefit from
a stable desired quality of the product, but also from the better profitability of the supplier. On the other hand, the
supplier also benefits from the organizations improved competitiveness.

Continual improvement via key indicators

er

pt

In order to provide the user of ISO 9001 with the recommendations of ISO 9004:2008 as well, the table in Part B
of this publication contains the column Practical hints for sustained success with recommendations for improving the organizations overall performance.

The requirement for continual improvement is a recurrent theme in all requirements of the standard. To verify the
fulfillment of the requirement, it is necessary to define, measure and compare key indicators.

xc

Key indicators are a core element for continual improvement and advancement of management systems.

-e

An oranization remains fit for the customer if the criteriameasured are precisely those which are decisive for the
customer, who wants to achieve competitive advantages.
Key indicators enable the companys potential for improvement to be identified and the progress of measures for
improvement to be monitored systematically. Furthermore, key indicators enable internal benchmarks to be applied, allowing internal performance competitions.
However, the definition of key indicators must be done in a manner specific to the organization and should be part of
defining quality objectives. They must be defined or confirmed by top management, for example using the Balanced
Score Card. In this regard, it must be considered that too many key indicators increase the effort of measurement, reducing the benefit. Moreover, it must be considered that employees must be able to influence key indicators and qual
ity objectives. The key indicators must also be updated permanently, at least periodically, as part of the quality targets.
The review of the quality management system should be based on key indicators and should provide evidence of
continual improvement. In addition, this requirement is emphasized by the fact that the requirements for corrective
and preventive actions have been defined as separate requirements see Clause 8.5.2 and 8.5.3.

Customer satisfaction

Increasing customer satisfaction, the foremost objective of ISO 9001, is intended to be achieved by effective application of the quality management system. This also includes compliance with legal and regulatory requirements.
Customer satisfaction must be monitored and measured continually, considering a great number of indicators. For
example, reducing the rate of complaints is an important indicator, but not the only one by far. Quality costs, sales
and profit figures, increasing occupational safety as well as the results of an active customer survey are o ther examples of important indicators.
TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Adaptation of existing quality management systems

The purpose of the ISO 9001 and ISO 9004 standards is to define appropriate requirements for an organizations
quality management system and to provide top management with a guideline for introducing and using the qual ity management system to improve the overall performance of the organization. ISO 9004 in particular offers a
guideline to achieve sustained success in an environment which is constantly changing. The combined application
of ISO 9001 and 9004 can contribute effectively and efficiently to customer satisfaction while at the same time effect benefits for other interested parties.
The organization should review whether its current QM system meets the detailed requirements of ISO 9001.
The following aspects should be reviewed in particular:
Identification of customer expectations

The obligation to determine and assess customer satisfaction

Documentation and assessment of continual improvement

Evaluation of the effectiveness of training courses

Description of resource management

Providing more precise evidence of the management systems effectiveness

Identification and definition of the processes required for the system, their sequence and interactions

pt

Required documentation for the management system

er

The extent of the QM documentation can differ from one organization to another due to the size of the organization, the complexity of the products and processes and the competence of employees. For this reason, the standard
requires the following content as a minimum:
Description of the quality policy and the quality objectives

Establishing a quality management maual

Description of the documented procedures required by the standard

Description of documents and records necessary to ensure the effective planning, operation and conrol of
the processes

-e

xc

The following minimum content is required for the quality manual:

Scope of the quality management system

Justification for any exclusion of requirements

Description of the following 6 processes required by the standard (documented procedures):

Control of documents

Control of quality records

Internal audits

Control of nonconforming products

Corrective actions

Preventive actions

Description of the interaction between the processes of the quality management system

To satisfy the further requirement of the standard for written records, at least the record type is to be defined in the
quality manual and its annexes.

10

TV Media GmbH

ISO 9001:2008 Interpretation of the Requirements

Table for interpretation of the requirements

To support the user of the standard in the practical implementation of the requirements and in the preparation and
performance of internal audits, the following table provides an interpretation of the standard requirements and additional useful information. A consistent set of columns is used for this purpose throughout this section:
Requirements of the
ISO9001:2008

Interpretation/Activities

Documentary examples/
Conformity evidence

Practical hints for sustained

success (ISO 9004:2009)

Examples of key
indicators

Explanations of the table columns

1

Requirements of the ISO 9001:2008

The requirements are listed by keywords, not the full wording. This facilitates work in practice, but it does not substitute for knowledge of the original text of the standard.

2 Interpretation/Activities

pt

This column explains what is meant by the requirement and/or which activities are needed, for example, for practical implementation of the requirement.

Documentation examples/Conformity evidence

Practical hints for sustained success (ISO 9004:2009)

xc

er

This column contains examples of documentary evidence which enable fulfillment of the requirements of the standard to be verified.

This column lists additional aspects of ISO 9004:2009 which can be considered for systematic,continual improvement of the organizations overall performance.

-e

If there is no information in this column, ISO 9004 has nothing further to add to this aspect. Conversely, ISO 9004
contains aspects for which there are no equivalents in ISO 9001.

Examples of key indicators

This column lists practical examples of key indicators. These examples provide guidance, but should not be as sumed to cover all aspects.
The following table uses an asterisk (*) after headings to indicate that the standard requires objective evidence
of the fulfillment of this requirement (records).
Two asterisks (**) indicate that the corresponding procedure must also be documented.

TV Media GmbH

11

ISO 9001:2008 Interpretation of the Requirements

Clause 4: Quality Management System

Requirement
ISO 9001:2008

Interpretation/
Activities

Documentary
examples/Conformity evidence

Practical hints for

sustained success
(ISO 9004:2009)

Quality manual
Process/procedure instructions and other
applicable documents
Process flow diagrams
Management review
Investment plans
Action plans
Organization charts
Self-assessments
Analysis plans
Test plans

Application of the
8QM principles (4.1,
Annex B), in particular the
process approach
and the
system approach
to management
(7.1)
Development of the
QM system with the
objective of
efficient use of
resources
decision-making
based on facts
consideration of all
relevant interested
parties, not just
customers (4.1)
regular process review
and improvement (7.1)

Note:
ISO 9004 provides no
specifications for documentation of the quality
management system

Time/cost for documentation revisions

Time/cost for information research
Content preparation
and maintenance costs
Distribution costs
Intervals for checking
Archiving period and
costs
Coordination effort
Handling effort

Examples of
key indicators

4.1 General requirements

Establishment of a
customer-focused organization by
definition and representation of appropriate and u nderstandable
processes, their sequence and interactions
definition of efficiency
criteria
consideration of type,
scope and management of excluded processes
with the objective of
progress in the organization

Process quality
Process performance
Process time
Process costs
Process flexibility
Operating margin
Profit/Loss
Benchmarking (ranking)
Degree of target specifications fulfillment
Capacity figures (resources)

pt

Process identification
Process sequence and
interactions
Process management
Process resources
Process monitoring
Process improvement

4.2 Documentation requirements

4.2.1 General

Quality manual with

Justification of exclusions
Process environment
Quality objectives for
specific areas, backed
by key indicators
Process/procedure instructions
Commitment for continual improvement
and review
Intermediation in the
organization
Description of interactions
Test plans
Process flow diagrams
Drawings
Organization charts
Order records
Production documentation
Logs
Checklists
Test records
Capability evidence
documents
Declarations of conformity
Other documented evidence of conformity
with requirements

er

Definition of documentation for efficient

operation of the QM
system and processes by
considering
contractual requirements and other customer requirements
laws and standards
Corporate strategy
wishes of other interested parties
for implementing quality
policy and achieving
the quantified quality
objectives.
The documentation
should be compilated
considering the following:
Functional efficiency
User-friendliness
Resources required
Information management
Interfaces to customers, suppliers and other interested parties

xc

Quality policy
Quality objectives
Quality manual
Process documentation
Quality records

-e

12

TV Media GmbH