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Interpretation of ISO 9001:2008-12 Requirementswith Consideration of ISO 9004:20096th revised edition

ISO 9001:2008

Umschl.QM ISO engl. komplett_Layout 1 21.11.11 10:00 Seite 1

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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 organi-zation 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.

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

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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

2 Compatibility with other standards

3 Process approach and interactions

4 Quality management principles

5 Practical hints for sustained success (ISO 9004)

6 Continual improvement via key indicators

7 Customer satisfaction

8 Adaptation of existing quality management systems

9 Required documentation for the management system

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

Explanations of the table columns

Clause 4: Quality Management System

Clause 5: Management responsibility

Clause 6: Resource management

Clause 7: Product realization

Clause 8: Measurement, analysis, improvement

Annex Correspondence between ISO 9001:2008, ISO 9004:2009, ISO 14001:2004 and OHSAS 18001:2007- e

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A 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 strict-ly 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

All the requirements defined in ISO 9001:2008 are of a general nature and are applicable to all organizations re-gardless of type and size and the nature of the products produced. Not to be overlooked, however, is that the word-ing 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 noncon-forming products” are examples of this. Among other things, this led to the development of a series of sector-spe-cific 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:

• Automotivesupplyindustry:ISO/TS16949

• Aerospaceindustry:EN9100

• Foodindustry:ISO22000

• Cropproduction:ISO22006

• Medicaldevicemanufacturers:ISO13485

• Medicaldevicepackaging:ISO15378

• Transportpackagingfordangerousgoods:ISO16106

• Software:ISO/IEC90003

• Healthcare:IWA1

• Educationalorganizations:IWA2

• Localgovernment:IWA4

• Transportation:EN12507and12798

1.3 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 Clause 4.2.2). Here the following can be considered:

• Producttype

• Customerrequirements

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• Statutoryandregulatoryrequirements

• Scopeofresponsibility

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 cor-porate 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 organization’s 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 mar-ket, 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.

2 Compatibility with other standards

After the revision of ISO 9004 in 2009, both standards are similar in structure but are not a “consistent pair of stan-dards” 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 in-terested parties (customers, suppliers, employees, owners/shareholders, the public, etc.) and provides guidance to systematic, sustained improvement of the organization’s overall performance.

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 commu-nity.

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 (oc-cupational safety management).

3 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 op-erate 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 re-ferred to as a “process approach” and must be implemented by the organization. ISO 9001:2008 supports this pro-cess approach to quality management. Figure 1 shows the ISO 9001:2008 process model.

The organization’s top management defines the requirements and takes responsibility for implementation and ap-plication 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 require-ments for the product. Process management handles all processes required for implementing the product and veri-fies or validates the process results. Measuring of the satisfaction of customers and other interested parties pro -vides the basis for reviewing product quality.

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Cointinual measurement of customer satisfaction reinforces the trust of customers in the or ganization’s ability to deliver quality. It is an importan t condition for documenting continual improvement. Efforts regarding these re-quirements 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,analysesandtimetables

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

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 cus-tomer satisfaction.

4 Quality management principles

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.

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

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 ganization’s objec-tives.

3) Involvement of employees Employees at all levels are the essence of an or ganization, and their complete involvement enables their

abilitiestobeusedfortheorganization’sbenefit.

4) Process approach Adesiredresultcanbeachievedmoreefficientlyiftheactivitiesandassociatedresourcesaremanagedas

a process.

5) System approach to management Identifiying,understandingandmanaginginterrelatedprocessesasasystemcontributetotheorganiza-

tion’seffectivenessandefficiencyinachievingitsobjectives.

6) Continual improvement Continual improvement of the organization’s overall performance schould be a permanent objective of the

organization.

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Continual improvement of the quality management system

Customers

Customers

Require-ments

Satisfaction

Product-realization

Managementresponsibility

Resourcemanagement

Measurement,analysis andimprovement

ProductInput Output

Value-adding activities

Information flow

Key

Fig. 1: ISO 9001:2008 process model

Fig 2: Example of a process flow chart

Management processes

Key processes

Supporting processes

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Design andDevelopment

Purchasing

CustomerService

ProductionPlanning

Production Sales

Human ResourcesPlanning

Agreementon Objectives

FinancialPlanning

QualityAssurance

Maintenance InformationManagement

Fig 3: Example of interactions between the processes

Fig 4: Excerpt of a flow chart for work processes

Customer Needs

Marketing

Design andDevelopment

Program Planning

Registration/Invitation

Purchasing

AssignmentTrainer

Servicing/Maintenance

Planning/Reali-zation Trainings

CustomerSatisfaction

Proposals, Improvement System, Complaints

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7) Factual approach to decision making Effective decisions are based on the analysis of data and information.

8) Mutuallybenefitialsupplierrelationships Anorganizationanditssuppliersaredependentoneachother.Amutuallybeneficialrelationshipincreas-

es the ability of both to create value.

5 Practical hints for sustained success

Basically, the objectives of ISO 9001 are improving the quality of products and processes as well as increasing cus-tomer 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, con-tinual improvement of the organization’s overall performance aiming towards the organization’s sustained success.

This objective explicitly includes efficiency and increased profits and thus the economic success of the organiza-tion. 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 organization’s improved competitiveness.

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 improv-ing the organization’s overall performance.

6 Continual improvement via key indicators

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.

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

An oranization remains “fit for the customer” if the criteria measured are precisely those which are decisive for the customer, who wants to achieve competitive advantages.

Key indicators enable the company’s 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 ap-plied, 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, re-ducing 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.

7 Customer satisfaction

Increasing customer satisfaction, the foremost objective of ISO 9001, is intended to be achieved by effective ap-plication 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 other ex-amples of important indicators.

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8 Adaptation of existing quality management systems

The purpose of the ISO 9001 and ISO 9004 standards is to define appropriate requirements for an organization’s 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 ef-fect 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:

• Identificationofcustomerexpectations

• Theobligationtodetermineandassesscustomersatisfaction

• Documentationandassessmentofcontinualimprovement

• Evaluationoftheeffectivenessoftrainingcourses

• Descriptionofresourcemanagement

• Providingmorepreciseevidenceofthemanagementsystem’seffectiveness

• Identificationanddefinitionoftheprocessesrequiredforthesystem,theirsequenceandinteractions

9 Required documentation for the management system

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

• Descriptionofthequalitypolicyandthequalityobjectives

• Establishingaqualitymanagementmaual

• Descriptionofthe“documentedprocedures”requiredbythestandard

• Descriptionofdocumentsandrecordsnecessarytoensuretheeffectiveplanning,operationandconrolofthe processes

The following minimum content is required for the quality manual:

• Scopeofthequalitymanagementsystem

• Justificationforanyexclusionofrequirements

• Descriptionofthefollowing6processesrequiredbythestandard(“documentedprocedures”):

– Control of documents

– Control of quality records

– Internal audits

– Control of nonconforming products

– Corrective actions

– Preventive actions

• Descriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem

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.

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B 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 ad-ditional useful information. A consistent set of columns is used for this purpose throughout this section:

Requirements of the ISO 9001:2008

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 sub-stitute for knowledge of the original text of the standard.

2 Interpretation/Activities

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

3 Documentation examples/Conformity evidence

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

4 Practical hints for sustained success (ISO 9004:2009)

This column lists additional aspects of ISO 9004:2009 which can be considered for systematic, continual improve-ment of the organization’s overall performance.

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.

5 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.

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Clause 4: Quality Management System

RequirementISO 9001:2008

Interpretation/ Activities

Documentary examples/Confor-

mity evidence

Practical hints for sustained success(ISO 9004:2009)

Examples of key indicators

4.1 General requirements• Processidentification• Processsequenceand

interactions• Processmanagement• Processresources• Processmonitoring• Processimprovement

Establishment of a customer-focused organi-zation by• definitionandrepre-

sentation of appropri-ate and understandable processes, their se-quence and interac-tions

• definitionofefficiencycriteria

• considerationoftype,scope and manage-ment of excluded pro-cesses

with the objective of progress in the organiza-tion

• Qualitymanual• Process/procedurein-

structions and other applicable documents

• Processflowdiagrams• Managementreview• Investmentplans• Actionplans• Organizationcharts• Self-assessments• Analysisplans• Testplans

• Applicationofthe8 QM principles (4.1, Annex B), in particu-lar the– “process approach”

and the – “system approach

to management” (7.1)

• DevelopmentoftheQM 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)

• regularprocessreviewand improvement (7.1)

• Processquality• Processperformance• Processtime• Processcosts• Processflexibility• Operatingmargin• Profit/Loss• Benchmarking(rank-

ing)• Degreeoftargetspeci-

fications fulfillment • Capacityfigures(re-

sources)

4.2 Documentation requirements4.2.1 General • Qualitypolicy• Qualityobjectives• Qualitymanual• Processdocumenta-

tion• Qualityrecords

Definition of docu-mentation for efficient operation of the QM system and processes by considering• contractualrequire-

ments and other cus-tomer requirements

• lawsandstandards• Corporatestrategy• wishesofotherinter-

ested partiesfor implementing quality policy and achieving the quantified quality objectives.The documentation should be compilated considering the follow-ing:• Functionalefficiency• User-friendliness• Resourcesrequired• Informationmanage-

ment• Interfacestocustom-

ers, suppliers and oth-er interested parties

Quality manual with• Justificationofexclu-

sions• Processenvironment• Qualityobjectivesfor

specific areas, backed by key indicators

• Process/procedurein-structions

• Commitmentforcon-tinual improvement and review

• Intermediationintheorganization

• Descriptionofinterac-tions

• Testplans• Processflowdiagrams• Drawings• Organizationcharts• Orderrecords• Productiondocumen-

tation• Logs• Checklists• Testrecords• Capabilityevidence

documents• Declarationsofcon-

formity • Otherdocumentedev-

idence of conformity with requirements

Note: ISO 9004 provides no specifications for docu-mentation of the quality management system

• Time/costfordocu-mentation revisions

• Time/costforinforma-tion research

• Contentpreparationand maintenance costs

• Distributioncosts• Intervalsforchecking• Archivingperiodand

costs• Coordinationeffort• Handlingeffort- e

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