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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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    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

    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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    ISO 9001:2008 Interpretation of the Requirements

    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 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 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 organizations 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 organizations 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 ganizations 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 ganizations objec-tives.

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

    abilitiestobeusedfortheorganizationsbenefit.

    4) Process approach Adesiredresultcanbeachievedmoreefficientlyiftheactivitiesandassociatedresourcesaremanagedas

    a process.

    5) System approach to management Identifiying,understandingandmanaginginterrelatedprocessesasasystemcontributetotheorganiza-

    tionseffectivenessandefficiencyinachievingitsobjectives.

    6) Continual improvement Continual improvement of the organizations overall performance schould be a permanent objective of the

    organization.

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    ISO 9001:2008 Interpretation of the Requirements

    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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    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) 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 organizations overall performance aiming towards the organizations 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 organizations 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 organizations 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 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 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 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 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

    Providingmorepreciseevidenceofthemanagementsystemseffectiveness

    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

    Descriptionofthedocumentedproceduresrequiredbythestandard

    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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    ISO 9001:2008 Interpretation of the Requirements

    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 organizations 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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