ISO 9001QUALITY MANAGEMENT SYSTEM - REQUIREMENTS

When Recognition Matters

WHITEPAPER

www.pecb.com

ISO 9001 // QUALITY MANAGEMENT SYSTEM2

PRINCIPAL AUTHORSEric LACHAPELLE, PECBBesnik HUNDOZI, PECB

CONTENT____

Introduction

An overview of ISO 9001:2008

Key clauses of ISO 9001:2008

Link with other quality management methods and techniques

Link with ISO 9004

Integration with other management systems

QualityManagementTheBusinessBenefits

Quality Management Principles

Implementation of a QMS with IMS2 methodology

Certificationoforganizations

Trainingandcertificationofprofessionals

ChoosingtherightCertification

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INTRODUCTION____

ISO9001:2008 is aqualitymanagement systemstandard, first published in1987by ISO (InternationalOrganizationforStandardization).Thisstandardisdesignedtohelporganizationsensurethattheymeetallrequirements of customers and stakeholders.

Itisneitheranindustrynorproductspecificstandard.Organizationsofallsizesandtypescanbecertifiedagainst ISO 9001. This standard can be used by manufacturing or service providing companies. This standardassuresqualityforallinterestedpartiesinvolvedinbusinessesthatarecertified.

ISO 9001 is considered as a key factor for doing business in global markets and for improving competitiveness.

ThetopthreecountriesforthetotalnumberofcertificatesissuedareChina,ItalyandGermany,whilethetopthreeforgrowthinthenumberofcertificatesin2013areItaly,IndiaandtheUSA.

It is the most popular standard worldwide and up to the end of December 2013, at least 1, 129, 446 certificateshadbeen issued in187countriesandeconomies, threemorethan inthepreviousyear.The2013totalrepresentsanincreaseof3%(+32459)over2012.

ThetablebelowsummarizesthestatisticsoftheISO9001certificationsaroundtheworld.

ISO 9001 // QUALITY MANAGEMENT SYSTEM 3

Standard Number of certificates in 2013

Number of certificates in 2012

Evolution Evolution in %

ISO 9001 1,129,446 1,096,987 32,459 3%Source: iso.org

Recentsurveysshowthat85%ofcertifiedorganizationshaveexperiencedexternalbenefits,while95%ofthemhaveexperiencedinternalbenefits.Theyalsohavereportedincreasedcustomerdemand,employeeawareness,operationalefficiencyandhigherquality.

AN OVERVIEW OF ISO 9001:2008____

ISO 9001 specifies requirements for a quality management system where an organization needs todemonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements; in addition to enhancing customer satisfaction through the effective application of the system, including processes for continual improvement of the system and assurance of conformity to customer and applicable statutory and regulatory requirements.

AllrequirementsofISO9001aregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.

QUALITY STANDARDIZATION EVOLVES WITH ISO 9001 BY ADDING:

Greater emphasis on setting the objectives, monitoring performance and metrics; Clearerexpectationsonmanagement;and More careful planning for and preparing the resources needed for ensuring quality.

ISO 9001 APPLIES TO ALL TYPES AND SIZES OF ORGANIZATIONS THAT WISH TO:

1. Establish, implement, maintain and improve an QMS;2.Assureconformitywiththeorganizationsstatedqualitypolicy;3. Demonstrate conformity to others;4.Seekcertification/registrationofitsQMSbyanaccreditedthirdpartycertificationbody;and5.Makeaself-determinationandself-declarationofconformitywiththisInternationalStandard.

KEY CLAUSES OF ISO 9001:2008Clause 4: Quality management systemClause5:ManagementresponsibilityClause 6: Resource managementClause7:ProductrealizationClause 8: Measurement, analysis and improvement

Each of these key activities are listed below.

CLAUSE 4: QUALITY MANAGEMENT SYSTEMTheorganizationshallestablish,document, implementandmaintainaQMSandcontinually improve itseffectiveness in accordance with the requirements of ISO 9001 by:

ISO 9001 // QUALITY MANAGEMENT SYSTEM4

What is Quality Management System?Quality management system is defined as a set of interrelated or interacting elements to establish policy and objectives for an organization and to achieve those objectives with regard to quality

DeterminingtheprocessesneededfortheQMSandtheirapplicationthroughouttheorganization; Determining the sequence and interaction of these processes; Determining criteria and methods needed to ensure that both the operation and control of these processes are

effective; Providing resources and information necessary to support the operation and monitoring of these processes; Monitoring,measuringandanalyzingtheseprocesses;and Implementing actions necessary to achieve planned results and continual improvement of these processes.

This clause also includes requirements related to the QMS documentation that includes: the quality policy and objectives, the quality manual, procedures, records, documents to ensure effective planning, operation and control ofprocessesandotherdocumentationspecifiedbynationalorregionalregulations.Italsoprovidesrequirementson how to control these documents and records.

CLAUSE5:MANAGEMENTRESPONSIBILITY

Top management shall demonstrate an ongoing commitment to the development and implementation of the QMS and continually improving its effectiveness by:

Communicating to the organization the importance ofmeeting customer as well as statutory andregulatory requirements;

Establishing the quality policy; Ensuring that quality objectives are established; Conducting management reviews; and Ensuring the availability of resources.

CLAUSE 6: RESOURCE MANAGEMENT

Theday-to-daymanagementofaneffectivequalitymanagementsystemreliesonusingtheappropriateresources for each task. These include competent staffwith relevant (and demonstrable) training andsupporting services, awareness and communication.

To achieve conformity to product requirements it is important to provide and maintain an appropriate infrastructure. Thisclausealsoincludesthemanagingoftheworkenvironment,whichmustbemanagedbytheorganizationin order to achieve conformity to product requirements.

CLAUSE 7: PRODUCT REALIZATION

This clause describes all processes related to product realization, starting from planning of productrealization, customer related processes, design and development to the end product and after salesservices. In detail this clause includes:

Planning of product realization: During this stage the organizationmust plan and develop all processesnecessaryforproductrealization;

Customer-relatedprocesses: It is important to manage processes related to customers in order to make sure theorganizationisdeterminingandmeetingtheirrequirements;

Design and development: The design and development process must include design and development planning, inputs,outputs,review,verification,validationandcontrolofdesignanddevelopmentchanges;

Purchasing: It is important to establish documented procedures to ensure that purchased product conforms to specifiedpurchaserequirements;

Production and service provision: Thissub-clauseincludesthecontrolandvalidationofproductionandserviceprovision.Theidentificationandtraceability,customerpropertyandpreservationofproductarealsopartofthissub-clause.

Control of monitoring and measuring devices: The requirements for what needs to be measured and the acceptancecriteriamaycomefromthecustomer,regulatory,industryortheorganizationitself.Monitoringandmeasurement must be carried out in consistency with the requirements

ISO 9001 // QUALITY MANAGEMENT SYSTEM 5

CLAUSE 8: MEASUREMENT, ANALYSIS AND IMPROVEMENT

Once the quality management system is implemented, permanent monitoring, measurement, analysis and improvementis required, to:

Demonstrate conformity to the product; Ensure conformity of the QMS; and Continually improve the effectiveness of the QMS.

Anorganizationcancontinuallyimprovetheeffectivenessofitsmanagementsystemthroughtheuseofthe quality policy, objectives, audit results, analysis of data, corrective and preventive actions.

LINK WITH OTHER QUALITY MANAGEMENT METHODS AND TECHNIQUES

Besides ISO 9001, there are many other methods and techniques related to quality management that are usedtoenhancequalityandproductivityinorganizations,suchas:

Quality Circle; TotalQualityManagement(TQM); SixSigma; Lean; Kaizen; ToyotaWay; EightDisciplinesProblemSolving(8D); Just-in-Time(JiT); TotalProductiveMaintenance;and BalancedScorecard(BSC).

LINK WITH ISO 9004

ISO 9001 and ISO 9004 are both quality management standards designed to complement each other; nonetheless, may be used independently.

ISO90001specifiesrequirementsforaQMSthatcanbeusedforinternalapplicationbyorganizations,forcertification,orforcontractualpurposes.ItfocusesontheeffectivenessoftheQMSinmeetingcustomerrequirements.

Whereas,ISO9004providesguidanceforachievingsustainedsuccessforanyorganizationanditprovidesawiderfocusonqualitymanagementthanISO9001.However,itisnotintendedforcertification,regulatoryor contractual use.

ISO 9001 // QUALITY MANAGEMENT SYSTEM6

QualityCircle

Toyota Way

JiT

TotalProductive

Maintenance

Lean

Six Sigma

TQMBSC

Kaizen8D

Continual improvement can be defined as all the actions taken throughout the organization to increase effectiveness (reaching objectives) and efficiency (an optimal cost/benefit ration) of quality processes to bring increased benefits to the organization and its stakeholdersy