[PDF] Guidance on the requirements for Documented Information of ISO PDF documented

ISO 9001:2015 clause 4 4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned

24 jui 2016 · In October 2015, the new version of ISO 9001 was released Requirements regarding documentation have been made easier To the same extent

[PDF] Support préparation à lISO 9001 - PQB

29 jan 2021 · Pour effectuer l'audit à blanc du SMQ (étape 6) les documents tels manuel qualité, procédures et autres sont vérifiés et approuvés par les

[PDF] Démarche qualité et norme ISO 9001 - Horizon IRD

selon ISO 9001 126 14 - Maîtrise du management qualité 128 15 - La documentation qualité 131 16 - Le manuel qualité 138 17-Procédures 140

[PDF] ISO 9001: 2015 QMS DOCUMENTATION TOOLKIT CONTENTS

ISO 9001 Req Section 4 Context of Organisation MSS DOC 4 1 4 1 Identification of Interested Parties Procedure

[PDF] QUALITY MANUAL ISO 9001:2015 Quality Management System

11/02/2015 1001 Original Release to ISO9001:2015 ISO 9001:2015 requirements, and is supported by additional procedures where necessary The

[PDF] Building Effective Document Control in an ISO 9001 - Quality Digest

ISO 9001:2015 Quality Management System Tim Lozier Delve into Document Control Elements Reporting on effectiveness of the Document Control System

[PDF] Checklist of Mandatory Documentation Required by ISO 9001:2015

While ISO 9001 does not require that y ou document all of the procedures, there are several processes that are mandatory to be established in order to generate

[PDF] Quality Management Principles & ISO 9001 Standard - ICAO

ISO 9001:2008 is the only standard in the series that specifies the requirements of a quality management system Page 13 ISO 9001 FAMILY OF STANDARDS a )

[PDF] Quality Manual PDF - ISO 9001 checklist

ISO 9001:2015 Quality Manual Template Insert your company's name or logo, and address This quality manual is the property of Your Company It must not be

[PDF] iso 9001 passer de la version 2008 à la version 2015

[PDF] iso 9001 pdf

[PDF] iso 9001 pour les nuls

[PDF] iso 9001 pour les pme comment procéder pdf

[PDF] iso 9001 pour les pme. comment procéder

[PDF] iso 9001 ppt francais

[PDF] iso 9001 requisitos

[PDF] iso 9001 version 1987

[PDF] iso 9001 version 2000

[PDF] iso 9001 version 2000 vs 2008

[PDF] iso 9001 version 2008 definition

[PDF] iso 9001 version 2015

[PDF] iso 9001 version 2015 avantages

[PDF] iso 9001 version 2015 pdf

[PDF] iso 9001 wikipedia

InternationalOrganizationforStandardization

BIBCII,ChemindeBlandonnet8,CP401,1214Vernier,Geneva,Switzerland

Tel:+41227490111,Web:www.iso.org

GuidanceontherequirementsforDocumentedInformation

ofISO9001:2015

1Introduction

TwoofthemostimportantobjectivesintherevisionoftheISO9000seriesofstandardshavebeen: todevelopasimplifiedsetofstandardsthatwillbeequallyapplicabletosmallaswellas mediumandlargeorganizations,and fortheamountanddetailofdocumentationrequiredtobemorerelevanttothedesired resultsoftheorganization'sprocessactivities. ISO9001:2015Qualitymanagementsystems-Requirementshasachievedtheseobjectives,andthe purposeofthisadditionalguidanceistoexplaintheintentofthenewstandardwithspecificregard todocumentedinformation. ISO9001:2015allowsanorganizationflexibilityinthewayitchoosestodocumentitsquality managementsystem(QMS).Thisenableseachindividualorganizationtodeterminethecorrect amountofdocumentedinformationneededinordertodemonstratetheeffectiveplanning, operationandcontrolofitsprocessesandtheimplementationandcontinualimprovementofthe effectivenessofitsQMS. ItisstressedthatISO9001requires(andalwayshasrequired)a"Documentedquality managementsystem",andnota"systemofdocuments".

2Whatisdocumentedinformation?ͲDefinitionsandreferences

ThetermDocumentedinformationwasintroducedaspartofthecommonHighLevelStructure(HLS) andcommontermsforManagementSystemStandards(MSS). ThedefinitionofdocumentedinformationcanbefoundinISO9000clause3.8. Documentedinformationcanbeusedtocommunicateamessage,provideevidenceofwhatwas plannedhasactuallybeendone,orknowledgesharing. Thefollowingaresomeofthemainobjectivesofanorganization'sdocumentedinformation independentofwhetherornotithasimplementedaformalQMS;

CommunicationofInformation

Asatool

forinformationtransmissionandcommunication.Thetypeandextentofthe documentedinformationwilldependonthenatureoftheorganization'sproductsand processes,thedegreeofformalityofcommunicationsystemsandthelevelof communicationskillswithintheorganization,andtheorganizationalculture.

Evidenceofconformity

Provisionofevidencethatwhatwasplannedhasactuallybeendone. c)Knowledgesharing d)Todisseminateandpreservetheorganization'sexperiences.Atypicalexamplewouldbea technicalspecification,whichcanbeusedasabasefordesignanddevelopmentofanew productor service. Alistofcommonlyusedtermsanddefinitionsrelatingtodocumentedinformationispresentedin

ISO9001:2015AnnexA.

Itmustbestressedthat,accordingtoISO9001:2015clause7.5.3Controlofdocumentedinformation requirements,documentsmaybeinanyformortypeofmedium,andthedefinitionof "document" inISO9000:2015clause3.8.5givesthefollowingexamples: paper magnetic electronicoropticalcomputerdisc photograph mastersample

3ISO9001:2015DocumentationRequirements

ISO9001:2015clause4.4Qualitymanagementsystemsanditsprocessesrequiresanorganizationto "maintaindocumentedinformationtotheextentnecessarytosupporttheoperationofprocessesand retaindocumentedinformationtotheextentnecessarytohaveconfidentthattheprocessesare beingcarriedoutasplanned."

Clause7.5.1General

explainsthatthequalitymanagementsystemdocumentationshallinclude: documentedinformationrequiredbythisInternationalstandard; documentedinformationdeterminedbytheorganizationasbeingnecessaryforthe effectivenessofthequalitymanagementsystem ThenoteafterthisClausemakeitclearthattheextentoftheQMSdocumentedinformationcan differfromoneorganizationtoanotherduetothe: a)sizeoforganizationanditstype ofactivities,processes,productsandservices; b)complexityofprocessesandtheirinteractions, c)competenceofpersons. AllthedocumentedinformationthatformspartoftheQMShastobecontrolledinaccordancewith clause7.5Documentedinformation.

4GuidanceonClause7.5ofISO9001:2015

ThefollowingcommentsareintendedtoassistusersofISO9001:2015inunderstandingtheintentof thegeneraldocumentedinformationrequirementsoftheInternationalStandard.Documented informationcanreferto: a)Documentedinformationneededtobemaintainedbytheorganizationforthepurposesof establishingaQMS(highleveltransversaldocuments).Theseinclude:

Thescopeofthequalitymanagementsystem(clause4.3).

Documentedinformationnecessarytosupporttheoperationofprocesses(clause4.4).

Thequalitypolicy(clause5.).

Thequalityobjectives(clause6.2).

Thisdocumentedinformationissubjecttotherequirementsofclause7.5. b)Documentedinformationmaintainedbytheorganizationforthepurposeofcommunicating theinformationnecessaryfortheorganizationtooperate(lowlevel,specificdocuments).See

4.4.AlthoughISO9001:2015doesnotspecificallyrequiresanyofthem,examplesofdocuments

thatcanaddvaluetoaQMSmayinclude:

Organizationcharts

Processmaps,processflowchartsand/orprocessdescriptions

Procedures

Workand/ortestinstructions

Specifications

Documentscontaininginternalcommunications

Productionschedules

Approvedsupplierlists

Testandinspectionplans

Qualityplans

Qualitymanuals

Strategicplans

Forms Whereitexists,allsuchdocumentedinformation,isalsosubjecttotherequirementsclause 7.5. c)Documentedinformationneededtoberetainedbytheorganizationforthepurposeof providingevidenceofresultachieved(records).Theseinclude: Documentedinformationtotheextentnecessarytohaveconfidencethatthe processesarebeingcarriedoutasplanned(clause4.4). Evidenceoffitnessforpurposeofmonitoringandmeasuringresources(clause7.1.5.1). Evidenceofthebasisusedforcalibrationofthemonitoringandmeasurement resources(whennointernationalornationalstandardsexist)(clause7.1.5.2). Evidenceofcompetenceofperson(s)doingworkunderthecontroloftheorganization thataffectstheperformanceandeffectivenessoftheQMS(clause7.2). Resultsofthereviewandnewrequirementsfortheproductsandservices(clause

8.2.3).

Recordsneededtodemonstratethatdesignanddevelopmentrequirementshavebeen met(clause8.3.2)

Recordsondesignanddevelopmentinputs(clause8.3.3).

Recordsoftheactivitiesofdesignanddevelopmentcontrols(clause8.3.4). Recordsofdesignanddevelopmentoutputs(clause8.3.5). Designanddevelopmentchanges,includingtheresultsofthereviewandthe authorizationofthechangesandnecessaryactions(clause8.3.6). Recordsoftheevaluation,selection,monitoringofperformanceandreͲevaluationof externalprovidersandanyandactionsarisingfromtheseactivities(clause8.4.1) quotesdbs_dbs12.pdfusesText_18

[PDF] [PDF] Guidance on the requirements for Documented Information of ISO