Explicación de la "información documentada" requerida por la nueva versión de ISO 9001:2015. El término información documentada a "mantener" se refiere a la que puede tener cambios como son procedimientos, instructivos de trabajo, etc. y la información documentada a "conservar" se refiere a la que no tiene cambios, como son los registros.

1. ISO/TC 176/SC2/N1286 www.iso.org/tc176/sc02/public
International Organization for Standardization
BIBC II, Cheminde Blandonnet8, CP 401, 1214 Vernier, Geneva, Switzerland
Tel:+41 22 749 01 11, Web: www.iso.org
Guidance on the requirements for Documented Information
of ISO 9001:2015
1 Introduction
Two of the most importantobjectives inthe revision of the ISO9000 series of standards have been:
a) to develop asimplified setof standards thatwill be equally applicable tosmall aswell as
mediumandlarge organizations, and
b) for the amountand detail of documentation required tobe more relevanttothe desired
results of the organization’s process activities.
ISO9001:2015 Quality managementsystems –Requirements hasachieved these objectives, andthe
purpose of thisadditional guidanceistoexplain the intentof the new standard withspecificregard
to documented information.
ISO9001:2015 allowsanorganization flexibility inthe way itchooses todocumentitsquality
managementsystem(QMS). Thisenables eachindividual organization todeterminethe correct
amountof documented information needed inordertodemonstrate the effectiveplanning,
operation andcontrol of its processes andthe implementation andcontinual improvementof the
effectiveness of itsQMS.
It is stressedthat ISO 9001 requires(andalways has required) a “Documentedquality
managementsystem”,and not a “systemof documents”.
2 What is documented information? - Definitions andreferences
The term Documented information wasintroduced aspartof the common High Level Structure (HLS)
and commontermsfor ManagementSystemStandards (MSS).
The definition of documented information canbe foundinISO9000 clause 3.8.
Documented information canbe usedtocommunicate amessage, provide evidence of whatwas
planned hasactually been done, orknowledge sharing.
The followingare some of the mainobjectives of anorganization’sdocumentedinformation
independentof whetherornotit hasimplemented aformal QMS;
a) Communication of Information
- As a tool for information transmission andcommunication. The type andextentof the
documentedinformation willdepend onthe nature of the organization’sproducts and
processes, the degree of formality of communication systems andthe levelof
communication skillswithinthe organization, andthe organizational culture.

2. ISO/TC 176/SC2/N1286 www.iso.org/tc176/sc02/public
b) Evidence of conformity
- Provision of evidence thatwhatwasplanned hasactuallybeen done.
c) Knowledge sharing
d) To disseminateandpreserve the organization’s experiences. A typical example would be a
technical specification, whichcanbe usedasa base for design anddevelopmentof anew
productor service.
A listof commonly usedtermsanddefinitions relatingtodocumented information ispresented in
ISO9001:2015 Annex A.
It mustbe stressed that, accordingtoISO 9001:2015 clause 7.5.3 Controlof documented information
requirements, documents maybe inany form or type of medium, andthe definition of “document”
inISO 9000:2015 clause 3.8.5 givesthe followingexamples:
− paper
− magnetic
− electronicoroptical computerdisc
− photograph
− mastersample
3 ISO 9001:2015 Documentation Requirements
ISO9001:2015 clause 4.4 Quality managementsystems and itsprocesses requires anorganization to
“maintain documented information to theextentnecessary to supporttheoperation of processes and
retain documented information to theextentnecessary to haveconfidentthattheprocesses are
being carried out asplanned.”
Clause 7.5.1 General explains thatthe quality managementsystemdocumentation shallinclude:
a) documented information requiredbythisInternational standard;
b) documented information determined bythe organization asbeingnecessary forthe
effectiveness of the quality managementsystem
The note after thisClause make itclearthat the extentof the QMS documented information can
differfromone organization toanotherdue tothe:
a) size of organization anditstype of activities, processes,products andservices;
b) complexity of processes andtheirinteractions,
c) competence of persons.
All the documented information thatforms partof the QMS hasto be controlled inaccordance with
clause 7.5 Documented information.
4 Guidance on Clause 7.5 of ISO 9001:2015
The followingcommentsare intended toassistusers of ISO9001:2015 inunderstandingthe intentof
the general documented information requirements of the International Standard. Documented
information canreferto:

3. ISO/TC 176/SC2/N1286 www.iso.org/tc176/sc02/public
a) Documented information needed tobe maintained bythe organization forthe purposes of
establishingaQMS (highlevel transversal documents).Theseinclude:
− The scope of the quality managementsystem(clause4.3).
− Documented information necessary tosupportthe operation of processes (clause 4.4).
− The quality policy (clause 5.).
− The quality objectives (clause6.2).
− Thisdocumented information issubjecttothe requirements of clause 7.5.
b) Documented information maintained bythe organization forthe purpose of communicating
the information necessary forthe organization tooperate (low level, specificdocuments).See
4.4. Although ISO9001:2015 doesnotspecifically requires anyof them, examples of documents
that can add value toa QMS may include:
− Organization charts
− Process maps, process flow chartsand/orprocess descriptions
− Procedures
− Work and/ortestinstructions
− Specifications
− Documentscontaininginternal communications
− Production schedules
− Approved supplierlists
− Testand inspection plans
− Qualityplans
− Qualitymanuals
− Strategicplans
− Forms
Where itexists, all suchdocumented information, isalsosubjecttothe requirements clause
7.5.
c) Documented information needed tobe retained bythe organization forthe purpose of
providingevidenceof resultachieved (records). Theseinclude:
− Documented information tothe extentnecessary tohave confidence thatthe
processes are beingcarriedoutas planned (clause 4.4).
− Evidence of fitness forpurpose of monitoringandmeasuringresources (clause 7.1.5.1).
− Evidence of the basisusedforcalibration of the monitoringandmeasurement
resources (when nointernational ornational standards exist)(clause 7.1.5.2).
− Evidence of competence of person(s)doingworkunderthe control of the organization
that affectsthe performance andeffectiveness of the QMS(clause 7.2).
− Resultsof the review andnew requirements forthe products andservices (clause
8.2.3).
− Records needed todemonstrate thatdesignanddevelopmentrequirements have been
met(clause 8.3.2)
− Records on designanddevelopmentinputs(clause 8.3.3).
− Records of the activities of design anddevelopmentcontrols (clause 8.3.4).
− Records of designanddevelopmentoutputs(clause 8.3.5).
− Designanddevelopment changes, includingthe resultsof the review andthe
authorization of the changes andnecessary actions(clause 8.3.6).
− Records of the evaluation, selection, monitoringof performance andre-evaluation of
external providers andany andactions arisingfromthese activities (clause 8.4.1)

4. ISO/TC 176/SC2/N1286 www.iso.org/tc176/sc02/public
− Evidence of the unique identification of the outputswhentraceability isarequirement
(clause 8.5.2).
− Records of property of the customeror external providerthatislost, damaged or
otherwise found tobe unsuitable foruse andof itscommunication tothe owner
(clause 8.5.3).
− Resultsof the review of changes forproduction orservice provision, the persons
authorizingthe change, andnecessary actionstaken(clause 8.5.6).
− Records of the authorized release of productsandservices fordelivery tothe customer
includingacceptance criteriaandtraceability tothe authorizingperson(s) (clause8.6).
− Records of nonconformities, the actions taken, concessions obtained and the
identification of the authority decidingthe actioninrespectof the nonconformity
(clause 8.7).
− Resultsof the evaluation of the performanceandthe effectiveness of the QMS (clause
911)
− Evidence of the implementation of the auditprogramme andthe auditresults(clause
9.2.2).
− Evidence of the resultsof managementreviews (clause9.3.3).
− Evidence of the nature of the nonconformities andanysubsequentactions taken
(clause 10.2.2).;
− Resultsof anycorrective action(clause 10.2.2).
Organizations are free to developotherrecords that may be neededtodemonstrate
conformity of their processes, products and servicesand qualitymanagement system.
Where theyexists, all such recordsare also subjectto the requirementsclause 7.5.
5 Organizations preparing toimplement aQMS
For organizations thatare inthe process of implementingaQMS, and wishtomeetthe requirements
of ISO9001:2015, the followingcomments maybe useful.
− For organizations thatare inthe process of implementingorhave yetto implementa
QMS, ISO 9001:2015 emphasizes aprocess approach. Thisincludes:
▪ determiningthe processes necessary forthe effective implementation of the
quality managementsystem
▪ determining the interactions betweenthese processes.
▪ documenting the processes tothe extentnecessary toassure theireffective
operation andcontrol. (Itmay be appropriate todocumentthe processes using
process mappingtools. Itisemphasized, however, thatdocumented process
mappingtoolsare nota requirementof ISO9001:2015).
− Analysis of the processes shouldbe the drivingforce fordefiningthe amountof
documented information neededforthe quality managementsystem, takinginto
account the requirements of ISO9001:2015. It should notbe the documented
informationthatdrivesthe processes.
6 Organizations wishing toadapt an existing QMS
For organizations thatcurrently have aQMS the followingcommentsare intendedtoassistin
understandingthe changes todocumented information thatmaybe required orfacilitatedbythe
transition toISO9001:2015:

5. ISO/TC 176/SC2/N1286 www.iso.org/tc176/sc02/public
− An organization withanexistingQMSshould notneedtorewrite all of itsdocumented
information inordertomeetthe requirements of ISO9001:2015. This isparticularly
true if an organization hasstructureditsQMS basedonthe way it effectively operates,
usinga process approach.
− An organization may be able tocarry out some simplification and/orconsolidation of
existingdocumented information inorderto simplify itsQMS.
7 Demonstrating conformity withISO 9001:2015
For organizations wishingtodemonstrateconformity withthe requirements of ISO9001:2015, for
the purposes of certification/registration, contractual, orotherreasons, itisimportantto remember
the need to provide evidence of the effectiveimplementation of the QMS.
− Organizations maybe able todemonstrate conformity withoutthe needforextensive
documented information
− To claimconformity withISO9001:2015, the organization hasto be able to provide
objective evidence of the effectiveness of itsprocesses anditsquality management
system. Clause 3.8.3of ISO9000:2015 defines “objectiveevidence”as“data supporting
the existenceor verity of something”aandnotes that“objectiveevidencemay be
obtained through observation, measurement, test, orothermeans.”
− Objective evidence doesnotnecessarily depend onthe existenceof documented
information, exceptwhere specifically mentioned inISO9001:2015. In some cases, (for
example, inclause 8.1(e) Operationalplanning and control, itisup to the organization
to determine whatdocumented information isnecessary inordertoprovide this
objective evidence.
− Where the organization hasnospecificdocumented information foraparticular
activity, andthisisnot required bythe standard, itisacceptable forthisactivity to be
conducted usingasa basisthe relevantclause of ISO9001:2015. Inthese situations,
bothinternal andexternal auditsmayuse the textof ISO9001:2015 forconformity
assessmentpurposes.