Iso 9001: 2015 new changes

1. ISO 9001:2015 - New Clauses:
4.1 Understandingthe organization and its context
NewChange to be addressed:
 The organizationto determine issuesandrequirementsthat may have an impact on the
planningof the QMS and can serve as input for the developmentofthe system.
Determinationof requirementsofrelevantstakeholders,the requirementsinclude:
Changesand trends,relationships,perceptionsandvaluesof stakeholders,strategic
priorities,the availabilityof resources,and other issueswhichcould have an impact on the
objectivesofthe organization.
 The contextof the organization refersto the businessenvironmentitis operating in.To do
this, firstdecide what the intendedresultsofits QMS are and thendetermine the relevant
internal and external issuesthat affectits abilityto achieve those results.
 Understandingthe external context can be facilitatedby consideringissuesarisingfrom
legal,technological,competitive,market,cultural,social, and economicenvironments,
whetherinternational,national,regional or local.
 Understandingthe internal context can be facilitatedby consideringissuesrelatedto
values,culture,knowledge and performance of the organization.
4.2 Understandingthe needsand expectationsof interested parties
NewChange to be addressed:

2. 4.2 - As an organization,we have to be aware of the importance of these interestedparties
(Suppliers,personnel,shareholders,legislativebodies,society,internal customers) requirements
and standards, and anticipate them in the featuresof your products and services.
This has always beenpart of the standard. We cannot make or delivera good product without
knowingthe requirementsandexpectationsof customersand interestedpartiesinany case. This
is the basis of a QualityManagementSystem.

3. 6.1 Actionsto addressrisks and opportunities
NewChange to be addressed:
6.1 - As an organization to use risk analysisin order to decide for our self, which challengeswe
may face in the managementof your businessprocesses.
Shall determine risksand opportunities:
 In accordance withthe requirementsthat can affect conformityof products and services
and the abilityto enhance customersatisfaction
 Give assurance that the qualitymanagement systemcan achieve itsintendedresult
 Prevent,or reduce,undesiredeffects
 Achieve continual improvement
 Integrate and implementthe actionsinto its quality managementsystemprocesses
 Evaluate the effectivenessofthese actions
 Post-delivery- associatedwith the products and services
 Effectivenessofactionsmanagementreview

4. NewChange to be addressed:
The definitionstatesthat it concerns ‘informationthat the organization has to control and
maintain’.The information can be inany format and come from various sources and media.
7.1.6 Organizational knowledge

5. NewChange to be addressed:
At organization level,safe guardingthe both external & internal training materialsand it should
be readilyavailable.
ISO 9001:2015 – Top Management
It requiresgreater involvementbytop managers and businessleadersin controllingthe quality
managementsystem. Because ISO 9001:2015 pays more attentionto risk management,interested
parties and the contextof the organization,the qualitymanagementsystem also fitsin better
with the needsof the top management.
The ideabehindthe change isthat qualityis a matter for everyone and for all levelswithinthe
organization.
Top management shall demonstrate leadershipand commitment:
 Ensuring that the quality policyis communicated,understoodand appliedwithinthe
organization
 Promoting awarenessof the process approach
 Engaging personsto contribute to the effectivenessofthe qualitymanagement
system;
 The risks and opportunitiesthat can affectconformity of products and servicesand the
abilityto enhance customersatisfaction are determinedandaddressed
 The qualitypolicy shall be available to relevantinterestedparties,as appropriate.