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Seven Seve n pri princ ncip iple le of Click to edit Master title style ISOMaster 9001:2015 Click to edit title style •
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Sr. to PRINCIPLES Click edit Master ISO/FDIS text styles 9001: 2015 APPROACH No. Click to edit text styles Meet customer needs and expectations Second level Master Principle – 1 determine levels of customer satisfaction / 1. Second level dissatisfaction. Strive to exceed customer Customer Third levelfocus expectations Fourth level Third level Principle – 2 unit y of purpose and engage » Fifth level Establish 2. Leadership people in achieving quality objectives Fourth level Principle – 3 Fifth level Focus on competency empowered and
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Engagement of people
engaged people in delivering value. Identify and manage human factors of the work place.
Principle – 4 Process approach
Systematically identify and manage the process employed. Understand activities and manage it as interrelated processes to get consistent predicted results
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Schematic Representation Representation of Process Click to edit Master title style Approachtitle style Click to edit Master Top Management Process Click to edit Master text styles Click to edit styles Second level Master text inputs Customers / Second level A B C Interested Third level parties Fourth level Third level » Fifth level Fourth level Support Processes Fifth level
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REALISATION REALISATION PROCESSES
Customers / Interested parties
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Top management processes processes include, include, for example, planning, allocation of resources, management review, etc. Realization processes Realization processes include, include, for example, customer related processes, design and development, product realization, etc. Support processes processes include, include, for example, training, maintenance, etc.
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Risk and Opportunity
Click to edit Master title style The obto jectiedit ve of thiMaster s presentationtitle are to astyle ppreciate and Click understand how an QMS is established in terms of:
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Four Phases Risk Click to edit Master textof styles Click to edit Master text styles Second level Risk Analysis Risk Evaluation Second level Third level Intended user Identification Risk acceptability decisions Area wise risk identification Fourth level Third level Risk estimation » Fifth level Fourth level Fifth level
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Risk monitoring and control
OPTION analysis Implementation of measures RESIDUAL RISK evaluation Overall RISK acceptance
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Post production information
Post-production experience Review of Risk management experience exper ience-- custo customer mer use Take appropriate actions
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Click to Main edit Master title style Changes Click to edit Master title style
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Click to edit Master text styles Risk-based thinking throughout the standard Click to edit Master text on styles supersedes a single clause preventive action Second level Second level Third level The term ‘documented information’ replaces Fourth and level records’ Third level ‘documents » Fifth level Fourth level The term ‘outsourcing’ is replaced by ‘external ‘external Fifth level provision’
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Increased leadership requirements
No requirement for a management representative
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Clauseto 4.2edit Understanding needs & Click Master the title style of interested Clickexpectations to edit Master titleparties style •
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Click to edit Master text styles Intere Int ereste sted d par partie ties: s: Click to edit Master text styles Second level The organization shall consider the following relevant interested Second level parties: Third level Fourth level Third level » ers Fifth a) Di Dire rect ct cu cust stom omer s level Fourth level b) End users; Fifth level • •
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c) Suppliers, Suppliers, distribut distributors, ors, retail retailers ers or others others invo involved lved in the the supply supply chain d) Regula lattors e) An Any y other other relev relevant ant intere intereste sted d parties parties..
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Internal Context
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Relationshi p with internal stake holders
Organizatio n Culture
Governanc e
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Decision making process
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Organizatio nal Structure
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Current Roles & Resp.
Process maturity
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Current system and tools
Strategy
Resource levels
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Current capabilities
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Areas to considered in risk and Click to edit Master title style identification Click to opportunity edit Master title style •
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Click to edit Master text styles Corporate Requirement Click to edit Master text styles Second level Business Requirement Second level Third level Contractual Requirement Fourth level Third level Client/customer » Fifth level Requirement Fourth level Process and product requirements Fifth level
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Regulatory Statutory
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Requirement
Requirements 8
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Documented Information Required by ISO 9001 : 2015
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List of Documented Information ( Continue)
Click to edit Master text styles Click to edit Master text styles 16.. Co 16 Cont ntra ract Second ct rev revie iew w res resul level ults ts an and d in info form rmat atio ion n on cu cust stom omer er req requi uirem remen ents ts (8 (8.2. .2.3.2 3.2a) a) 17.. In 17 Info form rmat atio ion n fo forr an any ylevel new ne w re requ quir irem emen ents ts fo forr th the e pr prod oduc ucts ts an and d se serv rvic ices es(( 8. 8.2. 2.3. 3.2b 2b)) Second Third level 18. Chan ange ges s to th the e cu cust sto ome merr re req qui uire rem men entt in ca cas ses of am amen end dmen entt ( 8. 8.2. 2.3) 3) 19. InforThird mation nelevel eFourth ded to dlevel emonstrate Design and development requirements have been met ( 8. 8.3. 3.2j 2j)) » Fifth level Fourth level 20.. In 20 Info form rmat atio ion n on de desi sign gn an and d de deve velo lopm pmen entt in inpu puts ts ( 8. 8.3. 3.3) 3) 21.. In 21 Info form rmat atio ion n fo forr de desi sign gn an and d de deve velo lopm pmen entt co cont ntro rols( ls( 8.3 8.3.4) .4) Fifth level 22. Information on design and development outputs output and suitability- development • Conf 15. nfir irm mat atio ion n of customer’s requirement in cases of verbal orders or no written statement provid pro vided ed by cus custom tomer(8 er(8.2.3 .2.3.1) .1)
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verif ve rifica icati tion on sh shee eett ( 8.3 8.3.5 .5)) 23. Information on design and development changes, result of reviews, authorization of the chan ch ange ges, s, ac acti tion on ta take ken n to pr prev even entt ad adve vers rse e im impa pact cts s ( 8. 8.3. 3.6) 6) 24.. Info 24 Inform rmat atio ion n fo forr ev eval alua uati tion on,, se sele lect ctio ion, n, mo moni nito tori ring ng of per erfo form rman ance ce an and d re ev eval alua uati tion on an and d ac acti tio ons arisi ar ising ng fro from m ev eval alua uatio tion n on ex exte tern rnal al pr prov ovid ider ers(8 s(8.4 .4.1 .1)) 25. Results of evaluation of external providers - External providers selection and evaluation record rec ords s (8.4 (8.4.2) .2) 122 /1/21/2 1 20/125 015 GMG
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