159 J00)220) 15 PANS LON EPNP ANALYSIS + Draft International Standard (DIS)-published We will help you understand the changes, in May 2014 interpret the new concepts and act on the + Final Draft International Standard (FOIS)- implications. expected January20 . ched September2015 Keep updated with the changes www.tomesb.com Please get in touch if you have any questions— ‘The structure of ISO 90012015 follows the high call 03-821008 level structure defined in AnnexSL: 1. Scope ee 2 Normative Heterences TOM oe sanactnenr 3. Termsand Defiitions WD censure iw) son. ono. 4. Context of theOrganization www.tomesb.com 5. Leadership 6. Plannin LOT 802A, DIAMOND COMPLEX, BANOI BUSINESS PARK JALAN MEDAN BANGI, 7. Support ANDAR BARU BANGI, 43650 SELANGOR DARUIL EHSAN ot ‘WEBSITE: WWW-TOMCSBCOM 8. Operation “TE: +603 82100800 FAX 603 92100862 9. Performance Evaluation 10. ImproverentGAP ANALYSIS AND ISO 9001:2015 CLAUSES 4 Context of the organisation 4.1 Understanding the organisation and your context 42. Understanding the needs and expectations of inlerested parties GUIDANCE ISO 9001:2008 CLAUSES New requirement! Now requirement! 43 Determining the scope ofthe GMS 1 Seope 44 Qualty ranagomont system and your 4.1, 54.2, 7.4, 8.1 and 8.2.3 procescos 5 Leadership 5.1. Loadorship and cornmitmant ‘5 Management Responsibility 52 Qualiy policy 5.8. Organisational roles, responstbitios and authortles 6 Planning for the QMS 6.4 Action to adores risks anc epportuniios 62 Quality objectives and planning to achive thom 6.3 Planning of changes 5.3 Quality policy 5.5 Responsibility, authority and ‘communication New requirement! 5.4 Planning 5.4.2 Quality management system planning 7. Support 74 Resources 711 General 6.1 Provision of resources 712 People 6.2 Human Resources, 6.2.1 General 713 Inrastiuctue 6.3 Infrastructure 7.14 Environment for he operation of 6.4 Work environment processes 718 — Monitoring and measuring ‘7.6 Control of monitoring and resources measuring equipment 7.1.6 — Organisational knowledge “New Requirement! GUIDANCE This new concept relates to the factors and conditions atfacting organisational operation 2.9. regulation, goveriance and stakeholders. Bo prepared to d'scuss the implications of your context with your assessor Consider who the interested parties might be and what their relevant interests might be, €.9. customers, shareholders, board members, Competitors, regulators. Be prepared to cigcuss with your assessor, Reference to “exclusions” has been removed. Etomants which do net apply can andl should be juslfied Under Clause 4.3 of 9001-2015. ‘An olevatod focus on procasses. Adoption of the process approach is now mandatory and will be Budted accorainghy. Enhaneos 5.1, Management commitment, from the 2008 standard. The 2015 DIS repositions some roquiromants to “loadarship", not management. ‘The emphasis has shited Irom ensuring to engaging” Enhanced requirements from the 2008 version ‘moro attention to be paid to the application of the policy actoss the organisation. There is a need for "documented information’, as opposed to a documented statement The tole of the Managemant Representative has disappeared; however the reauirements of the 2008 clause 5.5.2 sill neod to be mat. Thare is ‘new requirement that someone is tasked with prosarving tho intagity of the GMS wile iis in the process of change. Organisations must determine its context, and the aising risks and opportunities. Actions to address risk must be proportional tothe potential impact. Extension of 2008 clauses, 5.4.1, and 5.42. ‘Stronger emphasis on the importance of Objectives, which should be set for processes. The ‘organ sation must retain documented information, on aualty objectives, {An extension of the existing requirement: ‘organ sations must identily the purpose and Ikely ‘consequences of change, and the necessary resources and responsibiites, Need to evidence external as well as internal resource requirements, No significant change Enhanced reference to examples, e.g, hardware, software, transportation More prescriptive than before with a requirement to determine, provide and maintain a suitable environment, There is a note in the new clause thal examples of "environment for the operation of processes" nels soci, psyeroiogcal anc Measuring “equipment” becomes measuring “resource’, acknowledging that professional Judgement anc human senses may also be a ‘measuring resource, ©. tea lasting, Examples of such knowiodge could be intellectual 2.9. design or software and extemal sources of knowiodge ©.g, academia or conferences72. Compatence 6.2 Human resources ‘The requitemant has been exanced to include people performing work unde the organisation's onto, 6. oulsourced resource such as agencies. 73 Avaveness 8.22 Compatnce,taning and Th sow expan and ncaa Sento. Peope must be avare of polcy, bjectves, row they centile and te mplsaons of nt Conforming othe OMS 74 Communication 55.3 Internal communication This now uch mor preserve and nudes xtemal communications, Orgaiestons must now determine what when, wi wom ane owe ormmuniatons shoul ake ase, 75. Documented ivrration 42 Documentation requirements Tho DiS coes not menan manual prococues records. Documented rvormalion must be onroled bat hae sn longorarequernans to fave a coumenied proce ors process Requiterants now cand to acsees a Usage, roedgneng thal eectone formation can be fcooteed as readonly without author to orange 8. Operation 8.1. Organisational planning and contol 7.1 Planning of product realisation This is a reworking and reorganising of the 2008 Clause 7-7 requirements. The raqurement to plan and develop processes 's not new, but has been fxianded fo include implementation and contra 82 Determination of requirements for _7.2 Customer related processes A subtle change in the supplier customer produits & sarvices: relationship: the DIS stars from the postion thal the organisation has already determined he products and services it intends to otter, reflecting a more common business environment for cerfication customers. Requirements should Nnolude those ‘rom interested parties and also rnelude statutory and reguatory requirements relating to the product, 8.2. Design and development of products and services: 83.1 General New requirement! This new clause mandates the introduction o a design and development process where this activity is required 832-86 Design and dvelopment 7.8 Design and development Builds on existing 2008 clauses 7.3.1 -73.6 process requirements: Design and development needs to be approached planning. inputs, controls, as a process, ‘outputs, changes 8.4 Control of externally provided products 7.4 Purchasing Enhanced emphasis on external providers and sarvices land the extent of empioymart of contractors jn Current commercial practice, Extent of controls needs to take account of the potentia’ impact fon the organisation s abilly to consistently mest requirements, Risk assassmont wi be appl cable 8.5. Production and service provision _—_‘7.5 Production and service No significant changes. provision. 8.6. Roleaso of products and services 8.2.4 Monitoring and measurement No substartive change needed. Note ratveshed of product terminology referring to services in add tion to produt. 8.7 Control of nonconforming process 8.3. Control ef noncenforming Some minor changes. Thete is no longer a outputs, produste and services product requirement fot a documented procedure, but there Is a requirement to maintain documented information on actions taken, including concessions and authorisations 9 Performance evaluation 8.1 Monitoring, measurement, analysis and8.2.1 Customer satisfaction, and 8.4An onhanced emphasis on evaluation of results, in evaluation Analysis of data addin to measurement and anaysis. Mon toring Should be based on risk. Custorner pereaption now includes solciting perceptions about the organisation and is products and services, Preventive action and slalisical techniques are no longar references 9.2 Internal aucit 8.2.2 Internal audit ‘Thewe is no longer a need for a documented yocadure. Iniomal audit must cover eustomer feedback. organisalional changes and quality objectives. 93 Management review 5.6 Management Review Overall purpose remains the same, however inputs should now include strategic ems relating to context, risk and opportunites. Trends and indicators should 0 used to monitor quality performance:10. Improvement 10.1 Genoral 10.2 Nonoonformity and corrective action 108 Continual improvement New requirement! 8.5.2 Corrective action Continual improvement Proactive improvement must be sought, andl this may be as 2 result of corrective action, innovation ‘oF reorganisation, ‘The requiremant fora documented preventive action procedure has gone. \When corractive action has bean completed, the ‘organisaton can move on to consider whether any further action is requited to prevent a similar nonconformity occurring in future This requis the organisation to determine what caused the nonconfoxmiies and then to consider \whethor the potential for a sirlar problem remains, ‘The organisation is then reauired to implement any aciions denied as needed, review ther ‘fecrvenase and make changes to the quality management system ifnecessary, ‘Organisations wil now need to demonstrate that they are using the outputs from thet analysis and evaluation processes to idently araas Ofsndeperomance and opposites ior improvemer ‘Appropriate tools and methodologies should bo omployed by the organisation to suppor this activi. MAJOR DIFFERENCES IN TERMINOLOGY ‘You will ind that some of the familar terminology of ISO 9001-2008 has either been changed or removed, Here are the highlights, but please aso refer to our document on key concepts for additional guidance: ISO 9001:2008 Products Supplier Documentation and records Work environment Purchased product Exclusions Management representative Documented procedure Quality manual Preventive action Tem not used Term not used TOMC.... TOTAL ORGANISATION MANAGEMENT: CONSULTING (§) SDN. BHD. www.tomesb.com, ISO 9001:2015 Products and services External provider Documented information Environment forthe operation of processes Extemally provided products and services Tam not used Tam not used Tem not used Term not used Tem not used Leadership isk eee NE Mn aT AE cet Pretec kant ecm) Peniaantencon Pears) Some)