How to manage

the transition

ISO 9001:2015

Move Forward with Confidence

. Although the intention is not to externally recommend the sequence of proc. each organization is free to interpret the model as it Production sees fit. in an order that is consistent Clause 10 IMPROVEMENT with organizational planning and process management. It follows the well known PDCA cycle and the process approach from section 4 to 10. Clause 4 CONTEXT OF THE ORGANIZATION & services Clause 5 LEADERSHIP Clause 6 PLANNING The high-level structure proposed in Annex SL for all ISO Basic clauses. & activities that an organization follows services in the implementation of a management system. operation. For Clause 9 PERFORMANCE EVALUATION ISO 9001. 6.2 ISO 9001:2015 TOP MANAGEMENT . management systems includes. in addition to the usual 3 common to all management Clause 7 SUPPORT introductory clauses. of the QMS of products Documented & services information QMS & its processes The new model is similar to the previous Control of one. Non conformity to address the and planning measurement & corrective risks and organization commitment & control analysis actions opportunities and its context & eval. they will replace current clauses 4. They are: Clause 8 OPERATION context of the organization. performance evaluation and improvement. planning. 7 basic clauses common systems standards to all management system standards.QUALITY MANAGERS TECHNICAL GUIDE WHAT ARE THE MAIN CHANGES IN ISO 9001? PLAN DO CHECK ACT 4 5 6 8 9 10 CONTEXT OPERATION OF THE LEADERSHIP PLANNING PERFORMANCE IMPROVEMENT ORGANIZATION 7 EVALUATION SUPPORT Actions Understanding Leadership Resources Operational Monitoring. of interested & services parties & service provision Release of Clause 1 SCOPE products Introductory & services Clause 2 NORMATIVE REFERENCES clauses Clause 3 TERMS AND DEFINITIONS Non conforming processes prod. 7 and 8. Management Continuous responsibilities Planning of Communication review inprovement & authorities changes Scope Design & devel. support. Competence Quality policy Quality Determination Needs & objectives of requirements Internal audit Awareness expectations & planning for prod. 5. leadership.

The requirements include the consideration of changes international. and economic environments. if not addressed. technological. suppliers. The organization is required to monitor GOVERNMENT and review the information about these interested parties and their relevant requirements. The intention is also to anticipate current and future needs. whether results. However.QUALITY MANAGERS 3 3 TERMS AND DEFINITIONS TECHNICAL GUIDE Clause 4 CONTEXT OF THE ORGANIZATION 5 LEADERSHIP 4. would affect their ability to achieve conformity of products FAMILIES and services. determine issues and requirements that may have an impact on the planning of the QMS and can serve as input for the development of the The context of the organization refers to the business system. the organization EMPLOYEES must review the standard requirements and decide which. social. because it does not include only the direct customers but also the end- users. distributors. considering both the internal issues arising from legal. To do this. strategic priorities. regulators and any other relevant interested party. and external issues that may affect its ability to achieve the desired market. organization’s top management must be involved directly and actively Understanding the external context can be facilitated by considering 7 SUPPORT in the clarification of its mission and vision. knowledge and performance of the organization. 10 IMPROVEMENT BUSINESS ENVIRONMENT EXTERNAL ISSUES INTERNAL ISSUES TECHNOLOGICAL • ECONOMIC • CULTURE VALUES • CULTURAL INTENDED • LEGAL MARKET • R E S U LT S • SOCIAL COMPETITIVE • KNOWLEDGE PERFORMANCE Note : The concept of context of the organization is equally applicable to not-for-profit or public service organizations as it is to those seeking profits. cultural. Although reference is made to the determination of requirements environment it is operating in. ISO 9001:2015 TOP MANAGEMENT .3 DETERMINING THE SCOPE OF THE QMS STAKEHOLDERS DESCRIBED IN TERMS OF: INVESTORS • products and services • main processes involved PARTNERS • sites where processes are operated EXCLUSIONS CUSTOMERS This term is not used in ISO 9001:2015. it must first decide what of relevant 8 OPERATION stakeholders. there are no additional requirements to ensure are the intended results of its QMS and then determine the that goods and services meet the needs and expectations of external relevant internal and external issues that affect its ability to entities other than those already identified in ISO 9001:2008. COMMUNITY BUSINESS 4. competitive. The achieve those results. 4. regional or local. the availability of culture.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES This requirement goes beyond what is covered by current clause 7.2. . retailers and others involved in the supply chain. Understanding the internal and trends. EMPLOYEES because it could lead to the identification of opportunities for improvement and innovation. and other issues which could have an impact on the of the organization: 6 PLANNING Both clauses FOR require THE QMSthe organization to objectives of the organization. EVALUATION stakeholders.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT Annex SL has introduced two new clauses related to the context resources. relationships. perceptions and values of 9 PERFORMANCE context can be facilitated by considering issues related to values. national.

But previous terms. procedure. understood and applied within the QMS. perceptions and values of stakeholders • strategic priorities and availability of appropriate resources . The quality Lorem ipsum dolor sit amet. quality policy Top-level commitment and empowerment of senior • Appropriate RIBBONStoBANNERS to the purpose and context of the organization management has been raised up by the new standard. record can still be used if the organization RIBBONS BANNERS Lorem ipsum dolor sit amet. consectetur adipiscing elit. • Maintained as documented information 10 IMPROVEMENT TOP MANAGEMENT INVOLVED IN: • clarification of mission and vision • consideration of changes and trends • relationships. 9 PERFORMANCE EVALUATION Lorem ipsum dolor sit amet. as appropriate means that the responsibility will not RIBBONSlie on one BANNERS person. customer satisfaction and integrating • Top management to establish. consectetur adipiscing elit. Integer prefers them rutrum mattis mauris nec mollis. implement and maintain 7 SUPPORT QMS requirements into its business processes. which • Available relevant interested parties. and it must provide a framework organization (that is.4 ISO 9001:2015 TOP MANAGEMENT . consectetur • Commitment adipiscing elit.1 LEADERSHIP FOR THE AND COMMITMENT ORIGAMI QMS BANNERS OF RESPONSABILITIES Lorem ipsum dolor sit amet. This clause replaces the current clause on management responsibilities. consectetur adipiscing elit.QUALITY MANAGERS TECHNICAL GUIDE RIBBONS BANNERS Lorem ipsum dolor sit amet. a process) for “setting” the quality objectives. aspects of the • Communicated. Integer to improve the QMS rutrum mattis mauris nec mollis. Integer rutrum mattis mauris nec mollis.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES NEW REQUIREMENT: 2 NORMATIVE REFERENCES • Determination of risks and opportunities • Plan & implement actions to address them • Change to ‘documented information’ lets the organization 3 TERMS decide necessity. consectetur adipiscing elit. 4 CONTEXT OF THE ORGANIZATION Clause 5 LEADERSHIP NEW DESCRIPTION 6 PLANNING 5. such as quality manual. AND type and DEFINITIONS media. Integer policy must include a commitment to improve rutrum mattisallmaurisrelevant nec mollis. not just its effectiveness. Integer rutrum mattis mauris nec mollis. 1 SCOPE 4. 8 ofOPERATION The elimination the role of ‘management representative’ now requires a more proactive leadership role and greater involvement IMPORTANT CHANGES: of top management in identifying risks that can affect the conformity of products. services.

consectetur adipiscing elit.3 INFRASTRUCTURE and measuring equipment and. monitoring 7. RESOURCES It also makes clear that considerations of work environment is limited 7. Integer taking the risk order to pursue an opportunity.5 MONITORING AND MEASURING trends it shall consider current knowledge and how to acquire or access additional necessary knowledge. The organization 7.6 ORGANIZATIONAL KNOWLEDGE to the operations of processes. 3 inPERFORMANCE EVALUATION 9 Lorem ipsum dolor sit amet. changing the likelihood or consequences of risk or acceptance of risk by informed decision.QUALITY MANAGERS 5 TECHNICAL GUIDE 5 LEADERSHIP rutrum mattis mauris nec mollis. In clause . consectetur adipiscing elit. 7. MITIGATION.1.1. re-assignment of currently employed people or appropriate education. When addressing changing needs and 7.1 GENERAL Management of all resources is covered under the Support clause. Lorem ipsum dolor sit amet. rutrum mattis mauris nec mollis. There is no hiring or contracting of competent people. it is suggested that the options to address these risks may include avoidance of risk.1 ACTIONS TO ADDRESS RISKS 1 SCOPE AND OPPORTUNITIES 2 SUPPORT The clause 7on Planning is much broader than the current one.3 PLANNING OF CHANGES 5 LEADERSHIP Undertake changes in a planned and systematic manner by considering: • PLANNING Potential6consequences FOR THE QMS of change • Integrity of the QMS rutrum mattis mauris nec mollis. 10 IMPROVEMENT 4 CONTEXT OF THE ORGANIZATION 6. 9 PERFORMANCE EVALUATION It extends what is covered by the current clause with the same title 7. very important.1 the emphasisNORMATIVE REFERENCES is on the planning of actions to address risks identified as per clauses 4. Clause 6 PLANNING FOR THE QMS ELIMINATION OR ACCEPTANCE 8 OPERATION 6. Reference to preventive actions is now removed from the standard. Integer • Availability of resources RIBBONS BANNERS • Allocation or reallocation of responsibilities and authorities 8 OPERATION Clause 7 SUPPORT 7. Integer COULD INCLUDE ORIGAMI BANNERS AVOIDANCE. training OR experience.1 and 4. In a ‘note’. consectetur adipiscing elit.2 PEOPLE by adding outsourced products and services.1. Lorem ipsum dolor sit amet.4 ENVIRONMENT FOR THE shall provide the necessary manpower for the effective operation of OPERATION OF PROCESSES the QMS and its processes. Competence is achieved by training.1. mention of skills as in the current standard. people and 10 IMPROVEMENT organizational knowledge as a resource. ISO 9001:2015 TOP MANAGEMENT . eliminating the source TERMS AND DEFINITIONS RIBBONS BANNERS of risk.4 COMMUNICATION ORGANIZATION NEEDS TO DETERMINE: • Internal and external communication needs • On what it will communicate • When to communicate • With whom to communicate • How to communicate . mentoring.2 COMPETENCE This clause limits competence to those doing work that ways to acquire the necessary competence through provision of affects its quality performance. A note suggests different 7.

IMPROVEMENT where applicable. 5 LEADERSHIP 6 TECHNICAL GUIDE 2 NORMATIVE REFERENCES ISO 9001:2015 TOP MANAGEMENT . analysis and evaluation activities required by the QMS. Integer organization. taking into REQUIREMENTS customer feedback and changes impacting the changing account the rutrum mattis mauris nec mollis. now must include customer views and opinions of the organization and its products and services. Integer rutrum mattis mauris nec mollis. ANALYSIS AND EVALUATION 10 IMPROVEMENT Lorem ipsum dolor sit amet. Documented information must be retained as evidence of implementation of the audit programs and audit results. Integer rutrum mattis mauris nec mollis. 9. business Lorem ipsum dolor sit amet. ipsum dolor sit amet. • PlannedORIGAMI and carried BANNERS out. unless otherwise approved by a relevant authority10 and.QUALITY MANAGERS 6 PLANNING FOR THE QMS 3 TERMS AND DEFINITIONS EMPHASIS ON ORIGAMI BANNERS PLANNING Clause 8 OPERATION Lorem ipsum dolor sit amet. • DeliveryLoremshall not ipsum dolor sit amet. measurement. 9.1. The use of the output of analysis and evaluation is listed in detail and includes input to management reviews. of the degree to which requirements have been met. consectetur adipiscing elit.Customer satisfaction rutrum mattis mauris nec mollis. but there is no requirement for a documented procedure. consectetur adipiscing elit. THE QMS arrangements verify conformity. consectetur adipiscing elit.Issues concerning external providers & interested parties . . consectetur adipiscing elit. TRACKING & TRACING 4 CONTEXT OF THE ORGANIZATION 7 SUPPORT 8.Monitoring and measurement results RIBBONS BANNERS RIBBONS . MEASUREMENT.Adequacy of resources . analysis and evaluation • Evaluate the quality performance and effectiveness of the QMS This new clause covers all monitoring.1 RELEASE OF PRODUCTS AND SERVICES EXPORTING 5 LEADERSHIP • Implement planned activities at appropriate stages to verify that RIBBONS BANNERS product and PERFORMANCE 9 services requirements haveEVALUATION RIBBONS BANNERS beenLoremmet ipsum dolor sit amet.Non-conformities and corrective actions . by the customer • Documented OPERATION 8 information shall provide traceability to the BUSINESS RULES & STANDARDS people authorizing release of products and services for delivery to the customer TRACKING & TRACING 7 SUPPORT Clause 9 PERFORMANCE EVALUATION RIBBONS BANNERS 9. Integer rutrum mattis mauris nec mollis.Process performance and conformity of products & services • Effectiveness of actions to address risks & opportunities • New potential opportunities for continual improvement .1 MONITORING. in addition to the importance of the processes and environment and the strategic the results of previous audits.Audit Lorem results BANNERS Lorem ipsum dolor sit amet. Integer . measurement. RIBBONS describing BANNERS the requirements in more detail. Integer rutrum mattis mauris nec mollis.3 MANAGEMENT REVIEW NEW The audit program must take into account quality objectives. Integer rutrum mattis mauris nec mollis. Monitoring of the customer’s Lorem ipsum dolor sit perceptions amet.1 GENERAL • Determine what to monitor and measure • Determine methods for monitoring. consectetur adipiscing elit. Integer rutrum mattis mauris nec mollis. consectetur adipiscing elit. consectetur adipiscing elit.2 INTERNAL AUDIT 9. 6 proceed consectetur PLANNING FOR until the planned adipiscing elit. direction of the organization. A note refers • Consider information on the quality to ISO 19011 for guidance. performance. including trends and indicators for: .

Current certificates remain valid until the end of the transition period.QUALITY MANAGERS 7 TECHNICAL GUIDE WHAT IMPACT TO EXPECT ON YOUR MANAGEMENT SYSTEM? Maturity of the Management system CHANGES ARE MORE SIGNIFICANT THAN FOR THE PREVIOUS REVISION More advanced THE IMPACT OF THE CHANGES DEPENDS ON: Management LOW MEDIUM • The Management System current maturity System IMPACT IMPACT • The organization strategic decision to integrate more the different Management Systems More simple MEDIUM HIGH Management System IMPACT IMPACT Towards more integration of Management systems Keep the same level of integration Increase integration of of the Management system the Management systems WHAT IS THE TRANSITION PROCESS? GET THE NEW CERTIFICATION ISO: 2015 THE TRANSITION PROCESS TAKES INTEGRATE PARTS OF OTHER 6 TO 18 MONTHS MANAGEMENT SYSTEMS & UPDATE DOCUMENTATION MONITOR THE NEW PROCESSES. ISO 9001:2015 TOP MANAGEMENT . CEO) THEM COMPLIANT STARTING DATE DEAD-LINE TO MOVE TO TO PREPARE TRANSITION ISO 2015 CERTIFICATE 2ND QUARTER 2015 3RD QUARTER 2018 During the 3-year-transition period. An organization can still be recertified to the old standard during this period. ACT ACCORDINGLY TRAIN YOUR CORE TEAM ADAPT YOUR MANAGEMENT (QUALITY MANAGERS. . PRODUCE & ANALYSE NEW KPIs. PROCESSES TO MAKE INTERNAL AUDITORS. the organization decides when it transitions.

8 ISO 9001:2015 TOP MANAGEMENT .QUALITY MANAGERS TECHNICAL GUIDE WHAT ARE YOUR BENEFITS OF THE TRANSITION? Less directive requirements The creation of a knowledge-database Quality Management will ensure the effective is placed at the internal exchange of very core of business company-owned governance You will ensure knowledge long-lasting customer You will establish Less emphasis sustainable relationships satisfaction due on documents to improved with all relevant ‘risk-management’ stakeholders It will be easier Limiting the risks for you to meet involved in the the mandatory operation of relevant requirements from processes your customers HLS makes it easier for you to Simplified Fewer integrate more than language prescribed one standard in and text requirements your management The QMS will be system Better and timely closely aligned with decisions based the Core Business on relevant and Processes to pertinent information facilitate an effective You have more implementation It allows all types freedom to develop of businesses and your own way activity sectors to to address the better benefit from requirements ISO 9001 of the standard Increasing ability QMS will be to meet customer and closely taillored other relevant interested to each organization parties requirements Anticipation specificities Higher efficiency of future and current of the QMS due needs from your You will assure to higher involvement stakeholders will lead to deliver high quality of your employees to an early identification products and and stakeholders of business services opportunities Greater Continual motivated improvement employees Clients’ confidence Responsibility in your products for quality issues and services will be will be shared between strengthened several employees .

ISO 9001:2015 TOP MANAGEMENT . AVAILA BLE IN DIFF ERENT LANGU AGES ISO 9001:2015 GAP ANALYSIS TOOL AND GAP ANALYSIS ON SITE BUSINESS CHALLENGE In a world of ever changing economic. technological and environmental challenges. What are the key benefits? It helps to identify the gap between your current situation and the future state you want to reach to be compliant to ISO9001:2015. The international standard for Quality management.QUALITY MANAGERS 9 TECHNICAL GUIDE HOW CAN BUREAU VERITAS SUPPORT YOU IN YOUR TRANSITION? E-LEARNING COURSES NOW AVAILABLE! Get trained to the transition at your own pace and without engaging in travel expenses. With the Verification on Site. You want to manage your company transition to ISO 9001:2015 in a fully secure manner and want to know what areas of your quality management system have to be adapted to ISO 9001:2015? SOLUTION What is ISO 9001:2015 GAP ANALYSIS TOOL AND GAP ANALYSIS ON SITE ? With the gap analysis tool you can review your current quality management system against the requirements of ISO 9001:2015. ISO 9001 is being revised in 2015 to help drive this competitive advantage. a qualified Bureau Veritas auditor will then verify and validate the gaps you have identified in your current QMS. . companies need to constantly transform themselves to stay ahead.

QUALITY MANAGERS TECHNICAL GUIDE AUDIT OF TRANSITION DURING PLANNED AUDITS WHAT IS IT? Beware: from End of Sept2018. • Whenever you are ready with implementation of all changes • Whenever you are planning for your next surveillance or Recertification whichever is due at that time REQUEST A PRE-AUDIT WHAT IS IT ABOUT? WHAT VALUE DOES IT BRING TO YOUR TRANSITION: • An optional overview and validation audit of ISO 9001:2015 • An opportunity to fully understand the new requirements and their requirements against their current compliance in an ISO 9001:2008 impact on your existing management system. It does not grant 9001:2015 or 14001:2015 certification . This can then clarify the quality management system and the new changes coming from the actions you need to take to achieve transition successfully.10 ISO 9001:2015 TOP MANAGEMENT . BUT: • A pre-audit is completely independent from the transition audit. revision of the standard. non conformities will be raised requiring for closure WHEN TO DO IT: before a new certificate can be issued. • The transition requirements are audited as part of one of the ensuing planned audits such as the surveillance or Recertification WHAT ARE THE BENEFITS FOR YOUR COMPANY? audit • There is no need of a separate audit. • During this audit. conformance with the revised standard is assessed along with other requirements Beware: If the organization is found not conform to all the requirements. your certificate will no longer be valid.

classify. you will be able to apply your knowledge to identify. By attending you will transform your existing auditor skills to ISO 9001:2015. Building on your knowledge you will develop the skills to audit against the changing landscape of ISO 9001:2015 Quality Management System (QMS). ISO 9001:2015 TOP MANAGEMENT . This workshop will help you identify the requirements of ISO 9001:2015 with regard to process risk management and identify the tools and techniques to implement a risk based approach within your management system.You’ll gain the practical knowledge needed to build your auditing skills. This course will help you stay at the forefront of QMS strategy.QUALITY MANAGERS 11 TECHNICAL GUIDE A WIDE RANGE OF SPECIALIZED TRAINING This course will help you find out what you need to know about transitioning to the new ISO 9001:2015 standard. INTERNAL A series of deep dive workshops. RISK On completion of the course. PLEASE CONTACT YOUR LOCAL BUREAU VERITAS PARTNER . external provision and AUDITOR facilitated action are also available for you to attend. MANAGEMENT TRAINING TO FIND OUT MORE ABOUT TRAINING AVAILABILITY AND TIMES. It will assist you with the implementation of the changes within your business. leadership. On completion of the course. quantify and treat risks and develop an action plan to implement a risk your organizations. which focus on auditing risk. You will discover more about the AWARNESS changes and how these will affect your organization so you can start SEMINARS AND putting transition arrangements in WORKSHOPS place. TRAINING This course will enable you to identify the core changes and requirements of ISO. you will REVISED 2015 be able to apply your knowledge of the amended requirements to STANDARDS ISO 9001:2015 to develop TRAINING an action plan to aid your implementation processes. Follow us on Twitter .com ISO 14001:2015 @revision2015 TOP MANAGEMENT .ENVIRONMENTAL MANAGER TECHNICAL GUIDE Photos: contact.COM! LEARN ABOUT THE CHANGES SHARE YOUR QUESTIONS AND DISCUSS THEM WITH YOUR AND THE NEW REQUIREMENTS How to manage FELLOWS ON LINKEDIN AND TWITTER the transition IN ISO14001:2015 successfully WITH OUR TECHNICAL GUIDE FOR TOP MANAGEMENT - Join our community ENVIRONNEMENTAL MANAGER Bureau Veritas Certification Photos: www. HOW TO GET MORE INFORMATION ? STAY UP-TO-DATE THANKS TO OUR WEBSITE .com Move Forward with Confidence .