How to manage the transition successfully ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS Move Forward with Confidence
2 WHAT ARE THE MAIN CHANGES IN ISO 9001? PLAN DO CHECK ACT 4 5 CONTEXT OF THE ORGANIZATION LEADERSHIP 6 8 9 10 OPERATION PLANNING PERFORMANCE IMPROVEMENT 7 EVALUATION SUPPORT Understanding the organization and its context Leadership and commitment Actions to address risks and opportunities Resources Competence Operational planning & control Monitoring, measurement analysis & eval. Non conformity & corrective actions Needs & expectations of interested parties Scope of the QMS Quality policy Roles, responsibilities & authorities Quality objectives & planning Planning of changes Awareness Communication Documented information Determination of requirements for prod. & services Design & devel. of products & services Internal audit Management review Continuous inprovement QMS & its processes Control of externally proc.prod. & services Production & service provision The new model is similar to the previous one. Although the intention is not to recommend the sequence of activities that an organization follows in the implementation of a management system, each organization is free to interpret the model as it sees fit. Introductory clauses 1 2 SCOPE NORMATIVE REFERENCES Release of products & services 3 4 TERMS AND DEFINITIONS CONTEXT OF THE ORGANIZATION Non conforming processes prod. & services 5 LEADERSHIP Basic clauses, common to all management systems standards 6 7 8 9 10 PLANNING SUPPORT OPERATION PERFORMANCE EVALUATION IMPROVEMENT The high-level structure proposed in Annex SL for all ISO management systems includes, in addition to the usual 3 introductory clauses, 7 basic clauses common to all management system standards. They are: context of the organization, leadership, planning, support, operation, performance evaluation and improvement. For ISO 9001, they will replace current clauses 4, 5, 6, 7 and 8. It follows the well known PDCA cycle and the process approach from section 4 to 10, in an order that is consistent with organizational planning and process management.
3 TERMS AND DEFINITIONS 3 4 CONTEXT OF THE ORGANIZATION 5 4.1 UNDERSTANDING LEADERSHIPTHE ORGANIZATION AND ITS CONTEXT Annex SL has introduced two new clauses related to the context of the organization: 6 PLANNING Both clauses FOR require THE QMS the organization to 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 system. Although reference is made to the determination of requirements of relevant 8stakeholders, OPERATION there are no additional requirements to ensure that goods and services meet the needs and expectations of external entities other than those already identified in ISO 9001:2008. The organization s top management must be involved directly and actively in the clarification 7 SUPPORT of its mission and vision, considering both the internal and external issues that may affect its ability to achieve the desired results. The requirements include the consideration of changes and trends, 9 relationships, perceptions and values of PERFORMANCE EVALUATION stakeholders, strategic priorities, the availability of resources, and other issues which could have an impact on the objectives of the organization. The context of the organization refers to the business environment it is operating in. To do this, it must first decide what are the intended results of its QMS and then determine the relevant internal and external issues that affect its ability to achieve those results. Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local. Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. 10 IMPROVEMENT BUSINESS ENVIRONMENT EXTERNAL ISSUES INTERNAL ISSUES TECHNOLOGICAL ECONOMIC MARKET COMPETITIVE CULTURE KNOWLEDGE INTENDED RESULTS VALUES PERFORMANCE CULTURAL LEGAL SOCIAL 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. 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES This requirement goes beyond what is covered by current clause 7.2, because it does not include only the direct customers but also the endusers, suppliers, distributors, retailers and others involved in the supply chain, regulators and any other relevant interested party. The intention is also to anticipate current and future needs, because it could lead to the identification of opportunities for improvement and innovation. The organization is required to monitor and review the information about these interested parties and their relevant requirements. COMMUNITY EMPLOYEES GOVERNMENT 4.3 DETERMINING THE SCOPE OF THE QMS BUSINESS STAKEHOLDERS DESCRIBED IN TERMS OF: products and services main processes involved sites where processes are operated PARTNERS INVESTORS EXCLUSIONS This term is not used in ISO 9001:2015. However, the organization must review the standard requirements and decide which, if not addressed, would affect their ability to achieve conformity of products and services. EMPLOYEES FAMILIES CUSTOMERS
4 1 SCOPE 4.4 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 decide necessity, 3 TERMS type and AND media. DEFINITIONS But previous terms, such as quality manual, procedure, record can still be used if the organization prefers them 4 CONTEXT OF THE ORGANIZATION 5 LEADERSHIP 5.1 LEADERSHIP 6 PLANNING AND COMMITMENT FOR THE QMS This clause replaces the current clause on management responsibilities. The elimination 8 of OPERATION the role of management representative now requires a more proactive leadership role and greater involvement of top management in identifying risks that can affect the conformity of products, services, customer satisfaction and integrating SUPPORT QMS requirements 7 into its business processes. Top-level commitment and empowerment of senior management has been raised up by the new standard, which means that the responsibility will not RIBBONS lie on one BANNERS person. The quality 9 PERFORMANCE Lorem ipsum dolor sit EVALUATION amet, consectetur adipiscing elit. Integer policy must include a commitment to improve rutrum mattis all mauris relevant nec mollis. aspects of the QMS, not just its effectiveness, and it must provide a framework (that is, a process) for setting the quality objectives. 10 IMPROVEMENT ORIGAMI BANNERS NEW DESCRIPTION OF RESPONSABILITIES IMPORTANT CHANGES: Top management to establish, implement and maintain quality policy Appropriate to the purpose and context of the organization Available Lorem ipsum dolor sit amet, to consectetur relevant adipiscing elit. Integer interested parties, as appropriate Commitment to improve the QMS Communicated, understood and applied within the organization Maintained as documented information TOP MANAGEMENT INVOLVED IN: clarification of mission and vision consideration of changes and trends relationships, perceptions and values of stakeholders strategic priorities and availability of appropriate resources
5 LEADERSHIP 5 6 PLANNING FOR THE QMS COULD INCLUDE AVOIDANCE, MITIGATION, ELIMINATION OR ACCEPTANCE ORIGAMI BANNERS 6.1 ACTIONS 8 1 OPERATION SCOPE TO ADDRESS RISKS AND OPPORTUNITIES The clause 7on Planning is much broader than the current one. In clause 6.1 the emphasis 2 NORMATIVE is on the planning REFERENCES of actions to address risks identified as per clauses 4.1 and 4.2. In a note, it is suggested that the options to address these risks may include avoidance of risk, PERFORMANCE EVALUATION taking the risk 9 3 in order to pursue an opportunity, eliminating the source TERMS AND DEFINITIONS of risk, changing the likelihood or consequences of risk or acceptance of risk by informed decision. Reference to preventive actions is now removed from the standard. 10 4 SUPPORT IMPROVEMENT CONTEXT OF THE ORGANIZATION 6.3 PLANNING OF CHANGES 5 LEADERSHIP Undertake changes in a planned and systematic manner by considering: PLANNING FOR THE QMS Potential 6consequences of change Integrity of the QMS Availability of resources Allocation or reallocation of responsibilities and authorities 8 OPERATION 7 SUPPORT 7.1.1 9 PERFORMANCE GENERAL EVALUATION 7.1.2 PEOPLE 7.1.3 INFRASTRUCTURE 7.1.4 10 IMPROVEMENT ENVIRONMENT FOR THE OPERATION OF PROCESSES 7.1.5 MONITORING AND MEASURING RESOURCES 7.1.6 ORGANIZATIONAL KNOWLEDGE Management of all resources is covered under the Support clause. It extends what is covered by the current clause with the same title by adding outsourced products and services, monitoring and measuring equipment and, very important, people and organizational knowledge as a resource. The organization shall provide the necessary manpower for the effective operation of the QMS and its processes. When addressing changing needs and trends it shall consider current knowledge and how to acquire or access additional necessary knowledge. It also makes clear that considerations of work environment is limited to the operations of processes. 7.2 COMPETENCE This clause limits competence to those doing work that affects its quality performance. Competence is achieved by appropriate education, training OR experience. There is no mention of skills as in the current standard. A note suggests different ways to acquire the necessary competence through provision of training, mentoring, re-assignment of currently employed people or hiring or contracting of competent people. 7.4 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
6 5 LEADERSHIP 2 NORMATIVE REFERENCES 6 PLANNING FOR THE QMS 3 TERMS AND DEFINITIONS EMPHASIS ON ORIGAMI BANNERS PLANNING 8 rutrum OPERATION mattis mauris nec mollis. 4 CONTEXT OF THE ORGANIZATION 8.1 RELEASE 7 SUPPORT OF PRODUCTS AND SERVICES 5 LEADERSHIP product and 9 services PERFORMANCE requirements have EVALUATION been met Lorem ipsum dolor sit amet, 6consectetur adipiscing elit. Integer PLANNING FOR THE QMS Implement planned activities at appropriate stages to verify that Delivery shall not proceed until the planned arrangements verify conformity, unless otherwise approved by a relevant authority 10 and, where applicable, by the customer IMPROVEMENT 8 OPERATION Documented information shall provide traceability to the people authorizing release of products and services for delivery to the customer 7 SUPPORT TRACKING & TRACING EXPORTING BUSINESS RULES & STANDARDS TRACKING & TRACING 9 PERFORMANCE EVALUATION 9.1 MONITORING, 10 IMPROVEMENT MEASUREMENT, ANALYSIS AND EVALUATION 9.1.1 GENERAL Determine what to monitor and measure Determine methods for monitoring, measurement, analysis and evaluation Evaluate the quality performance and effectiveness of the QMS This new clause covers all monitoring, measurement, analysis and evaluation activities required by the QMS, describing the requirements in more detail. Monitoring of the customer s perceptions of the degree to which requirements have been met, now must include customer views and opinions of the organization and its products and services. The use of the output of analysis and evaluation is listed in detail and includes input to management reviews. 9.2 INTERNAL AUDIT The audit program must take into account quality objectives, customer feedback and changes impacting the organization, in addition to the importance of the processes and the results of previous audits. Documented information must be retained as evidence of implementation of the audit programs and audit results, but there is no requirement for a documented procedure. A note refers to ISO 19011 for guidance. 9.3 MANAGEMENT REVIEW Planned and carried out, taking into account the changing business environment and the strategic direction of the organization. Consider information on the quality performance, including trends and indicators for: - Non-conformities and corrective actions - Monitoring and measurement results - Audit results - Customer satisfaction - Issues concerning external providers & interested parties ORIGAMI BANNERS - Adequacy of resources NEW REQUIREMENTS - Process performance and conformity of products & services Effectiveness of actions to address risks & opportunities New potential opportunities for continual improvement
7 WHAT IMPACT TO EXPECT ON YOUR MANAGEMENT SYSTEM? Maturity of the Management system More advanced Management System LOW IMPACT MEDIUM IMPACT CHANGES ARE MORE SIGNIFICANT THAN FOR THE PREVIOUS REVISION THE IMPACT OF THE CHANGES DEPENDS ON: The Management System current maturity The organization strategic decision to integrate more the different Management Systems More simple Management System MEDIUM IMPACT Keep the same level of integration of the Management system HIGH IMPACT Increase integration of the Management systems Towards more integration of Management systems WHAT IS THE TRANSITION PROCESS? GET THE NEW CERTIFICATION ISO: 2015 INTEGRATE PARTS OF OTHER MANAGEMENT SYSTEMS & UPDATE DOCUMENTATION THE TRANSITION PROCESS TAKES 6 TO 18 MONTHS MONITOR THE NEW PROCESSES, PRODUCE & ANALYSE NEW KPIs. ACT ACCORDINGLY TRAIN YOUR CORE TEAM (QUALITY MANAGERS, INTERNAL AUDITORS, CEO) ADAPT YOUR MANAGEMENT PROCESSES TO MAKE THEM COMPLIANT STARTING DATE TO PREPARE TRANSITION 2 ND QUARTER 2015 DEAD-LINE TO MOVE TO ISO 2015 CERTIFICATE 3 RD QUARTER 2018 During the 3-year-transition period, the organization decides when it transitions. An organization can still be recertified to the old standard during this period. Current certificates remain valid until the end of the transition period.
8 WHAT ARE YOUR BENEFITS OF THE TRANSITION? Less directive requirements You will ensure long-lasting customer satisfaction due to improved risk-management HLS makes it easier for you to integrate more than one standard in your management system You have more freedom to develop your own way to address the requirements of the standard Higher efficiency of the QMS due to higher involvement of your employees and stakeholders The creation of a knowledge-database will ensure the effective internal exchange of company-owned knowledge Limiting the risks involved in the operation of relevant processes Better and timely decisions based on relevant and pertinent information Increasing ability to meet customer and other relevant interested parties requirements Continual improvement Less emphasis on documents Simplified language and text Anticipation of future and current needs from your stakeholders will lead to an early identification of business opportunities Quality Management is placed at the very core of business governance It will be easier for you to meet the mandatory requirements from your customers The QMS will be closely aligned with the Core Business Processes to facilitate an effective implementation QMS will be closely taillored to each organization specificities Greater motivated employees You will establish sustainable relationships with all relevant stakeholders Fewer prescribed requirements It allows all types of businesses and activity sectors to better benefit from ISO 9001 You will assure to deliver high quality products and services Clients confidence in your products and services will be strengthened Responsibility for quality issues will be shared between several employees
9 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. AVAILABLE IN DIFFERENT LANGUAGES ISO 9001:2015 GAP ANALYSIS TOOL AND GAP ANALYSIS ON SITE BUSINESS CHALLENGE In a world of ever changing economic, technological and environmental challenges, companies need to constantly transform themselves to stay ahead. The international standard for Quality management, ISO 9001 is being revised in 2015 to help drive this competitive advantage. 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. With the Verification on Site, a qualified Bureau Veritas auditor will then verify and validate the gaps you have identified in your current QMS. 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.
10 AUDIT OF TRANSITION DURING PLANNED AUDITS WHAT IS IT? The transition requirements are audited as part of one of the ensuing planned audits such as the surveillance or Recertification audit During this audit, conformance with the revised standard is assessed along with other requirements WHEN TO DO IT: 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 Beware: from End of Sept2018, your certificate will no longer be valid. WHAT ARE THE BENEFITS FOR YOUR COMPANY? There is no need of a separate audit. Beware: If the organization is found not conform to all the requirements, non conformities will be raised requiring for closure before a new certificate can be issued. REQUEST A PRE-AUDIT WHAT IS IT ABOUT? An optional overview and validation audit of ISO 9001:2015 requirements against their current compliance in an ISO 9001:2008 quality management system and the new changes coming from the revision of the standard. WHAT VALUE DOES IT BRING TO YOUR TRANSITION: An opportunity to fully understand the new requirements and their impact on your existing management system. This can then clarify the actions you need to take to achieve transition successfully. BUT: A pre-audit is completely independent from the transition audit. It does not grant 9001:2015 or 14001:2015 certification
11 A WIDE RANGE OF SPECIALIZED TRAINING AWARNESS SEMINARS AND WORKSHOPS This course will help you find out what you need to know about transitioning to the new ISO 9001:2015 standard. You will discover more about the changes and how these will affect your organization so you can start putting transition arrangements in place. INTERNAL AUDITOR TRAINING This course will help you stay at the forefront of QMS strategy. 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).You ll gain the practical knowledge needed to build your auditing skills. A series of deep dive workshops, which focus on auditing risk, leadership, external provision and facilitated action are also available for you to attend. REVISED 2015 STANDARDS TRAINING This course will enable you to identify the core changes and requirements of ISO. It will assist you with the implementation of the changes within your business. On completion of the course, you will be able to apply your knowledge of the amended requirements to ISO 9001:2015 to develop an action plan to aid your implementation processes. RISK MANAGEMENT TRAINING 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. On completion of the course, you will be able to apply your knowledge to identify, classify, quantify and treat risks and develop an action plan to implement a risk your organizations. TO FIND OUT MORE ABOUT TRAINING AVAILABILITY AND TIMES, PLEASE CONTACT YOUR LOCAL BUREAU VERITAS PARTNER
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