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ISO 9001

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ISO 9001

  1. 1. ISO 9001:2015 By: MBA, M.A, Dipl. Vet. Specialist. Mohammed Ghorab Handy : (+2) 01005474734, (+20) 01018717045, (+49) 017684345821, (+49) 015738597543 Ghorabmohammed@hotmail.com, M.ghorab@daad-alumni.de, M.ghorab@Egyptair.com
  2. 2. Introduction of participants • The 5 W’s ▫ Who are you ?  What is your preferred name in class? ▫ Where do you work? ▫ What is your job title, and ▫ What are your main responsibilities? ▫ Why are you attending this course?  Please define your expectations 2
  3. 3. keep 3 No smokingPunctuality Participation Certificates Documentation Phones Data forms
  4. 4. Agenda: • Welcome and Administration • Introduction to ISO 9001 History • Content of ISO 9001 • ISO 9001:2015
  5. 5. Course Objectives • ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction. • A new version of the standard, ISO 9001:2015, has just been launched, replacing the previous version (ISO 9001:2008).
  6. 6. Who must attend this course • Every body in the organization from different levels as ISO is everybody concern.
  7. 7. Name Tag
  8. 8. What is ISO?
  9. 9. What is ISO 9001? • The ISO 9001 Quality Management System is the world‟s most popular quality improvement standard, with over one million certified organizations in 180 countries around the globe. It is the only standard in the 9000 family of standards published by the International Organization for Standardization (ISO) that can be used for the purpose of conformity assessment. ISO 9001 also serves as the basis for many other important sector- specific standards, as well as widely used management system standards such as OHSAS 18001 and ISO 14001.
  10. 10. ISO 9001 Revision • The International Organization for Standardization (ISO) is working on a major revision of the ISO 9001 standard. The last revision dates back to 2008 and introduced a small number of new requirements. Publication of the final version of ISO 9001:2015 is expected at the end of 2015. The working draft, ISO/DIS 9001:2015, is now available, and has a clear objective.
  11. 11. Effectiveness and efficiency def: • Doing the right thing (Result) • Doing the thing in a right way (Methodology) Group Task: Give me example: A Football Match Goals achieved (WON) Performance and way in playing
  12. 12. W.I and SOP: How to do the Process Objective Procedures, Process 4W WI, SOPS How Record (Evidence)
  13. 13. ISO Introduction
  14. 14. Revision Timeline • The working draft, ISO/DIS 9001:2015 was distributed for review and comment on May 8, 2014. The Committee Draft (CD) published in the run-up to this draft received around 3,000 comments and was approved by 80% of the countries in a preliminary vote. The international community has been invited to submit their comments on this interim working draft by July 2014. • Publication of the official draft international standard (DIS) is expected in September 2014. After the commenting period, the final draft international standard (FDIS) will then be passed before its presentation, scheduled for November 2014. Publication of the final version of ISO 9001:2015 is expected in September 2015.
  15. 15. New Structure • It is certain that a “high-level structure“ will replace the existing structure. This structure is in accordance with the requirement of the ISO Directive, Annex SL 2013. • All management system standards developed in the future will use a consistent structure and outline such as identical core texts, common terms and core definitions. This is to ensure that all sections of management system standards share the same section headings and core texts. The ISO 14001 and BS OHSAS 18001 standards will also be revised in accordance with the same structure.
  16. 16. Summary of the Key Changes • The new draft is designed to make the standard more generic and more easily applicable by service industries. Therefore, the term “product“ has been replaced by “products and services“ when specifically referring to the deliverables for the customer.
  17. 17. Context of the Organization • The high-level structure and the core text established in Annex SL, Appendix 2, have introduced two new clauses related to the context of the organization: • 4.1 Understanding the organization and its context • 4.2 Understanding the needs and expectations of interested parties
  18. 18. These two clauses require the organization to determine the issues and requirements that can impact the planning of the quality management system (QMS) and can be used as input for the development of the QMS. The stakeholder approach, considered one of the most modern corporate governance principles, is new. This approach is based on the assumption that long-term business success can only be ensured by considering the requirements of company stakeholders. The approach has been described for many years in ISO 9004:2009, Section 4.4 “Interested parties, needs and expectations,“ and has been introduced in the draft standard. In comparison to “Customer Relationship Management“ (CRM), which only addresses the relationship between an organization and its customers, the principle of Stakeholder Relationship Management (SRM) goes significantly further. It tries to balance the relationship of the organization with all, or with the most important, stakeholders/interested parties. These could include direct consumers, suppliers and retailers and other parties along the supply chain, authorities and other relevant interested parties. As a new feature in this draft, the term “interested parties“ now also includes owners, people in an organization, bankers and even competitors.
  19. 19. • Although this DIS refers to the determination of the requirements of major interested parties, it does not require that products and services have to fulfill the need and expectations of external parties. This is with the exclusion of already mentioned external parties in ISO 9001:2008, i.e. customer and authorities, etc. Such a requirement would require a change in the scope of the standard, which is not covered under the revision.
  20. 20. Process Approach • The ISO 9001:2008 standard promoted the adoption of a process approach when developing, implementing and improving QMS effectiveness. The draft standard does so even more explicitly in Section 4.4 Quality management system and its processes. This sub-chapter lists the essential requirements of a process-focused management approach. Inputs and outputs of each process must be defined. In the future, the standard will require the measurement of performance indicators and the assignment of responsibilities.
  21. 21. What is the process approach? The systematic management of processes and their interactions to achieve intended results 24
  22. 22. What is the process approach? All organizations use processes to: • set interrelated or interacting activities • transform inputs into outputs • build in checks to meet objectives and promote continuous improvement The process approach integrates processes into a complete system to achieve strategic and operational objectives 25
  23. 23. How do I do it? To use the process approach an organization should: • understand and define the processes needed to meet its objectives • recognize that the processes are unique to its own context • integrate all of the processes and their interactions into a system that utilizes risk-based thinking . 26
  24. 24. Process approach and risk-based thinking • The process approach incorporates risk-based thinking • Risk-based thinking ensures risk is considered when establishing, implementing and maintaining a management system, each process and each activity 27
  25. 25. The process approach and PDCA Processes can be managed using the PDCA cycle 28 Plan set objectives and build processes necessary to deliver results Do implement what was planned Check monitor and measure processes and results against the objectives Act take actions to improve results
  26. 26. Documented Information • The term “documented information“ replaces the previous terms “documents“ and “records.“ The intention was to give users more flexibility. This also applies to the description of processes. The organization determines the extent of documented information on processes, depending on factors such as process complexity or employee competence. Documented procedures previously required by the standard are no longer necessary.
  27. 27. Management Responsibilities • The draft standards increase “management responsibilities.“ In the future, responsibilities previously held by the Quality Management Representative will rest with top management and a more precise assignment of roles and responsibilities will be required.
  28. 28. Management Review • The scope of the management review is extended by the addition of the aspects “strategic direction of the organization,“ consideration of the “relevant interested parties“ and “assessment of risks and opportunities“ at a strategic level.
  29. 29. Risk and Preventive Actions • The high-level structure and core texts specified in Annex SL, Appendix 2, does not include a clause stating specific requirements for “preventive measures.“ The reason is because acting as a “preventive tool“ is one of the key purposes of a quality management system (risk prevention). The emphasis on a risk-based approach is referenced in many places in the draft standard, from risk assessment in Section 4.4 “Quality management system and its processes,“ leadership issues in Section 5.1.1 and a separate sub-clause in Section 6.1.2 “Actions to address risks and opportunities“ to risk-based approaches in “Operational planning and control“ (Chapter 8.1) and “Management review“ (Chapter 9.3). While the draft demands that risks are identified and acted upon, there is no requirement for standardized risk management.
  30. 30. Q: What is Risk: Dr.Mohammed Ghorab 33
  31. 31. What is Risk ?
  32. 32. • "boiling frog syndrome," referring to the metaphor that a frog put in boiling water will jump out, while one in cold water won't notice the danger if the temperature heats up slowly. • “What the market needs to focus on now is the temperature of the water," Howard Esaki, global head of structured finance research at Standard & Poor's, said at a year-end 2014 commercial real estate briefing.
  33. 33. What is Risk ? Risk is “The level of exposure to uncertainties that the enterprise/organization must understand and effectively manage as it executes its strategies to achieve its business objectives and create value.” Source: Alain LeBlanc, CD, B.Eng., M. Sc, M. Eng. 2011, Canadian Society of Value Analysis
  34. 34. Define the following according to your business position giving examples: • Business objectives • Value • Lost value • Gained value-added value • Created value
  35. 35. Treatment Failure due to disease description disorder
  36. 36. A true story for understanding the next model:
  37. 37. Risk assessment and estimation differ from person to person
  38. 38. Risk: Internal or External ? Internal Your own Project Your own Business Inside the organization External Legislation Market Forces Exchange Rate Fluctuations Risk is not only something bad will happen but also something good will not happen (opportunities Vs. Problems)
  39. 39. Diagrams shows forming of risk appetite: (Green, High normal, above normal, yellow risky, dangerous
  40. 40. How Corporate Appetite could eliminate Risks:
  41. 41. Risk Management Process 5. Monitor and Review 4. Implement Countermeasures 3. Identify Countermeasures 2. Quantify Risks 1. Identify Risks Source: Andy Osborne, Risk Management Made Easy
  42. 42. Risk Management Process:
  43. 43. Flow Chart of Risk Process
  44. 44. 1. Identify Risks • Categorize and differentiate between different types of risks ▫ Strategic Risks:  Business Planning  Business Growth  New Markets/ Products/Services  Mergers/Alliances
  45. 45. 1. Identify Risks ▫ Operational Risks:  Production  Distribution  Service delivery  Pollution/Environmental Issues ▫ Financial Risks:  Cash Flow  Sales  Contracts
  46. 46. 1. Identify Risks ▫ Regulatory/Compliance Risks:  Breach of Regulation  Failure to meet Legal Requirements  Loss of Operating License ▫ Healthy and Safety Risks:  Workplace Accidents  Injuries or Death  Litigation
  47. 47. 1. Identify Risks ▫ Technology Risks:  IT Failure  Data Loss  Equipment Failure ▫ Project Risks:  Failure to meet time scales  Increased Costs  Failure to meet business requirements
  48. 48. 1. Identify Risks • List all the risks the business may face • Assess the loss from each risk • Focus on the most critical type of risk
  49. 49. 2. Quantify Risks • Here we want to assess: ▫ How likely a certain risk will happen ?  Probability/ Likelihood to happen ▫ How will it impact/hurt the business ?  Two Types of Impacts
  50. 50. 2. Quantify Risks
  51. 51. 2. Quantify Risks Impacts Ratings
  52. 52. 2. Quantify Risks Likelihood Ratings
  53. 53. 2. Quantify Risks
  54. 54. 2. Quantify Risks • A Risk Matrix: a tool used to rate the significance of the identified risks based on the impacts and likelihood ratings. • Different forms of the risk matrix can be used, however, the simplest one is 3 X 3 Grid
  55. 55. 2. Quantify Risks Example: 4 X 4 Matrix
  56. 56. 2. Quantify Risks Risk Assessment Summary
  57. 57. 2. Quantify Risks •The risk rating which is a combination of likelihood and impact is a rating of the significance of each identified risk. •The nearer is the risk to the top-right right corner of the matrix, •the more significant is the risk. Impact
  58. 58. 3. Identify Countermeasures • After the assessment of the identified risk and prioritizing the risks. How to deal with these risks ?
  59. 59. 3. Identify Countermeasures Risk responses based on significance
  60. 60. 3. Identify Countermeasures How to response to risks ?
  61. 61. 3. Identify Countermeasures • Risk Acceptance: When ? ▫ Likelihood = Low & Impact = Low ▫ Costs of addressing risk > Potential loss
  62. 62. 3. Identify Countermeasures • Risk Management: When ? ▫ Likelihood = High & Impact = Low ▫ Approaches through training, education and monitoring, improving processes
  63. 63. 3. Identify Countermeasures • Contingency Planning: When ? ▫ Likelihood = Low & Impact = High  E.g. Large financial losses, reputation damage
  64. 64. 3. Identify Countermeasures • Contingency Plans could be: - Crisis Management - Communication with customers and stakeholders - Alternative ways of supply and distribution - Relocation and recovery of critical business functions
  65. 65. 3. Identify Countermeasures Risk Transfer Insurance Outsourcing
  66. 66. • Example: To cross the road I may go directly or I may use a nearby footbridge. Which process I choose will be determined by considering the risks. • Risk is commonly understood to have only negative consequences; however the effects of risk can be either negative or positive. • In ISO 9001:2015 risks and opportunities are often cited together. Opportunity is not the positive side of risk. An opportunity is a set of circumstances which makes it possible to do something. Taking or not taking an opportunity then presents different levels of risk. • Example: • Crossing the road directly gives me an opportunity to reach the other side quickly, but if I take that opportunity there is an increased risk of injury from moving cars.
  67. 67. Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits • ISO 9001:2015 standard requires us to take a “risk-based approach to quality management.” This involves taking a greater strategic view of risk within your business, and also ties in with the changes in leadership requirements • So, given that your top management team should now be involved in the process of identifying, recording, removing, and mitigating risk, then you can see that from the start, using a risk-based thinking process should far surpass preventive action in terms of effectiveness. Ensuring that your management team has a forum for identifying risk at the regular management meetings can be a vital step toward this. Equally important is ensuring that all employees at a lower level have a channel where they can feed their opinions upwards for consideration by the management team.
  68. 68. • When these two processes are in place, you will have a “risk-based thinking” process that is presided over by the top management team, which holds all the key strategic knowledge about threats to the business, and is supported by information from all levels – some of which may have previously remained unknown to them. So, in effect, in place of a one-dimensional preventive action process, which usually was carried out at a lower level and remained there, you now have a risk-based thinking process presided over by the team who has all information available to them from the pinnacle of the company, filtering all the way down. With the decisions made from this process, and the ensuing actions, it is not difficult to see that the documented actions and objectives will be more effective on a company-wide basis than the preventive action process was.
  69. 69. what does your organization have to do to get up to speed with this change? • There will be a transition period of up to three years for implementation of the new standard, but some of the changes are so beneficial that the sooner you start, the better. Encouraging your top management team to embrace the changes in leadership requirements and coupling this with a new risk-based thinking process makes perfect sense. The sooner you can facilitate both, and encourage the synergy between the two, the more in tune your organization will be to the threats and risks you will have to navigate in the coming months and years. And, as we all know, where there are risks there are almost always opportunities, so identification of these are another positive spinoff of adopting this overall approach as soon as possible. Removal and mitigation of risk almost always ensures company growth, which can only be good news for your organization. ISO 9001:2015 is a standard that goes far beyond company quality standards, and its outputs ensure that your organization can be protected and improved, and new opportunities identified, as stated above. Given that these changes are so beneficial
  70. 70. Where is risk addressed in ISO 9001:2015? 74
  71. 71. • Introduction - the concept of risk-based thinking is explained • Clause 4 - organization is required to determine its QMS processes and address its risks and opportunities • Clause 5 – top management is required to ▫ Promote awareness of risk-based thinking ▫ Determine and address risks and opportunities that can affect product /service conformity • Clause 6 - organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them 75 Risk-based thinking is in:
  72. 72. Risk-based thinking is in: • Clause 7 – organization is required to determine and provide necessary resources • Clause 8 - organization is required to manage its operational processes • Clause 9 - organization is required to monitor, measure, analyse and evaluate the effectiveness of actions taken to address risks and opportunities • Clause 10 - organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities • Note, risk is implicit whenever suitable or appropriate is mentioned (clause 7 and 8) 76
  73. 73. Why use risk-based thinking? Successful organizations intuitively apply risk- based thinking because it brings benefits that: • improve governance • establish a proactive culture of improvement • assist with compliance • assure consistency of quality of products and services • improve customer confidence and satisfaction 77
  74. 74. How do I do it? • Identify what your risks are – it depends on context • Use risk-based thinking to prioritize the way you manage your processes • ISO 9001:2015 does not require formal risk management • ISO 31000 Risk management — Principles and guidelines may be a useful reference for organizations that want or need a more formal approach to risk (but its use is not obligatory) 78
  75. 75. How do I do it?  Balance risks and opportunities • Analyse and prioritize your risks what is acceptable? what is unacceptable? • Plan actions to address the risks how can I avoid, eliminate or mitigate risks? • Implement the plan; take action • Check the effectiveness of the action; does it work? 79
  76. 76. Conclusions Risk-based thinking: • is not new • is something you probably do already • is ongoing • ensures greater knowledge of risks and improves preparedness • increases the probability of reaching objectives • reduces the probability of negative results • makes prevention a habit 80
  77. 77. How Can You Prepare? • At this stage, it is relatively easy to predict the updated QM-specific contents that will be included in the ISO 9001:2015. The requirements of the above sections will only be subject to minor changes. Organizations that have established management systems should familiarize themselves with the changes and subsequently upgrade their management systems accordingly in 2015 and 2016.
  78. 78. • There will be a three-year transition period during which both the old and the new standard will apply in parallel. However, within the scope of certification, organizations should not leave the upgrade until the very end of the transition period. We recommend that organizations upgrade their systems to the new standard at an early stage within the scope of a regular re- certification audit.
  79. 79. Your Business Benefits • Save money and time – through quality management practices that increase your organizational efficiency, productivity and profitability. • Minimize risk – by consistently achieving a level of quality defined by the standard, thus ensuring your products and services are less likely to fall short of customer expectations. • Profit from an expert partnership – an internationally recognised and respected brand. • Increase your competitiveness – with a quality management system that attracts investors and lowers trade barriers to your business. • Gain market recognition – with the world‟s most widely known quality management system, which can help establish your presence as a supplier when entering a new market.
  80. 80. History
  81. 81. • ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. However, its history can be traced back some 20 years before that, to the publication of the United States Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979 before being submitted to ISO. The first revision was done in 1994, and the standard was issued as a quality assurance system. At this point, the standard had three sub- standards: ISO 9001, ISO 9002, and ISO 9003. The next revision of the standard was done in the year 2000, and this standard defined the Quality Management System. In 2008 the third revision was published, and now the 2015 revision is the current revision
  82. 82. What are the major differences ? • The most noticeable change to the standard is its new structure. ISO 9001:2015 now follows the same overall structure as other ISO management system standards (known as the High-Level Structure), making it easier for anyone using multiple management systems. More information can be found in Annex SL of ISO/IEC Directives Part 1 (the rules for developing ISO standards). • Another major difference is the focus on risk-based thinking. While this has always been part of the standard, the new version gives it increased prominence. More information on how to adapt to this risk-based thinking can be found on the Website run by ISO/TC 176/SC 2, the group of experts behind the standard (www.iso.org/tc176/sc2/public).
  83. 83. ISO 9001:2015 version follows the new high- level structure and comprises ten sections: ISO 9001:2008 ISO 9001:2015 0. Introduction 0. Introduction 1. Scope 1. Scope 2. Normative reference 2. Normative reference 3. Terms and definitions 3. Terms and definitions 4. Quality management system 4. Context of the organisation 5. Management responsibility 5. Leadership 6. Planning 6. Resource management 7. Support 7. Product realisation 8. Operation 8. Measurement, analysis and improvement 9. Performance evaluation 10. Improvement
  84. 84. DIFFERENT TERMINOLOGY IN ISO 9001:2008 AND ISO 9001:2015 ISO 9001:2008 ISO 9001:2015 Products Products and services Documentation, quality manual, documented procedures, records, instructions Documented information Work environment Environment for the operation of processes Monitoring and measuring equipment Monitoring and measuring resources Purchased product Externally provided products and services Supplier External provider
  85. 85. Assignment 1: • What does it require to eat an excellent sandwich?
  86. 86. Sandwich process:
  87. 87. What’s the new structure? • The new structure of 9001:2015 is similar to the 9001:2008 as the first 3 sections are Scope, Normative References, & Terms and Definitions. In the 2015 revision sections 4 through 8 are now 4 through 10, but still based on the PDCA model.
  88. 88. Detailed ISO:
  89. 89. So the structure is new, what else? • The standard will have a cross-reference in its Annex comparing the changes between 2008 and 2015. • Risk management: This is probably the most significant change and is mentioned throughout the standard. Formal risk management (e.g. according to ISO 31000) is not required, but some form of consideration needs to be applied. • Process approach: This no longer only relates to recognizing the workflows in the company, but now managing the workflows in a more specific manner. • Documentation: Now more flexible. Records and documents will become “documented information”. You shouldn‟t get rid of your documentation as you still need objective evidence of meeting the requirements, but how you document is more open to best fit for your organization • Leadership: A formal management representative is no longer specified, but the standard still requires commitment, responsiveness, active support, communication, and feedback from the organization to ensure the establishment, implementation and the maintenance of system. In short, someone still has to be responsible but the responsibility is shared. • Context of the Organization: Providing a high-level understanding of the issues that can affect, either positively or negatively, the way the organization manages its responsibilities for the system. Issues can include conditions, characteristics, or changing circumstances that can affect the system.
  90. 90. I have an integrated ISO 9001 with ISO 14001 and/or OHSAS 18001, how will this affect my system? ISO 9001:2015 HAS A HIGH LEVEL STRUCTURE (HLS) • The standards are now being based on Annex SL to allow for easier integration. You will need to plan your transitions carefully as they have different publication dates. • As a result of the new arrangement in ten clauses, ISO 9001:2015 now has the same unambiguous structure as all standardized management systems, known as a „High Level Structure‟ (HLS). • The core elements of ISO 9001, ISO 14001, ISO 22000, OHSAS 18001, etc. are therefore all the same from now on. This has made the integration of various management systems much simpler. If, for example, an organization wishes to implement ISO 14001 in addition to ISO 9001, the parts that cover the same topic can easily be seen in the standards.
  91. 91. HLS
  92. 92. Some of the proposed changes in the updated standard include: • New formatting of the Standard against Annex SL • Removal of the Management Representative role • Identification and management of Interested Parties • Removal of the preventive action principal • Addition of risk based assessment of opportunities • Reduction of Quality Principles from 7 to 8
  93. 93. How Change is addressed within ISO 9001:2015 • Purpose: To explain the new requirement for Change in ISO 9001:2015 • 6.3 Planning of changes • 8.1 Operational planning and control • 8.3.6 Design and development changes • 8.5.6 Control of changes
  94. 94. Purpose of this new requirement: • One of the goals of the ISO 9001:2015 revision is to enhance the requirements for addressing changes at system and operational levels. The ISO 9001:2015 requirements provide a strong basis for a management system for business that supports the strategic direction of the organization. Once the organization has identified its context and interested parties and then identified the processes that support this linkage, addressing changes becomes an increasingly important component of continued success.
  95. 95. • Once its processes are determined, an organization will need to identify the risks and opportunities associated with these processes. To achieve the benefits associated with the determination of risks and opportunities, changes may be needed. These changes can be related to any element of the process, such as inputs, resources, persons, activities, controls, measurements, outputs, etc.
  96. 96. • Changes are intended to be beneficial to the organization and need to be carried out as determined by the organization. In addition, consideration of new introduced risks and opportunities need to be taken into account.
  97. 97. • To achieve the benefits associated with changes, the organization should consider all types of changes that may need to occur. These changes may be generated, for example, in: • Processes • Documented information • Tooling • Equipment • employee training • supplier selection • supplier management • and many others
  98. 98. • The successful management and control of these changes has become a core requirement within the organization‟s QMS.
  99. 99. ISO 9001:2008 • Clause 4.1 (Quality management system – General requirements) of ISO 9001:2008 requires: • “The organization shall establish, document, implement and maintain a quality management system ….” • In addition clause 4.2.1 (Documentation requirements – General) of ISO 9001:2008 requires organizations to have a Quality Manual as a part of documentation. • Clause 4.2.2 (Quality manual) provides the details on what should be included in the Quality Manual.
  100. 100. ISO 9001:2015 Quality Manual? • Clause 4.4.1 (Quality management system – General) of ISO 9001:2015 Committee Draft (CD) requires: • “The organization shall establish, implement and maintain a quality management system ….” • Difference: • Newly release committee draft does not include the requirement to “document” the Quality Management System. • Also there is no mention of the word “Quality Manual” any where in the draft standard. • A Manual is not required to be produced for Environmental Management System (ISO 14001) and some other management standards. In an effort to ensure harmony between different management systems the requirement to produce a Quality Manual no longer
  101. 101. These new requirements are referenced in ISO 9001:2015 as outlined below. 6.3 Planning of changes • When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned and systematic manner (see 4.4). • The organization shall consider the: a) purpose of the changes and their potential consequences; b) integrity of the quality management system; c) availability of resources; d) allocation or reallocation of responsibilities and authorities.
  102. 102. 8.1 Operational planning • The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
  103. 103. 8.3.6 Design and development changes • During design and development changes that are identified will be reviewed and controlled to ensure there is no impact to the conformity of the product or service.
  104. 104. 8.5.6 Control of changes • The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. • The organization shall retain documented information describing the results of the review of changes, the persons authorizing the change, and any necessary actions arising from the review.
  105. 105. • Footnote: Other references to change are found in clauses; 4.4, 5.3, 9.2, 9.3, 10.2)
  106. 106. Things to consider when implementing the new requirement for Change • There are many triggers that can cause a change to the Quality Management System: ▫ Customer feedback ▫ Customer complaint ▫ Product failure ▫ Employee feedback ▫ Innovation ▫ Determined risk ▫ Determined opportunity ▫ Internal audit results ▫ Management review results ▫ Identified nonconformity ▫ Many others
  107. 107. • NOTE: These recommendations not necessarily applicable for every type of organization. • Background: Some changes need to be carefully managed while others can be safely ignored. In order to sort through this, the organization should consider a method to prioritize. (Executed Item) • To determine the priority, the organization should consider a methodology that allows them to take into account: ▫ Consequences of the change ▫ Likelihood of the consequence ▫ Impact on customers ▫ Impact on interested parties ▫ Impact on quality objectives ▫ Effectiveness of processes that are part of the QMS ▫ others
  108. 108. Typical steps to Implement changes ▫ Define the specifics of what is to be changed ▫ Have a plan (tasks, timeline, responsibilities, authorities, budget, resources, needed information, others) ▫ Engage other people as appropriate in the change process ▫ Develop a communication plan (appropriate people within the organization, customers, suppliers, interested parties, etc. may need to be informed) ▫ Use a cross functional team review the plan to provide feedback related to the plan and associated risks ▫ Train people ▫ Measure the effectiveness
  109. 109. What changes may need to be made? • Change to a process (inputs, activities, outputs, controls, etc.) • Communication with customers • Communication with the supply chain • Additional controls for processes • Inspection • Employee training • Implement a new process • Provide documented information • Change existing documented information • Improve employee competence • Outsource a process • Many others
  110. 110. • Other considerations: • Prior to making a change, the organization should consider unintended consequences • After making a change the organization should monitor the change to determine its effectiveness and to identify any additional problems that might be created • Records of some changes may be needed as part of the Quality Management System
  111. 111. Pyramid of Quality
  112. 112. Is there anything else companies need to know before they get going with ISO 9001 or the new version ISO 9001:2015? • The requirement for formal procedures and a quality manual have been scrapped in ISO 9001:2015, as was stated above. Only relevant information has to be available now. • Organizations that already have an ISO 9001 quality management system do not have to discard their existing procedures and documentation, of course. A good system remains a good system and you will still need a proper structure for your crucial documentation. • If something is no longer obligatory, it doesn‟t mean that you have to scrap it right away, of course. It‟s better to hang on to what you are happy with and what helps your organization to progress.
  113. 113. Assignment 2: Draw all ISO 9001 Claus in a organizational structure(Flow Chart)
  114. 114. CLAUSE # TITLE CONTENT 1 Scope •Similar to ISO9001 : 2008 with the introduction of the term "goods and services" as opposed to " products" 2 Normative references •Similar to ISO9001 : 2008 3 Terms and definations •Many terms are defined and in this section; need to wait to see if they stay or get moved to ISO9000
  115. 115. 4 Context of the organization •Need to define the organization's "purpose, scope, environment, systems and interested parties" •Expect the QMS to focus on " risks and threats" 5 Leadership •Roles and Responsibilities" need defining •Policies and objectives" need to be established •Similar to current Section 5 (ISO9001 : 2008) but no "management representative" 6 Planning •Focus on how to address "risks" and "opportunities" •Included are "structured planning processes", planning for change , and clear planning objectives"
  116. 116. 7 Support •Includes section on "Infrastructure, work environment , and control of monitoring and measuring equipment." •Includes terms focused on " competence , awareness, communication" and a new concept called "knowledge" •Documented Information" is in this section; "quality manual" and "documented procedures" are not specified. 8 Operation •This is the current (9001 : 2008) Clause 7.0 Product Realization plus non conforming product (8.3) •Clause 8.5 is a new version of the current 7.3 (Design and Development) 9 Performance Evaluation •This clause includes "monitoring, measuring, analysis and evaluation" •Internal audits, management review and customer satisfaction perception" are in this section 10 Improvement •Focus on the improvement of "suitability, adequacy, and effectiveness" •Corrective action" identified •Preventative action" and the term " continual improvement" is not in the CD draft
  117. 117. Assignment 3: Formulate a Checklist:
  118. 118. Audit from ISO
  119. 119. • ISO 9001:2015 certification introduces a few changes and revisions to accommodate the changing business environment of the modern world. Organizations operate in a quite dynamic business scenario where they are supposed to alter and tune business strategies at regular intervals. 2015 update takes care of it by including several terminologies, information restructuring, and importance to risk- based thinking make it further applicable and relevant today. • For ISO 9001:2015 upgrade, organizations should review the current approach. Business leaders are required to engage with process owners and team members to understand the process change with respect to the proposed version. They should identify, manage, and control these modifications as quickly as possible so that there is a minimized impact. • Organizations that are already certified for ISO 9001 should upgrade to 2015 version because it widens the horizon of applicability and relevance. As per ISO norms, a transition period of three is given to ISO 9001:2008 certified organizations. Organizations should apply the principles of quality management for enhancing the business in such a way that a sustainable business improvement can be obtained. It is the biggest benefit of ISO certification. ISO 9001:2015 is beneficial for small, medium and large organizations across industries.
  120. 120. What benefits does the new version bring ? • The new version of the standard brings the user a number of benefits. For example, ISO 9001:2015 : • Puts greater emphasis on leadership engagement • Helps address organizational risks and opportunities in a structured manner • Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity • Addresses supply chain management more effectively • Is more user-friendly for service and knowledge-based organizations
  121. 121. I am currently using ISO 9001:2008 What should I do ? • The 2015 edition has now replaced the 2008 version. Since it has been revised to meet the needs of today‟s business world, we recommend that you update your quality management system to fit the new version. • Every organization is different, so the steps needed to adjust your management system are likely to be unique to your situation. However, here are some tips that will help you get started on the journey.
  122. 122. Tip 1 – • Familiarize yourself with the new document. • While some things have indeed changed, many remain the same. A correlation matrix, available • from ISO/TC 176/SC 2, will help you identify if parts • of the standard have been moved to other sections.
  123. 123. Tip 2 – • Identify any organizational gaps which need to be addressed to meet the new requirements.
  124. 124. • Tip 3 – Develop an implementation plan. • Tip 4 – Provide appropriate training and awareness • for all parties that have an impact on the effectiveness • of the organization. • Tip 5 – Update your existing quality management • system to meet the revised requirements. • Tip 6 – If you are certified to the standard, talk • to your certification body about transitioning • to the new version.
  125. 125. I am certified to ISO 9001:2008. What should I do ? • If you wish to maintain your certification to ISO 9001, you will need to upgrade your quality management system to the new edition of the standard and seek certification to it. • You have a three-year transition period from the date of publication (September 2015) to move to the 2015 version. This means that, after the end of September 2018, a certificate to ISO 9001:2008 will no longer be valid.
  126. 126. So how will it affect your Organization and you? It is likely that you and your Organization will have to: • Purchase a copy of the updated Standard • Conduct a gap analysis/impact assessment against 9001:2015 • Alter the Management System to meet new requirements • Train staff in new 9001:2015 requirements as well as new Management System procedures/controls • Train and update existing auditors with relevant knowledge about 9001:2015. • To make sure that your Company keeps up with the development of the 9001 update and how it will affect your Company, keep reviewing this website for updates.
  127. 127. How can companies transition from ISO 9001:2008 to ISO 9001:2015? • Assuming that a company is already ISO 9001 certified, I recommend taking the following steps in order to comply with ISO 9001:2015:
  128. 128. 1. Baseline measurement • Perform a baseline measurement in your organization. Make a complete overview of the current status of your quality management system and your organization's conduct of business. 2. Plan of approach • Draw up a plan based on the baseline measurement. Thanks to this plan, you can take the time to make changes and to implement improvements step by step.
  129. 129. • 3. Implementation • Implement the changes in accordance with the plan of approach. Incorporate measurement points and milestones. • 4. Auditing and process analysis • Measure whether the changes have had the desired effect. Measure the input and output of the processes you consider to be important because they are critical or risky, for example.
  130. 130. 5. Certification • Have your organization certified according to ISO 9001:2015. 6. Communication with interested parties • Show your interested parties not just the certificate, but also show them the results with pride. Let them see how well your organization manages its processes and continuously improves them.
  131. 131. Conclusion: What is ISO about
  132. 132. Exam: • “Retain and Maintain documented information” Differentiate and specify the clause Nr. • Checklist formation for one clause or a part- how could you ask, please enumerate all available Q. • Risk Based Thinking is which Clause, please identify according to the ISO Standard • What are the main differences between ISO 9001:2008 and ISO 9001:2015
  133. 133. References and further information • International Organization for Standardization Tel: +41 22 749 01 11, Web: www.iso.org • ISO/TC 176/SC2/N1287 www.iso.org/tc176/sc02/public • http://www.iso-9001-2015.com/iso-9001-2015- requirements.html • http://advisera.com/9001academy/iso-9001-2015-revision/ • http://ferribygroupinternational.com/global-news/84/iso- 9001-2015-are-you-ready • http://webstore.ansi.org • https://www.pauwelsconsulting.com/blog/iso-9001-2015/ • http://isotc.iso.org/livelink/livelink/open/tc176SC2public • http://www.slideshare.net/PECBCERTIFICATION/pecb- webinar-49304033

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