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Quality Management System - ISO 9001-2015


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A report on ISO 9001-2015 quality standards

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Quality Management System - ISO 9001-2015

  1. 1. QUALITY MANAGEMENT SYSTEM ISO 9001:2015 Abhishek Raj Abstract ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizationsto be more efficientand improve customer satisfaction. A new version of the standard,ISO 9001:2015,has justbeen launched,replacingtheprevious version (ISO 9001:2008).
  2. 2. Quality Management System: ISO 9001:2015 2 ISO 9000 is a family of standards for quality management. It is maintained by the International Organization for Standardization and is administered by the accreditation and certification bodies. ISO 9000 addresses quality management standards as to what an organization needs to fulfil. It assesses the organizations ability to meet customer and regulatory requirements, quality management system, and provides guidelines for performance improvement. It is one of the renowned international standards that have been implemented by countless companies in more than 150 countries. ISO standards aim at:  A set of procedures to cover all key processes in the business.  Monitor the process and ensure its effectiveness.  Quality requirements of customers.  Checking outputs for defects, and taking corrective actions in appropriate places.  Applicable regulatory requirements to enhance customer satisfaction.  Achieve continuous improvement of performance. ISO standards is for:  ISO 9001 is suitable for organizations of all types, sizes and sectors.  In fact, one of the key improvements of the newly revised ISO 9001:2015 was to make it more applicable and accessible to all types of enterprises.  Smaller companies that do not have staff dedicated to quality can still enjoy the benefits of implementing the standard – ISO has many resources to assist them. ISO 9000:2000 and ISO 9001:2000: Earlier till December 2000, there used to be ISO 9000, ISO 9001, ISO 9002 and ISO 9003 standards. During December 2000, the International Organization for Standardization merged all of them into a revised ISO 9001 standard. To distinguish between the earlier standards and the revised one, the later was referred to as ISO 9001:2000 or ISO 9000:2000. For all practical purposes, ISO 9000 and ISO 9001 connote the same, and 2000 indicates the year of its revision. Application in the Textile and Apparel Industries: Textile and apparel industries have many complicated activities and challenges involved in the course of its operation. Their operation incurs heavy expenditure to the manufacturers. Many textile and apparel industries have implemented ISO standards to lower its operating costs and improve the quality of its output, ultimately increasing the level of customer satisfaction. Textile and apparel industries account for a sizable percent of manufacturing jobs in a global perspective. They employ millions of people directly and indirectly. They form a massive industrial complex and prove to be a big contributor among the manufacturing industries of any country. Some textile and apparel industries view ISO certification is only necessary as a factor for exports. But, the main matter of concern in textile industry is that an imperative relation exists
  3. 3. Quality Management System: ISO 9001:2015 3 between the quality of the materials and the quality of the final product. ISO standards enable the industry to enhance the quality of raw material input, thereby strengthening the quality of the ultimate product. This will result in a systematic approach to management, incessant performance improvement, factual approach towards the decision-making process, and a mutually benefiting supplier’s relationship. Thus, is helps the manufacturers in 'Weaving a Quality Industry'. Market for ISO Certification: As every day passes by, global competition is heating up. Textile and apparel industries are in the midst of major changes. To keep pace with the market scenario, industries rely more on quality and innovative fabrics, and apparels, and quick response to the needs of the customer. Innovations in the fields of nanotextiles, nonwovens, electro textiles, medical textiles, and geo textiles are providing new opportunities for the manufacturers and tap the market. Simultaneously, these opportunities also encompass them with critical challenges. Organizations today engage in many international trade activities, and this certification proves a pre-requisite for their survival in international competition. ISO certification helps the companies in market creation and penetration. Benefits of ISO: Implementation of ISO helps the textile and apparel industries to enhance their product and process quality, minimizes defective supplies and reworking. Furthermore, it can also be used as a marketing tool. As it is a well-recognized standard for quality, it shows the customers that the company takes quality seriously. ISO certified companies focus more on the quality of its products and operations. It also motivates the employees in improving quality. The cost of implementing ISO is comparatively cheaper to the benefits derived out of it. Many ISO certified companies positively assert that their total costs went down to a considerable extent regarding quality maintenance after the implementation of ISO. Implementing a quality management systemwill help you:  Assess the overall context of your organization to define who is affected by your work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.  Put your customers first, making sure you consistently meet their needs and enhance their satisfaction. This can lead to repeat custom, new clients and increased business for your organization  Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization. This increases productivity and efficiency, bringing internal costs down.
  4. 4. Quality Management System: ISO 9001:2015 4  Meet the necessary statutory and regulatory requirements.  Expand into new markets, as some sectors and clients require ISO 9001 before doing business.  Identify and address the risks associated with your organization. Case Studies: Some exclusive one on one questions with noted personalities of textile companies which has been certified under the ISO standards. How is ISO Certification integral for a Company's Operation? How would you distinguish yourself from a Non-Certified Company? Mr. Snehakar Bansal, Director, Prathibha Syntex Pvt Ltd: "It comes across as no surprise that solution providers today are increasingly opting to go for the coveted ISO certification in Textile sector. It has a universal appeal and helps improve various processes in a company, based on customer needs. Further, it increases customer confidence in the supplier's product quality and delivery commitments, in addition to helping solution providers penetrate in the global market, thus making the cash registers ring louder. Price, quality, and service are three primary elements that are carefully monitored at the Apparel Industry. There are a number of factors on which quality fitness of Apparel industry is based such as - performance, reliability, and durability, visual and perceived quality of the garment. Quality needs to be defined in terms of a particular framework of cost." Mr. Bansal shares his professional expertise regarding the textile sector. He states, "Competition is the name of the game and staying ahead is the key for survival. Like all else in the industry, this rule applies to the solutions provider community too. Against the face of growing business, and hence increased competition, solution providers have begun to realize the need to provide their customers a differentiation factor in terms of service, products, price and technology". "ISO provides a framework and systematic approach to managing business processes to produce a product/service that conforms to customer expectations. For customers, the certification of suppliers to ISO standards means that they can be assured that the development of their products and services are compliant to reference documents that are globally accepted. This, of course, means that customers and suppliers are able to compete in markets around the world. ISO is required for companies that largely design as well as produce and distribute their products or services. ISO 9002 is meant for companies that produce and distribute their products or services. ISO 9003 is required for companies that carry out only final inspection and testing. ISO 14000 is the new Environmental Management Standard (EMS). The ISO 9000 series appears to be sweeping the world and is rapidly becoming the most important quality standard."
  5. 5. Quality Management System: ISO 9001:2015 5 Mr. P. Sundararajan, Managing Director, SP Apparels:  "The Management is able to focus on the customer needs, expectations and effective measures to fulfil Companies Objectives.  Selection of appropriate and competent manpower.  Training needs are identified and imparted which guides them properly to achieve targets.  Each department has its own measurable objectives. Every individual has defined responsibilities and authorities.  Necessary resources like work space, machineries, equipments and other infrastructure are ensured. Also, the calibration of measuring equipments are monitored effectively" Mr. P. Sundararajan positively asserts that these advantages cannot be enjoyed by a Non- Certified Company. N.Thirukkumarian, CEO, Esstee Exports: He states that, "If we follow the ISO standards, we can be assured quality product. In a garment industry, right from the purchase of yarn to packing of the finished garments, the ISO system will take care. In a non-certified company you cannot trace the various inputs / outputs history." How does ISO Certification help your company in acquiring a share in the global market? Mr. Snehakar Bansal shares his opinion regarding the same. He states, "Pratibha Syntex is driven by a strong vision and a deep commitment to organic principles. Pratibha is the worlds first mostly vertically integrated textile manufacturing company, going from raw material to finished products, including cotton fibre production, spinning, knitting, dyeing and finishing, and apparel manufacturing". "Pratibha is accredited with ISO 9002, ISO 14001 Certifications. Certifications like the ISO undoubtedly turn out to be beneficial to companies that opt for them. These could be both tangible and intangible benefits. Pratibha has also achieved its benefits from both in tangible and intangible manner. It has benefited in not only improving the quality base but also in making a presence in the International market but also increasing customer base, improved environmental performance, pollution prevention and waste reduction, has also increased its goodwill in the eye of customers. It has also benefited us measurable process improvements, which have translated into productivity gains and significant time and cost savings by the virtue of attaining lower defect rates and lesser rework. One of the key elements of Pratibha’s success and growth story has been its ability to satisfy customers with superior quality of service, which has ensured steady growth, repeat business, positive customer referrals and presence in the global market. For penetrating in this competitive market, we have to provide and different product not only in the textile sector but also for every industry, which aims towards quality products and services". Mr. Sundararajan, shares his notions on how the certification is very helpful for SP Apparels to improve their 'Quality of Manufacturing, on time processing, and Customer satisfaction'.
  6. 6. Quality Management System: ISO 9001:2015 6  "Right from yarn purchase to shipment every activity is governed by documented standard operating procedures and instructions, which complies with the requirements of ISO 9001.  Each process is carried out with the PDCA process approach (ie Plan-Do-Check-Act), which gives better results in achieving better quality and on time shipments  Inspection and testing at each stage of manufacture assures quality requirements are met  Internal audit and external audit performed periodically ensures effective implementation of Quality Management System  Periodical feedback from customers reveals their level of satisfaction  Analysis of data towards continual improvement" Mr. Thirukkumarian accentuates how the certification has helped Esstee Exports to acquire a slice in the global market pie. He says, "In the global market, the first question raised by any customer, whether the Factory is certified for ISO 9001-2000. It is a pre-requirement for obtaining any export order." With the growing list of companies getting listed under the ISO certification; worldwide, the polarization of ISO certification is clear as crystal. Religious implementation of ISO standards in textile and apparel industries will result in a 'cultural transition' of continuous improvement. The ISO 9001: Quality Management Systems – Requirements standard sets out the criteria for a quality management system, and can be used to assess an organisation's ability to meet customer and regulatory requirements. It is the standard against which third party registration or certification can be achieved. This standard originally came into existence in 1987. It has been revised four times since then-in 1994, 2000, 2008 and 2015. The 2015 version is the fifth edition of ISO 9001 Quality Management Systems - Requirements. Currently, there are over a million organisations in over 170 countries certified to the requirements of this standard. ISO 9001:2015 was published in September 2015. For those organisations which are certified to ISO 9001:2008, there is a three-year transition period, starting from September 2015 to get certified to ISO 9001:2015. That means they have time till September 15, 2018 to make the transition. Those who fail to do so, would have to go through an entirely new audit and registration process. Why was ISO 9001 revised?  All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace.
  7. 7. Quality Management System: ISO 9001:2015 7  ISO 9001 has been updated to take into account the different challenges that businesses now face.  For example, increased globalization has changed the way we do business and organizations often operate more complex supply chains, and there are increased expectations from customers.  ISO 9001 needs to reflect these changes in order to remain relevant. What are the key improvements? Structure – ISO 9001:2015 now follows the same overall structure as other ISO management system standards (High-Level Structure), making it easier for anyone using multiple management systems. See Annex SL of ISO/IEC Directives Part 1 (the rules for developing ISO standards) for further information. What benefits does the new version bring? The new version of the standard brings the user a number of benefits. 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, particularly helpful to organizations using multiple management systems  Addresses supply chain management more effectively  Is more user-friendly for service and knowledge-based organizations Focus on risk-based thinking – This has always been part of the standard, but the new version gives it increased prominence. More information can be found on the Website run by ISO/TC 176/SC 2, the group of experts behind the standard ( The purpose of this article is to give an overview of the changes in ISO 9001:2015 version compared to 2008, so that apparel manufacturers can start working to meet the new requirements. The International Organization for Standardization (ISO) does not report the
  8. 8. Quality Management System: ISO 9001:2015 8 number of apparel manufacturers certified worldwide. Apparel manufacturers are lumped in the category 'Textile and Textile Products'. The 2015 revisions are hailed as "a game changer", "a real improvement that will lead to a more robust QMS", "this is a wonderful opportunity for organisations to refocus their QMS on their business operations", "ISO 9001:2015 will have huge impacts across the world", "it will provide more confidence that quality management systems really work"1. Changes in the ISO 9001:2008 were necessary due to increasingly demanding customers, increased complexity of the supply chains, emergence of new technology, greater awareness for the need to address sustainability, etc. While Table shows an overview of the clause of 9001:2015 and 9001:2008, the major differences between the two versions are as follows:  Title of the clauses and their order, and simplified language  A new clause addressing "Context of the Organisation"  Process approach strengthened and made more explicit  Concept of preventive action now addressed throughout the standard by risk identification and mitigation  A clause addressing "Leadership" as opposed to "Management Responsibility"  Fewer prescribed requirements and lesser emphasis on documentation Title of the clauses and their order – Title of the clauses and their order in the revised 9001 standards are aligned with other ISO management systems standards, such as the one on environmental management. All ISO Management Systems Standards are now required to use a common 10-clause high-level structure. These changes will make it easier for organisations to address the requirements of more than one ISO Management Systems Standards within a single integrated system. The simplified language of the revision makes it easier for service organisations to use this standard. The term "products and services" is now used throughout the standard to reflect the far greater use of the standard outside of the manufacturing sector, and to emphasise its applicability in service industries. Apparel manufacturers who are already certified to ISO 9001:2008 and are considering transition to the new standard may want to consider renumbering various quality management systems documents so that it would be easy to cross-reference them with the revised standard. Context of the Organisation – The "context of the organisation" means the environment in which an organisation functions and various external and internal factors that affect its business. The clause on "context of the organisation" was included so that the organisations can view themselves strategically which will influence their quality management practice. This clause requires organisations to have a high-level understanding of various factors that may affect their business-both positive and negative.
  9. 9. Quality Management System: ISO 9001:2015 9 These factors are the competitive and regulatory environment, market environment, operational factors such as labour, facilities, utilities, suppliers, logistics, etc. Clear understanding of how these factors affect an organisation will influence quality management system and practices of an organisation. Under this, the management is required to identify the internal and external issues that are relevant to its purpose and strategic direction, and understand needs and expectations of the relevant interested parties. "Context of the organisation" is the foundation of effective quality management system, because an effective quality management system can be put in place only if an organisation has a clear understanding of the context in which it operates. What this means for the apparel manufacturers is that they will have to identify their customers and their code of conduct or labour standards, local labour and environmental laws and figure out how to meet their customers' expectations while meeting all regulatory challenges. Thinking about the "context of the organisation" is new to the apparel manufacturers, ISO 9001:2015 just formalises it. Process approach – While there is no specific clause requiring an organisation to use a process approach, the language throughout the standard is such that it requires an organisation to identify its key processes for meeting the organisation's objectives as well as customers' needs. While the concept of the process approach was introduced in ISO 9001:2000, the 2015 revision makes it explicit through PDCA (plan, do, check, act) as a tool to manage processes and systems. "Plan" involves setting objectives of the processes and systems (what to do, how to do) to deliver results. Clauses 4,5, and 6, that is, context of the organisation, leadership, and planning, respectively address "Plan" part of the PDCA. "Do" involves actually implementing and controlling what was planned (operations). Clause 8, operation, addresses the "Do" part of the PDCA. "Check" involves monitoring the process through measures and comparing those measures to the requirements. Clause 9, performance and evaluation, addresses the "check" part of the PDCA. For the apparel manufacturers, this means all production processes, including quality inspection at various stages of manufacturing and testing components and final product. "Act" involves taking actions to improve performance of the processes. Clause 10, improvement, addresses the "Act" part. For apparel manufacturers, this would mean any actions taken based on the results of inspection and testing. Risk identification and mitigation – One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to considering risk, rather than treating "prevention" as a separate component of a quality management system. Identifying and addressing risk in itself is preventive action(s). The management is expected to identify risks in the processes of the quality management system that may affect the organisation's ability to meet its objectives, i.e. customer requirements, so that those risks can be addressed as appropriate. By systematically identifying and addressing risks an organisation can better meet requirements of its customers. The typical risk that most
  10. 10. Quality Management System: ISO 9001:2015 10 apparel manufacturers face is not being able to deliver merchandise when promised. The revised 9001 standard requirement would mean that apparel manufacturers must have some plans in place to address such a situation. Leadership – There is a change from "Management Responsibility" in ISO 9001:2008. The revised ISO 9001 standard requiring the leadership of an organisation to be "Leadership" is a significant change, and will result in organisations producing much better-quality products and services with much improved operations. This change puts quality management system in front of the top management like never before. The revised ISO 9001 standard requires leadership of an organisation to:  Be accountable for the effectiveness of the quality management system by allocating adequate resources and engaging, directing and supporting personnel to contribute to the effectiveness of the quality management system.  Ensure that the quality policy and quality objectives are compatible with the context and strategic direction of the organisation.  Ensure that the quality policy is communicated, understood and applied in the organisation.  Ensure the integration of quality management system requirements into the organisation's business processes.  Promote the use of process approach and risk-based thinking.  Communicate the importance of effective quality management and of conforming to quality management system's requirements.  Support relevant management roles.  Ensure that the quality management system achieves its intended results.  Promote improvement. What the above means is that the top management can no longer be a "supporter" or "observer" of the quality management system, but will have to be a "participant" of the quality management system. This will require a paradigm shift on most top management's part. According to one observer, "The days when quality managers would be thanked for their QMS status presentation and then asked to leave the meeting because 'we have business to attend' are over!" Let me give you an example of how one of the best apparel companies in the US addresses quality. This company has several manufacturing plants in the US, Mexico and several Caribbean countries. Every month, they have a plant managers meeting at their headquarters in the US, chaired by the executive vice-president of operations. Every meeting
  11. 11. Quality Management System: ISO 9001:2015 11 starts with a presentation by the corporate director of quality where he makes presentation on outgoing quality levels at each plant for the previous month, cost of rework and scrap, what corrective actions are in place, overall trend for each plant, etc. It is only after this presentation that other issues are addressed. Conducting a meeting in such a fashion sends out a very clear signal to all plant managers that the top management of this company is committed to quality. Since these plant managers' quality performance is reviewed every month in presence of their peers they have no place to hide. Nobody likes their weaknesses to be exposed in front of their peers. Therefore, every one of these plant managers is committed to quality in his respective plant and the quality level in each plant keeps improving. Table 1: Overview of ISO 9001:2008 and ISO 9001:2015 – While the prescriptive title of a management representative has been deleted, it is up to the top management to ensure that the roles and responsibilities are assigned for reporting on the performance of the quality management system. Some organisations might find it convenient to have a single person carry out this role, while others may find some other structure(s) depending on their organisational context. Documentation – The revised ISO 9001 allows organisation flexibility in the way it chooses to document its quality management system. Specific documented procedures are no longer mentioned. It is the responsibility of the organisation to maintain documented information to support the operation of its processes and to retain the documented information necessary to have the confidence that the processes are being carried out as planned. Documented information is defined as "information required be controlling and maintaining by an organisation and the medium on which it is contained." Documented information can
  12. 12. Quality Management System: ISO 9001:2015 12 include documents, records, data, and any other information that might be contained in an enterprise resource system (ERP) and computer aided design (CAD) programmes. A quality manual is no longer specifically required. If an organisation finds it convenient and appropriate to describe its quality management system in a quality manual, then it is perfectly acceptable. Because of this flexibility, each organisation will be able to determine the amount of documented information needed in order to demonstrate effective planning, operation, and control of its processes as well as implementation of continual improvement of the effectiveness of the quality management system. While the standard does not prescribe which documents to maintain, it would be wise for apparel manufacturers to maintain inspection results, test results, decisions regarding disposition of non-conforming merchandise, standard operating procedures, minutes of the meetings where quality management system performance was addressed/discussed, and the like. Frequently AskedQuestions – I am currently using ISO 9001:2008. What should I do ? As ISO 9001 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. Here are some tips that will help you get started on the journey.  Tip 1 – Familiarize yourself with the new document. 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.  Tip 2 – Identify any organizational gaps which need to be addressed to meet the new requirements.  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 – If you are certified to the standard, talk to your certification body about transitioning to the new version. 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.
  13. 13. Quality Management System: ISO 9001:2015 13 ISO 9001:2015 Quality Manual Sample Format –
  14. 14. Quality Management System: ISO 9001:2015 14 Quality Manual ISO 9001:2015 Quality Management System Quality management input comprises the standard requirements from ISO 9001:2015 which are deployed by our organization to achieve customer satisfaction through process control. Quality management input comprises the standard requirements from ISO 9001:2015 which are deployed by our organization to achieve customer satisfaction through process control.
  15. 15. Quality Management System: ISO 9001:2015 14 Internal Issues External Issues Market share Customers & suppliers Markets & competition Regulatory & statutory Economic backdrop Values & culture Technological Innovation &knowledge Cultural & social 4 About Our Organisation 4.1 Organizational Context Your organization is committed to defining our position in the marketplace and understanding how relevant factors arising from legal, political, economic, social and technological issues influence our strategic direction and our organizational context. Your organization identifies, analyzes, monitors and reviews factors that may affect our ability to satisfy our customers and stakeholders, as well as; factors that may adversely affect the stability of our process, or our management system’s integrity. To ensure that our QMS is aligned with our strategy, whilst taking account of relevant internal and external factors; we initially collate and analyze pertinent information in order to determine potential impact on our context and subsequent business strategy. Your organization then monitors and reviews this information to ensure that a continual understanding of each group’s requirements is derived and maintained. To facilitate the understanding of our context, we regularly consider issues that influence our context during management review meetings and are conveyed via minutes and business planning documents. The output from this activity is evident as an input to the consideration of risks and opportunities, and the actions that we take to address them. Refer to Section 6.1 for more information about our risk and opportunity management framework. Although we acknowledge that ISO 9001:2015 does not require our organizational context to be maintained as documented information, we maintain and retain; in addition to this document, the following documented information to describe our organizational context: SWOT Analysis PESTLE Analysis Organizational Strategy Local Factors Issues MacroEnvironment Interested Parties Figure 1: Typical QMS Input Hierarchy Business Planning Quality Policy Managment System Objectives KPIs/ Metrics Context Scope
  16. 16. Quality Management System: ISO 9001:2015 15 1. Analysis of business plans, strategies, and statutory and regulatory commitments; 2. Analysis of technology and competitors; 3. Economic reports from relevant business sectors; 4. Technical reports from technical experts and consultants; 5. SWOT analysis reports or schedules for internal issues; 6. PESTLE analysis reports or schedules for external issues; 7. Minutes of meetings (Management and design review minutes), process maps and reports, etc. 5 Leadership & Governance 5.1 Leadership and Commitment 5.1.1 Quality Management Your organization’s leadership is also responsible for implementing the QMS, which includes the development and deployment of the quality policy, the quality objectives, and product/project-specific plans that are customer focused. Top management provides the leadership and governance to all activities related to the lifecycle processes including defining the strategic direction, responsibility, authority, and communication to assure the safe and effective performance. Your organization’s governance structure provides necessary support for creating and establishing appropriate processes that are important for maintaining and achieving our quality objectives and policies. In addition, governance activities include systematic verification of the effectiveness our QMS by undertaking internal audits and analyzing performance data. Regular management reviews ensure that our quality management system is adequate and Plan - Establish your organizational context and strategies. Determine regluatory and statutory commitments. Do - Develop the policy and objectives. Provide resources, assign process owners. Focus on improving & acheiving objectives. Address risks and Leadership Act - Agree changes and implement improvements to maintain the integrity of the QMS and its processes. Check - Review system and process performance data, ensure alignment is maintained between context and strategy. Review your policy and objectives. Figure 3: Leadership PDCA Cycle
  17. 17. Quality Management System: ISO 9001:2015 16 effective, and that any necessary adjustments are made as a result. Top management is committed to implementing and developing the quality management system and this commitment is defined by our corporate policies and objectives. Your organization ensures that our policies are understood, implemented and maintained throughout at all levels of the organization through printed distribution of our policy statements and through periodic management review of the policy statements and corporate level improvement objectives. Your organization communicates our mission, vision, strategy, policies and processes to all employees in order to: 1. Create and sustain shared values of fairness and ethical behavior; 2. Establish a culture of trust and integrity; 3. Encourage commitment to quality; 4. Provide people with the required resources, training and authority to act with accountability; 5. Inspire, encourage and recognize people’s contribution. 6 Management System Planning 6.1 Addressing Risks & Opportunities The overall aim of risk and opportunity management within your organization is to ensure that organizational capabilities and resources are employed in an efficient and effective manner to take advantage of opportunities and to mitigate risks. Top management are responsible for incorporating risk based thinking in to our organization's culture. This includes the establishment of risk management policies and targets to ensure effective implementation of risk and opportunity management principles and activities by: 1. Providing sufficient resources to carry out risk and opportunity management activities; 2. Assigning responsibilities and authorities for risk and opportunity management activities; 3. Reviewing information and results from audits and risk and opportunity management activities. The scope of your organization’s risk and opportunity management process includes the assessment of the internal and external issues identified in Section 4.1, and the assessment of the needs and expectations of any interested parties identified in Figure 4: Risk & Opportunities PDCA Cycle Plan - Create plans to address risk and opportunities. Do - Implement plans to mitigate risks or to adopt opportunities. Risks & Opportunities Act - Implement changes to the QMS and continually review. Check - Monitor risk management plans using measurements and audits.
  18. 18. Quality Management System: ISO 9001:2015 17 Section 4.2. Risk and opportunity management is undertaken as part of your organization’s day-to-day operations and is captured at the following hierarchy: 1. Strategic level; 2. Programme level; 3. Department level; 4. Process level; Establishing such a hierarchy for capturing risk and opportunity ensures that each is managed at the most appropriate level within our organization. Typically, the following categories are assigned to each level in the hierarchy as shown in the table opposite. Your organization has classified its ‘risk appetite’ as the amount of risk that we are willing to accept in pursuit of an opportunity or the avoidance of risk where each pertains to product and/or system conformity, and which reflect the following considerations: 1. Risk management philosophy per product or process; 2. Capacity to take on or mitigate risk; 3. Our objectives, business plans and respective stakeholder demands; Business Hierarchy Strategic level Programme level Department level Process level Risk/Opportunity Budgets and profitability Performance and efficiency Resources and targets Evaluation and assurance
  19. 19. Quality Management System: ISO 9001:2015 18 Appendices A.1 Correlation Matrix This section provides a matrix to correlate the requirements of ISO 9001:2015 against the relevant sections in this document and should be used to determine where the new and amended clauses are located. ISO 9001:2015 This Document 4.0 Context of the Organization 4.0 About our Organization 4.1 Understanding the Organization and its Context 4.1 Organizational Context 4.2 Needs and Expectations of Interested Parties 4.2 Relevant Interested Parties 4.3 Scope of the Quality Management System 4.3.1 Management System Scope 4.4 Quality Management System and its Processes 4.3.2 Management System Processes 5.0 Leadership 5.0 Leadership & Governance 5.1 Leadership and Commitment 5.1 Leadership and Commitment 5.1.1 Quality Management System 5.1.1 Quality Management System 5.1.2 Customer Focus 5.1.2 Customer Focus 5.2 Quality Policy 5.1.3 Quality Policy 5.2.1 Establishing the Quality Policy Establishing the Quality Policy 5.2.2 Communicating the Quality Policy Communicating the Quality Policy 5.3 Roles, Responsibilities and Authorities 5.2 Roles, Responsibilities and Authorities 6.0 Planning for the Quality Management System 6.0 Management System Planning 6.1 Actions To Address Risks and Opportunities 6.1 Addressing Risk & Opportunities 6.2 Quality Objectives & Planning To Achieve Them 6.2 Quality Objectives 6.3 Planning of Changes 6.3 Planning for Change 7.0 Support 7 Support 7.1 Resources 7.1 Resources 7.1.1 General 7.1.1 General 7.1.2 People 7.1.2 People 7.1.3 Infrastructure 7.1.3 Infrastructure 7.1.4 Environment for the Operation Of Processes 7.1.4 Operational Environment 7.1.5 Monitoring and Measuring Resources 7.1.5 Monitoring and Measuring Tools 7.1.6 Organizational Knowledge 7.1.6 Organizational Knowledge 7.2 Competence Competence 7.3 Awareness Awareness 7.4 Communication 5.3 Communication 7.5 Documented Information 4.3.4 Documented Information 7.5.1 General Management System Documents 7.5.2 Creating and Updating Creating and Updating 7.5.3 Control of Documented Information Controlling Documented Information 8.0 Operation 8.0 Product & Service Development 8.1 Operational Planning and Control 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.2 Customer Requirements 8.2.1 Customer Communication 8.2.1 Customer Communication 8.2.2 Determining Requirements Related to Products 8.2.2 Determining Requirements
  20. 20. Quality Management System: ISO 9001:2015 19 O 9001:2015 This Document 8.2.3 Review of Requirements Related to the Products 8.2.3 Review of Requirements 8.2.4 Changes to Requirements for Products/Services 8.2.4 Changes in Requirements 8.3 Design and Development of Products 8.3 Design and Development of Products 8.3.1 General 8.3.1 General 8.3.2 Design and Development Planning 8.3.2 Planning 8.3.3 Design and Development Inputs 8.3.3 Inputs 8.3.4 Design and Development Controls 8.3.4 Controls 8.3.5 Design and Development Outputs 8.3.5 Outputs 8.3.6 Design and Development Changes 8.3.6 Changes 8.4 Externally Provided Products & Services 8.4 Control of Suppliers & External Processes8.4.1 General 8.4.1 General 8.4.2 Type & Extent of Control of External Provision 8.4.2 Purchasing Controls 8.4.3 Information for External Providers 8.4.3 Purchasing Information 8.5 Production and Service Provision 8.5 Production & Service Provision 8.5.1 Control of Production and Service Provision 8.5.1 Control of Production & Service Provision8.5.2 Identification and Traceability 8.5.2 Identification & Traceability 8.5.3 Customer or External Provider’s Property 8.5.3 3rd Party Property 8.5.4 Preservation 8.5.4 Preservation 8.5.5 Post-Delivery Activities 8.5.5 Post-Delivery Activities 8.5.6 Control of Changes 8.5.6 Control of Changes 8.6 Release of Products and Services 8.6 Release of Products and Services 8.7 Non-conforming Process Outputs and Products 8.7 Control of Non-conforming Outputs 9.0 Performance Evaluation 9.0 Performance Evaluation 9.1 Monitoring, Measurement, Analysis & Evaluation 9.1 Monitoring, Measurement, Analysis & Evaluation9.1.1 General 9.1.1 General 9.1.2 Customer Satisfaction 9.1.2 Customer Satisfaction 9.1.3 Analysis and Evaluation 9.1.3 Analysis and Evaluation 9.2 Internal Audit 9.2 Internal Audit 9.3 Management Review 9.3 Management Review 9.3.1 General 9.3.1 General 9.3.2 Management Review Inputs 9.3.2 Inputs 9.3.3 Management Review Outputs 9.3.3 Outputs 10.0 Improvement 10.0 Improvement 10.1 General 10.1 General 10.2 Non-Conformity and Corrective Action 10.2 Non-Conformity & Corrective Action 10.3 Continual Improvement 10.3 Continual Improvement
  21. 21. Quality Management System: ISO 9001:2015 20 A.1 Sequence & Interaction of Processes SUPPORT PROCESSES Communication Competence & Awareness Maintain Facilities & Equipment Calibrate Equipment Mitigate Risks & Impacts Document & Data Control Domain Knowledge ASSESSMENT PROCESSES Continual Improvement Corrective Action Evaluate Risks & Opportunities Management Review Product & Process Monitoring ASSESSMENT PROCESSES Evaluation of Compliance Internal Auditing Non-conformities & Corrective Action Customer Feedback & Satisfaction Analyze QMS Process Data Customer, Market & Stakeholder Feedback Storage, Dispatch & Delivery Incoming Inpsection, Handling & Storage Production Processes Customer Related Prcesses Quote Order Contract Review Product & Process Planning Design & Development Supplier Selection & Evaluation MANAGEMENT PROCESSES Quality Management System Set Objectives & Targets Customer, Market, Stakeholder & Legal Requirements Provide Resources & Infrastructure Identify Risks & Opportunities Identify Legal & Other Requirements Determine Roles & Responsibilties Quality Planning
  22. 22. Quality Management System: ISO 9001:2015 21 References –  Fibre2Fashion  change?page=1  and-apparel-industries?page=4  ISO - International Organization for Standardization  