Quality management system...................................
- 1. UNIT V QUALITY MANAGEMENT SYSTEM (QMS)
- 2. QUALITY MANAGEMENT SYSTEM (QMS) A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps to coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
- 3. PURPOSE OF QMS Quality management systems serve many purposes, including: Improving processes Facilitating and identifying training opportunities Engaging staff Setting organization-wide direction
- 4. BENEFITS OF QUALITY MANAGEMENT SYSTEMS Implementing a quality management system affects every aspect of an organization's performance. Two overarching benefits of quality management systems include: Meeting the customer’s requirements, which helps to install confidence in the organization, in turn leading to more customers, more sales, and more repeat business. Meeting the organization's requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit.
- 5. ELEMENTS AND REQUIREMENTS OF A QUALITY MANAGEMENT SYSTEM General elements of QMS includes: The organization’s quality policy and quality objectives Quality manual Procedures, instructions, and records Data management Internal processes Customer satisfaction from product quality Improvement opportunities Quality analysis Each element of a quality management system serves a purpose toward the overall goals of meeting the customers’ and organization’s requirements. Ensuring each of the elements of a QMS is present ensures proper execution and function of the QMS.
- 6. ESTABLISHING AND IMPLEMENTING QMS Establishing a quality management system helps organizations run effectively. Before establishing a quality management system, the organization must identify and manage various connected, multi- functional processes to ensure customer satisfaction is always the target achieved. The basic steps to implementing a quality management system are as follows: Design Build Deploy Control Measure Review Improve
- 7. DESIGN AND BUILD The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation. Senior management must oversee this portion to ensure the needs of the organization and the needs of its customers are a driving force behind the systems development.
- 8. DEPLOY Deployment is best served in a granular fashion i.e. breaking each process down into sub processes, and educating staff on documentation, education, training tools, and metrics. Company intranets are increasingly being used to assist in the deployment of quality management systems.
- 9. CONTROL AND MEASURE Control and measurement are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system. The specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact.
- 10. REVIEW AND IMPROVE Review and improvement deal with how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit.
- 12. How ISO certification can help your Manufacturing company Whatever product you manufacture, quality and customer satisfaction are of paramount importance. ISO Management Systems are internationally recognized and increase customer confidence in your products. They demonstrate that you’re committed to quality, comply with regulations, aim to avoid product recalls and failures, and have your customers’ needs at the forefront of your operations. All of which is annually checked and confirmed by a third party. .
- 13. Which ISO standards are best for my Manufacturing business? you can choose from various ISO Management Systems. However, the ones best suited to the Manufacturing industry are: ISO 9001 Quality Quality control is important for any industry, but for manufacturing it is even more so. An ISO 9001 certificate demonstrates that your organization is customer-focused and committed to delivering consistent, quality products. This globally recognized Standard ensures best-practice processes are in place which help to increase efficiency and drive continual improvement.
- 14. ISO 14001 Environment The ISO 14001 Standard will help you quantify, monitor and control the ongoing environmental impact of your operations. By managing the use of natural resources, energy and waste you can improve your corporate image and credibility, helping you to win new customers as well as identify opportunities for cost savings. ISO 45001 Health & Safety Gaining the ISO 45001 certification allows you to demonstrate that your business operates a best-practice Occupational Health and Safety Management System – reducing the likelihood of accidents and breaches of legislation, as well as improving your organization's overall performance
- 15. DEVELOPING AN ENERGY MANAGEMENT SYSTEM ISO 50001 is based on the management system model of continual improvement also used for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management. ISO 50001 provides a framework of requirements for organizations to: • Develop a policy for more efficient use of energy • Fix targets and objectives to meet the policy Use data to better understand and make decisions about energy use Measure the results • Review how well the policy works, and Continually improve energy management.
- 16. Like other ISO management system standards, certification to ISO 50001 is possible but not obligatory. Some organizations decide to implement the standard solely for the benefits it provides. Others decide to get certified to it, to show external parties they have implemented an energy management system. ISO does not perform certification.
- 17. ISO 22000 FOOD SAFETY MANAGEMENT Whatever their size, or product, all food producers have a responsibility to manage the safety of their products and the well-being of their consumers. That’s why ISO 22000 exists. ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product. This is becoming more and more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe.
- 18. What does ISO 22000 require? ISO 22000 requires that you build a Food Safety Management System. This means that you will have a documented system in place and fully implemented throughout your facility that includes: Effective Prerequisite Programs in place to ensure a clean sanitary environment A Hazard Analysis and Critical Control Plan developed to identify, prevent and eliminate food safety hazards. Established documented food safety management system processes to manage food safety throughout your organization - from management and business planning aspects to day to day communication and operations affecting food safety.
- 19. The ISO 22000 standard contains the specific requirements to be addressed by the Food Safety Management System. The standard requires food safety management system processes including: • Having an overall Food Safety Policy for your organization, developed by top management. • Setting objectives that will drive your companies efforts to comply with this policy. • Planning and designing a management system and documenting the system. • Maintaining records of the performance of the system. • Establishing a group of qualified individuals to make up a Food Safety Team. • Defining communication procedures to ensure effective communication with important contacts outside the company (regulatory, customers, suppliers and others) and for effective internal communication. • Having an emergency plan. • Holding management review meetings to evaluate the performance of the FSMS.
- 20. What Is Cyber Crime? Cyber terrorists usually use the computer as a tool, target, or both for their unlawful act either to gain information which can result in heavy loss/damage to the owner of that intangible sensitive information. Internet is one of the means by which the offenders can gain such price sensitive information of companies, firms, individuals, banks, intellectual property crimes (such as stealing new product plans, its description, market programme plans, list of customers etc.), selling illegal articles, pornography etc. This is done through many methods such as phishing, spoofing, pharming, internet phishing, wire transfer etc. and use it to their own advantage without the consent of the individual. Many banks, financial institutions, investment houses, brokering firms etc. are being victimized and threatened by the cyber terrorists to pay extortion money to keep their sensitive information intact to avoid huge damages.
- 21. IPR In Cyberspace Intellectual Property Rights (IPR) and Cyber Laws cannot be disconnected and digital content requires protection. ‘Cyberspace’ is the non-physical domain over which the communication between computers takes place through computer networks. With the growth of technology every individual has a right of accessing cyberspace and sharing information, unless they are in conflict with cyber law. In cyberspace, sometimes information is shared by a person, who is not the owner of the same, or the information which is private. Hence, privacy is violated, and one makes profit on another person’s creation. Such rights are protected under intellectual property rights. The types of IPR are: Patent, Copyright, Trademarks, Trade Secrets, Industrial and Layout Designs, Geographical Indications etc. When these rights are violated in cyberspace there are several remedies available for the various types of violation
- 22. 1.Copyright Infringement: Copyright protection is given to the owner of any published artistic, literary, dramatic or scientific work over his work to exclude everyone else from using that work on his own name and thereby gain profit from it. When these copyrighted articles are unauthorized used by anybody without the permission of the owner, this amounts to copyright infringement. When copies are made of commercial software which are distributed over the internet, and sold by a third person (other than owner), that amounts to be a copyright infringement. Copying website or blog content also amounts to a copyright violation. 2.Software Piracy: It is also covered under sections of Indian Copyright Act. This is the illegal use of software by copying and distributing them among organizations, groups etc for business personal use. This piracy can be of 3 types: Soft lifting, Software Counterfeiting, and Uploading-Downloading.
- 23. Cyber squatting and Trademark Infringement: Trademarks are distinctive marks can be words, pictures, sound or shape which describes the nature and quality about a certain product to the user. The lions roar of ‘Metro-Godwyn-Mayer’ or the word art of ‘Google’ are the trademarks for these respective companies, when these marks, whether registered or unregistered, are used by some other company on their product, that is called trademark infringement. Cyber squatting is the process by which domain names are registered, sold, trafficked-in with the intention to make profit from the goodwill of someone else’s trademark in bad faith. Cyber squatting is a punishable offence.
- 24. What are the benefits of ISO certification? An ISO certification for your manufacturing business could provide the following benefits: More efficient delivery of products Reduction in errors, resulting in reduced waste Improved environmental performance of your supply chain Compliance with legislation and regulations Reduced costs Increased business – both new and existing Enhanced reputation, by demonstrating your commitment to meeting international standards of excellence
- 25. MANAGEMENT SYSTEMS Management system means what the organization does to manage its processes, or activities in order that its products or services meet the organization’s objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives
- 26. MANAGEMENT SYSTEMS (CONT….) To be really efficient and effective, the organization can manage its way of doing things by systemizing it. Nothing important is left out. Everyone is clear about who is responsible for doing what, when, how, why and where. Management system standards provide the organization with an international, state-of-the-art model to follow.
- 27. What is an ISMS? An information security management system (ISMS) is a framework of policies and controls that manage security and risks systematically and across your entire enterprise—information security. These security controls can follow common security standards or be more focused on your industry. For example, ISO 27001 is a set of specifications detailing how to create, manage, and implement ISMS policies and controls. The ISO doesn’t mandate specific actions; instead, it provides guideline on developing appropriate ISMS strategies.
- 28. Continuous improvement in information security While ISMS is designed to establish holistic information security management capabilities, digital transformation requires organizations to adopt ongoing improvements and evolution of their security policies and controls. According to ISO 27001, ISMS implementation follows a Plan-Do-Check-Act (PCDA) model for continuous improvement in ISM processes:
- 29. Plan. Identify the problems and collect useful information to evaluate security risk . Define the policies and processes that can be used to address problem root causes. Develop methods to establish continuous improvement in information security management capabilities. Do. Implement the devised security policies and procedures. The implementation follows the ISO standards, but actual implementation is based on the resources available to your company. Check. Monitor the effectiveness of ISMS policies and controls. Evaluate tangible outcomes as well as behavioral aspects associated with the ISM processes. Act. Focus on continuous improvement. Document the results, share knowledge, and use a feedback loop to address future iterations of the PCDA model implementation of ISMS policies and controls.
- 30. ISMS security controls ISMS security controls span multiple domains of information security as specified in the ISO 27001 standard. The catalog contains practical guidelines with the following objectives: Information security policies. An overall direction and support help establish appropriate security policies. The security policy is unique to your company, devised in context of your changing business and security needs. Organization of information security. This addresses threats and risks within the corporate network, including cyberattacks from external entities, inside threats, system malfunctions, and data loss. Asset management. This component covers organizational assets within and beyond the corporate IT network., which may involve the exchange of sensitive business information.
- 31. Human resource security. Policies and controls pertaining to your personnel, activities, and human errors, including measures to reduce risk from insider threats and workforce training to reduce unintentional security lapses. Physical and environmental security. These guidelines cover security measures to protect physical IT hardware from damage, loss, or unauthorized access. While many organizations are taking advantage of digital transformation and maintaining sensitive information in secure cloud networks off- premise, security of physical devices used to access that information must be considered. Communications and operations management. Systems must be operated with respect and maintenance to security policies and controls. Daily IT operations, such as service provisioning and problem management, should follow IT security policies and ISMS controls.
- 32. Access control. This policy domain deals with limiting access to authorized personnel and monitoring network traffic for anomalous behavior. Access permissions relate to both digital and physical mediums of technology. The roles and responsibilities of individuals should be well defined, with access to business information available only when necessary. Information system acquisition, development, and maintenance. Security best practices should be maintained across the entire lifecycle of the IT system, including the phases of acquisition, development, and maintenance. Information security and incident management. Identify and resolve IT issues in ways that minimize the impact to end users. In complex network infrastructure environments, advanced technology solutions may be required to identify insightful incident metrics and proactively mitigate potential issues.
- 33. Business continuity management. Avoid interruptions to business processes whenever possible. Ideally, any disaster situation is followed immediately by recovery and procedures to minimize damage. Compliance. Security requirements must be enforced per regulatory bodies. Cryptography. Among the most important and effective controls to protect sensitive information, it is not a silver bullet on its own. Therefore, ISMS govern how cryptographic controls are enforced and managed. Supplier relationships. Third-party vendors and business partners may require access to the network and sensitive customer data. It may not be possible to enforce security controls on some suppliers. However, adequate controls should be adopted to mitigate potential risks through IT security policies and contractual obligations.
- 34. These components and domains offer general best practices towards InfoSec success. Though these may vary subtly from one framework to another, considering and aligning with these domains will provide much in the way of information security.
- 35. MANAGEMENT SYSTEMS (CONT….) ISO 9001 concerns the way an organization goes about its work. They are not product standards. They are not service standards. They are process standards. They Can be used by Product manufacturer and service providers. ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services.
- 36. CERTIFICATION AND REGISTRATION Certification is known as Registration in some countries organizations management system and verified that An Independent, external body has audited an it conforms to the requirements specified in the standard (ISO 9001).
- 37. BENEFITS The major reason why many companies want ISO 9001 certification is that they want to portray themselves as a worthy company to do business with, many of them do not really realize the benefits (some direct and others indirect): Direct Benefits: • Improved customer satisfaction; • Improved quality of products and services; • Employees satisfaction and more commitment to the organization; • Better management and a more effective organization; • Improve relations with suppliers; • Improved promotion of corporate image.
- 38. BENEFITS Indirect Benefits: It helps companies to • Review business goals, and assess how well the organization is meeting those goals; • Identify processes that are unnecessary or inefficient, and then remove or improve them; • Review the organizational structure, clarifying managerial responsibilities; • Improve internal communication, and business and process interfaces; • Improve staff morale by identifying the importance of their output to the business, and by involving them in the review and improvement of their work.
- 39. QMS PRINCIPLES Any organization can benefit from implementing ISO 9001 as its requirements are underpinned by 8 management principles: A customer focused organization Leadership The involvement of people Ensuring a process approach A systematic approach to management A factual approach to decision making Mutually beneficial supplier relations Continuous improvement.
- 40. 4 LEVELS OF DOCUMENTS
- 41. QUALITY MANUAL? A Quality Manual is the main, top-level document which establishes the quality policies and objectives of an organization.
- 42. WHAT WILL A QUALITY MANUAL PROVIDE TO A COMPANY? Overall it provides evidence of what specific controls are implemented to ensure product/service quality. Who will benefit ? • Customers • Suppliers • Employees • The Company
- 43. A QUALITY MANUAL SHOULD…. 1. Address all Quality System elements 2. Contain or refer to quality procedures “Documentation”
- 44. THE IMPORTANCE OF DOCUMENTATION
- 45. BENEFITS OF DOCUMENTATION: QUALITY MANUAL The Key is to move towards: Consistently repeating the best practices and Improving those processes which are lacking
- 46. BASIC QUALITY MANUAL OUTLINE Introduction Policy and Objectives Definitions Quality System Organization Authority and Responsibilities Compliance Internal Review and Audit Documentation and Change Purchasing Inspection and Testing Training
- 47. ADVANTAGES OF QUALITY MANUAL 1. To prevent risks 2. To detect deviations 3. To correct errors 4. To improve efficiency 5. To reduce costs 6. To meet customer needs 7. To market company
- 48. PROCEDURES Procedure is defined as-an established or official way of doing something. In this case we will follow the standard operating procedures .
- 49. WORK INSTRUCTIONS A work instruction is a tool provided to help someone to do a job correctly. This simple statement implies that the purpose of the work instruction is quality and that the target user is the worker.
- 50. DOCUMENTS , FORMS , RECORDS…. It includes data sheets, lab results sheets , customer feed back forms, evaluation forms of employees etc.
- 51. WHAT IS OUR QUALITY POLICY? EIA/EMP for carrying out environmental monitoring/analysis & audits in a professional , CPTL EIA division strives to become a leading consultants with highest standards in the active field of systematic & accurate manner. These objectives will be achieved through customer satisfaction with an attitude of dedicated professional expert in the organization All these objectives will be in accordance to ISO 9001: 2008 Quality Management System.
- 52. WHAT IS OUR QUALITY OBJECTIVE? The C.E.O ensures that this quality policy laid for CPTL- EIA division is available to all its personnel which is duly understood and meritoriously followed by all the staff.