dsj Management Systems Solutions

Dhawadwadi, Pune, Maharashtra

ISO/TS 16949 was originally created in 1999 to harmonize different assessment and certification schemes worldwide in the supply chain for the automotive sector. The primary focus of the IATF 16949 standard is the development of a Quality Management System that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. The standard, combined with applicable Customer-Specific Requirements (CSR’s), define the QMS requirements for automotive production, service and/or accessory parts. IATF 16949:2016 is an independent QMS standard that is fully aligned with the structure and requirements of ISO 9001:2015. Therefore, the IATF 16949 cannot be implemented alone as a stand-alone document, but must be implemented as a supplement and in conjunction with ISO 9001:2015. IATF 16949 standard provides guidance and tools for companies and organizations who want to ensure that their products consistently meet customer requirements and that quality and customer satisfaction are consistently improved. Benefits of IATF 16949 Demonstrate its ability to consistently provide products that meet customer and applicable statutory, regulatory and product safety requirements. Defines overall context, who is affected and what they expect from system. Clearly states objectives and identifies new business opportunities Gives assurance to sustain existing customers & increases customer loyalty, add new clients and increase business Expand into new markets, as some sectors and client requires effective implementation & certification of IATF 16949 to start business. Identify and address the risks associated with your organization. Work in a more efficient way to increase productivity and efficiency, bringing to reduce internal costs. Become more socially responsible through the documentation and implementation of corporate responsibility polices.

HACCP stands for Hazard Analysis and Critical Control Point and it is mainly designed to identify and minimize hazards in food production. In other words, HACCP is a process in which food safety is addressed by the analysis and control of biological and physical hazards. It is a global recognized standard for food safety and provides high credibility to the potential clients. HACCP define for the prevention of hazards not for the finished product inspection it helps to provide guideline to the organization on how to analysis the hazards and how to reduce or control them for human consumption. The main objective of HACCP is process and makes the product safe. The Preventive approach of HACCP is helps to improve the food management system as well as improve the quality management system. HACCP Principle HACCP approaches 7 principles Conduct a hazard analysis. Determine the critical control points. Establish critical limits. Establish a system to monitor control of the CCP. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control Establish procedures for verification to confirm that the HACCP system is under control. Establish documentation concerning all procedures and records appropriate to these principles and their application. Benefits of HACCP Consistent Improve food quality and food safety management system. Improve the market value of the organization. Reduce risk in food production system. Develop team work among the employees. Time saving and cost saving process. It helps to ensure that you are compliant with the law. Commitment to produce safe and quality food for human consumption.

ISO 14001 is the international standard that specifies requirements for an effective environmental management system (EMS). ISO defines an environmental management system as a “part of the management system used to manage environmental aspects, fulfills compliance obligations, and address risks and opportunities to minimize how their processes, negatively affect the environment.” EMS includes the organizational structure, planning and resources for developing, implementing and maintaining policy for environmental protection. Based on their own positive experiences, many companies with ISO 14001 certification have asked their suppliers to demonstrate their commitment to conserving resources and decreasing their impact on the environment.

ISO 13485:2016 specifies the requirements for quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that are consistently meet customer and applicable regulatory requirements for the design and manufacture of medical devices. ISO 13845:2016 is beneficial for many organisations and can be used by suppliers and external parties that are involved with providing medical device products. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organisation are the responsibility of the organization and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

ISO 50001 energy management system (EnMS) certification provides a framework for establishing energy management best practices to help the organizations to improve their energy efficiency. The standard enables organizations to establish the systems and processes necessary to improve energy performance, including energy efficiency, use and energy consumption. An energy management system (EnMS) establishes the structure and discipline to implement technical and management strategies that significantly cut energy costs and greenhouse gas emissions - and sustain those savings over time. Savings can come from no- to low-cost operational improvements. Manufacturers, corporations, utilities, energy service companies, and other organizations are using ISO 50001:2018 to reduce costs and carbon emissions. As of 2017, almost 23, 000 sites worldwide achieved ISO 50001 certification. Benefits of iso 50001:2018 >increase assist organisations in making better use of energy-consuming assets >facilitate transparency / communication on management of energy resources >promote best practices for energy management >assist facilities in evaluating and prioritizing the implementation of new energy-efficient technologies >provide framework for energy efficiency throughout the supply chain >facilitate energy management improvements for GHG emissions reduction projects

Iso 22000 is an international standard that defines the requirements of a food safety management system. It maps out what an organization needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe. It can be used by any organization regardless of its size or position in the food chain. Iso 22000 certification services provide clients a systematic method for analyzing food processes, determining the possible hazards, and designating the critical control points. Iso 22000 incorporates haccp principles and is compatible with iso 9001 quality management system, making it the ideal basis for implementing a comprehensive, cost effective food safety management system. Iso 22000 certification demonstrates your on-going commitment to food safety, proves your integrity to the market, and enhances consumer confidence in your brand. Benefits of iso 22000:2018 introduce to internationally recognized processes to your business. Give suppliers and stakeholder’s confidence in your hazard controls. Introduce transparency around accountability and responsibilities. Continually improve and update your systems so it stays effective on food safety aspects. Recognized by the global food safety initiative (gfsi) reduces food safety hazards promotes legal compliance

ISO 45001 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its oh&s performance. ISO 45001:2018 implement and maintain an oh&s management system to improve occupational health and safety, eliminate hazards and minimize oh&s risks (including system deficiencies), take advantage of oh&s opportunities, and address oh&s management system non-conformities associated with its activities. By successful implementation of an effective oh&s management system can gain an organization the recognition and reputation of being a safe place to work. ISO 45001:2018 helps an organization to achieve the intended outcomes of its oh&s management system. Benefits of ISO 45001:2018 - > increase awareness of health and safety risk associated with their business. > Development of oh&s policies and processes including setting oh&s objectives. > Reduction in accidents by way of systematization of all activities relevant to occupational health and safety > improved employee identification and motivation due to management involvement in oh&s processes > improved image and competitive ability based on documented and sustained OHS&S performance > improves the safety of all persons affected by the company’s activities.

ISO 9001 is international standard for a quality management system (QMS). The requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, business, regardless of size & industry type. The standard is based on seven quality management principles, including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. ISO 9001:2015 helps businesses and organizations be more efficient and improve customer satisfaction by meeting expectations of customers & legal compliance requirements. Benefits of iso 9001:2015 to the organization > improves product or service quality > improves organizations credibility in the market > improves customer satisfaction > process becomes streamlined & integrated > reduce waste > helps to continual improvement > achieve international quality recognition > communicates a positive message to staff and customers

An integrated management system (ims) integrates all organization’s systems & processes, combine all related components of a business into one system for easier management and operations organization to work as a single unit with unified objectives. Quality, environmental and safety management systems are often combined and managed as an ims. Organizations often focus on management systems individually, often in silos and sometimes even in conflict. A quality team is concerned with the qms, often an ehs manager handles both environmental and health and safety issues, or a qhse manager handles safety, health, environment and quality, etc. The three management systems share many common requirements and the continual improvement goal. They differ in their approach and degree of prescription, but the ISO 9001, ISO 14001 and ISO 45001 standards are compatible in content, terminology & many of the requirements. It is often more efficient to combine the three systems (QMS, EMS & OHSMS) into one and sharing the common clauses and procedures. Benefits of integrated management system > consistent objectives, planning, and document management > implementation and operation of the system cost less. > Easier internal audits > no redundancies, reducing the chance of conflict. > Cost reduction due to integrated audits and assessments, as well as optimize processes and resources. > Optimize processes and resource

We see capital letters CE on many products in free movement in the European Economic Area. This marking, meaning Conformity with Europe, demonstrate that the products have been audited/assessed in terms of minimum safety, health and environmental requirements. You would see CE marking on a new telephone, food processor, TV set or crayons purchased in the European Community. CE marking also indicates fair competition among manufacturers as it enforces accountability and conformity with the same requirements. CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. CE marking is described as a trade passport because it enables the free movement of products within the European market. According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark. The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.

Quality Management System ISO 9001:2015 Environmental Management System ISO 14001:2015 Occupational Health Safety Management System ISO 45001:2018 Internal Auditor Quality Improvement Techniques Quality Management System – Requirements for Medical Devices ISO 13485:2016 Risk Analysis Total Quality Management 5S at Workplace Kaizen Lean Management Failure Mode & Effects Analysis

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practices? Many countries have formulated their own requirements for GMP based on WHO GMP.