ISO 14001 (ENVIRONMENT MANAGEMENT SYSTEM)The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Advantages • 1. Creates a more efficient, effective operation • 2. Increases customer satisfaction and retention • 3. Reduces audits • 4. Enhances marketing • 5. Improves employee motivation, awareness, and morale • 6. Promotes international trade • 7. Increases profit • 8. Reduces waste and increases productivity • 9. A common tool for standardization
ISO Certification
ISO 9001 QUALITY MANAGEMENT SYSTEM
The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Advantages • 1. Creates a more efficient, effective operation • 2. Increases customer satisfaction and retention • 3. Reduces audits • 4. Enhances marketing • 5. Improves employee motivation, awareness, and morale • 6. Promotes international trade • 7. Increases profit • 8. Reduces waste and increases productivity • 9. A common tool for standardization
ISO 14001 (ENVIRONMENT MANAGEMENT SYSTEM)
The ISO 14000 family addresses various aspects of environmental management. It provides practical tools for companies and organizations looking to identify and control their environmental impact and constantly improve their environmental performance. Requirement of ISO 14001 Within the standard there are 17 elements of ISO 14001 that are required to be met by organizations seeking formal recognition for their EMS. ISO 14001 requirements are as follows: 1. An environmental policy supported by senior management; 2. The identification of environmental aspects and impacts, and the identification of significant environmental impacts that the organization may cause; 3. Identification of environmental compliance requirements; 4. The development of objectives and targets, and their environmental management programs; 5. Defined resources, roles, responsibilities and authorities for environmental management; 6. The development of competence, training and awareness procedures; 7. A communication process of the EMS to all stakeholders and interested parties; 8. The development of EMS documentation as required by the standard; 9. The development of document control procedures; 10. The development of operational control procedures; 11. The development of emergency preparedness and response procedures; 12. The development of procedures to monitor and measure operations that can have significant impact to the environment; 13. An evaluation of compliance procedure; 14. Procedures developed for the management of non-conformance, corrective and preventative actions; 15. The development of a records management procedure; 16. A program for completing internal EMS audits and corrective actions; and 17. The development of procedures for management review by senior management. Advantages 1. Reduced cost of waste management 2. Savings in consumption of energy and materials 3. Lower distribution costs 4. Improved corporate image among regulators, customers and the public.
ISO 45001 / OHSAS 18001 (OCCUPATIONAL HEALTH & SAFETY ASSESSMENT SERIES)
OHSAS 18001 Standards are British Standards but considering its benefit, impact & Popularity, it’s accepted by ISO. Health & Safety of employee is one of the most important aspects of any organization. Adaption of OHSAS 18001 should be a Strategic Decision of any Organization; Design & Implementation & time required for OHSAS 18001 may basically depend on the following factors: 1. Willingness to Implement, Maintain & continually improve OHS Management System & Policy 2. Organizational Environment & Occupational Risk associated. 3. Products or Services in which organization dealt with. 4. The Process adopted 5. Size & organizational Structure 6. Applicable Legal & regulatory Requirements. OHSAS (Occupational Health & Safety Management System) 18001 certification Services is offered to companies with a large work force involving manual and heavy work tasks, and/ or high risk work environments. The certification defines the health and labor protection system of an organization. OHSAS 18001 is a management system which is recognized globally. OHSAS 18001 Certification helps organization to formulate OHS Policy & OHS Objectives. OHSAS Performance ensures an accident free industrial environment. The OHSAS 18001 certifications validate that the organization is pro actively protecting the health and safety of its employees and stakeholders. OHSAS 18001 certification Services for environmental management systems can be integrated with ISO 9001 and ISO 14001. Benefit: 1. OHSAS 18001 helps Organization to reduce accidents & disturbance in production 2. OHSAS 18001 focuses on employee safety. 3. OHSAS 18001 helps Better Legal & Regulatory Compliances. 4. OHSAS 18001 Minimize administrative cost 5. OHSAS 18001 improve Brand Building. 6. Attract Good Manpower. 7. Reduction in Insurance Cost. 8. OHSAS Reduces Public Liability Insurances cost. 9. Demonstrate Forward thinking approach. 10. OHSAS 18001 Help Business, Government & Society.
ISO 13485 (QUALITY MANAGEMENT SYSTEM FOR THE DESIGN AND MANUFACTURE OF MEDICAL DEVICES)
ISO 13485 is an International Organization for Standardization (ISO) standard, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard.
ISO 27001 (INFORMATION SECURITY MANAGEMENT SYSTEM (ISMS)
ISO/IEC 27001 specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization. It also includes requirements for the assessment and treatment of information security risks tailored to the needs of the organization. The standard contains 11 domains: 1. Security policy - management direction 2. Organization of information security - governance of information security 3. Asset management - inventory and classification of information assets 4. Human resources security - security aspects for employees joining, moving and leaving an organization 5. Physical and environmental security - protection of the computer facilities 6. Communications and operations management - management of technical security controls in systems and networks 7. Access control - restriction of access rights to networks, systems, applications, functions and data 8. Information systems acquisition, development and maintenance - building security into applications 9. Information security incident management - anticipating and responding appropriately to information security breaches 10. Business continuity management - protecting, maintaining and recovering business-critical processes and systems 11. Compliance - ensuring conformance with information security policies, standards, laws and regulations
ISO 28000 (SECURITY MANAGEMENT SYSTEMS FOR THE SUPPLY CHAIN)
Standardization of design, construction, structural elements, outfitting parts, equipment, methods and technology, and marine environmental matters, used in shipbuilding and the operation of ships, comprising sea-going ships, vessels for inland navigation, offshore structures, ship-to-shore interface and all other marine structures subject to IMO requirements. Benefits: 1. Integrated enterprise resilience 2. Systematized management practices 3. Enhanced credibility and brand recognition 4. Aligned terminology and conceptual usage 5. Improved supply chain performance 6. Benchmarking against internationally recognizable criteria 7. Greater compliance processes
ROHS
RoHS Directive stands for ’the restriction of the use of certain hazardous substances in electrical and electronic equipment ’. This Directive bans the placing on the EU market of new electrical and electronic equipment containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. It is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC which sets collection, recycling and recovery targets for electrical goods and is part of a legislative initiative to solve the problem of huge amounts of toxic e-waste. Manufacturers need to understand the requirements of the RoHS Directive to ensure that their products, and their components, comply. The RoHS Directive and the UK RoHS regulations came into force on 1 July 2006 ROHS Benefits Electrical Product ’s Assurance of Quality. How can DRS.. CERT help to get RoHS? DRS.. CERT ensures that the products of a company comply to the RoHS Compliance Certification and regulations. DRS.. is expert in ce marking, rohs certification, Product Certification, quality management certification much more.
HACCP (HAZARD ANALYSIS CRITICAL CONTROL POINT)
Who is HACCP applicable to? HACCP can be used by any organization directly or indirectly involved in the food chain and pharmaceutical industry including: 1. Farms, fisheries and dairies 2. Processors of meats, fish and feed 3. Manufacturers of bread and cereals, beverages, canned and frozen food 4. Food service providers such as restaurants, fast food chains, hospitals and hotels and mobile caterers 5. Manufacturers of prescription and non-prescription drugs and remedies What are the immediate benefits of approval? • Improved food safety • Increased business awareness of food risks • Greater product and raw ingredient traceability • Increased buyer and consumer confidence • Consistency in inspection criteria • Promotion of internal review of processes • Supports business leadership through the direction of resources to • safety critical elements of the process • Compliance with food law • Reduction in complaints • Reduced risk of negative publicity • Improved responsiveness to problems through devised corrective action
HALAL CERTIFICATION
What is halal? Halal simply means permitted or lawful. So when we are talking about halal foods it means any foods that are allowed to be eaten according to Islamic Sharia law. This means that for any food to be considered halal it must comply with the religious ritual and observance of Sharia law. What is halal certification? This means that food has been subjected to approved certification systems which guarantee to consumers that nothing in the food has any forbidden components. Halal certificates are issued, for a fee, by a certifying body. What are the Benefits of Halal Certification? • Opportunities to tap a global Halal food market of about 2 billion people. • Halal logo is an authoritative, independent and reliable testimony to support Halal food claims • 200% profit of greater market share: No loss of non-Muslim markets/clients • Enhance marketability of products in Muslim countries/markets • Small cost investment relative to multiple growth in revenues • Image boosts in meeting varied customer needs. • Improve the food preparation hygienic system • Improve the food quality into global standards
ISO 50001 (ENERGY MANAGEMENT SYSTEMS)
ISO 50001:2011 specifies requirements for establishing, implementing, maintaining and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy
ISO 22000 (FOOD SAFETY MANAGEMENT SYSTEMS)
Food and drink industry ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. ISO 22000 specifies requirements to enable an organization: • To plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer • To demonstrate compliance with applicable statutory and regulatory food safety requirements • To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction. • To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain. • To seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000.
ISO/TS 29001
ISO/TS 16949 (AUTOMOTIVE QUALITY MANAGEMENT SYSTEM)
ISO 14001 (ENVIRONMENT MANAGEMENT SYSTEM)The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Advantages • 1. Creates a more efficient, effective operation • 2. Increases customer satisfaction and retention • 3. Reduces audits • 4. Enhances marketing • 5. Improves employee motivation, awareness, and morale • 6. Promotes international trade • 7. Increases profit • 8. Reduces waste and increases productivity • 9. A common tool for standardization
WHO - GMP COMPLIANCE
Good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. All guidelines follow a few basic principles: 1. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. 2. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. 3. Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices) 4. Operators are trained to carry out and document procedures. 5. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented 6. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. 7. The distribution of the drugs minimizes any risk to their quality. 8. A system is available for recalling any batch of drug from sale or supply. 9. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
ISO 15378 (PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS
ISO 15378 (PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS -- PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) ISO 15378 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. ISO 15378 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
ISO 10002 (QUALITY MANAGEMENT -- CUSTOMER SATISFACTION
ISO 10002 (QUALITY MANAGEMENT -- CUSTOMER SATISFACTION -- GUIDELINES FOR COMPLAINTS HANDLING IN ORGANIZATIONS) ISO 10002 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. ISO 10002 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes. It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses. ISO 10002 addresses the following aspects of complaints handling: Enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service. 1. Top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training. 2. Recognizing and addressing the needs and expectations of complainants. 3. Providing complainants with an open, effective and easy-to-use complaints process. 4. analyzing and evaluating complaints in order to improve the product and customer service quality. 5. auditing of the complaints-handling process. 6. reviewing the effectiveness and efficiency of the complaints-handling process. 7. ISO 10002 is not intended to change any rights or obligations provided by applicable statutory or regulatory requirements
ISO 30000 (SHIP RECYCLING MANAGEMENT SYSTEMS)
ISO 30000 specifies requirements for a management system to enable a ship recycling facility to develop and implement procedures, policies and objectives in order to be able to undertake safe and environmentally sound ship recycling operations in accordance with national and international standards. The management system requirements take into account the relevant legal requirements, safety standards and environmental elements that the ship recycling facility needs to identify and comply with in order to carry out safe and environmentally sound ship recycling Standards Applicable to: Establish, Implement, Maintain and Improve a safe and environmentally sound management system for the recycling of ships; assure itself of conformity with its stated safe and environmentally sound management policy; Demonstrate conformity with ISO 30000 by making a self-determination and self-declaration, or seeking confirmation of its conformance by parties having an interest in the facility such as customers, or seeking confirmation of its self-declaration by a party external to the organization, or seeking certification/registration of its management system by an external organization.
SA 8000 CERTIFICATION
The SA 8000 Certification is the Social Accountability System standard. It is applicable to companies of any size that wish to address the social and ethical aspects of their business. A Social Accountability System proves to customers that the company holds adequate provisions for the protection of workers' rights. Further, it ensures ethical production of all goods manufactured by the company. SA 8000 is the first auditable standard in this field. The initiative is based on the well-known ISO 9001/ISO 14001 certification structure, conventions of the International Labor Organization (ILO), the Universal Declaration of Human Rights and the UN Convention on the Rights of the Child.