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Iso 9001:2008\r\niso 9001 is a \'generic\' standard and is applicable to all organizations irrespective of its size, product, location & whether private / public / government. \r\nCertification is a internationally recognized quality management systems. Iso 9001:2008 clearly demonstrates the organizations ability to meet customer requirement(s), and commitment to continual improvement. \r\nAdvantages\r\n\r\n customers are benefited as they receive products & services conforming to requirements. \r\n owners & investors benefit by increased return on investment, improved operational results, increased market share, increased profile. \r\n people in the organization benefit through better working conditions, increased job satisfaction helps maintaining high morale. \r\n society benefits through fulfillment of legal and regulatory requirements, improved health and safety, reduced environmental impact. \r\n\r\nquality management system standards\r\nthe international organization for standardization has published a family of standards for quality management systems, and is administered by accreditation bodies through certification bodies. They are\r\n\r\n iso 9000 qms - fundamentals & vocabulary\r\n iso 9001 qms - requirements\r\n iso 9004 - guidelines for performance improve\r\n\r\nenvironmental management system standard\r\niso 14001:2004 environmental management system standard helps an organization to minimize the effect of its processes which negatively affect the environment (air, water or land) and comply with applicable regulatory and statutory requirements\r\ncertification to iso 14001:2004 demonstrates of the organization\'s earnestness and commitment to environmental performance. \r\nIso for environment management systems is based upon iso 9000 family of standards. \r\nBenefits\r\n\r\n reduction of waste hence cost savings. \r\n improved overall performance & efficiency\r\n better public perception of the organization to improved sales. \r\n reduction of impact of your activities, leading to more community support. \r\n\r\noccupational health and safety assessment series\r\nohsas 18001: 2009 occupational health and safety management systems - specifications\r\nthis standard prescribes requirements for an oh&sms to enable an organization to formulate its policies and objectives to protect its employees and others, whose health and safety may be affected by the activities of the organization. \r\nThe extent of application depends on nature of activities, complexity of its operations. \r\nIntegrated management system\r\niso 9001, iso 14001 and ohsas 18001 have common elements between them. These can be integrated to a single, management system or a combination of the above. Audit of joint systems is available and best cost effective method for some companies. \r\nIntegrated system not only help an organizations internally, by reducing duplication and providing a centralized document control system, results in cost benefits in third party audits. \r\n\r\nfood safety management systems\r\niso 22000:2005 -\"food safety management systems - requirements for any organization in food industry\",\r\niso 22000:2005 is a new international standards designed to ensure the safety of food supply chains worldwide while applying haccp programe, in addition to the harmonized applicable qms and prerequisite program. \r\nIso 22000 specifies a food safety management system that include interactive communication between supplier and producers and customers. It answered the growing demand for the certification of suppliers and gives more attention to quality aspects. \r\nThe standard is applicable to all organizations directly or indirectly involved in one of the stages, related to the food chain, intending implementing a management system that would guarantee food safety for consumers. \r\nVarious companies, from seed producers, meat or milk processors, etc., to food transportation companies and even retailers, private food unit or equipment manufactures for the food industry can successfully apply iso 22000:2005, \"food safety management systems - requirements for any organization in food industry\",\r\n\r\niso 27001\r\niso/iec 27001, part of the growing iso/iec 27000 series of standards, is an information security management system (isms) standard published in october 2005 by the international organization of standardization (iso) and the international electro technical commission (iec). Its full name is iso/iec 27001:2005 - information technology.- security techniques. \r\nIsms - requirements but it is commonly known as \'iso 27001\'. Iso/iec 27001 certification process usually involves a three stage audit process. \r\nStage 1: is a \"table top\" review of the existence and completeness of key documentation such as the (soa) and risk treatment plan (rtp)\r\nstage 2: is a detailed, in depth audit involving testing the existence and effectiveness of the information security control stated in the soa and rtp, as well as their supporting documentation. \r\nStage 3: is a follow-up reassessment audit to confirm that a previously - certified organization remains in compliance with the standard certification maintenance involves periodic reviews and re-assessments to confirm that the isms continues to operate as specified and intended. \r\nIso/iec 27001:2005 covers all types of organization [e.g. Commercial enterprises, government agencies, not for profit organizations). Iso/iec - 27001:2005 specified the requirements for establishing, implementing, operating, and monitoring, reviewing, maintaining system within the context of the organization\'s overall business risk. It specifies requirements for the implementation of security controls customized to the needs of individual organizations (or) parts thereof. \r\nIso/iec 27001:2005 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties. \r\nIso/iec 27001:2005 is intended to be suitable for several different types of use, including the following:\r\n\r\n use within organizations to formulate security requirements and objectives\r\n use within organizations as a way to ensure that security risks are cost effectively managed\r\n use within organizations to ensure compliance with laws and regulations\r\n use within an organizations as a process framework for the implementation and management of controls to ensure that the specific security objectives of an organization are met\r\n definition of new information security management process\r\n identification and clarification of existing information security management processes\r\n use by the management of organizations to determine the status of information security management activities\r\n use by the internal and external auditors of organizations to determine the degree of compliance with the policies, directives and standards adopted by an organization\r\n use by organizations to provide relevant information about information security policies, directives, standards and procedures to trading partners and other organizations with whom they interact for operational or commercial reasons\r\n implementation of business-enabling information security. \r\n use by organizations to provide relevant information about information security to customers. \r\n\r\n\r\nmanagement system for the design and manufacture of medical devices\r\niso 13485:2003 represents the requirements for a comprehensive management system for the design and manufacture of medical devices. All requirements of this international standard are specific to organizations providing medical devices, regardless of the type or size of the organization. This standard supersedes earlier documents such as en 46001 and en 46002 (both 1997), the iso 13485 published in 1996 and iso 13488 (1996). Iso 13485:2003 is a quality system standard designed specifically for medical device companies. The standard is applied by most class ii and iii (plus class iv in canada) medical device manufacturers to meet the quality system requirements of europe, canada, australia, japan and other parts of the world. \r\nCompliance with iso 9001:2008 is often seen as the first step in achieving compliance with iso 13485:2003, which is based on the iso 9001:2008 process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this international standard are specific to organizations providing medical devices, regardless of the type or size of the organization. \r\nIso 13485 in part designed to produce a management system that facilitates compliance to the requirements of customers and various global regulators. While being certified to iso13485 does not fulfill the requirements of either the fda or foreign regulators, the certification aligns an organization\'s management system to the requirements of the fda\'s quality system regulation (qsr) requirements as well as many other regulatory requirements found throughout the world. Therefore, iso13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements. \r\nThe iso 13485 standard supplements iso 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more. Individual countries such as canada and japan have additional requirements necessary to meet their specific regulations. Iso 13485 certification is not accepted by the us fda, although it shares many of the same characteristics as fda good manufacturing practice (gmp). \r\nThough based on iso 9001, iso13485 removes 9001\'s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. \r\nCe marking\r\nthe european union is keen to ensure that all products entering and used within the union are such as not to impose a threat to consumers or the environment. \r\nThe european community aims to ensure that industrial products made available on the community market respect a high level of protection of public interests such as health and safety, protection of consumers and the environment. \r\nA common indication of a product\'s fitness for placement within the community is the affixing of a ce mark. \r\nCe marking\r\n\r\n\r\napplication\r\nthe client can forward the application to pcs with organization details, manufacturing setup, etc.,\r\nreadiness review\r\na top level review will be conducted by the pcs at the manufacturer\'s premises. This is necessary because of the combined complexity of the ce marking and authorised representative processes. It can be likened to a stage one review. The readiness review will indicate to the manufacturer the likelihood of achieving ce mark status for their product, the probable timescale and whether or not specialist help may be necessary. Manufacturers should note that a common circumstance is that products will have developed during a period of several years. Moreover, the level of sophistication of a manufacturer\'s management practices and personnel will have developed in similar manner. Data regarding the excellence of the design of the product may not therefore be currently available. Often the requirement \'in the early days\' was either non-existent or unappreciated. Nonetheless, today\'s european community requirement is that products should posses known qualities and data relating to their health and safety properties. Collating such data may not be an easy or rapid task and for this reason a readiness review is considered essential in order to ascertain realistic project milestones and costs for ce marking. \r\nTechnical construction file\r\nthe manufacturer must prepare a technical construction file for the products intended for the european market. The file will contain evidence as to why the product, when installed, maintained and used in accordance with specified instructions, will not present an unreasonable hazard or risk to health and safety or to the environment. The technical construction file will contain product information, especially relating to the design evaluation and the risks and hazards evaluated. It will also address the manufacturing capability of the manufacturer and its ability to achieve the quality of design in a manufacturing environment. Typically a certificated quality management system such as iso 9001 will be of assistance in demonstrating this. However iso 9001 certification not necessarily, on its own, contain sufficient evidence of safeguards in the potential of design. Other information may be necessary and should be expected to be forthcoming on most occasions. Typically this will be information and data arising from the manufacturing process. \r\nProduct release\r\npcs does this in five stages:-\r\n\r\n stage one, on site document review. \r\n stage two, on-site assessment. \r\n stage three, ce mark certification. This is done at the pcs premises. \r\n stage four, product release. (i.e. Issue of appropriate certificates). \r\n surveillance. Typically this would be on a two year cycle but may be more frequent if necessary. \r\n\r\nit is the responsibility of the manufacture to advise the pcs of such changes in business structure, product design, or manufacturing systems that could impact upon the basic characteristics, fit, form or function of the product. Failure to advice of relevant changes may invalidate their ce mark status and relationship with the authorized representative. \r\nAssignment\r\nthe assignment process is that whereby the pcs assigns ascb(e) to the manufacturer as their authorised representative in europe. Notification to ascb(e) has to be done within a defined period of time. Reference numbers are allocated and where not previously performed, all technical documentation and documentation pertaining to stages three and four, shall be put into electronic format and copies submitted to ascb(e) for secure and confidential retention in europe. \r\nDocuments expected to be submitted are as follows:\r\n\r\n technical construction file\r\n declaration of conformity\r\n release certificate\r\n\r\nacceptance\r\nfollowing receipt of pcs submission, ascb(e) reviews documentation as appropriate and retains registries within europe of the ce marked products. A register is maintained for public access subject to the provisions of legislation requiring data security. \r\nAccreditations\r\npcs is striking a balance between providing popular accreditation to its customers at the same time providing cost effective service. \r\nPcs is accredited with accreditation bodies for certifying agencies, united kingdom (ascb (e)). \r\nPcs as required can organize other accreditation like anab,ansi-asq national accrediation board,us;dutch accreditation council, rva netherland; dar, t.g.a gmph german; & nabcb (national accreditation board for certifying bodies)india; through respective accredited cb\'s.
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