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Quality Standards

ISO 9001:2008 - A quality management systems

ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified. Although, This is revised during 2015 .This can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries . Quality Management Principles.The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.QMS specifies requirements for a a organisation needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements and aim to enhance customer sanctification through the effective application of the system,including processes for continual improvements of the system and the assurance of conformity to customer and applicable statutory & regulatory requirements.

ISO 14001:2004 - Environmental Management Systems

ISO 14001:2004 sets out the criteria for an environmental management system and can be certified to. It does not state requirements for environmental performance, but maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization regardless of its activity or sector. Using ISO 14001:2004 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved. Environmental Management System.By achieving ISO 14001 certification you will be able to clearly demonstrate your commitment to reducing waste and recycling materials where appropriate. The benefits to your organisation will not just be in cost savings, they may also prove beneficial when tendering for new business. The Environmental Management System to enable an organizational to develop and implement a policy and objective which take into account legal requirements and other requirements to which the organizational subscribes ,and information about significant environmental aspects.It applies to those environmental aspects that the orgational identifiers as those ,which it can control and those which it can influence.It does not itself state specific environmental performance criteria.

OHSAS 18001- Occupational health and safety management systems

OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks. It was devloped in response to widespread demand for a recognized standard against which to be certified and assessed. The OHSAS 18001 standard is internationally accepted as a method of assessing and auditing occupational health and safety management systems. Developed by leading trade and international standards bodies, it provides a framework for organisations to instigate proper and effective management of health & safety in the workplace. By having a clearly defined management system in place to identify and control health and safety risks, organisations are able to minimise risks to their workforce and visitors or external contractors on their premises. The standard will enable organisations to put in place processes for continually reviewing and improving occupational health and safety.Key areas that will be assessed by OHSAS certification Management systems in place Planning and risk assessment ,Staff training and awareness,Communication of safety management systems , Response to emergency situations,Monitoring and continual improvement,Health and safety management System.Achieving a structured health and safety management system throughout the organisation will demonstrate your commitment to the welfare of your staff and external parties.It will provide a framework to implement the OHSAS 18001 requirements and a process for continual improvement.The development of a robust and manageable system will provide benefits to the organisation and its workforce. Cost savings and a reduction in accidents are just two of the many benefits.OHSAS is an assessment specification for occupational healthy safety obligations in an efficient manner,OHSAS 18001 certification improves that efficiency of the internal operations,thus reduces the chance,accidents and downtime. The safety and security of the employees is the prime responsibility of the organization as the future hazards affects the efficiency.OHSAS 18001 assures the compliance with present legal requisities and reduces the risk of various penalties and possible litigation.

ISO 22000:2005- Food safety management system

ISO 22000:2005 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. It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources. ISO 22000:2005 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, 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 ensure that the organization conforms to its stated food safety policy,to demonstrate such conformity to relevant interested parties, and 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 22000:2005.

ISO 27001:2005- Information security management systems

ISO/IEC 27001:2005 specifies the requirements for establishing ,implementing ,operating,monitoring,reviewing, maintaining ,and improving a documented information security management system within the context of the organization's overall business risks, It specifies requirements for the implementation of the information security controls customized to the needs of individual organizational or part thereof.

ISO 13485:2003- Quality management system

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system. Gaining certification to ISO 13485 will help your organization do business in this highly regulated sector. Whether you are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help you demonstrate to customers and regulators that you are committed to quality. The regular assessment process will ensure that your processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises. Certification can improve overall performance, remove uncertainty and widen market opportunities.