It is applicable only to manufacturers’ inclusion devices on the market in Europe. For the rest of the world, ISO 13485:2003 remainders the applicable standard.
The European standard ISO 13485:2012 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, have been available, after approval by CEN on 24 January 2012. This replaces ISO 13485: 2003. The change was prepared as a number of European countries objected to the suggestion that ISO 13485 inferred compliance to the Medical Device Directive (MDD). To solve this problematic, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.
ISO 27001 sets out the requirements of information security management system. It is part of the ISO 27000 family of standards relating to information and cyber security and offers a comprehensive set of controls, based on best practice in information security.
Similar to the other management standards, it is suitable for organisations of all sizes. 70% of small businesses believe they are not a target for any data theft or misuse; it is a problem for either larger businesses or only those in the financial sector – this is simply not true.
The standard defines the Occupational health & Safety management system requirements to which organization subscribes. The organization develops the program to meet its policy, objectives and regulatory requirements and works towards continual improvement of the work environment and employee health & safety.
OHSAS 18001 is a globally recognized occupational health and safety management system. The standard defines the system for an organization related to health and safety of the employees and stake holders. The standard considers Prevention as an approach towards health & safety of employees.
ISO 14001 2004 is an environmental management standard that defines the environmental policy of an organization. This standard helps organizations to protect the environment, check pollution, and improve their overall environmental performance. ISO 14001 is a useful tool for an organization to step up from just maintaining regulatory compliance to an organization with improved productivity and enhanced competitive advantage.
The ISO 9001:2008 certification is an international standard that defines good management practices. The certification aims at providing a global standard that spells out quality and trust. To meet the requirements for the ISO 9001:2008 certification, an organisation should demonstrate its ability to consistently provide products that meet applicable regulatory requirements and continue to meet changing expectations of customers.
The purpose of ISO 9001:2008 is to facilitate international trade by providing a single standard that is recognized and respected globally. It is a generic standard and is applicable to organizations in all areas of work. Some of the areas are manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, and so on.
Certification Nagaland is an independent certification body. Certification Nagaland is one of the fastest growing international certification body consisting of highly experienced professionals offering the latest in systems certification and promoting quality concepts. This issue guarantee professional level of work and approach. Certification Nagaland is expanding its operations worldwide very fast. Certification Nagaland has its offices worldwide.
Certification Nagaland operates from India. Our client retention is unparalleled in the industry for information reporting and value adding principles. We offer the latest in system & product certifications and promote quality concepts.