Member of Quality Council of India , Membership No.: FM6293/2019-20
The most important asset of any company around the world would be its data. The stakeholders expect and demand for the confidentiality, availability of the data; it would be an absolute disaster if any sensitive information was hacked or stolen. Information security is even more vital for the internet of things era. ISO/IEC 27001:2013 is a Information security standard dealing with the information security for an organization.
Information Security Management Systems (ISMS) is a systematic and structured approach to securely handle company's sensitive information. ISO/IEC 27001:2013 provide requirements for establishing, implementing, maintaining and continually improving an information security management system.
In old standard ISO 13485:2013 a QMS had to established based on requirements of the standard & product, while in new version ISO 13485:2006 emphasis has been given on meeting regulatory requirements. Now QMS has to be established encompassing applicable regulatory requirements.
New standard ISO 13485:2016 expects you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has to be maintained in maintaining confidential health information.
New standard ISO 13485:2016 says to establish procedures for storage, handling of products, traceability, measurement & revalidation in addition to requirements of old standard ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing
The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.
The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.
The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.