Iso 13485 2016 certification in kozhikode

Iso 13485 2016 certification in kozhikode

Iso 13485 2016 certification in kozhikode is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical device directive in kozhikode. While it remains a stand-alone document, ISO 13485:2016 is based on ISO 9001:2008 with some additional clauses as well as the removal of some requirements. ISO 13485:2016 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 13485:2016 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 2016 certification in kozhikode & medical device directive certification in kozhikode & Management system certification are specific to organizations providing medical devices, regardless of the type or size of the organization.