Documentation Preparation

ISO 9001 is the most generic Quality Management System which can be applied to any industry. Organization going for the ISO 9001 certification for various reasons, such as for internal improvement, to fulfill customer requirements, market branding etc.

ISO 14001 is the Environmental Management System (EMS), the ultimate aim for this standards is to achieve the environmental objectives, enhance the environmental performance and fulfills the compliance obligations.

GDPMD is the Regulatory requirements for Medical Device Safety & Performance. In the Medical Devices Regulation 2012, Appendix 4 – Requirements on the Quality Management System, it specifies that Authorized Representative, Importer and Distributor is required to certify under GDPMD.

IATF 16949 Background:

The International Automotive Task Force (IATF) is an “ad hoc” group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide, for more details, please refer to https://www.iatfglobaloversight.org/about-iatf/.

Most of the organization having the Management Representative (MR) to handle the management system related matter. In the ISO 9001:2015, the MR requirements have been removed, but most of the organization prefer to maintain this role. In ISO 13485:2016, QMR still remain as a requirement.