Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in this website. Written by an experienced industry professional, this practical methods and suggestions provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing.
Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the websites translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. It provides you a full analysis of each clause and sub clause trough quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records.  It is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. Use it as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.