ISO 13485 Implementation & Procedure

We have developed a nine stage ISO 13485: 2016 implementation program. Sincere effort and dedicated team guarantees successful completion and certification through our consultancy.

Stage 01 > Appoint consultants - Well experienced in Medical device certification. Knowledge in FDA, MDD, and GMP are added advantages for the consultants
Stage 02 > Perform a 13485 GAP Analysis - If the organization already implemented ISO 9001 quality management system. This is not required for those implementing first time
Stage 03 > Project Schedule - Consultants will work with the acting MR to prepare a project schedule. The schedule will list the actions needed. The Process Owners will be informed about there duties and responsibilities along with timeline.
Stage 04 > Develop Process Mapping - Consultants will guide you to develop Process Mapping. There will be 2 levels of Process Maps:
  • Define process interactions.
  • Process Mapping based of its own.
Stage 05 > Develop Documentation Consultants will identify the required documents. This will include:
  • Quality Manual.
  • QMS procedures.
  • Protocols, Forms, Formats, Records, Reports etc.
Stage 06 > Employee Training Consultants will help you identify the training needs of your employees. Consultants will be providing training for all level of people in the organization like awareness, GMP and internal auditor training.
Stage 07 > Implementation Do what you documented, document what you does/td>
Stage 08 > Establish quality goals and understand how they can best be incorporated into your business operations.
Stage 09 > Internal Audit - Consultants will provide internal audit along with certified internal auditors.
Stage 10 > Certification Audit - Consultants will be present during the day of certification audit to help the in-house team..

We have understood from our old customers that, organizations implemented ISO 13485:2016 and later finding difficulty to implement 21 CFR 820 due to the structure of documents and not much focus on process controls and Device History Files.

To avoid this drawback, we always recommend our new clients to prepare well in advance even though it may cause some additional requirements and efforts.

Please contact us for more details

Benefits of ISO 13485:2016 Certification

ISO 13485:2016 Requirements in brief

ISO 13485 Implementation Chart for a medium level company

More relevant documents can be purchased from document section.