Diagram of ISO 13485:2016 Implementation Process

Note: This diagram shows the steps for ISO 13485 (2016 revision)
implementation and certification; it does not show the complete
Obtain
Plan-Do-Check-Act (PDCA) Cycle.
Management
Support
To learn more about ISO 13485 click here.

Establish the Project Plan Budget; Human

Project (not (not Resources Plan (not
mandatory) mandatory) mandatory)

Identify
Customer and
Other
Requirements

Define Scope,
Management Quality
Commitment Quality Policy Quality Manual
Objectives
and Text
Responsibilities

Implement Procedures for document and record

support control, internal audit, corrective and
procedures preventive actions, etc.

Develop risk Records of risk

management management
process for activities
production

Implement
Procedures for production, design
process
and development, purchasing, etc.
procedures
Monitoring & Measurement with Records of Results
Communication with Interested Parties

Perform
Training and Training
Awareness Records
Programs

Operate the
MDMS Records
(Medical Identified by
Device MDMS
Management
System)

Conduct Internal Audit Corrective

Internal Audits Report(s) Actions

Management
Management Review
Review Minutes (or
equivalent)

Choose a
Certification
Body

Stage 1 Stage 1 Audit

Certification Report Corrective
Audit (from Actions
(Documentation Registrar)
Review)

Stage 2 Stage 2 Audit

Certification Report Corrective
Audit (Main (from Actions
Audit) Registrar)

Courtesy of: 13485Academy

Copyright ©2017 Advisera Expert Solutions Ltd