Clarifying the traceability management method allows for standardization within the company.
Standardization will facilitate responses to FDA inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K65 Traceability Provision
・MD-QMS-S6501 Traceability Procedure

Table of Contents

Traceability Provision (MD-QMS-K65)

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 traceability
4.1 general rules
4.2 Degree and extent of traceability
4.3 Ensure traceability
4.4 Traceability records
4.5 Implementation of traceability（retrospective survey)
5 reference
6 by-laws

Traceability Procedure (MD-QMS-S6501)

1. Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 traceability
5.1 Procedures for Ensuring Traceability
5.2 Traceability procedures for implanted medical devices
5.3 Maintain records for traceability
5.4 Procedures for Conducting Retrospective Surveys
6 reference
7 by-laws