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课程内容

第一天

• Overview of SS 620:2016 requirements
• Reason for changes from previous HSA TS-01 to SS 620
• Understanding Requirements of Quality Management System – Organization Context
• Documentation Control
• Support and Resource Management
• Operation Control (i.e., Storage, Premises and Facilities, Delivery, Installation and Servicing Activities, Calibration, Return and Disposal of Medical Devices)
• Secondary Assembly
• Traceability of medical devices
• Management of non-conforming medical devices
• Complaint handling and Field Safety Corrective Action
• Management of Outsourced Activities

第二天

• Auditing Principles
• 审计目标
• Internal Audit Processes:

(A) Stage 1: Audit Preparation

– ISO 19011:2018 Guideline for Auditing Management Systems

– Determine Audit Scope

– Forming Audit Team

– Establish Audit Plan

(B) Stage 2: Conduct of Audit

– Evidence Gathering, Interview, Site Inspection & Document Review

– Triangulation of Facts

– Categories of Audit Findings

(C) Stage 3: Report Findings and Follow Up

– Closing Meeting

– Writing audit finding statement

– Preparation of Audit Report

– Follow up on Corrective Action on audit findings closure