武汉市MedAccred -AC8121电子电缆和线束组件的审核标准 (13)

3.1.3.7 Equipment/Tool ID:

3.1.3.8 In-Process or Paper Audit

3.1.3.9 Purchase Order Number:

3.1.3.10 Date of Job and Job Number:

3.1.3.11 (EC) Part Description:

3.1.3.12 Comments:

3.2 Audit Scope

Identify all capabilities to be included within the scope of accreditation:

4.0General Mandatory

5.0 Process Validation Mandatory

6.0 Medical Record Keeping Mandatory

6.1 Device History Record (DHR) Mandatory

6.2 Device Master Record (DMR) Mandatory

6.3 Product Traceability Mandatory

7.0 Electrostatic Discharge (ESD) Management [ ]

8.0 Tools and Equipment Mandatory

9.0 Calibration Mandatory

10.0 Preventive Maintenance Mandatory

11.0 Facility Environmental Management [ ]

12.0 Purchasing and Authorization Component Assurance Mandatory

13.0 Process Control Mandatory

14.0 Personnel Qualification Mandatory

15.0 Visual Acuity Mandatory