6.1.1.4增加第二方审核员需掌握技能及了解供应商工艺流程2. 6.

6.1.1.4 Adding second-party auditors requires skills and understanding of the supplier’s process <br>2. 6.1.1.6 Adding internal auditors to perform an audit once a <br>year 6.1.1.6 Adding an annual re-training with no less than 6H <br>6.1.1.6 Adding Quality management system auditors, manufacturing process auditors, and product auditors should all be able to demonstrate that they have at least the following capabilities: <br>1. Add <br>6.1.3.3.1 Audit deficiencies 2. 6.1.1.7 Compile "Internal Auditor Skill Requirements and Recognition Matrix" ( F-AU01-007) <br>3. 6.1.2 Update and compile "____ Annual Internal Audit Plan" (F-AU01-006) <br>4. 6.1.2.1.2 "Annual Quality System Audit Plan" (F-AU01- 002) <br>6.1.3.2.1 Increase the use of "ISO13485 Internal Audit Checklist" (F-AU01-008) for the medical system <br>6.2.4 Increase the use of "Process Audit Checklist" (F-AU01-009) for VDA6.3 process audits <br>d. Reason analysis needs to use 5why to analyze (at least 3why) to find out the root cause. <br>Correction 6.2.2 Process audit process audit & 6.2.3 Product audit description of product audit

6.1.1.4 Adding a second-party auditor requires skills and knowledge of the supplier's processes.<br>2. 6.1.1.6 Increase the number of internal auditors to implement the Government once a year.<br>6.1.1.6 The increase is scheduled to resume training once a year for a period not less than 6H.<br>6.1.1.6 Adding quality management system auditors, manufacturing process auditors, and product auditors should all be able to confirm that they have at least the following capabilities.<br>1. Add 6.1.3.3.1 audit missing.<br>2. 6.1.1.7 Preparation of the 'Internal Auditor Skills Requirements and Accreditation Matrix' (F-AU01-007)<br>3. 6.1.2 Updated annual internal audit plan (F-AU01-006)<br>4. 6.1.2.1.2'Annual Quality System Audit Schedule (F-AU01-002)<br>6.1.3.2.1 Increase in the use of iso13485 internal examination forms in the health care system (F-AU01-008)<br>6.2.4 Increase VDA6.3 Process Audit Using 'Process Audit Check form' (F-AU01-009)<br>D. The cause analysis needs to be analyzed with 5why (at least 3why) to find the root cause.<br>Amend the 6.2.2 Process Audit and 6.2.3 Product Audit Audit job description.

6.1.1.4 adding the second party auditor needs to master the skills and understand the supplier's process flow<br>2.6.1.1.6 add internal auditors to audit once a year<br>6.1.1.6 the training shall be arranged once a year for at least 6h<br>6.1.1.6 adding quality management system auditors, manufacturing process auditors and product auditors should all be able to prove that they have at least the following capabilities<br>1. Add 6.1.3.3.1 audit deficiency<br>2. 6.1.1.7 prepare "internal auditor skill requirements and recognition matrix" (f-au01-007)<br>3. 6.1.2 update____ Annual internal audit plan (f-au01-006)<br>4. 6.1.2.1.2 annual quality system audit schedule (f-au01-002)<br>6.1.3.2.1 add "ISO13485 internal audit checklist" (f-au01-008) in medical system<br>6.2.4 add "process audit checklist" (f-au01-009) for VDA6.3 process audit<br>d. Cause analysis needs to use 5 why to analyze (at least 3 why) to find out the root cause<br>Revise 6.2.2 process audit & 6.2.3 product audit<br>