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Training

MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM CERTIFICATION                   


TRAINING PROPOSAL:

  1. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICE (GDPMD)
  2. ISO 9001: 2015
  3. ISO 13485:2016
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Objectives

 

1Gap analysis

● Identifying processes relevant to GDPMD, ISO 9001:2015 and ISO 13485:2016

● Identifying gaps against GDPMD, ISO 9001:2015 and ISO 13485:2016

● Project schedule/program/identify working committee/management representative

● Identify scope of quality system

● Identify available documents

● Identify performance indicators

2Management overview of GDPMD, ISO 9001:2015 and ISO 13485:2016

● A session for Interpretation of GDPMD, ISO 9001:2015 and ISO 13485:2016 training for key personnel of all departments.

3Quality Management System

● Modification and documentation

● Determine structure of quality management system

● Quality manual setup/upgrade/modification

● Quality procedure setup/changes/addition

● Assign responsibilities for implementation

4Setting objective and improvement

● Key quality/performance indicators

● Setting of measurable objectives at company-wide and departmental

● Review quality policy

● Improvement plan strategies

5Quality management system implementation

● Execute new and additional procedure

● Process control implementation

● Collection of result

● Data analysis and improvement measures

● Internal quality audit training

● Internal quality audit

● Corrective action verification and implementation.

● Management review implementation and meeting.

● Continuous improvement measures

5Quality management system implementation audit

● Ensure implementation is in accordance with new/additional documentation.

● Pre compliance audit

● Recommend necessary corrective action

● Update and finale documents

    

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