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Культура Документы
Position: Owner of New Document Malaysia Document Number: Questionnaire Document Number: Document Description:
1 ADMINISTRATION
Facility Facility Facility Facility Facility
60036683 60036684 60036685 60036686 60036687 60036688 60036689 60036690 60036691 60036692 60036693 60036694 60036695 60036696 60036697 60036698 60036699
Facility Facility Facility Facility Facility Facility Facility Facility Facility Facility Facility Facility
60031201 60031202 60031289 60031290 60031291 60031292 60031986 60031987 60031988 60031989 60032104
Radiation Safety Program (Malaysia) Security Badges (Malaysia) Emergency Action Plan (Malaysia) Fire Prevention Plan (Malaysia) Scheduled Waste Material Collection Procedure (Malaysia Laboratory Safety and Chemical Hygiene Program (Malaysia) Facilities Service Request Procedure (Malaysia) Lockout/Tagout Procedure (Malaysia) Contingency Plan (Hazardous Chemical Spills) Malaysia Respiratory Protection Program (Malaysia) Bloodborne Pathogens Exposure Control Plan (Malaysia) Lithium Battery Disposal (Malaysia) Ergonomic Safety Program (Malaysia) Hazard Communication Program (Malaysia) Injury and Illness Prevention Program (Malaysia) Hearing Conservation Program (Malaysia) Occupational Safety & Health Policy (Malaysia)
3 ENG/DOCUMENTATION
60030435 60036700
QA QA QA QA QA QA QA QA HR QA QA
60030463 60030464 60030479 60030483 60030484 60030485 60030585 60030634 60030651 60030945 60036702 60036703 60036704 60036706 60036707 60036708 60036709 60036711 60036712 60036713
Processing of Standard Operating Procedures, Detailed Work Instructions, and Manuals (Malaysia)
Document and Part Obsolescence and Superseding Procedure (Malaysia) Document Distribution Requirements (Malaysia)
Documentation and Documentation System (Malaysia) Document Release Procedure (Malaysia) Document Standards (Malaysia) Generation and Control of Forms (Malaysia) Corrective Action and Preventive Action Procedure (Malaysia) Training Procedures (Malaysia) Configuration Management Procedure (Malaysia) Analysis and Reporting of Manufaturing NonConformances (Malaysia)
4 QUALITY ASSURANCE
60031215_REV_A Sheet 1 of 3
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Position: Owner of New Document Malaysia Document Number: Questionnaire Document Number: Document Description:
Material QA
60036512 60036583 60036513 60036477 60036584 60036585 60036514 60036515 60036516 60036517 60036518 60036519 60036520 60036521 60036522 60036523
60030559 60030581 60030582 60030586 60030587 60030632 60030635 60030705 60030727 60030815 60030832 60030946 60031037
Approved Source Listing (ASL) (Malaysia) Control of Suppliers for Procured Material and Services (Malaysia) Supplier Corrective Action and Preventive Action Procedure (Malaysia) Supplier Change Control Procedure (Malaysia) Component Skip Lot and Dock-to-Stock (DTS) Program (Malaysia) Receiving Inspection Policy (Malaysia) Material Review Board (MRB) (Malaysia) Quality and Environmental Records Maintenance and Retention Requirements (Malaysia) ENG Notebook Requirements (Malaysia) Internal Audit Procedure (Malaysia) Software Verification Plans, Methods and Reports Procedure (Malaysia) Statistical Techniques - CRMD (Malaysia) Metrology Manual (Malaysia) Management Review (Malaysia) Process Validation (Malaysia) Equipment and Tool Preventive Maintenance (Malaysia)
5- MANUFACTURING
60030588
ENG Material QA QA MFG MFG
60036479 60036489 60036490 60036491 60036492 60036493 60036494 60036495 60036496 60036497 60036498 60036499 60036500 60036501 60036502 60036503 60036504
Control and Use of Acceptance Stamps (Malaysia) Purchase Order Procedure (Malaysia) Material Control Methods (Malaysia) Control and Storage of Unqualified Products, Materials and Parts (Malaysia) Material Transactions (Malaysia) Receiving Center/Receiving Warehouse Procedure (Malaysia) Identification of ENG Hardware and Software (Malaysia) Request for Quotation (RFQ) (Malaysia) Finished Goods (Malaysia) Procedure for Generating Travelers (Malaysia) Product Build Pick Lists (Malaysia) Inventory Control Transaction Filing (Malaysia) Guidelines for Stockroom Operations (Malaysia) Expiration Control of Non-Production Use Chemicals (Malaysia) Purchase Requisition Procedure (Malaysia) Issuance of Chemical Materials (Malaysia) Control, Monitoring, and Recording of Temperature Controlled Equipment (Malaysia)
MFG Material Material MFG MFG Material MFG Facility Material MFG Facility
60030706 60030707 60030708 60030709 60030711 60030712 60030728 60030729 60030734 60030811
60031215_REV_A
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Sheet 2 of 3
Position: Owner of New Document Malaysia Document Number: Questionnaire Document Number: Document Description:
60030812 60030813 60030822 60030845 60030948 60030949 60030950 60035769 60030553 60030554 60030726
60036505 60036586 60036506 60036507 60036508 60036509 60036510 60036511 60036487 60036488 60036486
Control of Limited Shelf Life Materials (Malaysia) Control of Limited Shelf Life Products (Malaysia) Tool Identification and Control (Malaysia) Shipping Procedure (Malaysia) Issuance of Product Serial Numbers (Malaysia) Control of Needles, Syringes, Special Material (Malaysia) Issuance of Work Orders (Malaysia) Cycle Count (MFG/PRO or SAP) (Malaysia) Employment Requisition (Malaysia) Job Descriptions (Malaysia)
8 SALES/MARKETING 9 CLINICAL/REGULATORY
QA QA
60030636 60031132
60036483 60036484
Device History Record (DHR) (Malaysia) Inspections by Government Regulatory Agencies (Malaysia)
10 INFORMATION TECHNOLOGY
IT
60031443
60036485
60031215_REV_A
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Sheet 3 of 3