Storage Managment (Stock Control and Storage) procedure for Medical Device

C

Chua Kwan Teng

#1
Hi

Can anyone share with me storage management (Stock control and storage)procedure for medical device.

I need it as part of the implementation of ISO 13485 Std

Thanks in advance

KT Chua
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Storage managment procedure for medical device

What kind of device? Storage at what location...your shipping department, your distributor's warehouse, your end user's stockroom? What are the technical and managerial issues applicable to the product that cause a need for you to specify particular storage methods?
 
C

Chua Kwan Teng

#3
Re: Storage managment procedure for medical device

The medical device I am referring is vitro diagnostic devices (class C) and these devices will be stored in the company warehouse before shipping to customer. We will like to have a storage control procedure that will comply us to ISO 13485: 2003 requirements.

Thanks and regards

KT Chua
 
T

treesei

#4
Key issues:

1. Product identification. No mix-up etc.

2. If the product requires special storage environment, that is what you need to pay attention to. Understand, define, control, monitor this environment and keep records that show that the above have been successfully done.
 
Thread starter Similar threads Forum Replies Date
C Ambient temperature_how we claim storage condition in label? Other Medical Device Related Standards 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
S Medical device storage conditions Other Medical Device and Orthopedic Related Topics 1
E OSHA - 1926.252(e) - Oily Rag Storage Occupational Health & Safety Management Standards 22
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
K How to verify the Storage and Transport environmental condition for Medical Device Miscellaneous Environmental Standards and EMS Related Discussions 3
T 5ºC Storage Temperature Validation - Urology disposable devices EU Medical Device Regulations 3
Q Weigh Scale Electronics - Suggested Storage Humidity and Temperature Manufacturing and Related Processes 7
S Document Storage/Archival Procedure Document Control Systems, Procedures, Forms and Templates 18
shimonv Storage Conditions of 5-40 Celsius - Accelerated and real time aging - Dilemma EU Medical Device Regulations 3
O Storage of Calibrated Tools General Measurement Device and Calibration Topics 12
T Validation of Dropbox for File Sharing, Storage, and Retrieval ISO 13485:2016 - Medical Device Quality Management Systems 10
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
R Saudi Arabia - Temperature Storage Requirements Other Medical Device Regulations World-Wide 4
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
B Supplier Approval of electronic document storage service ISO 13485:2016 - Medical Device Quality Management Systems 8
Y Process Characteristics for Inspection and Storage FMEA and Control Plans 4
R Medical Device Storage Temperature Tests and Requirements EU Medical Device Regulations 14
D Requirements for Storage of Food Allergen Ingredients Manufacturing and Related Processes 1
T Sterile Medical Device Storage Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
A Hazardous material storage shed flooring material Miscellaneous Environmental Standards and EMS Related Discussions 6
R Digital Storage of ITAR Controlled Documentation Other ISO and International Standards and European Regulations 7
L Intellectual Property Protection - Storage, Access, Distribution, etc ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Determining the "storage volume" (ISO 8536-8:2004 clause 6.14) Other Medical Device Related Standards 4
A FDA guidance for MDDS, Medical Images Storage, Medical Image Communications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
A Calibration/Verification of thermo-hygrometer in storage areas ISO 13485:2016 - Medical Device Quality Management Systems 9
W Micrometer Storage while not in use General Measurement Device and Calibration Topics 4
shimonv Storage of finished medical devices per 21 CFR Part 820.150 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Cleaning of Medical Device Storage Areas ISO 13485:2016 - Medical Device Quality Management Systems 1
E Empty Test Tube Storage - Suggestions Please Manufacturing and Related Processes 8
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Storage Temperature Marking for something Temperature Degrades IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Storage Symbol for Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
M Critical Limits for CCP in a food storage warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 4
S Insulin Pen Injector Storage Requirements Other Medical Device and Orthopedic Related Topics 1
AmandaMusser How are Storage Requirements Determined for Epoxy, Paste, Solder, etc. ISO 13485:2016 - Medical Device Quality Management Systems 6
M Temperature and Humidity requirements for Raw Material Storage and Quality Labs IATF 16949 - Automotive Quality Systems Standard 13
S Checklist for a Chemical Storage Audit Document Control Systems, Procedures, Forms and Templates 12
R 5% to 95% Non-Condensing Humidity Storage Test Conditions and Failure Modes APQP and PPAP 2
R Test House Transport and Storage Conditions Verified IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Centralizing the Receiving and Storage of Electronic Customer Data Document Control Systems, Procedures, Forms and Templates 1
T International Medical Data Storage Requirements Other Medical Device Regulations World-Wide 4
S Aviation Industry Record Storage Period - (technical docs & product related records) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
L Discoloration of Tin Plated Surface from White to Black or Yellow during Storage Manufacturing and Related Processes 7
T ISO 2230 (Guidelines for Storage of Rubber Products) - Temperature, Humidity & Light Other ISO and International Standards and European Regulations 8
Similar threads


















































Top Bottom