Protection of Data in Calibration Software & ISO 9001

kedarg6500

Quite Involved in Discussions
#1
Friends

We have Calibration Software for maintaining calibration data. We get reports like gauges due for calibration and a reminder letter is sent to particular section/ vendor to submit the gauges for calibration. It also shows calibration status of gauges. All the measurement data is fed into software.

But there is general log in for all- no admin log in/supervisor log in. so anybody can change the data, frequency of calibration etc.

I feel we should have admin log in/supervisor log in to prevent. Whether it is data management inadequacy? Whether we should give NC for this? If yes, under what clause.

If I am not correct, please guide me.

Kedar
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Friends

We have Calibration Software for maintaining calibration data. We get reports like gauges due for calibration and a reminder letter is sent to particular section/ vendor to submit the gauges for calibration. It also shows calibration status of gauges. All the measurement data is fed into software.

But there is general log in for all- no admin log in/supervisor log in. so anybody can change the data, frequency of calibration etc.

I feel we should have admin log in/supervisor log in to prevent. Whether it is data management inadequacy? Whether we should give NC for this? If yes, under what clause.

If I am not correct, please guide me.

Kedar
Can someone help Kedar please?

Thank you very much!

Stijloor.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
If this is regarding control for ISO9001 I am not the one to help, someone else may be better.

If this regards ISO/IEC 17025:2005 then yes, there certainty must be control over who can access and change records, per several Clauses.

Can you verify which standard this regards?
 

kedarg6500

Quite Involved in Discussions
#4
If this regards ISO/IEC 17025:2005 then yes, there certainty must be control over who can access and change records, per several Clauses.
Thanks Hershal:applause:,

Actually I wanted to know about ISO 9001. But please specify the requirements of ISO/IEC 17025:2005 for knowledge purpose. There shall be control over changing/editing calibration records as good practices (GMP).

I request members to add their views also from ISO 9001 angle

Kedar
 
Thread starter Similar threads Forum Replies Date
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
F General Data Protection Regulation (GDRP) CE Marking (Conformité Européene) / CB Scheme 6
MrTetris GDPR - General Data Protection Regulation - Only applicable to EU data? Other ISO and International Standards and European Regulations 6
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
L GDPR scope - "Personal data" definition - General Data Protection Regulation EU Medical Device Regulations 5
S GDPR (General Data Protection Regulation) - My company is ISMS certified IEC 27001 - Information Security Management Systems (ISMS) 3
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
T GDPR - General Data Protection Regulation (EU and UK 2018) Other ISO and International Standards and European Regulations 7
K Thoughts on the impact of the General Data Protection Regulation? Medical Information Technology, Medical Software and Health Informatics 5
R Internal Audit of Information Security and Data Protection Internal Auditing 6
J Data Protection - Documents on Desktops ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Data Protection Compliance Plan example wanted Misc. Quality Assurance and Business Systems Related Topics 6
T ISO 13485 Documented Data Protection Procedure Requirement ISO 13485:2016 - Medical Device Quality Management Systems 3
M Data Protection Act that publishes information within the general factory area Records and Data - Quality, Legal and Other Evidence 3
V Data Protection Act Legislation - What do we do to comply? Misc. Quality Assurance and Business Systems Related Topics 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
J Surge Protectors and other power protection Manufacturing and Related Processes 7
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Defibrillation protection for patient connection except for electrodes IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L IEC 60601-1-11 IP22 Compliance - Ingress protection testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Are Defibrillator Protection and Pacemaker pulse detection features mandatory as per IEC 60601-2-25 or 2-27...? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S Defibrillator protection test IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
K Is Defib Protection mandatory for wearable ECG? IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
V Software as control or protection will lead to different Software Safety Class? IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
D IEC 60601 Defibrillation protection test - Metal foil IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601-1 and Active Current Protection Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Primary lithium battery protection and vented gas IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
P Question on Table 6 "Test voltages for solid insulation forming a MEANS OF PROTECTION IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K ESD Protection in the Assembly Bay ISO 13485:2016 - Medical Device Quality Management Systems 9
R Determination of IP (International Protection Marking) Rating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
U USB Connector Operator Protection (MOPP) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A IEC 60601-1 cl.15.4.2.1 - Tubular Heating Element (Protection against Overheating) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
F How to provide 2 MOPP (Means of Patient Protection) - Heating Rod IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F MOP (Means Of Protection) - Creepage and Clearance questions IEC 60601 - Medical Electrical Equipment Safety Standards Series 19
F Evaluation of MOP (Means of Protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
L Intellectual Property Protection - Storage, Access, Distribution, etc ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Use of Y1 capacitors for MOPP (means of patient protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Security Standard referred to as TAPA (Transported Asset Protection Association) Other ISO and International Standards and European Regulations 1
S 510(K) Ownership and Protection from Use by Others 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S How to implement protection for multi-winding transformer? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W Medical Device Single fault test-protection against fire IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
R Protection of Records from Unauthorized Access or Alteration Records and Data - Quality, Legal and Other Evidence 4
L ESD Protection and Danger for Operators Manufacturing and Related Processes 3
M Can I continue using IEC60601-1 Ed2 PSU for MOOP (Means Of Operator Protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M What is "protection" as in section 7.5.5 "Preservation of product" ? IATF 16949 - Automotive Quality Systems Standard 7
K Employee ESD Protection Methodologies - Need input. Training - Internal, External, Online and Distance Learning 8

Similar threads

Top Bottom