Classification of Fire Hazardous Materials

S

samuelng1

#1
#1
Hi everyone,

I was wondering if there is anyone out there who could help me. I have an Internal Auditor who raised an Non-conformance quoting paper sheets, empty carton boxes, recycle-paper box(with plastic sheets) found inside the main server room with hardwares and cables as Potential Fire Hazardous Materials without quoting the clause in ISO 14001 to fault against.

As such, I need to know if there is any website that classify the abovementioned as Fire Hazardous Materials. Preferable related to ISO 14001.

Thank you for your help in advance.

Best Regards
Samuel Ng
 
Paper to QMS ad
Elsmar Forum Sponsor
Claes Gefvenberg

Claes Gefvenberg

Admin
#2
#2
Hi Samuel,

I'm afraid I have never heard about a website like that. However... This was a finding by one of your internal auditors, and he didn't quote a clause? Why?

You'll have to ask him. He may have 4.4.7 Emergency preparedness and response or 4.5.2 Nonconformance and corrective and preventive action in mind, but it all depends on how you have interpreted the standard: What does your written procedures say?

That said, a fire is obviously not good for the environment. He's right about that, and a main server room is clearly the wrong spot to have one in any case :eek:

/Claes

P.s. I moved the thread to the ISO 14001 forum to get some more opinions.
 
Last edited:
Randy

Randy

Super Moderator
#3
#3
ISO 14001 doesn't care how much Fire hazardous material you have or where you store it. What ISO 14001 does address is compliance with applicable regulations (4.2 and 4.3.2), being prepared for emergencies (4.4.7) and the evaluation of your compliance to aplicable regulations (4.5.1).

I have questions.....

Has your auditor been trained and does he/she meet the requirements specified in ISO 19011:2002? (Understanding that ISO 19011:2002 is a guidance document that should be viewed as a best management practice)

How can you verify the competence of your auditor? (Just as important and maybe more so than anybody else)
 
D

db

#4
#4
Is there anything in your own documentation that the nonconformance could be written against?

Another possibility is 4.3.1. Is the storage of combustibles an environmental aspect (regardless of where they are stored)

I've seen internal auditors come across something they think is wrong (in both EMS and QMS), but they can't find a specific requirement to write against, but they write anyway. Even if no exact clause can be found, you have to ask if the auditor has a point? If the papers and boxes are a hazard, then who cares if the auditor cannot find the appropriate section.

I don't know about Singapore, but here in the US, there are laws governing combustibles. Randy’s comment on regulatory compliance may well apply here.

Also, if you do find a website where these things are laid out, post it so the rest of us can learn.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 2
D Classification of product for clinical trials EU Medical Device Regulations 9
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Surgical Instrument Tray Classification EU Medical Device Regulations 5
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
K Biological indicator system classification under MDR EU Medical Device Regulations 2
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
nadhar2 Classification of Action Items Misc. Quality Assurance and Business Systems Related Topics 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M Classification of Clean Rooms Other Medical Device Related Standards 9
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
M Barrier cream classification EU Medical Device Regulations 2
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
D Classification of Syringe (nozzle) of needle free injection system. EU Medical Device Regulations 8
S CE Mark - Classification Confusion EU Medical Device Regulations 12
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
D MDR 2017/745 Classification Guide EU Medical Device Regulations 8
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational EU MDR Classification Rule 11 – what??? Medical Device and FDA Regulations and Standards News 9
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 0
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
E Wristwatch Skin-proximal glucose sensor - Classification under MDR EU Medical Device Regulations 4
K MEDDEV 2.4/1 rev. 9 Classification EU Medical Device Regulations 1
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
N Medical Device Re-Classification EU Medical Device Regulations 2
B Class IIB Device - IEC 62304 Software Classification IEC 62304 - Medical Device Software Life Cycle Processes 13
C Suppliers re-classification from Critical to Significant or from Significant to Non-critical Supply Chain Security Management Systems 0
J Medical Device re-classification and marketing ISO 13485:2016 - Medical Device Quality Management Systems 13
M APQC PCF (Process Classification Framework) and ISO 9001 - Processes Based Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Medical Device News Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom