Dress Code in ISO Class 8 - Plastic Parts for Medical Devices

Ajit Basrur

Staff member
Admin
#1
Hi,

We have an ISO Class 8 for manufacturing plastic parts for medical devices. For cleanroom entry, we have coats, overcaps, beardcovers and haircovers.

Apart from these basic things, is there any restriction esp. for ladies not to wear skirts etc ?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Dress Code in ISO Class 8

Restrictions are established based on risk aren't they? If I understand this right a Class 8 controls at the >= 0,5 µm per cubic meter of air contamination rate.

What means did your group use to arrive at its present requirements? FMEA? HACCP? These same procedures can be revisited to address additional questions such as the one about skirts as they arise.

What ISO standard are you registered to? Did you use ISO 14644 series? I understand ISO 14644-4 and 14644-5 cover clean room deign and operation, respectively.

This site offers resources that are specific to clean room needs. http://www.s2c2.co.uk/merchandise/#iso I am not affiliated with the site or its included references. Since I don't know anything about your present requirement design procedure, I regretfully can't reliably tell you that skirts should be allowed.

If it's an opinion you want, I'd say no skirts as the chances for particulate introduction in skirts, especially loose and flowing fabric, is greater than that of slacks. Second problem is the exposed skin, which gives off contaminating particulates through ex-foliation.
 

Ajit Basrur

Staff member
Admin
#3
Re: Dress Code in ISO Class 8

We have only ISO 13485 certification.

Despite ladies wearing skirts, we are able to meet the particulate level for ISO Class 8 ie all the particulates are well within the acceptance criteria. However was wondering, if we continue with the practise, can anyone give a non conformance as the skin is exposed or not complying to the ideal dress code ?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
If skirts are found to be within compliance according to the standard, procedures and tests you have conducted, I see no reason why worry about a nonconformance.

My understanding is that ISO doesn't dictate details like attire, even for clean rooms. It dictates that organizations define levels of control, how to meet them, show adequate compliance/ follows the plan, etc.

Anyone out there with differing input?
 
Thread starter Similar threads Forum Replies Date
C Office Dress Code Coffee Break and Water Cooler Discussions 82
E Dress Code where you work Career and Occupation Discussions 44
D FAA 8130-3 Repaired Leather Dress Cover problem Federal Aviation Administration (FAA) Standards and Requirements 2
C How should Quality Professionals dress? Career and Occupation Discussions 78
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
John Broomfield CIOB - Code of Quality Management Misc. Quality Assurance and Business Systems Related Topics 1
Z Labeler Code - Private labelling for OTC (Over the Counter) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
K REF symbol with product code in the IFU EU Medical Device Regulations 1
DitchDigger Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133) Occupational Health & Safety Management Standards 2
John Broomfield Informational Chartered Institute of Building - Code on Quality Management Service Industry Specific Topics 2
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S GMDN Code for Chitosan Products CE Marking (Conformité Européene) / CB Scheme 1
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
M How to Select FDA Medical Device Product Code? Other US Medical Device Regulations 10
L GMDN code wanted - Software for handling records Service Industry Specific Topics 9
R How to find out the UMDNS code for medical devices CE Marking (Conformité Européene) / CB Scheme 1
Marc Informational Apple Tells App Developers To Disclose Or Remove Screen Recording Code World News 0
S Is Software code documentation required for FDA premarket submissions? IEC 62304 - Medical Device Software Life Cycle Processes 2
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
S IAF Codes - Examples of what falls under each code General Information Resources 2
L GMDN code differences, Manufacturer and Sponsor Other Medical Device Regulations World-Wide 3
Edward Reesor Exporting from China - Unified Social Credit Code ISO 13485:2016 - Medical Device Quality Management Systems 2
H FDA product code and regulation number Other US Medical Device Regulations 3
R Statutory/Regulatory for NACE Code 25.9 (Manufacture of fabricated metal products) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc 2017 ICD-10-CM Diagnosis Code W56.22XA - Struck by orca Coffee Break and Water Cooler Discussions 0
Marc IAQG-OASIS - 9101:2016 Form 4: Cause Code Listing Now Included in Form AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W CPU BIST IEC 62304 - Embedded code has CPU instruction tests IEC 62304 - Medical Device Software Life Cycle Processes 2
S What is the IAF code for Medical Devices? Other Medical Device Related Standards 2
K Colour Code Requirements for Waste Bins/Bags Other ISO and International Standards and European Regulations 2
Marc Modified Google Glass can teach you Morse Code in four hours World News 0
N Neutral Code Requirement - Medical Devices Outsourced from India ISO 13485:2016 - Medical Device Quality Management Systems 4
A Is the Labour Code one of the legal requirements of ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Jen Kirley How to evaluate hazards in using bar code scanners in chemical manufacturing Occupational Health & Safety Management Standards 1
M Canada preferred Name Code (PNC) Canada Medical Device Regulations 3
S ISO 9001 and a safety management system based to ISM code ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
somashekar Do NB's want the Declaration of Conformity with GMDN code? EU Medical Device Regulations 14
Wes Bucey Code of Federal Regulations Electronic Copy Searchable Database Quality Manager and Management Related Issues 1
T What is the correct UMDNS Code for Tracheostomy Tube? Other Medical Device Regulations World-Wide 2
S Disposable Loop Electrode - GMDN/or UMDNS code? Imported Legacy Blogs 3
K Coding Standard vs Coding Guidelines vs Code Review Checklist Quality Assurance and Compliance Software Tools and Solutions 2
M Help with HTS Tariff code for NAFTA certificate Various Other Specifications, Standards, and related Requirements 1
A Coke Reactivity Index (CRI) Testing Code Interpretation: ASTM D5341-99 (2004) Various Other Specifications, Standards, and related Requirements 2
P Classification of Medical Device with Sub Code Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Description for GMDN Code wanted Other Medical Device and Orthopedic Related Topics 1

Similar threads

Top Bottom