SBS - The Best Value in QMS software

Which part of ISO 14644 describe how can I classify cleanrooms between them?

Olgamargarita

Involved In Discussions
#1
Dear all, I would appreciate so much help me, which part of ISO 14644 describe between 2 airlocks of different clasification (Class C and class D) must have one airlock
with the most demanding classification (class C) or it is possible to classify 2 clean rooms together with diferent clasification?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S Why is Microbiological (viable) monitoring not part of ISO 14644 ? Manufacturing and Related Processes 5
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
A ISO 41001:2018 - Clause No.8 Operations Part Quality Management System (QMS) Manuals 2
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 16
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
L Implementation of ISO 27001 as part of the GDPR compliance journey Other Medical Device Related Standards 2
C ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
N ISO 17020 Inspection Bodies - NDE as part of manufacture? Other ISO and International Standards and European Regulations 1
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
C Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158 Other US Medical Device Regulations 2
S Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 14
U Compliance with CFR 21 Part 11 vs. ISO 9001 Certification Qualification and Validation (including 21 CFR Part 11) 9
D Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH Q10 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
A Risk Assessment, Business Continuity Planning, Testing, BCP, etc as part of ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 8
Q Books that have a combination of ISO 13485 and FDA Title 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 9
S ISO/TS 16949 certification no longer valid when automotive part production ends? IATF 16949 - Automotive Quality Systems Standard 7
R What part of ISO 14971 does FMEA address? FMEA and Control Plans 2
T Matrix for Documented Procedures (US FDA Part 820, ISO 13485 and ISO 9001) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Auditing Schedule to ISO 9001, ISO 13485, IVD, MDD and 21 CFR Part 820 General Auditing Discussions 8
Q ISO 13485 vs. 21 CFR Part 820 Management Summary wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M ACPAC Accounting System Generated Forms - Part of ISO? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Manufacturing Agreement with Sub-Contractors - Part of ISO 9001? Quality Manager and Management Related Issues 8
chris1price ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthcare ISO 13485:2016 - Medical Device Quality Management Systems 17
F Conical gauges (ISO 5356) how to use on PVC (soft part) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P Deletion of whole or part of document vs. ISO 9001 Clause 4.2.3c ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Clarification of ISO 2768-1 - Inside bend radius tolerance - Metal stamped part Various Other Specifications, Standards, and related Requirements 2
A Major differences between 21 CFR Part 820 and ISO 13485? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Does ISO 13485 certification require a company to follow 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 13
I Must Quality Incoming fill the checksheet for checking the Supplier part, In ISO TS? IATF 16949 - Automotive Quality Systems Standard 5
M 21 CFR Part 11 Control of Data Requirements in light of ISO 17025 ISO 17025 related Discussions 8
G Does ISO 9001 require a procedure for every part of the business? Document Control Systems, Procedures, Forms and Templates 8
D Retention Sample Requirements ISO 13485 and 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 8
S FDA Part 820 Audit vs. ISO 9001 - Anything I should be aware of as an auditor? Various Other Specifications, Standards, and related Requirements 13
J ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Sidney Vianna Should the billing process be part of ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 99
C Part 145 Repair Station Rating and Capability List vs. ISO 9001 certificate Scope AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 66
C Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485 Quality Management System (QMS) Manuals 3
D ISO 13485 - Part 11: Electronic Records - Small Biotech Company - What is required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R ISO/TS16949, 8.2.1.1 Customer satisfaction - Delivered part quality performance IATF 16949 - Automotive Quality Systems Standard 4
J ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets ISO 13485:2016 - Medical Device Quality Management Systems 64
Casana ISO part of QS certificate - upgrade to version 2000? QS-9000 - American Automotive Manufacturers Standard 10
K ISO 10012 Part 1 (replaced by ISO 10012:2003) and Part 2 General Measurement Device and Calibration Topics 3
G FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Dielectric withstand of applied part IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M List of FAA Part 145 Repair Stations in MS Excel format? Federal Aviation Administration (FAA) Standards and Requirements 0
K 10 parts, 4 operators, 3 replications and each part has 3 location to measure. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
Q Can I use Cpk to compare if one part is usable in another part? Capability, Accuracy and Stability - Processes, Machines, etc. 5

Similar threads

Top Bottom