SBS - The best value in QMS software

ISO 14644 training in Austria, Germany and Switzerland

Aphel

Involved In Discussions
#1
Dear all!

As you know - ISO 13485 refers to the ISO 14644 standard.

Can anybody give me a hint - where can I find organisations or trainers for this ISO 14644 standard? (if possible in Austria, Germany or Switzerland).

Thanks a lot in advance for your feedback!

BR
Aphel
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: ISO 14644 training

Dear all!

As you know - ISO 13485 refers to the ISO 14644 standard.

Can anybody give me a hint - where can I find organisations or trainers for this ISO 14644 standard? (if possible in Austria, Germany or Switzerland).

Thanks a lot in advance for your feedback!

BR
Aphel
I could not find any reference in ISO 13485:2003 to ISO 14644 :(
 
Thread starter Similar threads Forum Replies Date
L ISO 14644 Class 7 Clean Room Requirements Training Presentation Training - Internal, External, Online and Distance Learning 2
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Ajit Basrur Why is ISO 14644-3:2019 not approved by US? Other Medical Device Related Standards 1
A Construction of an ISO 8 Clean Room - ISO 14644-1 Manufacturing and Related Processes 2
O Which part of ISO 14644 describe how can I classify cleanrooms between them? Other ISO and International Standards and European Regulations 0
M ISO 14644 Airborne Particle Count Testing Requirements Miscellaneous Environmental Standards and EMS Related Discussions 6
S Cleanrooms - Particle Measuring - ISO 14644 Other Medical Device and Orthopedic Related Topics 3
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
N ISO 14644-1 Clean Room Occupancy State Validation Requirements Manufacturing and Related Processes 3
M ISO 14644 - Cleanrooms and associated controlled environments -Recovery Test Other ISO and International Standards and European Regulations 0
V Not using gloves in Clean Room Class 8 (ISO 14644) Manufacturing and Related Processes 21
A Is ISO 14644 harmonized for US? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Why is Microbiological (viable) monitoring not part of ISO 14644 ? Manufacturing and Related Processes 5
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
R ISO 14644-1 maximum particulate concentration limits concern Other ISO and International Standards and European Regulations 2
J ISO 14644-5 section C3 - ISO Class 7 question Other Medical Device Related Standards 4
V Updated Clean Room Classification Table of ISO 14644 Other ISO and International Standards and European Regulations 2
J ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) Other ISO and International Standards and European Regulations 4
L ISO 14644 Result Sheets for Particle monitoring and related monitoring? Other ISO and International Standards and European Regulations 2
S The requirements of an ISO 14644 Class 8 Clean Room Manufacturing and Related Processes 1
R Standard on Clean room - Where can I buy ISO 14644-1 and ISO 14644-4 US Food and Drug Administration (FDA) 3
L Can anyone help me with ISO 14644? Other Medical Device Related Standards 17
I Non-sterile device - Rapid Test Kits - ISO 14644 Clean Room required? ISO 13485:2016 - Medical Device Quality Management Systems 12
ISOsandy ISO 14644-3 - Testing Air for Particle Counts Other ISO and International Standards and European Regulations 10
I Building a new cleanroom - ISO 14644-3 or ISO 14644-4 ISO 13485:2016 - Medical Device Quality Management Systems 4
Marc Federal Standard 209E Replaced by ISO 14644 Various Other Specifications, Standards, and related Requirements 1
A ISO 14644 - Contamination Control Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2

Similar threads

Top Bottom