In addition to the standard, what other ISO 13485 sources do people recommend?

outdoorsNW

Involved In Discussions
#1
If one is in the process of implementing ISO13485, what sources (other than the standard) do people recommend?
We are already AS9100, so I am more interested in ISO13485 specific vs. general QMS type sources.
We are a contract manufacturer, so no design.
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
This from ISO.ORG is likely helpful (I haven't bought it):
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE

Edit: and ISO 14971 - Medical devices — Application of risk management to medical devices

Edit2: Even though you are a CM, the requirements placed on you will vary with your customer. Some customers might not only audit you to 13485 but they may also want to push some FDA controls for medical devices to you as well.
 
Last edited:

DannyK

Trusted Information Resource
#5
I have helped several contract manufacturers with both ISO 13485 and AS9100.
The biggest issue with implementing ISO 13485 is software validation. If you have an ERP system or other software used in the manufacturing process, then you may have to spend quite a bit of time validating these software.
 
Thread starter Similar threads Forum Replies Date
shrutisancheti Addition of flat panel detector EU Medical Device Regulations 1
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
C Addition of Design & Manufacture - CE Mark Reissue? EU Medical Device Regulations 1
K Addition of a test reader to existing CE marked product. Other ISO and International Standards and European Regulations 2
M CO2 Incubators - Equipment Qualifications in addition to Calibration Qualification and Validation (including 21 CFR Part 11) 5
Q Actions Taken - Updating a FMEA for the addition of a downstream poke yoke FMEA and Control Plans 3
E Addition of Label by Initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Addition in the Scope of Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Is TGA approval required for a ARTG listed IVD for a sample type addition? Other Medical Device Regulations World-Wide 11
WCHorn Informational How the addition of "Risk" will affect ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 103
G Document Control - Are hard copies required in addition to soft copies maintained? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
S MDD Technical File CE Mark - Addition of a Device to our Current CE Marked Family EU Medical Device Regulations 4
D Packaging Addition - Non-sterile barrier to protect the whole package 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
P Addition of Testing to Our ISO 17025 Scope - How? ISO 17025 related Discussions 1
E Addition of French Language (translation) - New 510(k) required? Other US Medical Device Regulations 1
somashekar ISO 13485 & ISO 9001 certified with addition of site. Covegratulations 10
N AS9100 Certification in addition to TS-16949 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
J Addition of a Class 1 (Sterile) Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
L CEDAC (Cause and Effect with Addition of Cards) - Sharing Experiences and Form(s) Training - Internal, External, Online and Distance Learning 15
K Differences - ISO17025:1999 vs. ISO17025:2005 - The addition of "Improvement" in 4.10 ISO 17025 related Discussions 16
S Value addition to product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Validation of Processes in addition to Customer Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000 ISO 13485:2016 - Medical Device Quality Management Systems 25
C Is it necessary to have a documented 3 R recycling plan in addition to measures? Miscellaneous Environmental Standards and EMS Related Discussions 10
B Purchasing AS9100D Standard in Japanese AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 4
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
R Standard Filter for Calibration Colorimeter ISO 17025 related Discussions 1
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
R QMS Standard appilications on different Defense Sector Quality Management System (QMS) Manuals 1
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
B To detect the non standard variable IATF 16949 - Automotive Quality Systems Standard 5
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
Similar threads


















































Top Bottom