Need to update our training format to ISO 13485:2003.

K

KWunderlich

#1
Hello all.

In need of some direction. We have old training materials referencing ISO 9001:2000 (ok so not that old), but we are a registered ISO 13485:2003 facility. I have been unable to locate even reasonable training DVD's or VHS material that I can use to train the troops.

Any source with DVD or VHS would be fine. I'd even take Beta at this point.

Ken
 
Elsmar Forum Sponsor
A

Aaron Lupo

#2
KWunderlich said:
Hello all.

In need of some direction. We have old training materials referencing ISO 9001:2000 (ok so not that old), but we are a registered ISO 13485:2003 facility. I have been unable to locate even reasonable training DVD's or VHS material that I can use to train the troops.

Any source with DVD or VHS would be fine. I'd even take Beta at this point.

Ken

How detailed do you want the training to be?


If you check in the 13485 forum there is a posting that contains a powerpoint presentation that expalins the differences between 13485:2003 and 9001:2000.
 
K

KWunderlich

#3
Thanks for the response Aaron.
Maybe I should be more desciptive - this training will be for the average business associate with little knowledge of why our business has chosen to be certified and what should "ISO 13485" mean to them.
 
Thread starter Similar threads Forum Replies Date
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 10
M If I update a DFMEA do I need to submit to my Customer? FMEA and Control Plans 7
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Work instructions inaccurate - Need to update and improve documentation system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Need tips to update resume Career and Occupation Discussions 15
P Company Acquisition - What do we need to update with our registrar? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Need Service to update External Documents and Specifications Document Control Systems, Procedures, Forms and Templates 3
V Need to update to ISO 9001:2000, current registered to ISO 9002 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
Randy The Need to Update / Revise Work Instructions and Procedures Miscellaneous Environmental Standards and EMS Related Discussions 5
N do you need to update PPAP due to a discrepancy APQP and PPAP 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
W Need for current design or process control FMEA and Control Plans 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
S Need help with analysing a survey on minitab Using Minitab Software 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
G Need resources / tutorials about OPS (Operation) for ISO IT (Information Technology) Service Management 8
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
M AQL table - I need to sample 1250pcs AQL - Acceptable Quality Level 3
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
I IATF16949 Audit Preparation, Need "searchable" ANPQP 3.1 or latest IATF 16949 - Automotive Quality Systems Standard 1
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
S New to FAIR, need help in filling it out AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
Similar threads


















































Top Bottom