Update on 17025 Assessment

C

crendfrey

#1
Greetings all,

:thanx:Thank you for all of your support!!
I hold in my hand a very pretty Certificate of Accreditation (finally after 30 days of waiting after an initial assessment with NO FINDINGS!) from my last audit at one of our divisions.:magic:


Unfortunately, I do not have time to run down the street waiving very pretty document as I am in the middle of re-assessment for the parent company. Our auditor is at the witness as I write this.

I just wanted to let you all know, and thank you for putting up with my silly questions.

I will let you know how we make out for our re-assessment as soon as I know.

Wish me luck ( as I have truly neglected the parent during the satellite assessment):mg:
There is always HOPE!!
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#3
A big congratulations to you!! :applause:When you get a chance, more details!!:lol:

And thanks for letting us know.
 
C

crendfrey

#5
Well,
WE DID IT!!!!!

Sorry to shout….lets try this again…
We passed our re-assessment with no findings.
Do you believe it?

2 full /2day assessments in 2 months…….
Gees, I need a vacation……

No such luck, now I get to play catch up with the rest of my work.

Have a glorious day all….
I will…..
Tomorrow I will worry about the rest;)
 
D

Dean Frederickson

#6
Congratulations. Yes I would say you have earned a vacation, so take one and let somebody else catch up on your other work.:applause:
 
Thread starter Similar threads Forum Replies Date
Hershal Update from MSC........ ISO/IEC 17025 - Challenges and Solutions ISO 17025 related Discussions 1
A When will ISO13485 Update be Released? EU Medical Device Regulations 1
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M Trigger to update of TLL VDA Standards - Germany's Automotive Standards 0
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
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
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
Marc Software Update 23 November 2018 Forum News and General Information 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
S How to enforce my colleagues to update SOPs? Document Control Systems, Procedures, Forms and Templates 4
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
Marc 2018 Software update - Donations Appreciated Forum News and General Information 21

Similar threads

Top Bottom