Updates / Amendments to the ISO 9000:2000 Standard

Z

zenquality

Starting to get Involved
#1
#1
Have there been any recent updates to the ISO 9000:2000 quality standard? If yes, where can I find these? Are there any planned updates?

Many thanks,

/Roger
UK
 
Download Free White Paper
Elsmar Forum Sponsor
A

AndyN

Moved On
#2
#2
Re: Updates / Amendments to the Standard

Roger:
There are plenty of threads here about this topic. Use the search function and you will be taken to the latest and greatest there is to know.

Welcome to the Cove, by the way. What part of Blighty are you from?
 
Z

zenquality

Starting to get Involved
#3
#3
Re: Updates / Amendments to the Standard

Thanks Andy

I'm from London, and I spent a good few years in the Midlands: Birmingham, Stratford and the surrounding areas.

//Roger.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Subscribe to harmonized standards updates EU Medical Device Regulations 5
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
G Updating FMEAs after Design Updates FMEA and Control Plans 4
P Updates to Technical Documentation EU Medical Device Regulations 7
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
H Layered audit updates after COVID-19 shutdowns Process Audits and Layered Process Audits 0
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
B CQI-11 (Plating Audit) - New revision updates IATF 16949 - Automotive Quality Systems Standard 0
U What is the process for making updates to our Processes? Design and Development of Products and Processes 11
M Informational US – MITA UPDATES SERVICING AND REMANUFACTURING WHITE PAPER Medical Device and FDA Regulations and Standards News 0
M Informational Several revised or updates USFDA guidance - 9/9/2019 Medical Device and FDA Regulations and Standards News 12
K Unique Device Identifier for updates to legacy standalone software Other US Medical Device Regulations 1
M CER (Clinical Evaluation Reports) updates - Product Codes EU Medical Device Regulations 2
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
G KPC & KCC verification and updates FMEA and Control Plans 15
M Informational US FDA – FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device Medical Device and FDA Regulations and Standards News 0
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
K Risk Analysis Updates due to complaints ISO 14971 - Medical Device Risk Management 10
M Medical Device News FDA News - 27-08-18 - 2018 Learning program and GUDID updates Other US Medical Device Regulations 0
M Updates to EN 62366 & ISO 14971? Other Medical Device Related Standards 3
B Company Name Change - ETL Labels and Report Updates CE Marking (Conformité Européene) / CB Scheme 2
C Change Order necessary to document FMEA Updates? FMEA and Control Plans 1
F Quality Manual Updates - ISO 9001:2015 and API Q1 9th Editition Quality Management System (QMS) Manuals 14
B Update our PFMEA after Supplier updates their PFMEA? FMEA and Control Plans 4
M Updates on proposed EU Medical Device Regulations - June 2016 EU Medical Device Regulations 20
Q FDA - Annual Report Submission Format and QMS updates Other US Medical Device Regulations 2
M FDA's expectation for validating OTS software updates Other US Medical Device Regulations 8
M Automated Revision Updates - Notifications of new revisions for ISO's to subscribers Document Control Systems, Procedures, Forms and Templates 2
E Design Dossier/DHF Updates - What to Keep EU Medical Device Regulations 2
Jim Wynne Windows 8.1: No Security Updates Without Update 1 After Work and Weekend Discussion Topics 4
T Select Updates for Non-Clinical Engineering Tests - Intravascular Stents Other US Medical Device Regulations 0
Sam Lazzara February 2013 Medical Device "State-of-the-Art" updates Other Medical Device Related Standards 6
Ronen E Updates to FDA standards recognition - Aug 2012 Other US Medical Device Regulations 0
BradM Class action lawsuit against Apple - iPod Software updates - 2006 thru 2009 After Work and Weekend Discussion Topics 2
M ISO TS 24971 Updates and formal objection of the European Commission to ISO 14971 ISO 14971 - Medical Device Risk Management 24
A Current Control Periodic Document Reviews - Process Updates in the FMEA FMEA and Control Plans 3
Mikey324 How to Check for Legal (OSHA Federal & State) Updates Occupational Health & Safety Management Standards 5
T Technical Directives (TD's) not used for Technical Updates - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Recent Updates to 21 CFR Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Predicate Device Requirements - Firmware vs. Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Regulatory Requirement Updates? Medical Device Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 6
Sam Lazzara US FDA CFRs April 1, 2010 updates are live Other US Medical Device Regulations 0
D Technical File Updates and Notified Body Notification EU Medical Device Regulations 5

Similar threads

Top Bottom