SBS - The Best Value in QMS software

ISO 13485 ISO 13488 vs. EN 4600 EN 4601 Series

Elsmar Forum Sponsor
C

Christian Lupo

#2
Global Engineering Documents, they have an easy to navigate website, and they have everything you can imagine. I'm not sure what the exact address is but plug it in to webcrawler or another search engine and I'm sure you will find it.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#3
I'm not sure how big their library is, but another possible source is:

<a href="http://www.doccenter.com" target=blank> Document Center </a>

The SAE also has tons of specs:

<a href="http://www.sae.org/" target=blank> Society of Automotive Engineers </a> (Go to the Bookstore)

Global (Christian's post) has long been a 'standard'. I've used them in the past - expensive, but fast.

[This message has been edited by Marc Smith.]
 

Marc

Fully vaccinated are you?
Staff member
Admin
#4
ISO13485 ISO13488 vs EN46000 Series

Subject: Re: EN46000 /Andrews/Meron/Moore
Date: Tue, 23 Nov 1999 16:09:43 -0600
From: ISO Standards Discussion <[email protected]>

From: [email protected]

To All,

Just for your early information...

At the 1999 Global Harmonization Task Force Meeting in Bethesda, Maryland the European attendees indicated that the EN46000 sereies of standards are in discussion to be "phased out" in favor of the "almost the same standard series" ISO13485/ISO13488.

In addition, the current ISO13485/ISO13488 are also not stand alone standards (just like EN 46001/EN 46002) and they are structured with heavy references to ISO 9001 and ISO 9002.

With the current changes afoot with ISO 9000:2000, including Customer Satisfaction and Continuous Improvement there are concerns from the government regulators regarding future references to ISO 9000:2000 in conjunction with Medical Device Quality Systems Standards (ISO13485/88 and EN46001/2). The government regulators indicated that they are not responsible nor do they want to be responsible for auditing compliance to customer satisfaction and continuous improvement standards requirements.

(IMHO) The bottom line is that we will see a "Stand Alone" Medical Device Quality System Standard in the near future without references to ISO 9000:2000 (how near is uncertain).

Jack Moore
 
A

Aaron Lupo

#5
ISO 13485

Does anyone know the status of ISO13485, I know it is currently under review, but I was wondering if it is in th DIS, FDIS stage? If anyone knows could you please let me know.

Thanks
ISO GUY
 
Thread starter Similar threads Forum Replies Date
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 7
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lead time to schedule an ISO 13485 audit Auditing Quality and Environmental Management Systems 2
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 2
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
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
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
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 Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3

Similar threads

Top Bottom