Radio Equipment Directive (2014/53/EU)
There is a new publications in the OJEU of standards harmonised under the Radio Equipment Directive:
This brings the total number of standards harmonised under the RED to 100
(compared to over 200 standards harmonised under the R&TTE Directive).
The list of harmonised standards will continue to be published every month.
This months Gainspeed Newsletter is here. Its a friendly complimentary newsletter on everything compliance.
Some of this months features are.
Headlines
Standards Watch
Update on Harmonised Standards Lists
EU Guidelines – a reminder
Environmental
New Standards
Compliance Calendar
Radio Equipment Directive (2014/53/EU)
There is a new publications in the OJEU of standards harmonised under the Radio Equipment Directive:
This brings the total number of standards harmonised under the RED to 111
(compared to over 200 standards harmonised under the R&TTE Directive).
There will be only one more list of harmonised standards published before the Radio Equipment Directive becomes mandatory on 13th June 2017.
A new list of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) was published in the Official Journal on May 13, 2016 – OJ C173
9 new standards have been added:
PD ISO/TS 9002:2016 Quality management systems — Guidelines for the application of ISO 9001:2015 has recently been published
This document has been developed to assist users to apply the quality management system requirements of ISO 9001:2015, and provides guidance, with a clause by clause correlation to Clauses 4 to 10 of ISO 9001:2015, (although it does not provide guidance on Annexes A and B). It gives examples of what an organization can do, but it does not add new requirements to ISO 9001.
The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization, and include descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization.
While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes.
