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2 - ISO 9001:2015
3 - ISO 13485:2016
5 - Potential Timings
EN ISO 13485:2003
EN ISO 13485:2012
International version of the Foreword &
Standard European Annex Zs only
Harmonised • No change to
Standard requirements
(Normative
Text)
• Obsolete as of
• Annex Z’s to
30 August provide greater
2012 clarity on
applicability &
alignment with
AIMDD, MDD &
IVDD
EN ISO 13485:2012
Annex ZB
Relationship between
Annex II of 93/42/EEC and
clauses of ISO 13485
10 Clause
Structure
• Many additions
Records to
+ Document
meet Medical Device
role(s)
regulatory + Requirement File
undertaken by
requirements. to validate the
organization + Detailed list
Change control computer
under of items (a-f)
regulatory software used that shall be
requirements for QMS prior included to
For outsourced to initial use &
+ Risk based meet
processes after changes
approach to regulatory
control based
control QMS requirements
on risk and
processes ability
Procedures
required,
Top mgmt Focus on document
shall awareness of planned
Increased DOCUMENT quality intervals
emphasis on the management
regulatory system and the
interrelation removal of
requirements of all + More bullet
customer
personnel requirements points for
who.... from bullet c) inputs, new
bullet for
outputs
+ Maintain
competency
+ Prevent product
Shall document the + NOTE mix up, ensure
processes for Methodology used orderly handling;
establishing to check Maintenance of
competence, effectiveness to be equipment applies to
providing training, proportionate to risk production, control
and ensuring associated with of work env, monitor
awareness work for which and measurement.
training or other
action is provided.
6.4.1 6.4.2
Work environment Contamination control
V/V of device
Requirement to interfaces. All
+ List of items document: the
to document: Inputs + Usability, validation
V/V plan, the activity must
+ Traceability standards, ability methods of
to verify/validate be conducted
of outputs to V/V, criteria for
inputs Review + specific acceptance,
on
record rationale for representative
+ Resources product or
including requirements sample sizes.
Connections documented
competence equivalent
and interfaces
devices
New sub-clause
Was 7.3.7 – more + Shall maintain a D&D
detail added. Link to file for each medical
risk management device type or family.
New sub-clause and product This file shall include or
realization added. reference records
Procedures required Detail regarding generated to
determining demonstrate conformity
significance of to the requirements for
change added. D&D and records for
D&D changes
New Clauses
Regulatory Improved
Requirements
linkage of
clauses
Annex B
• Correspondence between ISO 13485:2016 and ISO 9001:2015
• Comparison of content
between ISO 13485:2003
and ISO 13485:2016
• List of ‘Comments on
change compared with
ISO 13485:2003’
• Comparison of content
between ISO 13485:2016
and ISO 9001:2015
29 December 2015
March 2016
• e-Updates
• Webinars & Recordings
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Questions – Coming Soon
http://medicaldevices.bsig
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