QUALITY RISK MANAGEMENT COMPETITIVE ADVANTAGE

EXPERTISE FURTHER EXCELLENCE MARKET INTELLIGENCE

REGULATORY COMPLIANCE SPEED TO MARKET PATIENT SAFETY

HOW CAN YOU ADOPT A RISK-BASED

APPROACH TO YOUR MEDICAL DEVICE QMS?
THE NEW ISO 13485:2016 MEDICAL DEVICE – QUALITY MANAGEMENT SYSTEM
First issued as a draft international standard (DIS) in February 2015, ISO 13485:2016 has now been finalised,
and the new version was released on 1 March 2016.

The new version of ISO 13485, published KEY CHANGES RESOURCE MANAGEMENT
on 1 March 2016, has evolved. To
The emphasis in ISO 13485:2016 is very There is additional emphasis in the
streamline and improve the quality
much on managing risk and compliance 2016 version on documenting the
management of medical device design
with regulatory requirements. It has process for establishing competency,
and manufacture, the standard now
also expanded its scope to include all awareness and training. Infrastructure
encompasses all stakeholder roles within
stakeholder roles. Furthermore, it provides has additional requirements too, to
the medical device life cycle. Furthermore,
clarification for design and validation ensure product mix-up is prevented and
it also requires organisations to adopt
activities (including software validation), documentation relating to the procedures
a risk-based approach to their quality
as well as for improving supplier control. to manage these aspects. In addition,
management systems.
To align itself with the forthcoming medical resource management relating to the
In a market subject to increasing levels of work environment and contamination
device regulations, ISO 13485:2016 also
regulation, ISO 13485:2016 also places control have been updated to prevent
includes improvements to the feedback
increased emphasis on meeting regulatory contamination in the workplace and to
processes and clauses surrounding
requirements. manage contaminated or potentially
identification and traceability.
contaminated products.
Specifically, the changes impact the
STRUCTURE & TERMINOLOGY
following ISO 13485 clauses:
ISO 13485:2016 has been structured with PRODUCT REALISATION
• Quality Management Systems
three key aims: In the new version, there are now
• Management Responsibility
• To meet the requirements of additions to clause 7.1, Planning of Product
• Resource Management
manufacturer’s and service provider’s Realisation that require documentation
• Product Realisation
quality systems of risk management processes. Also,
• Measurement, Analysis &
any need for user training must be
• To ensure that all key stakeholders in Improvement
documented to ensure the safe and
the industry are able to demonstrate
QUALITY MANAGEMENT SYSTEMS effective operation of a device. Customer
compliance
Related Process and Communication
• To cover the life cycle of a medical Changes for this version primarily focus on have been updated to emphasise the
device the General Requirements sub-clauses, need to demonstrate communication with
including the definition of roles within an regulatory authorities.
The structure of ISO 13485:2016 is very
organisation, documentation requirements,
similar to its previous versions. Changes In addition, the Design & Development
and demonstrating compliance and
are apparent with the addition of new sub- of a product must be planned and
control. Key omissions in this clause
clauses within key sections. controlled, and the design planning must
include the removal of reference to ISO/TR
NOTE: It is important to note that ISO 13485:2016 does 14969, the removal of references to ISO be documented. Records of Design &
not follow the ‘Annex SL’ structure adopted by ISOs 13485 following the ISO 9001 format, and Development Inputs must be maintained,
9001 and 14001. Instead, it retains the same clause the removal of the Notes section. and the verification methods documented.
structure as its 2003 and 2012 version. The Design & Development Validation
requirements have also been updated.
MANAGEMENT RESPONSIBILITY
The purchasing content too has been
The terminology of ISO 13485:2016 is
Within this clause, the emphasis on updated, to help identify risk and product
largely unchanged. New terms appear
meeting regulatory requirements changes.
in the standard’s ‘Terms & Definitions’
now applies to Customer Focus and
section, and reference: Design Transfer is a new clause,
Quality Objectives, and there is a formal
requiring documentation on the design
• Additional stakeholders in the requirement for clients to document the
transfer process, from design centre to
medical device industry to whom this management review process. References
manufacturing facility, while the new
standard applies: to Statutory Requirements and Safety and
Design & Development Files clause aims
• Authorised Representative Performance of the Medical Device from
to demonstrate traceability. Other new
the 2003 version, have been replaced with
• Distributor clauses include:
Regulatory Requirement and Assessment
• Importer of Risk in the 2016 version. The nominated • Cleanliness of Product

• Manufacturer person required by national or regional • Servicing Activities

regulations has been replaced, with the
• Key themes of the new version: • Identification
new role of Authorised Representative.
• Risk Similarly, the Management Representative • Traceability

• Risk Management from 2003 has been removed, as this is The last two points have been called
now included within 2016’s clause 8.2.3 out as separate clauses to clarify and re-
• Performance Evaluation
Reporting to Regulatory Authorities. emphasise their importance.
Sections on the Validation of Processes THE BIGGER PICTURE SGS SOLUTIONS
and Control of Monitoring and Measuring
ISO 13485:2016 was just the first of SGS can offer a wide range of services to
Equipment have also been updated, to
several regulatory changes taking place, organisations currently certified against
emphasise their importance and update
and the new version was written with the 2003 and 2012 version of ISO 13485,
requirements.
these in mind: as they transition to ISO 13485:2016.
Omissions from this clause revolve around
• In Europe, release of the new Our experts can help clients to understand
the removal of ‘NOTES’ from the above-
Medical Device Regulation and the requirements of the standard and the
mentioned sections, because in the 2016
In-Vitro Diagnostic Regulation is new focus on risk-based thinking, through
version their detail has been incorporated
imminent; publication is expected to attendance at one of our approved training
within the main body of the text.
happen mid-2017. courses.
• In Japan, the PMD Act is now in SGS is also able to provide expert advice
MEASUREMENT, ANALYSIS &
place. to support clients during the transition/
IMPROVEMENT
• At the global level, the Medical implementation phase, and finally,
Focusing on outcomes and the to conduct certification audits and
Device Single Audit (MDSAP) began
requirement to document all aspects of assessments against the ISO 13485:2016
its operational phase on 1 January,
feedback within the quality management standard.
2017.
system, ISO 13485:2016 introduces new
sections for Complaint Handling and WHY SGS?
Reporting to Regulatory Authorities, as
NEXT STEPS
well as updates to Feedback, Monitoring Three years may seem a long time, but SGS is the world’s leading inspection,
and Measuring of Products and the organisations currently certified against verification, testing and certification
Control of Non-Conforming Product. ISO 13485 should start planning their company. SGS is recognised as the global
This defines roles and responsibilities, transition to the new 2016 version as soon benchmark for quality and integrity. With
documentation requirements and the as possible. There are a number of steps more than 90,000 employees, SGS
need to use key inputs to ensure device that should be planned and implemented, operates a network of over 2,000 offices
safety when changes are made. in order to achieve a successful and timely and laboratories around the world.
transition. We are constantly looking beyond
TRANSITION PERIOD TIMING Gap Analysis: organisations need to customers’ and society’s expectations in
complete a review of the new version, order to deliver market leading services
There is a three-year transition period for
compare the requirements against their wherever they are needed. We have a
ISO 13485:2016, by the end of which all
existing quality management systems and history of undertaking and successfully
certificates against the 2003 and 2012
identify any gaps. executing large-scale, complex
versions must have been transitioned, or
international projects. With a presence
they will cease to be valid. This three year Transition Plan: taking control of the in every single region around the globe,
transition period started on 1 March 2016, process is key. A transition plan should our people speak the language and
the date on which the 2016 version was be defined, including timescales and understand the culture of the local market,
published. milestones, as well as allocating roles and and operate globally in a consistent,
As of 28 February 2018, certificates responsibilities. reliable and effective manner.
against ISO 13485:2003 will no longer Resource Identification: it is important
be issued. All certification holders are to determine any additional resources
expected to have made the transition to that may be necessary to complete the
the new version by 31 March 2019. transition, and any related costs. For an optimal transition towards
ISO 13485:2016 contact
medicaldevices@sgs.com or visit
www.sgs.com/iso13485-2016
© SGS Group Management SA – 2017 – All rights reserved – SGS is a registered trademark of SGS Group Management SA

WWW.SGS.COM