Medical Device Local
Manufacturing
Dr Elsabe Steyn
3 December 2015
Regulators
• Regulators are increasingly realizing the benefit
of recognizing the quality management system
standard ISO 13485 – Medical Devices – Quality
Management Systems – Requirements for
Regulatory Purposes.
• This international standard provides the basis for
medical device regulations to be harmonized
around the world.
Regulators
• SANAS agreed with the DOH and the MCC to
establish
an
accreditation
programme
for
certification bodies that will provided ISO 13485
certification
Why ISO 13485?
• ISO 13485 is intended to address medical device
regulatory requirements for a quality management
system.
• Although ISO 13485 is based on the Quality
Management Systems standard ISO 9001, it
focuses less on business performance and more on
risk management.
• ISO 13485 ensures that medical device
manufacturers consistently produce medical devices
that meet regulatory requirements and are designed
and manufactured to be safe for their intended use.
The relationship of Risk Classification of
Medical Devices to QMS requirements
• The significance of risk classification to the QMS is that based on
whether the medical device is higher or lower risk, the regulator may
or may not require the manufacturer’s quality management system
to be independently certified to ISO 13485.
• The purpose of classification is to match regulatory oversight and
market clearance to the level of risk of the device’s risk.
• Lower risk medical devices usually do not require independent
certification of the manufacturer’s QMS.
• The illustration below is a very basic example of how ISO 13485
certification could be applied to four different risk classifications for
medical devices:
Manufacturers Obligations to a Quality
Management System
Medical Device Risk
Classification
GHTF
Risk
Class
Accredited
certification to
ISO 13485
Accredited
certification to
ISO 13485
Accredited
certification to
ISO 13485
Not Required
Required
Including
Design and
Development
Controls
High Risk
D
x
Medium-high Risk
C
x
Medium-low Risk
B
Low Risk
A
x
x
Practical Aspects of Specifying Accredited
ISO 13485 Certificates in Medical Device
Regulations
•
•
•
•
Requirements for accredited certification are designed to enforce one
credible and transparent ISO 13485 audit to meet the needs of the regulator
In order for this to occur, ISO 13485 certificates issued by accredited
certification bodies should be identified in the national medical device
regulation through appropriate national legislative processes.
By recognizing accredited ISO 13485 certificates in the national legislation,
countries gain access to the audit reports issued by accredited certification
bodies.
Although there are many ways in which ISO 13485 accredited certificates
may be included into a new medical device regulation, the most likely
approach would be to specify it as a requirement for registering medium\risk
or higher risk medical devices with the Regulator.
SANAS and the Regulator
• In order for the SANAS accreditation programme for certification
bodies to contribute to an efficient regulatory system, it is vital for
effective communication channels to exist between the regulator,
SANAS and the conformity assessment bodies.
• Communication is a key element of this initiative and is intended to
support mutual confidence building.
• SANAS and the MCC is in the process of formalising our
relationship through a MOU
Time to comply
• Although it can be expected that accredited certificates
for ISO 13485 may become available within the first year
of finalising regulations in South Africa regulators need
to provide manufacturers with an opportunity to learn
and adapt to any new regulation.
• Enforcing accredited certification before industry has had
time to prepare could have an adverse impact on the
healthcare system if it is enforced too soon.
Accreditation
infrastructure
Manufacturers for local
and export markets
Conformity assessment
body- certification body
Accreditation body – SANAS
Compliance with
voluntary
standards or
compulsory
regulations
What is SANAS accreditation?
• In general accreditation is a formal process of assessing
and recognising whether a conformity assessment body
that offers services is competent to provide such
services.
• In the case of a certification body for medical devices
SANAS will assess the bodies competence to provide
audits against ISO 13485 to medical devise
manufacturers.
• The certification bodies will have to comply with ISO/IEC
17021
International recognition
• At an international level the International Accreditation
Forum has developed mandatory requirements that
accreditation bodies and all accredited conformity
assessment bodies have to comply with if the provide
certification to ISO 13485
• By utilizing the international standard ISO 13485, with
cooperation of IAF member accreditation bodies, the
medical device industry can be provided with one ISO
13485 certificate that can be accepted everywhere, while
also meeting the importing countries demand for safe
and effective medical devices
• The work of the IAF further enables consistent and
credible ISO 13485 certification
International recognition
• IAF is an organization of accreditation bodies and other
interested stakeholders from more than 50 countries.
Most accreditation bodies operate under the authority of
their own nation’s government and cooperate in the
development and maintenance of Multilateral
Recognition Arrangements (MLAs).
• Signatories to the IAF MLA agree to promote acceptance
of accredited certificates issued by all the other IAF MLA
signatories within the scope of the MLA. Thus the MLA
underpins the recognition of ISO 13485 certificates
issued by certification bodies accredited by IAF member
accreditation bodies.
Relationship with Global Harmonization
Task Force ??
• The IAF initiative utilizes GHTF guidance concerning
regulatory auditing practices.
• The initiative incorporates this guidance to support an
infrastructure that links regulatory authorities,
accreditation bodies, certification bodies, and medical
device manufacturers.
How ISO 13485 certification
relates to product certification
• Although an audit performed under the ISO 13485 may
include an examination of a product’s design and
development, ISO 13485 is not a product certification
standard.
• The certification based on ISO 13485 is not directly
linked to the specification of the manufactured products.
ISO 13485 certification indicates that the processes for
designing and manufacturing medical devices are
appropriate for providing consistent product quality
• and safety.
ISO 17021
• Principles of impartiality
- It is essential that a CAB’s decisions are based on objective evidence of conformity (or
nonconformity) and that its decisions are not influenced by other interests or by other
parties.
• Safeguarding and management of impartiality
- A CAB shall be a third-party body independent from the organisation or the product it
assesses.
- A CAB’s top level management and the personnel responsible for carrying out the
conformity assessment tasks shall not be the designer, manufacturer, supplier,
installer, purchaser, owner, user or maintainer of the products which they assess, nor
the authorised representative of any of those parties.
• Consultancy services are understood in the context of this document as participation
in the design, production, installation, maintenance or marketing of the assessed
products or in the design and implementation of the assessed quality system. This
does not preclude exchanging technical information between the manufacturer and
the CAB.
• All personnel have to formally commit themselves to the adherence of confidentiality
as well as independence from commercial and other interests or relationships, arising
from any existing or prior association with customers, that may result in a conflict of
interest.
ISO 17021
Established under national law and have legal personality
• A body shall be established under national law and have legal
personality.
• The body shall be a legal entity or a defined part of a legal
entity such that it can be held legally responsible for all its
activities and so that it can bear rights and obligations.
Competent personnel
• Qualifications, training and on-going competence monitoring
of staff of the conformity assessment body is important. The
technical competency of the staff has to be relevant in terms
of experience and sector expertise.
ISO 17021
Monitoring
• The CAB shall ensure the satisfactory performance of the conformity
assessment activities including the review and attestation process by
establishing, implementing and maintaining procedures for monitoring the
performance and competence of the personnel involved.
• In particular, the body shall review the performance and competence of its
personnel in order to identify training needs.
• Even if the standard does not mention monitoring it is often part of the
internal mechanisms used by the CAB to supervise its activities and
persons involved.
• The CAB shall conduct monitoring e.g. by on-site observations, or by using
other techniques such as review of conformity assessment reports and
feedback from customers to evaluate performance of conformity
assessment personnel and to recommend appropriate follow-up actions to
improve performance.
• The CAB shall maintain evidence that its personnel is continuing to
perform competently.
• Equipment
• Outsourcing (subcontracting)
• Confidentiality
ISO 17021
Confidentiality
• The personnel of the CAB shall be bound to observe
professional secrecy with regard to all information gained
in carrying out their tasks.
• Proprietary rights shall be protected.
• The confidentiality arrangements shall ensure that no
results or other proprietary information are disclosed to
any other party than the manufacturer or its authorised
representative.
• Information about the client obtained from sources other
than the client (e.g. complainant, regulators) shall be
treated as confidential
What Happens During a SANAS
Accreditation Assessment
The accreditation assessment have two main components
namely:
• The analysis of the documentation of the body
(Management system/Quality Manual).
• The observation of its practical behaviour (Technical
competence).
Accreditation application
Process
 Application and Submission of the Quality Manual
 Document Review
 Initial assessment
 Clearance of non-conformance
 Approvals Committee
 Accreditation
 Six Month visit
 Annual assessment
 Re-assessment
Regular Visits And Reassessments
• Once accredited, regular visits are made to the
CAB to assess on-going demonstration of
competence and compliance with accreditation
requirements
• SANAS also selects a sample of the CAB’s
personnel for witnessing of technical activities
• A re-assessment takes place when then
accreditation cycle requires it.
Thank You