Who is ISO 13485 for?
ISO 13485 is designed to be used
by organizations complex in the design, production, installation and service of
medical devices and related services. It can also be used by internal and
external parties, such as certification bodies, to help with their auditing
processes.
Steps to follow during ISO
13485 Certification
To confirm medical products will
pass certification, here are the key steps that organization should follow
during the ISO 13485 implementation and certification:
·
Conduct a Gap Analysis:
This is an audit that controls the level of compliance
versus the standards that are being held.
·
Develop a project plan:
After the audit and gap analysis, describe a
corrective plan which lists all non-conformities, including how to fix problems
to comply with ISO 13485 necessities and related regional standard
implementation.
·
Develop documentation:
Put together the ISO 13485 documents
that includes a Quality Manual, procedures, work instructions and documentation
with proof of implementation.
·
Develop & conduct training:
This is one of the most significant steps in
checklist. Delivery of training to anyone who will be complicated in any stage
of the production of the medical device is mandatory. The first training
educates the team on appropriate requirements of the ISO 13485 standards, with
those relevant to regional and product certifications. The next training is to
set in place a Quality Management System that delivers a standard for complying
with work instructions and required sanitary procedures, as well as recording
of proof of execution on specific documentation.
·
System Implementation:
A period of three to six months is specified to
implement the new Quality Management System as per ISO 13485 requirements and
preparation of documentation to prove compliance.
·
Conduct an internal audit:
The dealer should conduct an internal medical device
audit to measure agreement and accurate any noted deviations. Internal audit
can also be performed by a third-party auditor.
·
Conduct a management review:
If the Quality Management System is not executed
according to ISO 13485 procedure, and does not meet the well-defined
policy and objectives, it must be adjusted to meet the essential requirements.
·
Apply for ISO 13485 certification:
An external audit of ISO 13485 is the concluding step. This
external audit is typically directed by certification bodies. Based on the willingness
of organization, the certification body will issue the ISO 13485 certificate if
pass, or issue a non-conformance report that will need corrective actions. Once
all non-conformance items are closed, the organization can then re-apply for
certification.
ISO 13485 Certifications Supports
Medical Device Companies:
The medical device sector is a
high-pressure industry where people admiration innovation as long as it doesn’t
sacrifice user safety. Moreover, creators must respond to demand spikes, as examples
like the flow in ventilator needs during the COVID-19 pandemic showed. Getting
an ISO 13485 certification
can help a business make positive, permanent quality and process developments.
Thus, representatives from certified companies often find that ISO 13485
contributes to organizational flexibility. It’s not right for every association,
but the associated advantages make it well worth consideration.
Source:
https://13485certificationprocedures.wordpress.com/2022/03/28/mandatory-steps-for-effective-iso-13485-certification/
