WHAT IS THE PROCEDURE TO GET ISO CERTIFICATION FOR MEDICAL DEVICE INDUSTRIES?
Now Medical Device Industries are thinking about implementing a QMS (Quality
Management System). They getting certified against ISO 9001:2015
Certification, ISO 45001 Certification, ISO
13485 Certification, you may be wondering about where – and how – to
get started. This list of the 13 steps you need to take so that you don’t miss
anything as you work through your implementation and get ready for
certification through ISO 13485 Certification Services.
WHAT IS THE STEPS TO GET ISO 13485 Certification ?
1) Get management support.
This step is number one for a reason: without management support,
your ISO 13485 implementation project is doomed to failure (if it gets started
at all). You’ll need to craft a well-though-out presentation outlining the
benefits your company can realize through ISO 13485 implementation, and
get your management team on board right from the start.
2) Identify requirements.
The next critical step toward a successful implementation is making
sure that you ascertain all the requirements you need to satisfy with your QMS
which is similar to ISO
9001:2015 Certification. Such requirements usually include legal
and regulatory requirements, customer requirements, and other requirements
depending on your company’s needs and culture.
3) Define the scope.
You want to avoid applying the QMS to areas of your business that
don’t pertain to quality, but you don’t want to make the scope so narrow that
the company sees no benefit. When you define your QMS scope, you will have a
better idea of what needs to be done, and the boundaries of your
implementation. Your best tools to help you with scope definition are the
quality policy and quality manual, so these need to be the first documents you
develop for your QMS.
4) Define processes and procedures.
The ISO 13485 standard defines certain required procedures that must
be part of your QMS, however you will also need to determine what processes and
procedures within your company must be defined in order to ensure adequate and
consistent quality. The first thing to do is to define all of your company’s
processes, and then see how they interact with each other. These interactions
are often where problems become evident.
5) Implement processes and procedures.
For most companies, all that needs to happen is the documentation of
existing processes and procedures to ensure consistent quality that meets
requirements. You don’t have to document every process, but you do need to
decide which processes need a documented procedure in order to guarantee
consistency in the quality of products and services.
6) Deploy training and awareness programs.
It is vital to the success of your Quality Management System that
every employee in your organization understands how the QMS works, and where
they fit into the mix. ISO 13485 Certification Body provides ISO 13485
accreditation necessitates that the organization occasionally review its
quality procedures. All employees need to be trained on the basics
of ISO 13485, so they get an idea of the purpose of implementation; in
addition, they need to be aware of any changes to be made in the processes they
are a part of.
7) Choose a certification body.
The right certification body can make all the difference, because
this is the organization that comes in after your implementation to audit your
Quality Management System, and determine whether or not it conforms to ISO
13485 requirements. In addition, they will also decide how effective your QMS
is, and whether it indicates continual improvement.
8) Operate the QMS / Measure the system.
When you will collect the records that will be required in audits to
show that your processes meet the requirements set out for them that
they are effective, and that improvements are being made in your QMS as needed.
Certification bodies need this to happen over a certain length of time, which
they will identify, in order to ensure that the system is mature enough to show
compliance.
9) Conduct internal audits.
After you have operated the QMS for the prescribed length of time,
but before the certification body conducts their audit, you will need to
perform an internal audit of each process. This will tell you whether or not
the processes are performing as planned, and if not, you’ll have the
opportunity to take corrective action to resolve any issues you find.
10) Conduct management review.
Not only must management be supportive of the company’s ISO 13485
implementation – it is imperative that they stay involved in the ongoing
maintenance of the Quality Management System. During the management review,
they will examine data from the QMS activities to make sure that all processes
have the resources they need to continue to be effective, and to improve over
time.
11) Take corrective action.
Here is where you look for the root cause of the problems discovered
during internal audits, measurements, and management review, and take the
necessary action to correct the problems at the source. This is a crucial step
in the continual improvement of the Quality Management System, which is a key
aim of ISO 13485 and ISO
45001 Certification.
THE STAGES OF CERTIFICATION AUDIT BY ISO 13485 Certification Services
12) Perform the stage 1 certification audit.
Now is the time for the auditors from your chosen certification body
to review your documentation and verify that – at least on paper – all of the
ISO 13485 requirements have been addressed in your QMS. You’ll receive an audit
report detailing the areas in which you are compliant, as well as those in
which you have problems. You will be given an opportunity to implement the
necessary corrective actions to resolve the problems. This is often done during
the same timeframe given for the initial operation of the Quality Management
System.
13) Stage 2 certification audit.
During this audit, the ISO certification body
which provides the ISO
13485 Certification Services will
send auditors to have a look at the records you have collected through the
operation of QMS processes. These records will include those from management
review, internal audits, and corrective actions. When the review is completed,
which often takes a few days, the auditors will provide you with an audit
report that outlines their findings, including their determination as to
whether or not your QMS appears to be effective, and if it complies with
requirements of the ISO 13485
standard. If they find that your QMS meets all of the requirements set out for
it, the auditors will recommend you for certification. If they have found any
major nonconformance, you will have an opportunity to implement corrective
action to make sure the problems are resolved, and that you are ready for
certification.
What are the benefits of being ISO 13485 certified?
Whether you are hoping to operate internationally or develop locally, ISO
13485 Certification can enable you improve overall performance, abolish
uncertainty, and broaden market opportunities. Organizations with this
certification communicate a commitment to quality to both customers and
regulators.
- Increase
access to more markets worldwide with ISO certification
- Outline
how to review and improve processes across your organization
- Increase
efficiency, cut expenses and monitor supply chain performance
- Demonstrate
that you produce secure and more effective medical devices
- Meet
regulatory requirements and customer desires.
Frequently asked questions: Click here
Contact Information
EMPOWERING ASSURANCE
SYSTEMS PVT LTD,
Address: 1495/1, Manasarovar, 16th Main Road,
Anna Nagar West, Chennai-600040.
Mobile: +91 9962590571
Phone: 044-42693624 ,044-26162670
E-Mail: info@easiso.com
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