WHAT IS THE PROCEDURE TO GET ISO CERTIFICATION FOR
MEDICAL DEVICE INDUSTRIES IN SINGAPORE?
Now
Medical Device Industries are thinking about implementing a QMS (Quality
Management System). They getting certified against ISO 9001:2015 Certification in Singapore,
ISO 45001 Certification in Singapore, ISO 13485 Certification in Singapore,
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 in Singapore.
WHAT IS THE STEPS TO GET ISO 13485Certification in Singapore?
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 in Singapore. 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 reviews 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 in Singapore.
THE STAGES OF CERTIFICATION
AUDIT BY ISO 13485 CERTIFICATION SERVICES IN SINGAPORE
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.
AUDIT PROCESS: CLICK HERE
13) Stage 2 certification audit.
During this audit, the ISO certification body in Singapore which provide the ISO
13485 Certification Services in Singapore 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 in Singapore 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 Us
INFORMATION & REGISTRATIONINTEGRATED ASSESSMENT SERVICES PTE LTD,
Mail: info@iasiso.com
Website: www.ias-singapore.com
