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For ISO 13485 Implementation

The document discusses the top four activities medical device companies can undertake to prepare for ISO 13485 certification: 1) Identify the basic ISO 13485 requirements and how they apply to your business; 2) Establish quality goals and understand how they can be incorporated into operations; 3) Identify the quality management system's parameters and develop and implement a documented plan; 4) Research and select a certification entity. ISO 13485 certification brings benefits like increased efficiency and quality assurance. Proper preparation includes understanding requirements, setting goals, addressing gaps, and choosing an accredited registrar.

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261 views3 pages

For ISO 13485 Implementation

The document discusses the top four activities medical device companies can undertake to prepare for ISO 13485 certification: 1) Identify the basic ISO 13485 requirements and how they apply to your business; 2) Establish quality goals and understand how they can be incorporated into operations; 3) Identify the quality management system's parameters and develop and implement a documented plan; 4) Research and select a certification entity. ISO 13485 certification brings benefits like increased efficiency and quality assurance. Proper preparation includes understanding requirements, setting goals, addressing gaps, and choosing an accredited registrar.

Uploaded by

Yusran
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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For Medical Devices

Top Four Activities to Prepare for ISO 13485


Certification
By James Jardine
The International Organization for Standardization (ISO) has developed more than
17,000 international standards on numerous subjects. For medical device companies,
the most important of these standards is ISO 13485:2003, which provides internationally
recognized guidelines pertaining to quality management systems (QMS). Certification to
ISO 13485 does not necessarily fulfill the requirements of regulatory agencies such as
the U.S. Food and Drug Administration (FDA), but it will bring a company's QMS in line
with the FDA's Quality System Regulation (QSR) standards.

The benefits of ISO 13485 certification are numerous: increased efficiency, cost savings,
more effective risk management and quality assurance, and an improved ability to
respond to customer requirements are just a few of the potential results that certification
to ISO 13485 can bring. There are four key activities that your company can undertake
to prepare for ISO 13485 certification and ultimately enjoy such benefits.

1. Identify the basic ISO 13485 requirements and how they apply to your
business.

Since the needs of medical device manufacturers are as varied as the needs of
regulatory agencies, the ISO 13485 guidelines have been written so as to
present specific medical device requirements in a generic framework. Therefore,
the starting point on the journey toward certification is familiarization with the
guideline's basic requirements and understanding how your company fits into the
requirements under that broad structure.

When identifying and determining the applicable ISO guidelines, the company
seeking certification bears the following responsibilities in regards to the QMS:
o
To identify those processes that are vital to the system
o
To determine the appropriate sequences and interactions of such
processes
o
To determine appropriate criteria and methods, thereby making process
effectiveness certain
o
To determine the availability of required resources
o
To track, gauge, and analyze the processes necessary to reach the
intended results
o
To ensure that any outsourced activities comply with the standard

In order to identify appropriate guideline requirements, it may be helpful in some


instances to employ the services of a quality system registrar that is authorized to
conduct ISO 13485 compliance audits.
2. Establish quality goals and understand how they can best be incorporated
into your business operations.

Quality objectives should be outlined and compiled in a quality manual, if such a


manual has not already been created. Again, this is another instance where it
may be necessary to hire a qualified consultant if no in-house personnel have
experience with the development of quality management systems. A quality
policy must be developed that can demonstrate exactly how the ISO 13485
requirements are to be met. The quality policy should be evaluated and the
regulatory requirements prioritized to insure that they can be met.

During this process it may also be helpful to identify potential connection points
between the quality system and the enterprise-wide risk management system.

3. Identify the quality management system's parameters and develop and


implement a fully documented plan.

Once the quality system has been reviewed and goals have been set--or once a
new quality system is in place--a gap analysis should be conducted to assess the
system in comparison with ISO 13485. Once the gap analysis is complete, a
comprehensive plan can be developed and put into practice.

In the article Implementing ISO 13485:2003 Rich Basler and Raymond Pizinger
state that a dependable plan should delineate specific tasks that need to be
completed. The authors highlight several suggested activities to conduct when
developing and implementing a viable plan:
o
Reformat and edit the quality manual
o
Identify specific tasks to address gaps highlighted in the gap analysis
o
Create specific procedures that require changes
o
Assign tasks their expected completion dates 1

4. Research and select a certification entity.

Registration to ISO 13485 by an accredited registrar proves that a medical


device company is demonstrating its commitment to its customers and shows
that it is continually striving to improve quality and efficiency. There are several
factors to take into account when choosing a certification body, such as:
o
Consider that the registrar must be accredited by an accrediting body and
that 13485 certification must be included within the scope of both the
registrar and the accrediting body.
o
Make certain that the registrar's accrediting entity's range is
geographically appropriate relative to those markets where the device will
be sold. For companies intending to sell medical devices in North
America, the ANSI/ASQ National Accreditation Board (ANAB) is a
prominent example of a suitable accreditation organization.
o
Registrars should be able to prove that they have worked with similarly
sized organizations in the past and be able to provide an ample number
of references and credentials.
Conclusion
ISO 13485 is the principle driving force behind the vision of a common set of global
quality requirements for the medical device industry. The ISO 13485 guideline is the
underpinning factor in the correlation between quality, overall business performance,
and public health and safety in the industry. Companies that achieve ISO 13485
certification enjoy the benefits of an increased amount of customers who have more
reason to trust and purchase products of consistent high quality. Developing and
implementing a plan to achieve ISO 13485 certification and choosing the right registrar
are the first steps on the road toward superior and compliant quality processes.

References

1. Implementing ISO 13485:2003, by Rich Basler and Raymond Pizinger, Medical


Product Outsourcing, March/April 2004.

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