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Quality Systems - ISO 9000 - EN 46000
- CE Mark?
It can be recognized in the
worldwide development of regulatory requirements for medical devices, inclusive of in
vitro diagnostic devices, that the introduction of quality systems is more and more
requested. It is no secret that a suitable quality system, which is implemented in all
relevant stages, may be an important factor for maintaining and improving product safety
and performance.
For whatever reasons, a lot of
manufacturers persistently believe that a quality management system according to ISO 9001
is the key to CE marking. This is simply wrong. The ISO 9000 series of standards is the
most widely known and popular way for the organization of a quality management system. EN
46003 in combination with the guidance standard EN 928 -which all include ISO 9001- are
harmonized European standards, which may also be taken into consideration. But harmonized
standards are not the only way to demonstrate compliance with the IVDD.
The IVDD requires that the manufacturer maintains a product-related, adequate and
efficacious quality system. The application of the quality system must ensure that the
products conform to the provisions of the IVDD. All the elements, requirements and
provisions adopted by the manufacturer for his quality system must be documented in a
systematic and orderly manner in the form of written policies and procedures such as
quality programs, quality plans, quality manuals and quality records.
The IVDD gives seemingly more flexibility to the device manufacturer in organizing his
company according to size, social environment, culture of countries and nature of the
devices than the ISO 9000 series of standards. On the other hand even ISO 9001 in
combination with the additional requirements of EN 46003, under consideration of EN 928,
does not fully cover the requirements of the IVDD.
Additional aspects to be
covered by the quality management system include:
the technical documentation
reference to the essential
requirements according to Annex I of the IVDD
information about harmonized
standards, CTS (possibly) and regulations for IVDs
risk analysis
labeling (labels and
instructions for use)
different languages
post-marketing surveillance
reporting under the
vigilance system
retention of certain
documents
It is the task of the
Notified Body to understand the culture of the manufacturer and to evaluat e whether or
not the quality management system meets the minimum requirements of the IVDD, and to give
advice where deficiencies are detected.
The standards ISO 9001/2/3 have been replaced by ISO 9001:2000 in december 2000 with a
transition period of 3 years. The previous standards are yet the basis for EN 46003 and
the nearly coextensive ISO 13485/88. The standards ISO 13485:2000 and ISO 13488:2000 have
been replaced by ISO 13485:2003, which is based on ISO 9001:2000. ISO 13485:2003 owns an
independent content and diverges from the requirements of ISO 9001:2000 in particular. the
standards ISO 13485:2000 and ISO 13488:2000 will expire on 2006-07-31, whereas EN 46003
and 13485:2003 will be effective further on.
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