In
general, a company would use customer specifications, process charts, product plans,
checklists, bills of materials, supplier agreements, and a whole host of other
documents to control ISO 13485. With test instructions and test protocols,
companies will know what’s required to ensure the products or services are safe
for the public. Technical specifications and manufacturing specifications
provide the necessary instructions to build a product in the manner it were
intended. Diagrams, process charts, and drawings provide the visuals necessary
to achieve quality.
Any
document that will ensure proper control of the process will be necessary.
Reports of nonconformity and internal audit plans are often necessary to
achieve the quality required of medical suppliers. Each and every document can
be used to control ISO 13485. Even material specifications and approved lists
of suppliers will make a difference in how the products are produced.
ISO 13485
will only emerge in conversations surrounding medical devices and services.
Medical devices and services must be monitored to ensure that the processes are
consistent, and quality is ensured. These standards do not focus on the
product, but it does focus on the process. It’s important to review these
standards before developing a quality management system to ensure that it is in
compliance and meets all the legal requirements in relation to medical devices.
All
organizations are required to have documentation on file with regional
regulations. All processes, including those that are not specified in the
organization but have an effect on the product, should be included in the
quality management system documentation. Documents should be reviewed and
revised periodically to ensure the process remains up-to-date. This keeps the
products competitive in the medical industry.
Factories producing medical devices would need to know which licenses are required to remain in compliance with the law. The standards should be written to meet all of these rules and regulations to ensure that there will not be any fines or lawsuits associated with improper production or development. Failure to comply with the rules may lead to harm to consumers. This is why standards are in place to avoid this documentation.
Validation is important to know when developing documentation. Keep in mind that the validation time should be equal to or greater than the lifespan of the medical device. If there should be any arguments about the product or device, the documentation should be on file. In fact, ISO 13485 requires that records be accessible for the entire lifespan of the product and possibly two years after the date of expiration.
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