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ISO
9001:2015 specifies requirements for a quality management system where
an organization needs to demonstrate its ability to consistently provide
product that meets customer and applicable statutory and regulatory
requirements, and aims to enhance customer satisfaction through the
effective application of the system, including processes for continual
improvement. |
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AS
9100-D, includes all of the elements of ISO 9001, as well as additional
requirements specific to the aerospace industry. |
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The
primary objective of ISO 13485:2016 is to facilitate harmonized medical
device regulatory requirements for quality management systems. As
a result, it includes some particular requirements for medical devices
and excludes some of the requirements of ISO 9001:2015 that are not appropriate
as regulatory requirements. |
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Whether
it's a simple thermometer or a sophisticated cardiac pacemaker, the
goal of FDA's 21 CFR Part 820 standard is to ensure medical device
quality and safety and to reduce, if not prevent, injuries and deaths. |
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Clients
save time and money with minimal maintenance supplier relationships
based on PSP's tightly-monitored ISO 13485:2016 and AS 9100-D certified
quality management system. PSP effectively helps clients minimize
their risks through strict compliance with these standards. |
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