Arquivo mensal: April, 2022
The Principles right at the beginning
When we talk about “Context outside the text! ” and imagine that Management shall be experienced, it is also important to remember the Principles! The Quality Management Principles described in the Standard – in its item 0.2 – belong to the non-auditable Requirements; that is, they do not undergo Audits such as items 4, 5, […]
Non-electrical equipment for explosive atmospheres
The basic requirements and protection concepts for mechanical equipment installed in explosive are covered by part of ABNT NBR ISO 80079. Examples of non-electrical equipment are couplings, pumps, gearboxes, brakes, hydraulic and pneumatic motors, and any combination of devices for making machines, fans, motors, compressors, assemblies, etc. Generally, there are two situations where ignition […]
MDSAP Audit Process Sequence
MDSAP Audit Process The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure that a single audit provides efficient and complete coverage of regulatory requirements. These requirements include: Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016); Quality Management System Requirements of the Australian Therapeutic Goods […]
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