ISO 9000 |
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ISO 9000 is an ISO standard for Quality Management Systems.
ISO 9000 was developed from the British Standards Institution's BS 5750. The ISO 9000 standard is maintained by ISO (the International Organization for Standardization) and administered by accreditation and certification bodies. It is widely used in manufacturing, although high costs and difficulties with implementation have led to many companies using alternatives such as IC9700, or IC9200, both of which are issued by the International Charter, or their own specific in-house 'standard'.
Some countries re-label ISO 9000 as a national standard. (e.g. IR 9000 in Iran).
It should be emphasised that ISO 9000 does not guarantee the quality of the end products - rather, it certifies that the correct manufacturing process is being carried out.
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MEDICAL DEVICES |
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A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
as defined by the US FDA.
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QUALITY ASSURANCE |
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In engineering and manufacturing, quality control and quality engineering are involved in developing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. These systems are often developed in conjunction with other business and engineering disciplines using a cross-functional approach.
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