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ISO 13485 QMS for Medical Devices
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If your organization designs, develops, produces, installs or services medical devices, it will be necessary to achieve certification in ISO 13485 in order to meet regulatory requirements in some markets. The standard is based on ISO 9001:2000 but does not include the ISO 9001 requirements for continual improvement and customer satisfaction. Instead, it requires additional documented procedures applicable to medical devices sector.
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SIRIM QAS International Sdn. Bhd.
Building 8, SIRIM Complex,
1, Persiaran Dato' Menteri, Section 2,
P.O. Box 7035, 40700 Shah Alam
Selangor Darul Ehsan, MALAYSIA.
Tel: 603 5544 6400 Fax: 603 5544 6810
Website: www.sirim-qas.com.my
Email: cserviceqas@sirim.my |
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