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What is ISO9001:2008.

ISO 9001:2008,Quality management systems Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation. ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

What is IS013485:2008.

ISO13485:2003, Medical Devices Quality Management systems(QMS). Implementation and maintenance of an effective QMS to provide medical devices meeting customer and regulatory requirements. Ensure control of outsourced processes.

Documentation requirements what is to be done and by whom, when, where and how it is to be done, what materials, equipment and documents to be used. How an activity is to be monitored and measured. Design history, Technical File, complaint file, device records, etc.

What is GMP.

"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics,foods,pharmaceutical products, and medical devices. GMPs are guidance that outline the aspects of production and testing that can impact the quality of a product.

What is CE.

CE marking (originally EC mark) is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives Legally, the CE marking is no quality mark. But depending on the applicable directive the CE marking factually can be considered to be a quality mark. Deviating from sectoral directives regulating other industrial goods,medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC, according to which medical devices have to be not only safe but also function in a medical-technical way as described in the manufacturer's "intended purpose". Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485.