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Clause - 7 is one the main clause of ISO 13485:2016. This Clause is divided into six sub-clauses. In this topic, Clauses from 7.1 to 7.3 are discussed. The six sub-clauses are:
Planning of product realization (Clause - 7.1)
Customer-related processes (Clause - 7.2)
Design and development (Clause - 7.3)
Purchasing (Clause - 7.4)
Production and service provision (Clause - 7.5)
Control of monitoring and measuring equipment (Clause - 7.6)
Requirements stated in Clause - 7.1 are:
Plan the QMS processes that are required to realize products.
Develop the processes that organization needs to realize products.
Establish a risk management process for product realization.
Plan how is your organization is going to realize each product.
And others.
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