Mega March Sale! 😍 25% off Digital Certs & DiplomasEnds in  : : :

Claim Your Discount!
    Study Reminders
    Support

    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.

    (Continued...)