what are the new requirements of the new standard?

• Statutory requirements are given scale as any other legal or customer's requirements.
• The statutory requirements are including the suppliers as well.
• A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality system.
• You may include two quality processes in one document and split one process to two documents.
• The management representative must be a member of the management.
• A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.
• Information system in now officially considered as a substructure.
• Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
• Measuring is considered as one of the activities of product realization.
• The product must be identifying not only on the shelves but also throughout the realization process.
• The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered suring audit.