7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of

product realization shall be consistent with the requirements of the other processes of the quality

management system.

The organization shall document one or more processes for risk management in product realization.

Records of risk management activities shall be maintained (see 4.2.5).

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

b) the need to establish processes and documents (see 4.2.4) and to provide resources specific to the product, including infrastructure and work environment;

c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product

acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.5). The output of this planning shall be documented in a form suitable for the organization’s method of operations.

NOTE Further information can be found in ISO 14971.

7.2 Customer-related processes

7.2.1 Determination of requirements related to product

The organization shall determine:

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

b) requirements not stated by the customer but necessary for specified or intended use, as known;

c) applicable regulatory requirements related to the product;

d) any user training needed to ensure specified performance and safe use of the medical device;

e) any additional requirements determined by the organization.

7.2.2 Review of requirements related to product

The organization shall review the requirements related to product. This review shall be conducted prior to the organization’s commitment to supply product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:

a) product requirements are defined and documented;

b) contract or order requirements differing from those previously expressed are resolved;

c) applicable regulatory requirements are met;

d) any user training identified in accordance with 7.2.1 is available or planned to be available;

e) the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.5).

When the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

When product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

7.2.3 Communication

The organization shall plan and document arrangements for communicating with customers in relation to:

a) product information;

b) enquiries, contracts or order handling, including amendments;

c) customer feedback, including complaints;

d) advisory notices.

The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements.

8.2.3 Reporting to regulatory authorities

If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the organization shall document procedures for providing notification to the appropriate regulatory authorities.

Records of reporting to regulatory authorities shall be maintained (see 4.2.5).