Common use of Production Controls Clause in Contracts

Production Controls. 6.1. SRC must have in place and maintain a Quality System that meets the appropriate requirements of ISO 9001/2, EN46001/2, and EU MDD for the production of Broncus product. 6.1.1. If the SRC Quality System is certified, SRC must provide Broncus with copy of certificates. 6.1.2. If the SRC Quality System is hot certified or registered, Broncus must evaluate the SRC Quality System per Broncus Assessment procedures. 6.2. SRC must grant access for inspection/audit of its facilities, its Quality System, and its production/inspection/test processes used for the production of Broncus product to Broncus, to Broncus’ Notified Body, and to other Regulatory Authorities/Organizations. Where appropriate and upon Broncus request, SRC must ensure that access for inspection/audit of its Sub-Contractors involved in the production of Broncus product is also granted. 6.3. Broncus may review SRC production methods and inspection/test procedures for Broncus product and specify for which, if any, Broncus approval is required. 6.4. SRC must inform Broncus in advance of any substantial changes to product specifications, product indications for use, product safety, product sterilization, materials, production processes, inspection procedures, and product labeling. SRC must obtain written approval from Broncus for such changes.

Production Controls. 6.1. SRC must have in place and maintain a Quality System that meets the appropriate requirements of ISO 9001/2, EN46001/2, and EU MDD for the production of Broncus product. 6.1.1. If the SRC Quality System is certified, SRC must provide Broncus with copy of certificates. 6.1.2. If the SRC Quality System is hot not certified or registered, Broncus must evaluate the SRC Quality System per Broncus Assessment procedures. 6.2. SRC must grant access for inspection/audit of its facilities, its Quality System, and its production/inspection/test processes used for the production of Broncus product to Broncus, to Broncus’ Notified Body, and to other Regulatory Authorities/Organizations. Where appropriate and upon Broncus request, SRC must ensure that access for inspection/audit of its Sub-Contractors involved in the production of Broncus product is also granted. 6.3. Broncus may review SRC production methods and inspection/test procedures for Broncus product and specify for which, if any, Broncus approval is required. 6.4. SRC must inform Broncus in advance of any substantial changes to product specifications, product indications for use, product safety, product sterilization, materials, production processes, inspection procedures, and product labeling. SRC must obtain written approval from Broncus for such changes.