Supply Chain Management compliance with MED -SC2024

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Clause (2): Quality system

• "The manufacturer shall operate an approved quality system for production, final product inspection and testing"

  N/A

• How do we flow down our quality system requirements to our suppliers?

• What documents do we supply in order to achieve this?

• What information from the suppliers do we review?

• How is this process described?

• Does this particular supplier report on their performance?

  Yes

  No

  N/A

• How do we monitor the supplier's performance?

• Do we flow down EH&S and/or Sustainability requirements?

  Yes

  No

  N/A

Regular purchasing process

• How does this process work?

• What information is supplied to buyers, in order to purchase items?

• What information do you provide to the supplier?

• How is this process described?

Clause (3.2): Quality system requirements - 2nd & 3rd items

• "The quality system shall ensure that the products are in conformity with the type described in the EC type- examination certificate and that they comply with the requirements of the international instruments that apply to them. It shall, in particular, contain:<br>• [the quality objectives]<br>• the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions<br>• the examinations and tests that will be carried out before, during and after manufacture"

  N/A

• What documents do we provide to the supplier to ensure these requirements are met?

• Where do they originate?

• Where are they held?

• How are they changed?

• How is this process described?

• Are actions specified should an examination or test fail?

  Yes

  No

  N/A

• How do we ensure that non-conforming product is corrected or scrapped?

Clause (3.2): The quality system shall ensure that the products are in conformity with the type described in the EC type- examination certificate and that they comply with the requirements of the international instruments that apply to them. It shall, in particular, contain: • [the quality objectives] • [the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions] • [the examinations and tests that will be carried out before, during and after manufacture] • *the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned* • [the means of monitoring the achievement of the required product quality and the effective operation of the quality system.]

• Where are the per item records (e.g. job cards) held?

• Do these reference test equipment used and personnel who have performed the specified operations?

  Yes

  No

  N/A

• How do we ensure appropriate test equipment and personnel have been used?

• Where are the general records (test equipment calibration and personnel qualifications) held?

• How many years are these retained for ?

• Do we specify requirements for calibration and personnel qualifications?

  Yes

  No

  N/A

• How do we ensure that appropriate test equipment and personnel have been used?

• How do we do this?

Clause (3.2): The quality system shall ensure that the products are in conformity with the type described in the EC type- examination certificate and that they comply with the requirements of the international instruments that apply to them. It shall, in particular, contain: • [the quality objectives] • [the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions] • [the examinations and tests that will be carried out before, during and after manufacture] • [the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned] • *the means of monitoring the achievement of the required product quality and the effective operation of the quality system.*

• How do we ensure that this requirement is met?

• Which parts of this are performed by the supplier?

• Which parts of this are performed by ourselves?

Articles 9 & 10 – Wheel mark (10.2): The wheel mark shall be affixed at the end of the production phase.

• How do we ensure that the wheel mark is only applied to conforming product?

Article 12 – Obligations (12.6): Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification

• How is this flowed down?

• How do we specify the marking requirements for each product?

• How are serial and batch numbers allocated?