Purchasing Conditions Sanitary Product

Total Planning describes below the requirements demanded from its suppliers of medical devices in compliance with the ISO13485 standard.

1. STRUCTURE OF THE PURCHASE ORDER

The item or subcontracted process requested is indicated in the supplier purchase order. Said order contains the information regarding the deadlines, the manufacturing order (OT), the drawing number (attached to the order), the quantity of items required, the price, as well as any other technical specification that Total Planning SL indicates. At the bottom of the order, a 3.1 certificate of raw material and treatments and compliance with REACH/ROHS regulations is required in both cases. Information is also provided on the evaluation made of the supplier in terms of quality and reliability of delivery times. In addition, specification of tolerances and general finishes and request for corrective actions in the event of incidents found at reception are indicated.

2. SUPPLIER COMMITMENT

The supplier undertakes to comply with the specifications of the plan and the indications of the purchase order, as well as the quantity and delivery time and delivery of raw material and/or treatment certificates.

The supplier undertakes to ensure the traceability of the raw material and/or treatments in its manufacturing process, in cases where it occurs. In the event that Total Planning provides the raw material or the semi-finished product, the supplier must immediately report any incident on it in order to take the appropriate measures and thus ensure the traceability of the entire process from the raw material to the delivery to the final customer. .

The supplier must carry out the quality control that it deems pertinent, to ensure that all the specifications requested by the plan and/or the order are met. If the drawing does not indicate general tolerances, the ISO 2278-mH standard and maximum roughness of Ra 1.6μm must be complied with. Geometric tolerances must be measured in accordance with UNE-1-121-91/1, ISO 1101, ASME Y14.5M-1994 and ISO2278mH. The supplier agrees to keep the record of its quality controls, verifications or tests so that they are available if necessary and required by Total Planning for verification.

By accepting the order, the supplier undertakes to provide the certificate of material and/or treatment and quality control or test records, complying with the instructions of the order and send it via email to calidad@totalplanning.cat within the delivery period of the order. 

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3. DELIVERY TIMES AND RETURNS

As indicated in section 1, the purchase order itself contains the information regarding the delivery period. The supplier must meet this delivery deadline. In case of not being able to comply with it, the supplier must immediately inform the purchasing department of the delay that will be suffered and must propose a new term, which will be accepted or rejected by said department. Total Planning SL reserves the right to reject the order if the delivery deadline is not met.

Total Planning SL reserves the right to return the items to the supplier if the specifications of the plan and the purchase order and of this document are not met, as well as the minimum required cosmetic and presentation criteria (detailed in section 4).

In case of return, the term for the replacement of the order must not be greater than the initial delivery term of the order. In case of not complying with it, the supplier must notify the purchasing manager and inform of the new delivery period. If Total Planning could not accept it due to customer requirements, it could cancel the order or take charge of the recovery, passing a reprocessing charge to the supplier. All returns require the supplier to take corrective actions so that said incident does not occur again and report it to the quality department for acceptance and follow-up.

4. COSMETIC AND PRESENTATION CRITERIA

It is required that the cosmetic criteria of the items be appropriate to their function and/or their specification in the requested plan.

The minimum presentation required by Total Planning is that the pieces are free of burrs, that they are clean and free of chips or solid adherent particles. It should not be in direct contact with porous materials, such as paper or cardboard, or with bubble wrap, as they can cause oxidation or stains on the surface. In metal parts, use anti-rust paper or anti-corrosion protection.

The turning parts can be packaged in bulk, if the drawing of said parts does not indicate roughness less than or equal to 0.8µm. Even so, they must be protected from possible oxidation or knocks.

All deliveries must be correctly identified with a label, indicating the drawing number, quantity, order number or manufacturing order (OT) to maintain traceability. The label must be securely attached or attached to the material to prevent loss.

5. CONCESSIONS AND DEROGATIONS

When the supplier detects, in its process, a deviation with respect to the order or drawing, it can process a concession query to the quality department, indicating the order number and WO, drawing number, the anomaly detected and the number of parts affected. If the concession is accepted, the affected pieces will be delivered segregated, identified and with the concession or derogation of Total Planning accompanying the pieces in question.

When the supplier does not agree with any of the tolerances of the plan, due to its operation or because it cannot guarantee said tolerance, it can process a permanent derogation query for the reference in question. This implies that, except for a new revision of the plan, if the derogation is accepted, the tolerance is permanently modified.

These requests must be sent to the quality department via email to calidad@totalplanning.cat. The quality department undertakes to answer any query within a maximum period of 48 hours.