This procedure is established to ensure that the purchased product conforms to specified purchase requirements and to describe the criteria for selection, evaluation, and re-evaluation of the suppliers.
This procedure applies to the Purchase Department and related departments who are supporting the Purchase Process of a manufacturing company.
Role of ISO 13485 Consultants
Medical Device regulatory experts and ISO 13485 Consultants guide manufacturers to implement systems based on the law of the land, followed by guiding the team on regulatory requirements for medical devices and thereby proper implementation of each section of the standard.
Cost of ISO 13485:2016 Certification
ISO 13485 Certification Cost depends on various factors such as company size, number of products manufactured in the same facility, number of employees etc.
How to control the Purchase Procedure?
The activities of the Purchase Department functions at any manufacturing location are generally divided into two. They are:
Direct purchase
The directly purchased goods are categorized as below.
· Raw Materials
· Accessories/Consumables
· Tools
· Test Equipment
· Office Supplies
Outsourcing
The items purchased or services sourced from various vendors are made as per requirements based on mutually agreed contracts.
· Technical Consultancy
· Trainings
· Certification
· Calibrations
· Testing
· Logistics
· Machine Maintenance
· Pest Control
· Validation
· Waste Management
How to select a Supplier?
Vendor/Supplier Identification
Vendors are identified by references, advertisements, or contacts. The identified vendors are questioned over the phone for the capabilities and parts/components of Interest. If suitable follow the next stage. For patents, monopoly product suppliers and monopoly Service Vendors identified can be approved directly.
Evaluation and Selection of Vendor/Supplier
· Material being purchased for assessment or as a “one-time” purchase of a commodity for testing and use in production after the material is approved the specifications can be purchased from a non-approved vendor provided the purchase requisition includes a justification as to why the vendor does not need to be added to the Approved vendor list (AVL).
· The selection and qualification of Vendors is done based on the needs of the business and includes an assessment of the vendor’s capabilities which are ultimately verified by conducting a vendor evaluation.
· The vendor assessment considers the overall capabilities of the Vendor in so far as those capabilities relate to the goods or services provided to the company. The assessment should include an evaluation of the Vendor’s technical competence, their quality and safety systems, as well as a review of evidence of their performance and reliability in providing goods and/or services to their customers (e.g. references, or industry excellence awards, etc.). The financial viability of prospective vendors should also be investigated if the goods and/or services they provide are required for more than a short period (e.g. key component suppliers, contract manufacturers, etc.). Appropriate questionnaires are sent and references from other potential vendors also sought.
· If the goods or services provided by a Vendor constitute the embodiment of a medical device, the Vendor must have an ISO9001 / ISO 13485 certification. If the goods or services are general components or operations that are independent of the embodiment of a medical device, ISO 9001 certification can be accepted with a written justification that is included in the Vendor’s file. If the supplier is ISO/LCSO/MIL/CE/UL/TUV approved, it can be included in the approved supplier list.
· Final Vendor selection is made by comparing the assessment to the pre-determined Vendor criteria and creating a written report evaluation of the Vendor Assessment that is included in the Vendor’s file and attached to the AVL (Approved Vendor List). The main criteria for selection are the capability of the Vendor to provide the necessary goods/services to the company in the time required and with the quality required and that they shall commit to and maintain compliance with the contract.
· Assessment of quality system and capability are verified during the selection of new subcontractors. On successful inspection, they will be included in the approved supplier list.
· Wherever manufacturer outsources machine maintenance or calibration, approved sources specified by the machine manufacturers are also considered during selection. Vendors should have a procedure for calibration of test and metrology devices or equipment. Such calibration shall be verified to traceable standards (e.g. NIST or NABL)
· The Vendor shall have means of ensuring the goods/services provided meet their operational specifications. Such means to include:
· Verification and Validation of processes.
· Test reports from in-process and final test procedures.
· Periodic process control audit reports.
· Final Vendor selection is made by comparing the assessment to the pre-determined Vendor criteria and creating a written report of evaluation of the Vendor Assessment that is included in the Vendor’s file and attached to the AVL. The approved vendor list is maintained and updated as and when needed.
Vendor/Supplier Audit
· If required a site audit has to be carried out to understand the supplier in detail. The audit report should be prepared and attached along with registration for vendor approval.
· Advance samples or trail orders from the new supplier obtained and subjected to evaluation/testing as per specified requirements. On completion of successful completion of test/evaluation, they will be included in the approved supplier list.
Vendor/Supplier Registration and approval
· Once the supplier is finalized, the Commercial officer will collect the vendor registration form duly filled in and signed by the vendor with the necessary details.
· Vendor Registration Form to have all necessary statutory details of the vendor company. Specifications if any for the materials to be procured. Also, details of the proprietors/directors of such vendor companies are to be collected. Also, in the case of overseas suppliers, their banker details are to be collected in advance.
· Purchase department to cross-verify the details given by the vendors for correctness of the declarations.
· Purchase In charge may propose the requirement of an Agreement with the vendor in addition to normal registration.
· Only on receiving the above, the purchase department register the vendor with of manufacturer apart from the above registrations, certain criteria are considered for selection and evaluation, and results of evaluations and any necessary actions arising from the evaluation shall be maintained.
· The Purchase In charge approves each of the vendors based on the evaluation carried out. The list of approved suppliers and sub-contractors (AVL)is maintained for the selected vendors.
Agreements or Contracts with Supplier/Vendor
· Vendors performing services for of manufacturer (including purchasing) shall have a contract with the Company specifying the terms of the contract. The terms shall include the duration of the contract, responsibilities and obligations of parties, communication methods, cost and billing arrangements and deliverables. The vendor shall guarantee the quality and workmanship of deliverables and shall maintain adequate controls to back up the guarantee.
· Purchased components or commodities shall be purchased under a purchase order system, either stand-alone P.O.s or a standing order for materials to meet manufacturing forecasts. All standing POs will be reviewed yearly to ensure an adequate supply of purchased parts.
Supplier Monitoring and Improvement
· Critical suppliers will be evaluated every year and other suppliers will be monitored.
· Any inconsistency in supply, the same is noted in the remark column in the performance evaluation sheet.
· In the process of periodic performance monitoring, Suppliers observed with downtrend performance shall be intimated to improve their performance.
· If no improvement is observed, the supplier is eliminated from the List of Approved Suppliers provided there is an alternate supplier for the same material.
· Re-approval of a supplier will be permitted only after satisfactory confirmation from the supplier of the criteria for their disqualification.
· However, the final decision for elimination of the supplier from the List of Approved Suppliers is vested with the Purchase in charge.
Purchase request/indent.
· Purchasing activity is initiated based on the production review.
· Present availability of stock is verified against the requirement.
· The purchase in charge decides the quantity to be ordered.
· Purchase department to collect quotations from approved vendors List.
· Purchase in charge of collecting quotations from at least two approved vendors if wherever possible.
· This need not be required manufacturer has already entered into to rate agreement with any specific vendor for a defined period.
· Detailed Performa Invoice to be collected in case of overseas supplier.
Purchase order.
For the extent required for traceability, the organization will maintain relevant purchasing information through PO by generating a unique purchase ordering number for each PO. Necessary information regarding the products to be purchased is sent to the supplier through purchase order. This will include as appropriate.
· Details of the product requirements/service
· Technical information and specifications
· Requirements regarding the qualification of personnel if any.
· Delivery period
· Dispatch information etc.
· quality management system requirements/qualification of personnel (If applicable)
The organization will ensure the adequacy of specified purchase requirements before they communicate with the supplier. The process includes the following steps:
· Purchase In charge will prepare Purchase Orders in the prescribed format on approved suppliers.
· Purchase Orders to be signed by the Top management or in his absence the MR can approve the Purchase order.
· Duly signed purchase order to be issued to the vendor.
· In case of any advance payments to be made the same is to be issued along with the purchase order
· Acknowledgement to be collected from the vendor for the acceptance of the PO of high value and advance payment if any. In the case of an overseas supplier, wire transfer remittances are to be made as per payment terms.
· Purchase In charge of appointing clearing agents if required in case of imports.
· Clearing agent’s details to be given to the overseas supplier in case of Ex-works, FOB basis purchases. (In the case of CIF-based import, clearing agent details need not be given to the supplier)
· Purchase In charge to follow up with supplier to ensure timely delivery of the materials. In case of any delay from the vendor it should be intimated.
· Purchases are carried out by the purchase department as and when required without the PO, however, proper identification and traceability will be ensured with the documents for such procurements.
· Purchases are also carried out by the purchase department as and when required by email communication without PO, however, proper identification and traceability will be ensured with the documents for such procurements.
Verification of Received material.
All goods and materials received by the Stores Department of the Company shall be matched to its Supplier Invoice / Purchase Order in the Receiving Area. The information on the shipper shall be compared against the PO and any discrepancies noted shall be informed immediately to the purchase department. If there are any shortages (partial shipment) or other discrepancies between the shipper and the PO also to be intimated.
· Many simple components from reliable vendors can be issued directly to stock once the quantities on the shipper are confirmed.
· Materials that are deemed to be Critical to Quality (CTQ) or Critical to Safety (CTS) may be checked by a sampling plan once the vendor has established a track record for quality. The sampling plan must be described in the material specification data sheet and is executed at Incoming Inspection.
· Material that does not meet its requirements at the incoming inspection is considered non-conforming and shall be segregated from receiving/inspection/stores pending a decision on the disposition of the material and it will be handled as per Control of Non-conforming products.
