sop-purchasing

Copy the text below to a new Google Doc.

SOP Purchasing

ISO 13485:2016 Section Document Section
7.4 All

Summary

This SOP describes requirements for the purchasing of goods and services by the organization. It includes initial supplier evaluation, budget approval and continuous supplier surveillance. It ensures that only high-quality goods and services are purchased in order to guarantee the manufacturing of high-quality products for own customers.

General Considerations

1.1 Supplier Qualification

Goods and services that can impact the quality of the organization’s medical devices are only purchased from qualified suppliers.

Initial supplier evaluation is carried out by following the Supplier Evaluation Checklist.

1.2 List of Qualified Suppliers

Suppliers which are deemed critical and which underwent initial supplier evaluation are added to the List of Qualified Suppliers. The list is also used to document continuous supplier surveillance and the latest evaluation status of every supplier.

1.3. Supplier Criticality

A supplier is classified as critical:

If a supplier could have an indirect impact on the safety, performance or regulatory compliance of the organization’s medical devices, it is up to the QMO to determine the supplier’s criticality on a case-by-case basis.

A supplier is is classified as non-critical if the purchased goods or services have no impact on the safety, performance or regulatory compliance of the organization’s medical devices.

1.4 Supplier Evaluation

Suppliers are evaluated according to the evaluation categories described below:

Quality of Products/Services Quality is assessed based on the number of identified nonconforming purchases and reported reclamations, also taking into account delivery.
Timeliness / Punctuality Timeliness is assessed based on the number of delayed purchases.
Cooperation Cooperation is assessed e.g. based on the availability for follow-up questions and responses to complaints.
Payment Terms Payment terms are assessed e.g. based on pricing and discounts, payment options, overdue fees and return policies compared to alternative suppliers.

Suppliers are evaluated along these categories by assigning a score value to each category. Score values are as follows:

In order to complete the evaluation, an average score is calculated from all categories. The quality value is weighted double.

The overall score results in the following evaluation outcome:

Process Steps

2.1 Preliminary Regulatory Assessment

Before purchasing any product or service, employees are required to check compatibility with the organization’s quality standards.

Employees therefore first check if the supplier is approved in the List of Qualified Suppliers. If so, s/he can continue with step 2.3.

If the supplier is documented als blocked in the List of Qualified Suppliers, the employee looks for an alternative supplier.

If the supplier is not mentioned in the List of Qualified Suppliers, employees need to request regulatory approval for the purchase from the QMO. The QMO checks the supplier’s criticality, i.e. the impact of its goods and services on the quality of the organization’s medical devices, by review against the criteria described in section 1.3. The QMO can decide that a supplier is obviously uncritical and that no further supplier evaluation is needed. If so, the process continues with step 2.3.

If the supplier is not mentioned in the List of Qualified Suppliers and not deemed obviously uncritical, the QMO first conducts an initial supplier evaluation.

Participants Purchasing employee
QMO
Input Preliminary regulatory assessment
List of Qualified Suppliers
Supplier Checklist
Output Regulatory approval for purchase
or: need for initial supplier evaluation

2.2 Initial Supplier Evaluation

The QMO conducts the initial supplier evaluation by completing the Supplier Checklist. S/he can therefore request additional information from the supplier. Only the QMO decides on the approval of a critical supplier.

If the supplier is deemed critical and the initial supplier evaluation is completed successfully, the supplier is added to the List of Qualified Suppliers and the process continues with the next step. Based on the supplier’s criticality for the quality of the organization’s medical devices, the QMO may define additional measures for supplier surveillance which are also documented as part of the List of Qualified Suppliers.

If the supplier is deemed critical and the evaluation is unsuccessful (meaning, the supplier cannot be qualified for purchasing), the supplier is also added to the List of Qualified Suppliers, but marked as blocked. In this case, the order cannot be placed and the employee looks for an alternative supplier.

Blocked suppliers can be approved by repeating this process step and conducting a new supplier evaluation.

Participants QMO
Input Purchase need
List of Qualified Suppliers
Output Completed supplier evaluation
Updated List of Qualified Suppliers
Regulatory approval

2.3 Budget Approval

The employee requests his/her supervisor for budget approval for the respective purchase. The supervisor reviews the purchasing costs against the organization’s budget plan and approves or denies the request. Upon approval, the employee places the order.

Participants Purchasing employee
Supervisor
Input Documented regulatory approval
Output Documented budget approval
Order placement

2.4 Verification

The purchasing employee verifies that the received services or goods match the order and fulfill expected quality standards.

In case sub-standard quality or in any other way nonconforming services or goods, the QMO is notified to document the purchase’s effect on continuous supplier evaluation (next step). A complaint is sent to the supplier and defect products are returned if applicable.

Invoices and receipts are attached to expense records and archived accordingly.

Participants Purchasing employee
QMO
Input Received services or goods
Output Archived reclamation records (if applicable)
Updated List of Qualified Suppliers (if necessary)
Invoices processed

2.5 Supplier Surveillance

NOTE: for class II or higher, the annual re-evaluation of suppliers should be completed prior to the Management Review.

The QMO can decide to undertake various surveillance measures such as:

2.5.1 Continuous Supplier Surveillance

Supplier evaluations are updated continuously in the context of every new purchase, but at minimum once per year. Surveillances measures are carried out continuously as considered appropriate and documented in the List of Qualified Suppliers.

Any new information about a supplier can lead to an update of the supplier’s evaluation status. Following a decrease of a supplier’s evaluation status, the QMO can decide over appropriate measures, such as opening a CAPA, further surveillance measures or blocking a supplier in case of a significant decrease in quality standards. Opening a CAPA is always required in case of a decrease by one grade according to the evaluation criteria outlined in step 1.3.

Participants QMO
Input New supplier records
Output Updated List of Qualified Suppliers

2.5.2 Annual Supplier Evaluation

At minimum once per year, the QMO reviews all available information (incl. public records such as complaints, ratings, certificates) to update the evaluation status of suppliers listed in the List of Qualified Suppliers.

Following a decrease of a supplier’s evaluation status, the QMO can decide over appropriate measures, such as opening a CAPA, further surveillance measures or blocking a supplier in case of a significant decrease in quality standards. Opening a CAPA is always required in case of a decrease by one grade according to the evaluation criteria outlined in step 1.3.

Participants QMO
Input Supplier records
List of Qualified Suppliers
Output Updated List of Qualified Suppliers

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.