Scribd
Upload
354 views5 pages

ISO 13485 Purchasing

This document outlines requirements for purchasing goods and services to ensure only high-quality suppliers are used. It describes initial supplier evaluation, classification of supplier criticality based on their impact on product quality, annual evaluation of qualified suppliers, and continuous surveillance of suppliers to guarantee purchased items meet quality standards.

Uploaded by

Subhash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
354 views5 pages

ISO 13485 Purchasing

This document outlines requirements for purchasing goods and services to ensure only high-quality suppliers are used. It describes initial supplier evaluation, classification of supplier criticality based on their impact on product quality, annual evaluation of qualified suppliers, and continuous surveillance of suppliers to guarantee purchased items meet quality standards.

Uploaded by

Subhash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 5

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 eval-
uation 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 the purchased goods or services could have a direct impact on the safety
of the organization’s medical devices; OR:
• If the purchased goods or services could have a direct impact on the
performance of the organization’s medical devices; OR:
• If the purchased goods or services could have a direct impact on the
regulatory compliance of the organization’s medical devices; OR:
• If the organization is not able to manufacture its medical devices without
the supplier’s goods or services; AND:
• If there is no alternative and equivalent supplier for these goods or services.
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.

1
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 Quality is assessed based on the number of identified


Products/Services
nonconforming purchases and reported reclamations, also
taking into account delivery.
Timeliness / Timeliness is assessed based on the number of delayed
Punctuality purchases.
Cooperation Cooperation is assessed e.g. based on the availability for
follow-up questions and responses to complaints.
Payment Payment terms are assessed e.g. based on pricing and
Terms 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:
• 0: unacceptable
• 1: moderate
• 2: good
• 3: excellent
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:
• Average score 2 - 3: supplier can be approved.
• Average score 1 - 2: supplier can be approved, provided that surveillance
measures are in place (see step 2.5 of this process).
• Average score 0 - 1: supplier cannot be approved and is marked as blocked
in the List of Qualified Suppliers.

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.

2
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 employeeQMO


Input Preliminary regulatory assessmentList of Qualified
SuppliersSupplier Checklist
Output Regulatory approval for purchaseor: 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 needList of Qualified Suppliers
Output Completed supplier evaluationUpdated List of Qualified
SuppliersRegulatory approval

3
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 employeeSupervisor


Input Documented regulatory approval
Output Documented budget approvalOrder 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 employeeQMO
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:
• Supplier Certification: a supplier can be requested to provide valid and
ongoing certification as a proof of its quality management system’s efficacy.
In this case, the QMO keeps a copy of the current supplier certificates
with the organization’s QM records. The validity of supplier certification
is checked at least once per year as part of the annual supplier evaluation.
• Quality Assurance Agreement (QAA): a supplier can be requested
to sign a QAA as a commitment to specific quality assurance measures.
• Supplier Audits: supplier audits and site visits can be requested where
previous supplier documentation (records, certification) did not establish
sufficient objective evidence of a supplier’s QM system efficacy and com-
pliance. The QMO is responsible to conduct supplier audits. As part of
conducting a supplier audit, an audit plan and audit report are created

4
following the organization’s process for Internal Auditing. Additionally, the
QMO may decide to set up a continuous audit program for the supplier.

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. pub-
lic 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 recordsList of Qualified Suppliers
Output Updated List of Qualified Suppliers

You might also like