When it comes to resource requirements, ISO 17025 has a clause encompassing externally provided products and services. Likewise, there are key aspects your laboratory must be aware of when creating a document control.
ISO 17025 requires your laboratory to ensure that only suitable externally provided products and services are used for activities. Meanwhile, a certain procedure defines the requirements for control of and communication with all external organizations providing products and services.
Note that even external providers must comply with the requirements of ISO 17025, otherwise, the laboratory must take appropriate action.
In this post, QSE Academy details the ISO 17025 procedure needed for externally provided products and services. For more efficient development of your laboratory’s controlled copy, our experienced ISO consultants can also assist you.
Things to Remember:
- A controlled copy’s appropriate revision is available at points of use.
- The prevention of obsolete versions is achieved through their removal based on the Document Master List.
- The Quality Manager has authority over the distribution of the controlled copy.
- Your laboratory’s document contains confidential information. Thus, it must not be distributed without prior approval from Company XYZ.
For better understanding, QSE Academy explains every aspect of creating a controlled copy of the procedure for externally provided products and services to ensure your laboratory complies with ISO 17025 standards and requirements.
The purpose of this procedure is to outline the steps for defining, reviewing, and approving your laboratory’s requirements for externally provided products and services. It also identifies the criteria for selection, monitoring of performance, evaluation, and re-evaluation of the external providers.
Furthermore, it ensures that externally provided products and services conform to your laboratory’s fixed requirements, as well as applicable or relevant requirements of ISO/IEC 17025. This is before products and services are used or directly provided to the customer.
As a result, your laboratory can take necessary actions based on the monitoring of performance, evaluations, and re-evaluations of the external providers.
Definitions and Acronyms
- Request for Purchase – It refers to the document initiating procurement of supplies, services, or equipment.
- Qualification Process – It refers to the process of demonstrating whether an entity is capable of fulfilling specified requirements.
- Grade – It refers to the rank or category given to an entity having the same functional use, yet different requirements for quality.
- Responsibility & Authority – It refers to the responsibilities of individuals who will perform the process.
The information on the request for purchase orders suppliers to determine packaging supplies and packing slips with the applicable details:
- Name of product/service/material
- Vendor’s name and address
- Lot number
- Material specification number and date
- Certification documentation
Afterward, copies of requests for purchase of test materials and reagents are forwarded to the purchasing department. The copies will then be reviewed to make sure that the latest requirements are correct.
Note that the requests for purchase records, receiving documents, and any certifications are used as control over the material being received.
It is the facility clerk’s responsibility to check shipments of materials received for the correct quantities, for certification, if required, and to match the packing slip against the request for purchase.
Materials may undergo inspection procedures to identify if they meet specifications. If the material is accepted, the material is logged in and stored with details such as identification of the material, vendor, date, and request for purchase number. However, the material is replaced and a disposition record is kept should some discrepancies could impact the laboratory output’s quality.
Moreover, the container should include a label that shows the date of receipt and the shelf-life expiration date. No standard solutions, chemicals, reagents, or other time-sensitive materials must be used after the expiration of the assigned shelf-life date. Your laboratory must assign an expiration date if there’s no shelf-life expiration date.
The quality manager regularly requires checks on purchased material’s certification or validity of a grade. A subcontractor or your laboratory can conduct the check. Do not forget to notify the vendor if the materials do not meet their specified certification or grade, especially if the material is replaced.
On the other hand, the facility clerk monitors the inventory at least once a month to determine the material approaching the expiration date.
In this manner, inventory records are updated to prevent running out of stock as supplies are used. Disposition records are reviewed for trends in vendor performance and to ensure high-quality materials and supplies are accepted.
The user of supply or in-stock material checks to make sure the material is properly identified and has a current shelf-life expiration date. QSE Academy reminds us that the oldest is used first when more than one container of material is in stock.
Lastly, the quality of media, solutions, solvents, chemicals, and reagents are checked against standards as part of the test method they are used in. They are not checked before placing them in storage, other than to validate the identity, shelf-life or certification, as covered in the steps above.
Defining, reviewing, and approving the requirements of externally provided services such as a calibration service provider or subcontractor for tests are based on a formal accreditation, registration, certification, or compliance to a recognized standard for the service.
Evidence of compliance, like a certificate of accreditation, is used for selection monitoring of performance, evaluation, and re-evaluation of the service provider.
QSE Academy’s toolkits can help your laboratory ensure that an external service provider conforms to your laboratory’s established requirements, including a full review of the approved register of external service providers by the quality manager every year.
Finally, take action to notify the service provider of non-conforming work to resolve the issue and prevent a recurrence. Or else, implement the substitution of the service provider as outlined in this section of the procedure.
- Documents & Records
When it comes to records and documentation of ISO 17025’s procedure for externally provided products and services, your laboratory must entail the approved external provider list and external provider evaluation record. It must also include the request for purchase, performance data of contractor performance, packing slips, and evidence of compliance.
Keep in mind that by following this procedure involving externally provided products and services, your laboratory successfully complies with ISO 17025 standards and requirements. To guarantee an effectively controlled document, do not hesitate to consult with our ISO 17025 experts or avail our toolkits.