Conformity assessment bodies (CABs) are responsible for verifying and demonstrating the suitability of any products and services that may affect their technical activities. This applies to items used as inputs into measurement activities (e.g. test equipment, consumables) as well as subcontracted work like equipment calibration, maintenance services, and third-party testing (when outsourced). Beyond simply ensuring the suitability of products and services used, CABs are also required to operate a dedicated procedure and maintain records demonstrating the actions taken to confirm the acceptability of the materials and services they use.
This article is intended to serve as a practical walkthrough of the requirements involved in vendor selection, purchasing, and review of incoming materials. Beginning with a resource need, we’ll walk through the fundamental steps of the purchasing process and provide comments on the key considerations that can be involved.
Step One – Resource Need
Let’s imagine your organization is in the process of developing some new test capabilities. While your organization has many of the required instruments in place, there is a key item which will need to be acquired. You have been tasked with sourcing the test instrument and assuring that it meets all applicable criteria for purchase and use. In this example, we will use a balance as the required resource.
Step Two – Acceptance Criteria (ISO/IEC 17025:2017 6.6.2.a)
As part of your organization’s purchasing procedure, you are required to determine the applicable criteria for use of the instrument. This will typically involve reviewing a particular standard or test method and confirming equipment specifications. Where relevant, you should review test program requirements supplementing the standard criteria. As needed, reference standards or other industry guidance may be useful for fully determining the needs and function of a given instrument.
Let’s define our balance’s acceptance criteria to be as follows:
– ISO/IEC 17025 accredited calibration
– Capable of measuring to an accuracy of ± 2 milligrams.
Step Three – Vendor Approval (ISO/IEC 17025:2017 6.6.2.b)
Once you’ve determined the applicable criteria, you’ll be able to identify equipment vendors who can fulfill your order. Prior to selecting a vendor, you will need to confirm that the vendor meets the selection criteria defined by your organization’s purchasing process. For equipment vendors, the main criteria will usually be their ability to fulfill the order and provide relevant documentation and support; however, it is possible that your organization could require other types of criteria like accreditation, vendor assessment, or some form of industry credential. For our scenario, it will be critical to note whether the instrument will arrive with or without measurement traceability.
Upon evaluation and approval, it is common for organizations to maintain a list of approved vendors. In this scenario, we will require the following criteria for our calibration provider:
– ISO/IEC 17025 accredited
– Satisfactory customer service (Performs calibrations within two weeks, responsive, etc.)
– Competitive pricing for the requested calibration
In addition, we will evaluate our calibration providers utilizing a table. The table will use a binary system to indicate whether the provider meets the criteria listed above. The provider must receive positive remarks for all areas in order to be approved, as well as, maintain approval. to indicate whether the provider meets the criteria listed above. The provider must receive positive remarks for all areas in order to be approved, as well as, maintain approval.
Step Four – Purchasing (ISO/IEC 17025:2017 6.6.3)
Back in step two, we defined the acceptance criteria for the equipment. These criteria must be relayed to your approved vendor.
Clear and unambiguous communication with your vendor is essential for ensuring that your order is properly received and processed. Typically, this is done via a Purchase Order; however, any line of communication is acceptable per ISO/IEC 17025.
Step Five – Incoming Inspection (ISO/IEC 17025:2017 6.6.2)
Upon receipt of the order, it is your organization’s responsibility to confirm that the order was properly fulfilled. Depending on the material involved, this may be a matter of inspecting the materials against purchase order requirements or confirming the material by test or verification. For new equipment purchases, this will often involve a verification or functional check. Regardless of how you confirm the instrument meets the criteria, ensure that a record is maintained. Upon successful verification, the instrument is then added to your organization’s equipment inventory. For our scenario, we would want to confirm the calibration certificate received for our balance met the criteria we defined in Step Two:
Step Six – Vendor Performance and Re-evaluation (ISO/IEC 17025:2017 6.6.2b)
To maintain a supplier’s approved status, you will need to re-evaluate your vendors for ongoing acceptance. In many cases, re-evaluation is a matter of confirming that the supplier continues to meet its initial acceptance criteria. For test labs, calibration labs, and reference material producers, this involves periodically verifying that they remain appropriately accredited.
Approved suppliers are also required to undergo some form of performance monitoring. Be sure to work with your quality management representatives to confirm an appropriate monitoring plan is in place for each vendor. For some scenarios, this may be as simple as reporting vendor issues on an as needed basis. In cases where an organization heavily relies on a given supplier, a more comprehensive monitoring activity may be warranted. The table used in Step Three could also be used to re-evaluate and monitor the performance of the approved suppliers.
Step Seven – Repeat
Steps One through Six are the fundamental requirements for vendor selection, purchasing, and review of incoming materials. This process can also be applied to services, such as subcontracting. As referenced throughout, more specific information will be specified in normative documents and your organization’s management system. A significant part of your contribution to that system is consistent adherence to management system practices and objectives. As a stakeholder of that process, be sure to share your experience and insights with management staff to adapt and improve the process as needed.