The lab fuctions as a supplier by offering products (reports), services (consulting), and information (collection procedures).  The lab is a customer of equipment and istruments, disposables, service (ref lab).

Supplier qualifation process evaluates whether or not a company, product or service is capable of fulfilling specific requiremnts. 

Qualified is the status given to a company,product or service when the capability of fulfilling the specified requirement has been demonstrated.

Identify critical supplies and services, establish criteria and apply, select and qualify suppliers, and approved supplier list is maintained.

A critical supply or service is one that is capable of affecting the quality of your lab products and services.  Identify critical supplies and services from reviewing pre-analytical, analytic, and post-analytic processes in the labs path of workflow and also the QSE's.

Successful outcome needs to take into consideration safety, quality, timeliness, appropriateness, usefulness, and cost-effectiveness.  Critical supplies would be items such as tubes, reagents and analyzers.  Critical services would be reference labs, software etc.

Select a supplier capable of providing the critical supplies and ensure the supplies are made according to applicable requirements.  Ask if the supplier can provide the service and supplies reliably.

After your laboratory has qualified the suppliers of currently used supplies and services, and has selected and qualified any suppliers of new supplies and services and their suitable alternatives, an approved supplier list can be developed.

 

The names of all reference laboratories used by your laboratory need to be on the Approved Supplier List!

 

The Approved Supplier list is a controlled document - meaning that your laboratory needs to keep it and all copies up-to-date.

 

Your laboratory also needs to share the current version of the Approved Supplier List with those in the organization who will order supplies and services.

  • Supervisors or staff with responsibility for completing purchase orders
  • Laboratory Director(s) with responsibility for completing purchase orders
  • Laboratory or organization's purchasing function (buyers or agents for your laboratory)

The approved supplier list controls the quality of the supplies and services you use to produce the labs product (results!)  Only order from a supply on the approved list.  If the supplier is not on your list they must be qualified.

Agreements:   Contracts clearly communicating each parties requirements and obligations.

1.  Lab and suppliers

2.  Lab and providers of reference lab services

3.  Lab and persons, services and facilities you provide results for.

The agreement should contain material specifications and contact information.   Also additional requirements, price, method and terms of payment, delivery method and time frame, length of contract term, termination clause, and confidentiality agreement.  Suppliers must notify of any changes in quality or safety of labs products and services and provide info is a product is not safe.

Reference Labs:

  • Agreements should include requirements including methods are defined, documented and understood. 
  • Assurance that reference labs can meet the requirements. 
  • Statement that any conflicts of interest are identified and resolved. 
  • Tests to be referred are appropriate for intended use. 
  • Definition of the respective responsibilities for interpretation of results.

Lab Services:

  • Defined requirements for your lab and referring facility that are documented and understood by both sides including list of methods used. 
  • Assurance that the lab has the capability and resources to meet the clients requirements. 
  • Assurance that the processes and procedures used meet the contract requirements and clinical needs of users. 
  • Conflicts of interest are identified and resolved. 
  • Discussion and documentation of amendments or changes to the contract.
  • Assurance that any deviations from the contract are communicated.

Review of Contracts:

  • At time of initial agreement
  • End of contract period for consideration of renewal
  • When amendments are made.

Identify:

  1. Requirements defined, documented and understood.
  2. Capabilities ans resources are assured.
  3. Clients informed of any deviations
  4. Amendments are documented, reviewed and communicated.
  5. Records of reviews and discussions maintained.

You should be providing feedback to your suppliers and a file for each supplier should include copies of complaints and problems.

Products:  choices, appearance, physical characteristics, quality, reproducibility

Service:  predictability, completeness, comflict management

Delivery:  timeliness, accuracy, dependability, cost

Price: lower appropriate price, value added service.

Technical Support:  ease of ordering, response capability, timeliness, consultation.