Question
I have sent a sample for testing to a lab which is ISO certified, they have provided me with the test results, however, when I asked them for the Raw Data to support the testing performed as well as to keep it on record for the future investigational use, the testing lab refuses to provide the raw data, stating that we are not a GMP lab and as an ISO certified lab, we are not obliged to provide the raw data. They say the raw data could be shown to the regulatory authorities. Is this true?
The contract testing lab we mentioned is certified to ISO 17025.
Answer
Since the laboratory is “accredited” to ISO/IEC 17025, it will be useful to review a few relevant passages from that standard (note that the term “certified” or “registered” is usually used for organizations registered or certified to ISO 9001 quality management systems).
ISO/IEC 17025 Clause 4.13.2.1 states:
“The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.”
ISO/IEC 17025 Clause 5.10.1 paragraph 3 states:
“In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way. Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.”
Further, ISO/IEC 17025 Clause 5.10.4.2 paragraph 2 states:
“When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference.”
The ISO/IEC 17025 accredited laboratories are required to retain test results when they do not report the results on the test certificate (or report) to the customer. A word of caution: The laboratory may have a record retention policy (it should be documented in their quality system per ISO/IEC 17025 Clause 4.13.1.2). Ensure that future record requests are made within the record retention policy period!
In the future, it would be best to specify in the purchase requisition what test data the customer requires from the test laboratory. This forms the basis for a contractual requirement and can be contested legally if the laboratory does not fulfill the customer’s requirements if it accepted the purchase requisition (This would apply to both ISO 9001 registered and ISO/IEC 17025 accredited laboratories).
The laboratory’s other argument about “GMP lab and as an ISO certified lab, they are not obliged to provide the raw data” is not consistent with the requirements of ISO/IEC 17025. The customer should file the refusal to provide data as a complaint to the laboratory under the clauses cited and ask the laboratory for corrective action under ISO/IEC 17025 Clause 4.8 (complaints) and 4.11 (corrective action).
If an ISO/IEC 17025 accredited laboratory refutes to provide corrective action under the requirements stated in this article, it is possible to escalate this complaint to their accrediting body.
Dilip A Shah
ASQ Fellow, ASQ CQE, CQA, CCT
President, E = mc3 Solutions,
Technical Director, Sapphire Proficiency Testing Services.
Past Chair, ASQ Measurement Quality Division (2012-2013)
Former Member of the A2LA Board of Directors (2006-2014)
For more about this topic, please visit ASQ’s website.