In response to the confusing question "What is a lab?" Here is my take on the definition which I believe is fully supported by the text of the standard...
The key here is to answer the question..."What is the primary purpose of
the lab?" The QS-9000 glossary defines a laboratory as "...a test facility that may include chemical, metallurgical, dimensional, physical, electrical,reliability testing or test validation." The operative words in this definition are TEST FACILITY. If the primary purpose of the lab is to produce a test or inspection result (this would include calibration), it is a lab and requires a scope as defined in the standard. If the primary purpose of the lab is for engineers and scientists to play, tinker, and design a new product, it probably doesn't meet the
definition even if it may have a couple pieces of measuring equipment they use as an aid in their development. With this in mind, a scope of operations would not be required. Again, the operative words are TEST FACILITY. This certainly does not exclude a development "lab" from following other resident procedures such as calibration, safety, ESD, chemical handling, housekeeping, cleanliness, etc. that may be established.
This position is further supported by looking at the context of the 4.10.6 requirement...Inspection and Testing. 4.10.6.1 starts right off by saying,"The laboratory (supplier's testing facility..." The clear intent of this element is to ensure that when accept/reject decisions are made about a product's integrity or quality, the test data or inspection results used in that decision are from a reliable and credible source.
We have used this approach without any argument from any of our assessors for 4 years now. It is a common sense approach and has not even been debated. (Except for Incoming Inspection...which our registrar
stated was a lab and we didn't agree. In the end, we applied the logic stated above and agreed. The primary purpose of Incoming Inspection is to produce a test or inspection result.)
Hope this helps.
