Welcome back ‘test equipment’? Well a rose by any other name. The requirements are similar, a little watered down, but the intent is still important. The standard says…
The company determines and provides the resources to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services and to requirements. The company shall ensure that the resources provided: a) suitable for the specific type of monitoring and measurement activities being undertaken; b) are maintained to ensure their continuing fitness for purpose. The company retains appropriate documented information as evidence of fitness of purpose of the monitoring and measurement resources.
My biggest concern here, as with most of 2016 is the lack of prescription. The wonderful term of ‘appropriate’ documented information. Not even maintained or retained prescription. I know they are trying to talk about equipment and people and other stuff, but the lack of finite direction lends toward unnecessary discussion during audits. I recommend training records and calibration registers combined with a procedure and instruction that will make test equipment and personnel real.
And yet we still have this traceability blurb. The standard. When measurement traceability is a requirement, or is considered by the company to be essential part of providing confidence in the validity of measurement results, measurement equipment is: a) calibrated or verified or both at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration verification shall be retained as documented information; b) identified to determine their status; c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
The company determines if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose and shall take appropriate action as necessary.
Back to the future with this subclause and anyone with the registers will have no issues. The fact this clause now appears in a different section of the standard, will confuse some, and for those wish to bury it entirely, has the convenience of the hidden nature of the clause.
And lastly in the world of support and resources, we have the boffins trying to catch up to the century in which we live and then giving it a kitschy name so that we get to impress upon the great unwashed. A cynical comment? Perhaps, but the intent is a little bewildering.
Organisational knowledge. What? The company determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge is maintained and made available to the extent necessary. (as my eyes begin to bleed, we read on). When addressing changing needs and trends, the company considers its current knowledge and determines how to acquire or access any necessary additional knowledge and required updates. Such knowledge specific to the company is generally gained by experience. It is information that is used and shared to achieve the company's objectives. Organizational knowledge can be based on internal resources and external sources.
Really! Blowed if I know what the advantage of describing this tripe is, but described it is. I have seen a few interpretations, and most stick to the standard line of; get it, share it, stay on top of it, make it relevant. I reserve my judgement and continue to be led by our academia with what needs to be done here. My best guess is use your road map / cross reference table and link it to documented information, competence and awareness, even management review and quality objectives. Just have your best shot and be prepared to discuss as and when the auditors get it stuck in their craw.