I wanted to be certain of the requirement for certification. Does our quality system need to be up and running with 6 months of records before a notified body/registrar will grant certification?
I need to clarify this ro ensure the company has the correct timeline for obtaining certification.
Thanks for the training you provide, I have joined in on a few of your webinars.
There is no specific period of time that is required; however the laboratory must have sufficient data and information available for assessment. This is needed to provide evidence of effective implementation, monitoring, and improvement. It will therefore depend on how much management, testing or calibration data is available as evidence, say after three months. This is typical period for most laboratories.
You need to have monitored all the activities that are inputs for management review and completed at least one management review. This need not be on a fully implemented system for all activities, for example you may not yet have enough customer feedback. What is important is that you would have a process in place which is being followed and that actions are being taken to provide evidence.
On the technical side, participation in external proficiency testing / interlaboratory comparison is often the activity that delays the process. You need evidence of participating in at least one round for each test you are being accredited for and you have to have evaluated the laboratory’s performance and taken corrective action if required. Another examples are that there must be sufficient data on maintenance of equipment, and trends for method quality control.