Re: Not having training documentation for documentation changes - ISO 13485 Clause 4
Set of policies, procedures or requirements are defined as audit criteria as per the standard ISO 19011- 2004: Guidelines for quality and/or environmental management systems auditing. Since you are a medical devices industry, procedure for change control and training are mandatory requirement as required by ISO 13485:2003. The auditor can write non conformity, if your internal procedures (audit criteria) either training or change control called for the information stating that “Training required if there any revision changes in the documents”. But I don’t know what your procedure says.
In our organization, we described our internal training procedure that “procedural training for affected personnel is completed prior to employees using a new or revised procedure.” and also described in our document and change control procedure “Training records must be submitted when there is revision changes in the existing procedures. If training is not required, provide justification why not required”. (i.e.) as stated above by arios, if there is any administrative changes such as minor typographical errors, page alignment and etc.
Some organizations are maintaining integrated procedure (ISO 13485 & FDA QSR) and follow their requirements (e.g) 21 CFR 820.40 “Approved changes shall be communicated to the appropriate personnel in a timely manner”.
Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
In our organization, we described our internal training procedure that “procedural training for affected personnel is completed prior to employees using a new or revised procedure.” and also described in our document and change control procedure “Training records must be submitted when there is revision changes in the existing procedures. If training is not required, provide justification why not required”. (i.e.) as stated above by arios, if there is any administrative changes such as minor typographical errors, page alignment and etc.
Some organizations are maintaining integrated procedure (ISO 13485 & FDA QSR) and follow their requirements (e.g) 21 CFR 820.40 “Approved changes shall be communicated to the appropriate personnel in a timely manner”.
is that a simple checkpoint in your change request form, where the requester and.or the approvers note whether the particular change warrants a training and/or notification.