Atema conducts two types of assessments at your site to assist you in the development of your quality management system. Contact me about the specifics of an onsite assessment
Gap Analysis
Chose a gap analysis if you have just completed your documentation and have limited implementation and staff training. A gap analysis determines if there are major omissions to the compliance within requirements) or system that have not been addressed. Samples sizes are usually limited to one. There are two parts.
- Documentation: Evaluate the existence of the required procedures, actions and components. Documentation submission typically includes the quality manual and referenced procedures that address the certification requirements.
- Onsite: all critical questions of the certification requirement are covered to determine if the issues have been addressed.
The gap analysis report will tell you: - Procedures have been identified and documented.
- Records have been identified and referenced.
- Document the results of the critical questions for evaluation.
- Full determination of implementation and the effectiveness of the implementation are not addressed.
Pre-assessment
Choose a pre-assessment if you believe your system is implemented and staff is trained -- you are ready to verify that you are compliant with the requirements or standard.
A pre-assessment determines if compliance is present. It is a formal and complete assessment of the system to the standard or requirements. There is a formal opening and closing meeting with results delivered in a final verbal report. This presentation includes commendations, concerns and items requiring corrective action. It typically does not include a formal corrective action follow up which happens during an official registration (follow-up can be part of the scope if desired).
Registration or certification is not part of the scope of a pre-assessment. The pre-assessment report: - Delivers assessment on the existence and the implementation of the required elements as well as their current effectiveness in meeting requirements of the standard
- A Written report may be requested as well as documented corrective actions. Follow-up assessment of corrective actions may also be requested.
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