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Methodology

1.       Gap assessment to review what we have in place and what needs to be done – the existing management system is assessed vis-à-vis the desired ISO 9001:2008 management system desired and the gaps identified. An action plan is generated out of this assessment -

2.         Awareness training with all staff – in order for the system to be successfully implemented, the staff need to be trained on the requirements of the ISO 9001:2008. This enables them to understand exactly what is going on, their role and what is required of them

3.         Documentation training with core team – The implementing team is the team that shall help the Quality Management Representative to run the system once it is implemented, audited and the certificate awarded. This team must be trained on documentation (establishment and review), in order to maintain the system in future.

4.         Actual documentation is done - After the awareness training, next follows the implementation of the actions proposed in 1 above and the mandatory requirements of the standard. This shall include the review / formulation of the quality policy statement, the mandatory documents and the standard operating procedures

5.        Continual improvement – this shall include continual improvement training where delegates shall be shown the various ingredients to use in continual improvement of the management system and how to use them.

6.       Set quality policies and objectives – Quality objectives shall be set / reviewed at this stage and the criteria for monitoring them set.

7.       System implementation – at this stage, the implementation team shall implement the documented system and implement the monitoring system set in place and gather evidence (fill in the established records)

8.         Internal audit training – the system internal auditors shall then be trained to build their capacity t0o be able to conduct self-assessment on

the implementation of the system and its continual improvement

9.         Internal audit – the trained internal auditors shall be assisted to conduct the first internal quality management system audit.

10.         Corrections and corrective actions – once the internal audit has been done, any non-conformities discovered shall be corrected within agreed timeframes and follow-ups done. Where HOD’s have not taken action then escalation of the issues shall be done to make the management aware of the pending issues.

11.         Management review - to review the whole implementation process, internal audit, resource needs, etc – management review shall then be done to inform management of the progress made and aid management make decisions on the way forward for the management system. This system of regular management reviews is one of the tools for continual improvement.

12.         Pre-assessment audit – the pre-assessment audit shall be done by the consultant to give a final appraisal of the system and advice management on whether they are ready to call for first stage audit ie whether the system is ready for certification. Once this is done, any pending issues shall be resolved and the external auditor then invited to conduct first stage audit

13.         Stage 1 audit by the certification body – this is the first of a two stage audit by the certification body of choice. This audit mainly involves the assessment of the adequacy of the documentation of the system ( the intentions of the management system). On passing the 1st stage audit the organisation shall be recommended for stage 2 audit

14.         Stage 2 audit – this stage of the audit assesses the implementation of the intentions of the management system. On passing the second stage audit, the organisation shall be recommended for certification

15.         Certification – this shall involve the issuance of the ISO 9001:2008 compliance certificate and the rules that govern the use of the certificate as set out by the issuing certifyi