Decide on what the scope of the certification: Sites and product/service lines to certify. Share the commitment to seeking ISO 9000, ISO 14000, Six Sigma, GMP, ISO 16949, OHSAS 18000, GMP, TL 9000 or ISO 13485 certification with all levels of management, choose a management representative, decide whether to use a consultant or not. Train the management representative and some key team members on the standard at a higher level (see
Online training).
Step 2: Gap Assessment and implementation planning
Review the existing management system, determine what processes need to be established and/or documented, what needs to be modified, what needs to be implemented, what training needs to be provided, and decide on how to format and structure the documented management system required by the standard or regulation you need to comply with. Set a timetable to certification.
Step 3: Targeted training and process establishment
Use the findings of the gap assessment (report) to have the appropriate employees receive very precise and targeted training. Work with applicable resources (persons, departments, consultant) on developing or formalizing the processes and documentation required to have a compliant management system.
Step 4: Management System Review and update:
Review and update the documented management system in order to achieve completeness, cohesion and compliance with the standard or regulation. Generate a process map to illustrate the interrelation of all the processes.
Step 5: Baseline Training
Train all levels of the organization on the processes, procedures, the Manual, quality or environmental objectives, and the concepts of the standard (see
Online training). Provide internal auditor training.
Step 6: Internal Audit and Corrective Action
Conduct the required Internal Audit to verify compliance with the procedures and processes. Initiate and conduct corrective actions on any deviation or finding.
Step 7: Management Review Meeting
Conduct an annual Management Review Meeting to review the performance of the management system. Review the Internal Audit, the Corrective action and Preventive action process, and the Quality or Environmental Policy. Use this meeting as the driving force for continuous improvement/management planning.
Step 8: Registration or Compliance Audit
Bring in the "Registrar" to conduct a preliminary audit (optional) or the certification audit.
