Quality policy – Develop a statement of your company’s commitment to quality. Use this framework for subsequent planning and action.
Quality aspects – Identify quality attributes of your company’s products, activities and customer services. Determine the attributes that have or could have significant impacts on the quality. Keep this information up-to-date.
Legal and other requirements – Identify and provide access to laws and regulations that are relevant to your company (as well as other requirements to which it adheres).
Objectives and targets – Establish quality goals in line with your company’s quality policy. Consider significant quality aspects, legal and other requirements and the views of interested parties, among other specified factors.
Quality management programs – Plan actions to achieve quality objectives and targets. Define “who, what, how and when” in these programs.
Structure and responsibility – Establish roles and responsibilities for quality management and provide adequate resources. Appoint a top management representative for the quality management system (QMS) with specific responsibilities.
Training, awareness and competence – Ensure that your employees receive proper training, are aware of QMS requirements and are capable of carrying out their quality management responsibilities.
Communication – Establish processes for internal and external communications on quality management issues. Consider communicating externally on your company’s significant quality aspects.
QMS documentation – Maintain information on your QMS and related documents.
Document control – Ensure effective management of operating procedures and other quality management system documents.
Operational control – Identify, plan and manage your operations and activities in line with your quality policy, objective and targets. Define requirements (as needed) for contractors and suppliers.
Emergency preparedness and response – Identify potential emergencies and develop procedures for preventing and responding to them.
Monitoring and measurement – Monitor key activities and track performance. Conduct periodic compliance evaluations.
Nonconformance and corrective/preventive action – Identify and correct problems and prevent reoccurrence.
Records – Keep adequate records of your QMS and its performance.
QMS audits – Conduct audits periodically to verify that your QMS is operating as intended.
Management review – Periodically review your QMS with an eye to continual improvement of the system.