ISO 9001 is A Quality Management System (QMS). A QMS is a set of policies, processes and procedures required for planning and execution in the core business area of an organization i.e. areas that can impact the organization's ability to meet customer requirements. ISO 9001 includes the process of continual improvement of the system and assurance of conformity to customer and applied statutory and regulatory requirements. Certification to ISO 9001 requires an initial certification audit and regular surveillance audits by an external body.