The reasons are almost always the same and can easily be avoided.Ī fairly common indicator that a company's QMS is heading towards failure is a majority of employees complaining about ISO 9001. If you find your company's QMS to be bureaucratic and cumbersome, if you find your employees feeling negative about ISO 9001, or if you need to spend excessive time preparing for each audit, then your Quality Management System has plenty of opportunities for improvement and you should consider a complete makeover.įar too many Quality Management Systems fail. These revisions can range from small corrections to a total makeover of the entire ISO 9001 documentation. Revising the ISO 9001 procedures and other documents should be a normal part of the ever-improving Quality Management System. Act: Take actions to improve performance as required.Check: Monitor and, if necessary, measure processes and the resulting products and services against policies, objectives and requirements.Plan: Define the objectives of the ISO 9001 Quality Management System and its processes, and the resources needed to deliver results in accordance with customers' requirements and expectations, and in line with company policies.Following them will lead to continuous improvement. The four steps in the PDCA cycle are explained below. We generally agree with this opinion and believe the PDCA model is a valuable tool for ensuring a robust QMS, generating continuous improvement and maintaining ISO 9001 certification. A great idea is to periodically send tips to all employees.Īchieving and maintaining continuous improvementĪccording to the American Society for Quality, one of the most widely used tools for ISO 9001 continuous improvement is a four-step quality model – the plan-do-check-act (PDCA) cycle, also known as the Deming or Shewhart Cycle. We recommend keeping all employees involved in the ISO 9001 Quality Management System. The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement." To quote directly from the published ISO standard: "The organization shall continually improve the suitability, adequacy and effectiveness of the Quality Management System. Many small and medium-sized businesses err in thinking an ISO 9001 Quality Management System (QMS) is a static entity.Ī QMS needs to evolve in order to reflect your company's evolution it must be allowed to develop as market conditions change and your products and technologies improve.īy treating your QMS as a living entity, the more likely your company will realize quantifiable benefits and maintain ISO 9001 certification.Ī key requirement of ISO 9001:2015 is "continual improvement" – this refers not only to a company's products and services, but also to the QMS.