ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
According to the American Society for Quality, a quality management system (QMS), is a “formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.” A QMS will allow a company to meet customer needs and continually improve its effectiveness and efficiency. A quality management system should help an organization recognize and then address their needs, in addition to their customers’ needs. All quality management systems have similar elements which help achieve this goal:
Leaders in the organization will need to have the following: Customer Commitment and Focus,Quality Policy,Quality Objectives,QMS Plans,Defined Responsibilities, Authority, and Communication ,Management Review
Management will be required to provide resources to their employees across multiple departments to understand, implement, and maintain ISO requirements: Infrastructure Resource,Work Environment,Human Resources,Competence,Awareness,Training for HR
This section of the ISO 9001 is the only area where organizations can choose to opt-out of some of the requirements mentioned. For example, companies that do not provide design work or services can disregard the section outlining design requirements.
The remaining requirements that must be fulfilled by companies seeking ISO 9001 certification are related to planning for products and/or services:
This final section of the ISO 9001 outlines the tools needed to understand how effective your QMS is and whether or not it builds a foundation for continual improvement
