Documented information required by the QMS (7.5.1b). Evidence of competence of people doing work under the control of the organization that affects the performance and effectiveness of the QMS (7.2). Evidence of the basis used for calibration of the monitoring and measurement resources (7.1.5.2). Evidence of fitness for purpose of monitoring and measuring resources (7.1.5.1). Information necessary to support the operation of QMS processes (4.4). The scope of the quality management system (4.3). Your organization must have the following documents and records available (for re-certification over a period of three years): Maintain and retain the following quality management system documentation: ‘Access’ can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information. The organization needs to determine the level of documented information necessary to control its management system. Documented information can be in any format and media and from any source. are all examples of ‘documented information’. Operational procedures, work instructions, flow charts, process maps, signs, placards, container markings, labels etc. The terms ‘documented procedure’ and ‘record’ used in earlier versions of the starndards have been replaced by the term ‘documented information’, which is defined as the information required to be controlled and maintained by an organization, as well as the medium on which it is contained. If you need a procedure and forms to help control your business's documents and records, click here.Įnsure that your organization’s management system includes the documented information that is required to be maintained and retained by ISO 9001, ISO 14001 and ISO 45001, and the documented information identified by the organization to demonstrate the effective operation of its management system processes as defined below. It should be noted that there is no need to maintain a documented procedure but organizations may still chose to operate one. 
The guidance shown on this page is relevant to ISO 9001, ISO 14001 and ISO 45001. Our range of templates cover the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement your next management system. ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret and better implement the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.
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