Table 7- Required Documentation for ISO 9001:2015 Clause [Document Information Descri 43 ‘Scope ef the QMS Describe products and services covered and justty anything the organization decides is out of scope for ISO 9001:2015. AA2 | Operation of OMS processes Maintain documents that support the operation of the QMS and retain documents that provide confidence and evidence that processes are being carried out correctly 522 | Communicating Quality policy Distribute and facilitate interaction with the Quality policy ‘Quanity Objectives Maintain documentation of the Quality objectives and their relevance to the OMS. Resources Maintain documentation that provides evidence of the suitability of menitoring and measuring resources for the OMS. Measurement traceability Maintain the basis for calibration or verificaton az documented information when ne standards for these activities ext 72 ‘Competence Retain documentation as evidence of the competence of all human resources supporting the OMS. 75.1 |Decumented Information Nginesin documentation required by ISO 9001:2015 for the effectiveness of the OMS. ‘Creating ang updating Ensure that all documentation has appropriate identific eseription, formas, and review policies. i ‘Control af documented inform: Ensure documentation is available for use and adequately protected by effective information governance policies. ‘Operational planning and control Provide gevernance of documentation to demenstrate that process Products and services have met all requirements and expectations. Requirements fer products and services Retain documentation to demonstrate reviews of the requirements for products and services and of any new or additional requirements. ‘Changes to requirements for products and se ‘Amend documentation te reflect changes to the requirements fer products and services. 2.3.3 | Design and development inputs Retain documentation relating to design and development inputs. 83.4 — | Design and development controls Retain documentation of the controls relating to the gesign and development process 235 | Design and development outputs Retain documentation relating to the design and development outputs. 836 _ | Design and development changes Retain documentation relating to any changes to the design and evelopment controls. B41 | Control ofesternal processes, products | Retain documentation relating to externally provided processes, products and services, B51 | Control of preduction and service Ensure the availability of Gocumentation that defines the provision characteristics of the product. services, and activities, as well as the results of each, &5.2 | Identification and traceability Maintain documentation to ensure traceability of outputs and of products and services. 5.3 | Property belonging to customers or | Retain documentation relating to any incident involving customer oF extemal providers rovider property while in the care. of the organi B56 | Control ofchanges Retain documentation relating to any incident involving customer or external provider property while in the care of the organization, 86 Release of products and services Retain documentation of + the conformity of the release of products and services with accep. tance criteria, and +_traceability relating co the authorization of the release. 87.2 _ | Control of noneonforming outputs Retain documentation relating to nonconforming outputs 3.1.1 | Monitoring measurement, analysis and | Retain documentation relating to the monitoring, measurement, analycis and evaluation of the QMS. Internal audit Retain documentation relating te audits of the OMS. 933 | Management reviewo Retain documentation of results of management reviews of required changes and improvements 10.2.2 | Nenconformity and corrective action _ | Retain documentation on nonconfarmities and corrective actions taken.