Thread Content
Which clauses of the ISO9001:2015 quality management system require documentation? ●4.3 Determining the scope of the quality management system: The scope of an organization’s quality management system should be documented as information that is available and maintained. ●4.4.2 Quality management system and its processes: a. Maintain documented information to support the operation of processes; b. Keep documented information to ensure that processes are carried out as planned. ●5.2.2 Communicating the quality policy: The quality policy should be a) available and maintained as documented information. ●6.2.1 [Quality objectives and planning for their achievement]: An organization should maintain documented information related to quality objectives. ●7.1.5.1 General requirements for monitoring and measurement resources: An organization should keep appropriate documented information as evidence that monitoring and measurement resources are suitable for their intended use. ●7.1.5.2 Measurement traceability: a. Calibrate and/or verify measurements against standards that can be traced to international or national standards at specified intervals or before use; if such standards are not available, documented information that can serve as a basis for calibration or verification should be kept. ●7.2 Competence: d. Keep appropriate documented information as evidence of personnel competence. ●8.1 Planning and control of operations: e. Determine and maintain documented information, to the necessary extent, to: 1–Ensure that processes are carried out as planned; 2–Verify that products and services meet requirements. ●8.2.3.2 Review of product and service requirements: Where applicable, an organization should keep documented information related to: a. Results of reviews; b. New requirements for products and services. ●8.2.4 Changes to product and service requirements: If there are changes to product and service requirements, an organization should ensure that the relevant documented information is updated, and that relevant personnel are aware of the changed requirements. ●8.3.2 Planning for design and development: j. Keep documented information required to demonstrate that design and development requirements have been met. ●8.3.3 Design and development inputs: An organization should keep documented information related to design and development inputs. ●8.3.4 Control of design and development: f. Keep documented information related to these activities. ●8.3.5 Design and development outputs: An organization should keep documented information related to design and development outputs. ●8.3.6 Changes to design and development: An organization should keep documented information related to: a. Changes in design and development; b. Results of reviews; c. Authorization for changes; d. Measures taken to prevent adverse effects. ●8.4.1 Control of externally provided processes, products, and services: General requirements: An organization should establish and implement criteria for evaluating, selecting, monitoring performance, and re-evaluating external suppliers, based on their ability to provide processes, products, and services as required. For these activities and any necessary actions resulting from evaluations, the organization shall retain documented information. ●8.5.1 Control of production and service provision a. Documented information that is available 1–Characteristics of the products to be produced, services to be provided, or activities to be carried out 2–Desired outcomes ●8.5.2 Identification and traceability When traceability is required, the organization shall control the unique identification of outputs and shall retain the necessary documented information to enable traceability. ●8.5.3 Customer’s or external supplier’s property If customer’s or external supplier’s property is lost, damaged, or found to be unsuitable, the organization shall inform the customer or external supplier and retain documented information regarding what occurred. ●8.5.6 Change control The organization shall retain documented information, including the results of change reviews, the persons authorized to make changes, and the necessary actions taken as a result of those reviews. ●8.6 Release of products and services The organization shall retain documented information related to the release of products and services. The documented information includes: a. Evidence meeting the acceptance criteria; b. Information traceable to the authorized person who gave permission for release. ●8.7.2 Control of non-conforming outputs The organization shall retain the following documented information in order to: a. Describe the non-conformities; b. Describe the actions taken; c. Describe any concessions granted; d. Identify the authorized person responsible for dealing with the non-conformities. ●9.1.1 General principles for monitoring, measuring, analyzing, and evaluating The organization shall retain appropriate documented information as evidence of the results obtained. ●9.2.2 Internal audits f. Retain documented information as evidence of the audit plan implemented and of the audit results. ●9.3.3 Outputs of management review The organization shall retain documented information as evidence of the results of management reviews. ●10.2.2 Non-conformities and corrective actions The organization shall retain documented information as evidence of the following: a. The nature of the non-conformities and the actions taken thereafter; b. The results of the corrective actions taken