Iso 9001 2015 documented information guidlines

Iso 9001 2015 documented information guidlines

• 1.
  ISO 9001:2015 DOCUMENTED INFORMATION GUIDLINES
• 2.
  Clause 7.5 of ISO9001:2015 • The term documented information refers to information that must be controlled and maintained and its supporting medium. • Documented information can be in any format and on any medium and can come from any source
• 3.
  Objectives of Documented information •Communication of Information • Evidence of conformity • Knowledge sharing • Preserve the organization’s experiences.
• 4.
  Documents may bein any form or type of medium • paper • magnetic • electronic or optical computer disc • photograph • master sample
• 5.
  DOCUMENTED INFORMATION Shall include?
• 6.
  Documents Required forISO 9001:2015 & Documents necessary for the effectiveness of the quality management system
• 7.
  D.I - Neededto be maintained by the organization for the purposes of establishing a QMS − The scope of the quality management system (clause 4.3). − Documented information necessary to support the operation of processes (clause 4.4). − The quality policy (clause 5.). − The quality objectives (clause 6.2). − This documented information is subject to the requirements of clause 7.5.
• 8.
  Documented information necessaryforthe organization to operate − Organization charts − Process maps, process flow charts and/or process descriptions − Procedures − Work and/or test instructions − Specifications − Documents containing internal communications …………Continue
• 9.
  Documented information necessaryforthe organization to operate − Production schedules − Approved supplier lists − Test and inspection plans − Quality plans − Quality manuals − Strategic plans − Forms
• 10.
  DOCUMENTED INFORMATION RECORDS
• 11.
  Records are: • Documentedinformation needed to be retained by the organization for the purpose of providing evidence of result achieved
• 12.
  Records Include: • −Documented information to the extent necessary to have confidence that the processes are being carried out as planned (clause 4.4). • − Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1). • − Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2). • − Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS (clause 7.2).
• 13.
  Records Include: • −Results of the review and new requirements for the products and services (clause 8.2.3). • Records needed to demonstrate that design and development requirements have been met (clause 8.3.2) • − Records on design and development inputs (clause 8.3.3). • − Records of the activities of design and development controls (clause 8.3.4). • − Records of design and development outputs (clause 8.3.5).
• 14.
  Records Include: • −Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6). • − Records of the evaluation, selection, monitoring of performance and re‐ evaluation of external providers and any and actions arising from these activities (clause 8.4.1) • Evidence of the unique identification of the outputs when traceability is a requirement (clause 8.5.2). • − Records of property of the customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to the owner (clause 8.5.3).
• 15.
  Records Include: • −Results of the review of changes for production or service provision, the persons authorizing the change, and necessary actions taken (clause 8.5.6). • − Records of the authorized release of products and services for delivery to the customer including acceptance criteria and traceability to the authorizing person(s) (clause 8.6). • − Records of nonconformities, the actions taken, concessions obtained and the identification of the authority deciding the action in respect of the nonconformity (clause 8.7).
• 16.
  Records Include: • −Results of the evaluation of the performance and the effectiveness of the QMS (clause 911) • − Evidence of the implementation of the audit programme and the audit results (clause 9.2.2). • − Evidence of the results of management reviews (clause 9.3.3). • − Evidence of the nature of the nonconformities and any subsequent actions taken (clause 10.2.2).; • − Results of any corrective action (clause 10.2.2).
• 17.
  Thank You Rajeesh thumpayil