What documents and records are required under the ISO 9001:2015?

With this current ISO 9001:2015 standard, there are significant changes occurred in terms of requirements and documentation. Compare to previous ISO 9001:2008 version, standards seems to become quite liberal in terms of documentation. There are some major changes occurred in this new standard which are important to note for every industry.

Broadly saying, new standard no more require quality manual in place. Nevertheless, industry can evolve it if they wish to. Standard has now adopted common term as “Documented Information” in place of documents and records. However, it is still important to identify where there is a requirement of document and record. For it, standard uses term “Maintain documented information” for document requirement and “retain documented information” for record requirements.

Following list indicates the clause wise mandatory required documents and records that any organization need to present in order to get ISO 9001:2015 compliant.

Clause No.Document/RecordDocumented Information of
4.3DocumentThe scope of the organization’s quality management system
5.2DocumentThe quality policy of the organization
6.2.1DocumentThe quality objectives of the organization
7.1.5.1RecordFitness for purpose of the monitoring and measurement resources.
7.1.5.2RecordBasis used for calibration or verification (If any)
7.2RecordCompetence of person(s), Action taken to acquire the necessary competence
8.1RecordPlans and controls over the processes
8.2.3.2RecordReview of the requirements for products and services
8.3.3RecordDesign and development inputs
8.3.4RecordDesign and development controls
8.3.5RecordDesign and development outputs
8.3.6RecordDesign and development changes, results of reviews, the authorization of the changes and actions taken to prevent adverse impacts.
8.4.1RecordEvaluation, selection, monitoring of performance, and re-evaluation of external providers
8.5.1DocumentCharacteristics of the products to be produced, the services to be provided, or the activities to be performed and the results to be achieved.
8.5.2RecordIdentification and traceability
8.5.3RecordLost, damaged or unsuitable property of a customer or external provider along with information on what has occurred.
8.5.6RecordResults of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
8.6RecordRelease of products and services
8.7.2RecordType of nonconformity, actions taken, any concessions obtained and authority deciding the action
9.1.1Record Monitoring, measurement, analysis and evaluation results
9.2.2Record Implementation of the audit programme and the audit results.
9.3.3RecordResults of management reviews.
10.2.2RecordNon-conformities and corrective actions

2019-04-02T10:28:36+00:00