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 complaint.
Clause No. | Document/Record | Documented Information of |
4.3 | Document | The scope of the organization’s quality management system |
5.2 | Document | The quality policy of the organization |
6.2.1 | Document | The quality objectives of the organization |
7.1.5.1 | Record | Fitness for purpose of the monitoring and measurement resources. |
7.1.5.2 | Record | Basis used for calibration or verification (If any) |
7.2 | Record | competence of person(s), Action taken to acquire the necessary competence |
8.1 | Record | Plans and controls over the processes |
8.2.3.2 | Record | Review of the requirements for products and services |
8.3.3 | Record | Design and development inputs |
8.3.4 | Record | Design and development controls |
8.3.5 | Record | Design and development outputs. |
8.3.6 | Record | Design and development changes, results of reviews, the authorization of the changes and actions taken to prevent adverse impacts. |
8.4.1 | Record | Evaluation, selection, monitoring of performance, and re-evaluation of external providers, |
8.5.1 | Document | Characteristics of the products to be produced, the services to be provided, or the activities to be performed and the results to be achieved. |
8.5.2 | Record | Identification and traceability |
8.5.3 | Record | Lost, damaged or unsuitable property of a customer or external provider along with information on what has occurred. |
8.5.6 | Record | Results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review. |
8.6 | Record | Release of products and services |
8.7.2 | Record | Type of nonconformity, actions taken, any concessions obtained and authority deciding the action |
9.1.1 | Record | Monitoring, measurement, analysis and evaluation results |
9.2.2 | Record | Implementation of the audit programme and the audit results. |
9.3.3 | Record | Results of management reviews. |
10.2.2 | Record | Non-conformities and corrective actions |
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