The Quality audit process required in ISO 9001 specifies that you have to do internal audits and yearly external audits to maintain system certification.
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ISO 9001 is the most popular quality management system standard which is recognized across the world. ISO 9001 helps organizations in increasing customer satisfaction and higher operational efficiency by prescribing a systems approach to business processes. Apart from the operational benefits, ISO 9001 certification provides a marketing edge and increased brand image to certified organizations. ISO 9001 is a generic standard which can be used across all industry types, all sizes and all types. ISO 9001:2015 is the latest version of the ISO 9001 standard. ISO 9001:2015 has brought in few major changes to its previous versions. Considering the Organizational context, analyzing the risks and opportunities of the organization, considering the interested parties of the organization in the design and development of an organization’s Quality management system are the major changes.
Internal audit is one of the primary requirements of ISO 9001 certification. Internal audit refers to the audit of various functions/departments of the organization by trained auditors. Internal audits are conducted by auditors who are qualified as ISO 9001 internal auditors. Organizations are required to have a defined process/procedure for the internal audit. Typically, the internal audit process/procedure covers the selection of departments for the audit, determining the audit frequency, selecting the auditors, communicating the audit schedule, conducting the audit and reporting the audit findings. Typically, organizations prepare their own internal audit checklist which is used to conduct the internal audit. This checklist covers the list of points to be audited. This checklist covers the requirements of the ISO 9001 standard as well as the requirements of the Quality Management system of the organization.
The journey of ISO 9001 certification has typically been a manual exercise with Quality Management system documents being prepared by QMS consultants, followed by training and deployment. With improvement in technology, the use of web based applications for QMS has increased. The workflow of the entire internal audit process is automated by these applications. The roles of auditor, auditee, Quality assurance function are programmed in such a way that the entire audit process sails smoothly across the different stakeholders.
Effivity is well known Quality Management system software which facilitates the QMS definition and deployment, based on ISO 9001:2015. Effivity offers a readymade platform which automates the entire internal audit process, end to end. By using this application, compliance to the defined internal audit procedure is ensured by default. Also, Effivity has been built based on a predefined internal audit procedure which is well in line with the requirements of ISO 9001:2015.
Added to that is the expertise of experienced quality management professionals is built into the internal audit procedure. Another advantage is that the Effivity application facilitates seamless deployment of the internal audit procedure across the organization, irrespective of the size of the organization, number of locations and functions. Apart from acting as a one stop repository for all the documents and records that are demanded during the ISO 9001 external audit, Effivity acts as a repository for all the internal audit reports of the organization, which can be accessed anywhere, anytime.