When an eQMS is implemented in a medical device company, such software must be validated. It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the…
A remote audit, also known as virtual audit, is the method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence, just like during an on-site audit. The overall aim is to evaluate this evidence objectively to determine the…
Remote audits may have many benefits when it comes to efficiency, access to competence, increased reach and mitigating risks. But companies have to use it in the right context. The main benefit of remote auditing is cost flexibility. Auditors will incur fewer costs through every remote audit they conduct, such as…
Audits are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system performance, evaluating the adequacy and effectiveness of the quality management system; etc. A remote internal audit is usually done partially or completely off-site employing…
Lecture summary: In this part of ISO 9001 – Improvement means, in a way, finding the parameters that affect the realization of goals and submitting them to change. The challenge is to identify the specific processes that have the most effect on the conformity of goods to customer…
Lecture summary: A management review is a management tool in the hands of the top management for evaluating the QMS. It is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness. The QMS has to be reviewed at…
Lecture summary: An internal audit is an effective tool that is used for self-assessment of your organization and to determine the extent to which it fulfills the QMS requirements. The audit findings will show you the effectiveness of your QMS and identify nonconformities and opportunities for improvement. ISO 9001…
Lecture summary: ISO 9001 Standard considers this activity as one of the tools that promote the improvement of the QMS. It aims to reflect the quantitative and qualitative performance of your QMS. In this clause, it’s expected from you to plan and decide on how you…
Lecture summary: Treating and managing nonconformities is one of the basic objectives of the ISO 9001 Standard. Nonconforming outputs are the outputs of processes that don’t meet a needed requirement or an expectation of one of the interested parties of the organization that are specified, implied,…
Lecture summary: Release of the product or services is about verification that the product and service requirements have been met according to customer requirements. Release activities aim to ensure that the realization of the product or the service has been expectedly completed and that the product or…
