qmsWrapper Blog
Validation efforts
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 system fits for purpose.
Software validation process
Validation for intended use...
Benefits of remote auditing
Remote audits can have many benefits in terms of efficiency, access to competencies, increased reach and risk mitigation. Check out what the benefits might be.
Do remote audits becoming 'new normal'?
Remote audits refer to the use of information and communication technology for collecting information, questioning audited personnel, etc.
Continual Improvement and Nonconformity and corrective action – Lecture 24
Improvement means, in a way, finding the parameters that affect the realization of goals and submitting them to change.
Management review – Lecture 23
It’s is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness – learn how with qmsWrapper.
Internal audit – Lecture 22
It’s an effective tool that is used for self-assessment of your organization and to determine the extent to which it fulfills the QMS requirements – find out more with qmsWrapper.
Monitoring measurement, analysis, and evaluation – Lecture 21
This part of the ISO 9001:2015 is critical for assessment of the performance of your QMS. Find out more about monitoring, measurement, etc.
Control of Nonconforming Outputs – Lecture 20
Controlling the nonconforming outputs will allow you to minimize their effect, mapping the problem and tracking down the root cause – learn more with qmsWrapper.
Release of products and services – Lecture 19
Release of the product or services is about verification that the product and service requirements have been met according to customer requirements.
Production and service provision – Lecture 18
Learn how to control, identify and preserve production and service provision according to ISO 9001:2015, with qmsWrapper.
Control of externally provided processes, products, and services – Lecture 17
It all varies widely depending on the nature of the processes, products, and services.
Design and Development of products and services – Lecture 16
ISO 9001 standard requires you to control the entire design and development cycle - explained step by step by qmsWrapper through its lectures.
Requirements for products and services – Lecture 15
In this chapter is the point to determine exactly what your product's specifications are, and to evaluate them later, to make them clear, documented, and … Learn more, explained by qmsWrapper.
Operational planning and control – Lecture 14
The ISO 9001 requires practical actions for planning and control so you can conduct it through the processes. It includes a Quality plan as well – learn more.
Documented information – Lecture 13
Documented information is the key element of your QMS and it has to be controlled – why and how – find out here. ISO 9001 lectures by qmsWrapper.
Communication of support – Lecture 12
Efficient flow of data, information, and knowledge shared between as requirements by ISO 9001.
Awareness of support in ISO 9001 – Lecture 11
Awareness of the QMS increases the motivation and devotion of employees in your company – emphasizes ISO 9001, clarifies qmsWrapper.
Top 5 trends in the MedDev industry for 2021
Follow trends related to MedDev industry with qmsWrapper. 5 fields are innovative and impactful as technology and healthcare are developing daily.
Competence in Support of ISO 9001 – Lecture 10
Employees' competency is crucial for your successfully produced product or service. Importance of training, education, qualification explained by qmsWrapper team.
Resources of Support – Lecture 9
They are critical zones and should be support for achieving your QMS goals, aligned with the objectives – how, why, when – more here in lectures by qmsWrapper.
Planning of changes – Lecture 8
Understanding the purpose of the change is critical for the planning of the change – ISO 9001 - now easy to understand by qmsWrapper.
Quality objectives and planning to achieve them – Lecture 7
Quality objectives are measurable goals relevant to enhancing customer satisfaction. Learn how to establish objectives throughout your company.
Planning: Actions to address risks and opportunities – Lecture 6
Risk-based thinking will guide your top management to make better decisions. Find out more about actions on how to address risk.
Organizational Roles, Responsibilities, and Authorities – Lecture 5
How to define the hierarchy, functions, role, and relations in your company – easy to follow, by qmsWrapper.