qmsWrapper Blog

If you want to use secured and reliable software, this is what you must know about QMS software validation.

A virtual audit is a method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence.

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.

Remote audits refer to the use of information and communication technology for collecting information, questioning audited personnel, etc.

Improvement means, in a way, finding the parameters that affect the realization of goals and submitting them to change.

It is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness.

The internal audit is one instrument for self-review of whether requirements are achieved. More in our next lesson.

This part of the ISO 9001:2015 is critical for assessment of the performance of your QMS. Find out more about monitoring, measurement, etc.

Controlling the nonconforming outputs will allow you to minimize their effect, map the problem, and track down the root cause – learn more with qmsWrapper.

Release of the product or services is about verification that the product and service requirements have been met according to customer requirements.

Learn how to control, identify and preserve production and service provision according to ISO 9001:2015, with qmsWrapper.

It all varies widely depending on the nature of the processes, products, and services.

ISO 9001 standard requires you to control the entire design and development cycle - explained step by step by qmsWrapper through its lectures.

This chapter is the point to determine exactly what your product's specifications are, and to evaluate them later, to make them clear, documented, etc.

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 is the key element of your QMS and it has to be controlled – why and how – find out here. ISO 9001 lectures by qmsWrapper.

Efficient flow of data, information, and knowledge shared between as requirements by ISO 9001.

Awareness of the QMS increases the motivation and devotion of employees in your company – emphasizes ISO 9001, clarifies qmsWrapper.

Follow trends related to MedDev industry with qmsWrapper. 5 fields are innovative and impactful as technology and healthcare are developing daily.

Employees' competency is crucial for your successfully produced product or service. What is the importance of training, education, and qualification?

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.

Understanding the purpose of the change is critical for the planning of the change – ISO 9001 - now easy to understand by qmsWrapper.

Quality objectives are measurable goals relevant to enhancing customer satisfaction. Learn how to establish objectives throughout your company.

Risk-based thinking will guide your top management to make better decisions. Find out more about actions on how to address risk.

How to define the hierarchy, functions, role, and relations in your company – easy to follow, by qmsWrapper.