qmsWrapper Blog

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.

The quality policy is a document where you should state your commitment to your improvement. Learn more about how to establish it and maintaining it.

Leadership is like the steering wheel of the company and commitment is the key to success. All that you need to know about the 5.1 clauses of ISO 9001 Standard.

It’s the ISO 9001 requirement and it explains how to maintain your internal and external issues in your company. qmsWrapper made it easy to understand.

Find out what is the core of the ISO 9001 standard. qmsWrapper explained it all in simple terms, for QMS beginners. Learn more.

qmsWrapper brought the library folder to its full potential. The easy-access place to put what you need to find easily and much more. Find out here.

Find out if and when you need to perform a GAP analysis for implementing your ISO 9001 or ISO 13485. Learn more about GAP analysis activities.