Charles Wilson

The Quality Management System described in ISO 13485 manual must intended to meet the requirements of quality management system of ISO 13485 standards. It addresses Regulations quality system for the...

ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems in order to achieve compliance in the medical device industry. Meeting legislative...

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to prove its capability to provide medical devices and related services that constantly meet customer...

Getting an ISO 27001 certification is not easy to obtain but certainly provides a range of benefits to help prevent breaches of a business’s Information Security Management System (ISMS). The audit...

ISO 15378 is an ISO - International Organization for Standardization – a standard that specifies Good Manufacturing Practices (GMP) for producers of basic pharmaceutical packaging. It also specifies...

As you would know, ISO 13485 deals with the quality standards and requirements pertaining to the design and manufacture of medical devices. This ISO 13485 standard helps you to establish a...

Are you from the healthcare industry? Do you deal with the manufacturing of medical devices? Are you struggling to meet required quality standards? Then, you definitely need to know about ISO 13485...

The International Standard of ISO/IEC 17025 that demonstrates the general requirements for the competent, impartial, and consistent operation of laboratories. ISO 17025 specifies the activities that...

What is ISO 15189? ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, measures their competence and confirms...

To sell medical devices in the European Union (EU), there must be required to obtain CE Marking or apply CE Marking for product. CE Marking indicates that medical device complies with the applicable...

The Capability Maturity Model Integration (CMMI) provides a comprehensive framework that helps organizations enhance processes in several areas, such as development, service delivery, and acquisition...

A food safety culture is described as the food safety values, beliefs, and attitudes shared by any group of people. A healthy food safety culture of an organization determines the complete assurance...

Most of the people agree there do not seem to be sufficient hours in the day. No matter what is occupation, almost everybody has trouble getting everything done. But frequently the problem isn't that...

Today, any organization setting operates on electricity. Electrical equipment, from computers to machinery can all be possibly dangerous and can cause shock and burn damages if inappropriately used or...

The terminology audit checklist refers to a document that is developed during the audit planning stage. The document is essentially a list of the audit tasks that must be done during the audit. Most...