Quality Management ISO 9001
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
What is ISO 9001?
ISO 9001 is the first international management system standard that specifies the requirements for the establishment, implementation, operation, maintenance, and continual improvement of a quality management system in an organization.
ISO 9001 is based on seven quality management principles and it aims to help organizations be more efficient and improve customer satisfaction. The requirements of ISO 9001 are generic and applicable to any organization, regardless of its type, size, or the products or services it provides.
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Why should you attend one of our ISO 9001 training courses?
Many organizations are unable to fully realize the benefits of a QMS implementation. There are different factors which contribute to the inability to integrate the QMS into the organization’s processes. Such factors include, but are not limited to:
- The perception of the QMS as a system of documentation.
- The inability to identify nonconformities.
- The inability to ensure continual improvement.
Medical devices — Quality management systems Requirements ISO 13485:2016
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
What benefits will ISO 13485 bring to my organization ?
Safety and performance of medical devices are paramount in this highly regu- lated industry ; this is why quality management systems are a regulatory or legal requirement in many countries. ISO 13485 can help organizations involved in any part of a medical device’s life cycle :
- Demonstrate compliance with regulatory and legal requirements
- Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
- Manage risk effectively • Improve processes and efficiencies as necessary
- Gain a competitive advantage
ISO/IEC 17025:2017 TESTING AND CALIBRATION LABORATORIES
ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.
This standard now brings an element of risk assessment.
WHAT YOU NEED TO KNOW ABOUT ISO/IEC 17025
WHO IS ISO/IEC 17025 FOR?
ISO/IEC 17025 is useful for any organization that performs testing, sampling or calibration and wants reliable results. This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.
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