ISO 17034 2016 Package

The ISO 17034 document package is designed to help laboratories achieve and maintain performance in accordance with international expectations. It provides guidelines for primary reference material production, quality control, and use, as well as good practices in this area. The documents focus on the identification, marking, and certification of primary reference materials by the responsible organizers.

They also include information on the scientific value of the products and guidance on the appropriate use of primary reference materials to help laboratories achieve and maintain accurate results. ISO 17034 documents are intended for suppliers, customers, and users of primary reference materials to build mutual confidence and improve the quality of results obtained from the use of the materials. They can also help laboratories to meet specific requirements imposed by customers or other entities.

👉What is ISO 17034?

ISO 17034, also known as the “Specifications for the capabilities of laboratories in the management of testing and calibration”, is an international standard that defines the requirements for the quality of the processes and capabilities needed to perform testing and calibration services.

This standard addresses areas such as qualified personnel, working environment, and specialized equipment, as well as organizational and documentation requirements. It also outlines how to maintain and regularly verify proficiency performance, as well as how to ensure a high level of practice that is consistent with the fundamental principles of ISO/IEC 17025.

ISO 17034 also requires an integrated quality management system that ensures that the laboratory’s internal documentation procedures are followed. This system must be adaptable to changes in the technical or organizational environment of the laboratory and include controls over the accreditation and operation of the laboratory. It should provide a complete record of the processes carried out by the laboratory, as well as clear documentary evidence that the technologies used are sufficiently reliable.

👉The requirements of the ISO 17034 standard?

• Qualified personnel.
• Environment and specialized equipment .
• Requirements for organization and documentation.
• Measures to maintain and regularly verify proficiency performance .
• Ensuring a high level of practice in accordance with the fundamental principles of ISO/IEC 17025 .
• An integrated quality management system that ensures compliance with the laboratory’s internal documentation procedures.
• Adaptability to changes in the technical or organizational framework of the laboratory .
• Controls over the accreditation and operation of the laboratory.
• Ability to provide a complete record of the processes performed by the laboratory .
• Clear documentary evidence that the technologies used are sufficiently reliable

👉This package will help you to

• Identify, mark, and certify primary reference materials by responsible organizers.
• Understand the scientific value of products and obtain guidance on the appropriate use of primary reference materials.
• Assist laboratories in meeting specific requirements imposed by clients or other entities.
• Ensure a high level of practice in accordance with the fundamental principles of ISO/IEC 17025.
• Provide a complete record of the processes performed by the laboratory and provide clear documentary evidence that the technologies used are sufficiently reliable.
• Implement an integrated system that ensures compliance with the laboratory’s internal documentation procedures.

👉 Who this package is for?

• Organizers responsible for Laboratories that must meet specific requirements imposed by customers or other entities.
• End users and professionals of primary reference products who are looking for quality certification
• Industry professionals who want to ensure that their products meet current standards
• Accreditation bodies, regulatory authorities, and laboratories who want to ensure that their processes comply with ISO 17034 standards
• Quality- and standards-conscious professionals around the world
• All organizations seeking internationally recognized certification for their product or service.
• Individuals interested in continuous improvement of their quality management system and testing/calibration practices.

👉 What are the expected results??

• Provide quality certification for primary reference material
• Assist laboratories in meeting specific requirements imposed by clients or other entities
• Ability to provide a complete record of the processes performed by the laboratory
• Clear documentary evidence that the technologies used are sufficiently reliable Meet and maintain compliance with industry standards
• Continuously improve the quality management system and testing/calibration practices.