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ISO 17025/ ISO 15189

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. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

ISO 15189 standard, Medical laboratories - Requirements for quality and competence, hereafter referred to as ISO 15189, was first published in 2003 and revised in 2007 and again in 2012. ISO 15189 is not a tool merely to meet accreditation requirements or provide quick fixes for individual mistakes. Instead, laboratories implementing ISO 15189 strive to: Create systems that are as failure resistant as possible, will catch mistakes before they become a problem, and reduce errors by getting things right the first time Identify opportunities for improvement at all times Involve and empower their staff by involving them in the solving of problems and the implementation of solutions.  

Integration with other standards:

ISO/IEC 17025 and/or ISO 15189 can be implemented as it has been based on ISO 9001. It is international recognition, and is an auditable standard which can be accredited by certification body. When a business already has ISO 9001 in place, achieving the standard becomes much simpler. Quality Associates is an expert in system integration. We can embrace the standard into other management systems such as ISO 14001, ISO 45001, ISO 9001 and others that related to your business as your needs. Please contact our customer service for inquiry. CONTACT US!

IH Training

ISO/IEC 17025

standard requirement training The training course will also demonstrate the compliance of ISO 17025 with those ISO 9001 and GLP (Good Laboratory Practice) requirements that are relevant to the scope of testing services. The course includes;

Quality Management Principals

Process Approach and Laboratory Practice

ISO/IEC 17025– Requirements interpretation

Documentation for laboratory

Risk Management

The laboratory is inherently risky, and in order for any organization to succeed in today’s fast paced, environment, the ability to proactively identify, assess and reduce risk and uncertainty is essential, but is not always managed effectively. This training course is suitable for a wide range of professionals who are involved in any aspect of Risk Management. the content incluses;

Introduction of Risk-based thinking

Risk management framework

The use of ISO 31000 in Laboratory

Risk assessment tools

Internal Audit

One of the key tools for ensuring the suitability and effectiveness of your aerospace Quality Management System (QMS) is the internal audit process. The internal audit process is a systematic way to compare what is actually happening in your processes to what the expected outputs of your processes are. By doing this you can ensure that your processes are happening as planned and therefore implemented correctly, and you can assess the effectiveness of the processes in place.

Learn the audit conventions for preparing, performing, reporting, and follow-up. You will learn what they need to know to conduct an audit using ISO/IEC 17025 (or ISO 15189) standard as required by customer.