The role of ISO 17025 in activities of laboratories

With regard to the quality of laboratories, ISO/IEC 17025 has currently considered as the first international standard certifying the capability of laboratories all over the world.

Over the past few decades, Vietnam has participated in most large economic organizations in the world such as WTO, AFTA, and so on. Thanks to following the open door and integration policies, Vietnam has grasped many potential opportunities. However, unless there are the “strength” and “ high status”, it is hard for Vietnam to take the advantage of the participation in such organizations effectively or even worse, we can suffer big losses. Entering WTO, AFTA requires Vietnam to perceive the laws, conventions, and treaties and meet requirements enacted by these establishments.

Establishing laboratories that meet the requirement of ISO/IEC 17025 for the sake of integrating into the world economy

In the field of testing and calibration, it is essential to have a common standard to standardize the results. To do that such results have to originate from “globally- certified” laboratories. This indicates the significance of accreditations in reducing technical barriers in trade; avoid the repetition of testing/certifying activities, save time and money; build up the reputation of laboratories in the eyes of clients including direct and indirect customers.

For each batch of goods, there will be an attached test result of the product sample taken from that lot. These results are frequently required to be globally-accepted. As a result of the integration trend, there are more and more opportunities for businesses in Vietnam to export their products abroad. At the same time, the demand for sending sample tests to internationally-certified laboratories is increasing rapidly.

General information about ISO/IEC 17025

ISO/IEC 17025 was established based on the demand of having a common standard concerning the capability of laboratories in the world. Certification bodies certifying the capability of laboratories will use this standard as a foundation of the certification. The latest version of this standard is ISO 17025:2017 with improvements accredited by ISO/IEC 17025.

Benefits of applying ISO 17025

Once the capability of a lab is international - certified, it is likely to gain more advantages and opportunities than other uncertified ones. As the economies are gradually entering the process of globalization, getting ISO 17025 will become inevitably not only for foreign countries but also for Vietnam.

The basis for an internationally-recognized laboratory is that that lab must be accredited by an organization (such as VILAS) in accordance with the international standard ISO / IEC 17025: 2005.

Besides, the application of ISO/IEC 17025 not only helps businesses to focus resources to improve capacity but also builds their reputation through tests and results.

More importantly, the results of measurement/tests from accredited laboratories are recognized by the State.

This is confirmed in Article 16 Chapter III in Decree 179/2004 / ND-CP

According to the decree, it is clearly stated that “The results of testing, inspection and quality certification of products, goods and quality management systems of the corresponding testing, inspection and certification organizations are given priority as legal documents in product and goods quality management activities in the country and trade relations with foreign countries ”.

The first benefit is to enhance the credibility of customers.

Steps to construct laboratories according to ISO 17025

STEP 1:

Leaders of laboratories should perceive the standard and determine the scope of application in their laboratories. Furthermore, they need to be aware of the role of ISO 17025 explicitly, and orient their activities to define specific objectives and conditions of application.

STEP 2:

The management board establishes a steering committee for the ISO 17025 project. Normally, the business will elect this committee at the lab. This department will include representatives of the leadership and departments within the scope of application of ISO 17025. Then a technical leadership representative will be appointed to direct the application of ISO 17025 on behalf of the management board and be in charge of the technical activities of the lab.

STEP 3:

Evaluate the current situation of the laboratories in comparison to the requirements of the standard. It is necessary to review process-oriented activities, consider which requirements are not applicable and the current response level of the activities in the laboratory. This assessment serves as a basis for determining activities that need to be changed or supplemented, from which a detailed implementation plan is developed.

STEP 4:

Design a system and compile documentation of ISO 17025. The document system should be built up and completed in order to meet the requirements of the standard and executive  demand of the lab which includes:

• ISO 17025 Handbook
• Related processes and procedures
• The necessary work instructions, statutes and regulations

STEP 5:

Apply ISO 17025 by following these steps:

Disseminate to all lab employees the right and sufficient pre-audit about ISO 17025.

Instructing employees to follow the established procedures and guidelines

Define responsibilities and powers related to each specific process and procedure.

STEP 6:

Audit internally and prepare for ISO 17025 certification audits:

• Organize internal audits to determine the suitability of the system and conduct necessary corrective and preventive activities.
• Select certification body: Enterprises have the right to select any certification body to evaluate and issue a certificate because every ISO 17025 certificate has the same value regardless of the organization that issued it.

Audit before certification to determine the level of completeness and availability of the ISO 17025 system for certification audits. This activity is usually carried out by Certification Organization.

STEP 7:

The assessment by the Bureau of Accreditation is carried out to assess the suitability of the system following ISO 17025 and a certificate of laboratory competence will be awarded.

STEP 8:

The laboratory needs to maintain the system of ISO 17025 after being awarded. With the issues after being overcome through the evaluation process, the laboratory needs to maintain and improve the activities to meet the requirements of the standards. Laboratory managers should use ISO 17025 to continually improve their systems.

It can be said that if a laboratory wants to develop and survive, it is necessary to be accredited by ISO 17025. This needs to conform to the ISO 17025: 2017 standard which is mandatory whether it is the laboratory of a private enterprise or the laboratory of an old multinational corporation in the world