Vietnam Businesses: ISO 17025

1. Overview of ISO 17025

History and Evolution of ISO 17025

The history and evolution of ISO 17025 reflect significant updates in the 2017 version. This standard, first established in 1999, sets requirements for the competence of testing and calibration laboratories. The 2017 update introduced risk-based thinking, reducing prescriptive requirements in favor of performance-based ones. Greater flexibility was added for processes, procedures, and organizational responsibilities. This edition also introduced a clear definition of “laboratory” to ensure consistency. These changes aimed to enhance the standard’s applicability and efficiency, fostering better compliance and improved laboratory performance.

Differences between the ISO 17025:2017 standard and the old version

The ISO 17025:2017 standard introduces several significant changes compared to the previous version from 2005. One of the most notable updates is the incorporation of risk-based thinking, which has replaced some prescriptive requirements with more flexible, performance-based requirements. This shift allows laboratories greater autonomy in defining processes, procedures, and documentation, emphasizing outcomes over strict adherence to prescribed methods. Additionally, the 2017 version includes a formal definition of a “laboratory” to ensure clarity and consistency across different types of testing and calibration environments.

Another major difference is the increased focus on the flexibility of laboratory operations. The new standard provides laboratories with greater leeway in managing their organizational responsibilities and documented information. This flexibility extends to the implementation of management system options, which can be tailored to fit the specific needs and context of each laboratory. Moreover, the 2017 edition aligns more closely with the principles of ISO 9001, particularly in areas related to the management system and addressing risks and opportunities. This alignment helps laboratories integrate ISO 17025 more seamlessly into broader quality management systems

Definition and scope of ISO 17025

ISO 17025 is an international standard that specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It applies to all organizations performing laboratory activities, regardless of their size. This standard covers testing and calibration performed using standard, non-standard, and laboratory-developed methods. It ensures that laboratories have a quality management system in place and are technically competent. By adhering to ISO 17025, laboratories demonstrate their ability to produce valid results, fostering confidence in their work globally. Compliance with this standard also facilitates cooperation and the acceptance of results across different countries.

Key requirements and standards covered by ISO 17025

Technical Requirements:

• Equipment Calibration: Ensure accurate and periodic calibration of measuring equipment.
• Traceability of Measurement: All measurements must trace back to international measurement standards.
• Sampling Procedures: Establish and adhere to standard procedures to ensure sample reliability.
• Handling of Test Samples: Manage and handle test samples accurately and carefully.
• Environmental Conditions: Maintain suitable environmental conditions to ensure accurate test results.
• Continuous Quality Control: Implement regular quality control measures to ensure stability and reliability of results.
• Evaluation of Staff Competence: Ensure staff have the necessary skills and qualifications for testing and calibration.
• Risk Management: Identify and manage risks affecting the quality of test results.

Performance Requirements:

• Process Efficiency: Ensure testing and calibration processes are carried out effectively and consistently.
• Measurement and Monitoring: Establish a measurement system to monitor performance for continuous improvement.
• Internal Audits: Conduct regular internal audits to ensure compliance with standards and identify areas for improvement.
• Document Management: Maintain control over relevant documents, ensuring information is updated and easily accessible.
• Recovery and Contingency Capability: Develop measures to respond to emergency situations and ensure continuous operation.
• Data Analysis: Analyze data to evaluate performance and identify improvement trends.
• Transparency and Reporting: Ensure transparency in operations and provide accurate and timely reporting of results to customers.
• Leadership Commitment: Laboratory leadership must commit to and actively participate in maintaining and improving the quality management system.

The certification process

The certification process of ISO 17025 involves several key steps:

• Initially, the laboratory must conduct a gap analysis to identify areas that need improvement.
• Following this, the laboratory implements the necessary changes to meet ISO 17025 standards. Documentation of procedures and processes is essential.
• Next, an internal audit is performed to ensure compliance. The laboratory then applies for certification from an accrediting body.
• An external audit is conducted by the accrediting body, evaluating the laboratory’s adherence to ISO 17025 requirements. Preliminary document review assesses whether the laboratory is ready for formal evaluation.
• Subsequently, certification organization experts conduct the official assessment onsite. They examine the laboratory’s processes and quality management system.
• If any non-conformities are found, the laboratory must implement corrective actions and report back to the certification organization.
• Once non-conformities are addressed and accepted by the certification organization, the laboratory receives ISO 17025 certification.
• The certification body then conducts regular audits to ensure the laboratory continues to comply with ISO 17025 requirements.

2. Importance of ISO 17025 Certification

ISO 17025 enhances the credibility and reputation of laboratories. This standard assures that laboratories operate competently and generate valid results. Meeting ISO 17025 requirements demonstrates a commitment to quality, fostering trust among clients and stakeholders. Laboratories with ISO 17025 certification are seen as reliable and professional, boosting their market competitiveness.

Ensuring consistency and reliability of results is a key benefit of ISO 17025. The standard mandates procedures for monitoring the validity of results and applying statistical techniques to detect trends. It includes using reference materials, inter-laboratory comparisons, and proficiency testing. This systematic approach ensures laboratories produce accurate and consistent results.

ISO 17025 plays a vital role in facilitating global trade and collaboration. By ensuring that laboratories worldwide adhere to consistent standards, it promotes mutual recognition of test results. This harmonization reduces technical barriers and fosters trust between trading partners. Consequently, companies can more easily enter international markets, knowing that their products meet universally accepted criteria.

Moreover, ISO 17025 encourages cooperation between laboratories and other entities across borders. This standardization simplifies the exchange of information and methodologies, leading to more efficient and reliable collaborations. As a result, it enhances innovation and development through shared knowledge and resources, ultimately benefiting global industries.

3. Vietnamese Companies Certified to ISO 17025

Prominent Vietnamese companies with ISO 17025 certification

1. Techmaster Electronics Joint Stock Company
169/1/5 Luong Dinh Cua Street, An Khanh Ward, Thu Duc City
Ho Chi Minh City Viet Nam
Techmaster Việt Nam stands out among prominent Vietnamese companies with its ISO 17025 certification, showcasing a commitment to quality and reliability in testing and calibration services. This certification underscores Techmaster’s adherence to international standards, ensuring impartiality, confidentiality, and accurate results. By meeting ISO 17025 requirements, Techmaster demonstrates its technical competence through qualified personnel, robust infrastructure, and advanced equipment. Case studies highlight Techmaster’s success in implementing effective processes for method selection, result validation, and risk management. This certification not only enhances Techmaster’s credibility but also fosters trust among clients, affirming its capability to deliver consistent and dependable laboratory outcomes.

2. Micro Precision Calibration Vietnam Ltd. Co. – Ho Chi Minh City
No. 201, 2nd Floor, Sacom Chipsang Building Saigon High Tech Park, Thu Duc City
Ho Chi Minh City Viet Nam

3. UL VS (VIET NAM) CO. LTD.
Lot C5, Conurbation 2, Street K1, Cat Lai Industrial Zone, Thanh My Loi Ward, District 2
Ho Chi Minh City   Viet Nam

4. CalTek Electronics Joint Stock Company
03rd Floor Ha Nam Plaza, West Quarter, Vinh Phu Ward Thuan An Town
Ho Chi Minh City, Binh Duong Province Viet Nam

Sectors and industries with high certification rates

The food industry in Vietnam has seen a significant rise in ISO 17025 certifications. Companies in this sector prioritize quality control and safety standards. ISO 17025 certification ensures that their testing laboratories produce reliable and accurate results. This focus on certification helps the food industry maintain high safety standards, crucial for consumer trust.

The healthcare sector in Vietnam also has a high rate of ISO 17025 certifications. Medical testing laboratories adopt these standards to ensure accurate diagnostic results. This certification is essential for patient safety and effective treatment. Environmental testing laboratories in Vietnam have also embraced ISO 17025 standards. These labs need to meet stringent regulatory requirements, and ISO 17025 certification helps them achieve that. The high certification rates in these sectors demonstrate their commitment to maintaining high testing standards. This certification underscores their dedication to quality, accuracy, and compliance.

Another sector with high certification rates is the electronics industry. Companies in this field need precise and reliable testing to ensure product compliance and safety. ISO 17025 certification is vital for maintaining high-quality standards in electronic products.

4. Common challenges faced by Vietnamese companies in achieving ISO 17025

Achieving ISO 17025 certification poses several challenges for Vietnamese companies. Many struggle with the high costs of implementing necessary changes. These costs include upgrading equipment, training personnel, and modifying existing processes. Additionally, maintaining compliance with ISO 17025 standards requires continuous effort and resources. Companies often face difficulties in understanding and interpreting the complex requirements of the standard. Limited access to local expertise and consultants further complicates the certification process. Moreover, companies must balance certification efforts with their regular operations, which can strain their resources and productivity. Finally, cultural resistance to change can hinder the adoption of new practices and procedures​.

5. Ensuring Accreditation Credibility: A Guide to Proper ISO 17025 Logo Usage

• Direct Association: Use the logo only in direct association with accredited activities.
• Accurate Representation: Ensure the logo accurately represents compliance with ISO 17025.
• Avoid Misuse: Do not use the logo for non-accredited services.
• Maintain Credibility: Adhering to these guidelines helps maintain trust and credibility in the ISO 17025 standard.
• Penalties: Misuse of the logo can lead to penalties from the accrediting body.

6. ISO 17025 Certification Bodies

ISO 17025 certification bodies play a crucial role in verifying and ensuring the quality of testing and calibration laboratories. These organizations include national and international accreditation bodies such as A2LA (American Association for Laboratory Accreditation), ANAB (ANSI National Accreditation Board), UKAS (United Kingdom Accreditation Service), and JAS-ANZ (Joint Accreditation System of Australia and New Zealand). These bodies evaluate laboratories based on the stringent standards of ISO 17025. They ensure that laboratories meet and maintain the requirements for technical competence and quality management.