The NVLAP is transitioning to ISO/IEC 17025:2017-General requirements for assessing the competence of testing and calibration laboratories. Accreditation to ISO/IEC 17025:2005 will not be recognized as of November 30, 2020.

The need for ISO/IEC 17025:2017 was driven by the change in market conditions and change in technology, more emphasis is given adoption of IT techniques. The 2017 Standard includes changes in its structure and scope.

Key Changes to ISO 17025

• The requirements of structure are more process-oriented that aligns to ISO/IEC 17000 series on conformity assessment. The process-oriented approach now matches with that of ISO 9001. The scope has been expanded to include all lab activities, sampling associated with testing and calibration, etc.
• The addition of a new section on risk-based approach to quality. The laboratories are now required to identify risks, plan and implement actions to mitigate them and seek opportunities that may emerge from perceived risks. The intentions of the risk-based approach to quality is to give assurance to the management system that it achieves its results, prevents and reduces potential failures in the process and develops opportunities to achieve the objectives of the lab.
• The 2005 version of Control of Records has been rewritten to Control of Data and Information Management. The laboratories are responsible to have proper information management system, that is validated and protected. As laboratories increasingly utilize electronic records, manuals, and store results and reports, ISO 17025:2017 mandates them to have policies in place for improving quality using information technologies. It also mandates them to identify potential risks in information security and develop policies and plan to mitigate them. 

Migration Timelines

For the laboratories currently accredited by NVLAP under the 2005 version of ISO 17025, here are the pathways for migration to 2017 version:

1. If your lab is due for an assessment with your renewal, you do not have an option, but to migrate to ISO 17025:2017.
2. If you are not due for an assessment this year, you may get renewed now under ISO 17025:2005, without substantial changes in your quality system. But this will trigger migration to 2017 version within a year as all laboratories are mandated to be assessed to the new version before December 2020.
3. Even if you are not due for assessment this year, you may migrate your Quality System to ISO 17025:2017 and submit the documents for your renewal (will require substantial work). Your assessment in 2021 will be conducted to the new version.

NVLAP has created a checklist, NVLAP General Criteria Checklist (ISO/IEC 17025:2017), which contains the clauses of the 2017 revision.  You can download this by logging on to the NVLAP portal.  This will give an idea of the quantum and complexity of work needed to migrate. 

Our Services

Lumentra has helped lighting test labs in the US and China to achieve NVLAP accreditation in 2018.  We become the first independent lighting testing lab to get accredited to NVLAP under ISO 17025:2017, in October 2018.  We provide services in:

1. Educating your management and technical staff on new ISO 17025:2017
2. Reviewing your current Quality System and revise it to comply with ISO 17025:2017 and associated NVLAP new requirements.
3. If you prefer to write your own Quality Manual revisions or have already written, perform gap analysis and help improve the QM.
4. Conducting internal audit to evaluate your management, administrative, and laboratory technical performance under the NVLAP requirements.
5. Migrating your Quality System documentation to full electronic documentation that is hosted on cloud or in your internal server. The QM, Standard Administrative and Operating Procedures and related documents will be fully hyperlinked for easy and fast reference. This wiki-based system is easy to maintain and upgrade.  The built-in version control system will ensure that all changes are tracked and your staff will always have access to the latest approved version of documents.  Any section can be immediately rolled back by a single click.

We will be glad to assist you in the process and help accelerate the migration of your quality system to the new ISO 17025 revision.  Please contact us at services@lumentra.com.