With the recent updates to ISO 9001: 2015 and ISO 13485: 2016, many companies are now beginning to...
With updates to the ISO 17025 standard released in 2017, now is a great time to review some of the changes that we have seen come through, and what updates may be required to maintain compliance to the standard. While there were a number of alterations, there are three key areas to note.
Newly Designed Process Approach
The general focus of recent standards has been on emphasizing performance-based results, rather than standard directives. While this has the benefit of leaving more room for interpretation and adaptability, it does place the burden on management to identify and closely track key metrics. Failure to do so adequately will likely be viewed as a non-conformance to the revised standard.
Stronger Attention to Information Technology
In recent years, there has been increased scrutiny regarding software validation, and this trend continues in ISO 17025:2017. While most off the shelf software can be considered validated under the revised standard, any altered or custom software will likely require a thorough validation. While software validation can time consuming, this increased focus will help to ensure testing results are reliable and reduce the risk of faulty tests.
Increased emphasis on Risk-Based Thinking
As with the revisions to ISO 9001:2015, the updates to 17025 include a heavy emphasis on implementing a risk-based approach throughout the QMS. This requirement is again somewhat open to interpretation for individual companies but should be present and traceable throughout the entirety of the quality system
While there is still time to adopt the new standard, the November 29, 2020 due date will approach quickly. Medpoint can help you get started with expert consultants ready to perform gap analysis, pre-assessments, mock audits and assist with any necessary QMS updates or remediation activities. Responding to an updated standard is never simple, but Medpoint has the expertise to help you make a smooth transition. To learn more, contact us: hello@medpoint.com or +1 800-200-9292.
