Transition Planning for ISO 17025:2005 to ISO 17025:2017
The new ISO 17025:2017 was released at the end of November. As everyone knows, all ISO 17025:2005 laboratories will need to transition to the new standard within a certain time period based on the accrediting body. It is very important that each laboratory plan for any change that would impact the quality management system.
Labtopia can help with this process! Labtopia offers training and quality management system support for many types of testing laboratories.
WHAT'S NEW IN ISO 17025:2017
- The most noticeable change to the standard is the new
structure. ISO 17025:2017 adopts the same High-Level Structure as ISO 9001:2015, new terms, and definitions as other ISO management system standards.
- Key ISO 17025 items are in Sections 1-7 and Quality
- Accredited laboratories (testing and calibration) can choose either Option A or Option B (Section 8) for the quality management portion of their quality system. The laboratory still has to adhere to Sections 1 to 7 to meet ISO 17025:2017.
- Conflict of interest becomes “Impartiality”. This is a key component of the laboratory’s management system and how the laboratory safeguards impartiality in all the laboratory’s activities. How does this impact your lab?
- Significant emphasis on risk-based thinking. While this has always been part of the standard, the new version gives it increased prominence. Evaluating risk will be important in all facets of the management system. Do you understand risk management?
- Increased focus on process management, with greater emphasis on producing desired outputs.
- Puts greater emphasis on leadership engagement.
- Fewer and less explicit requirements for documented procedures. More explicit requirements on documented information. This does not mean abandon all procedures or the quality manual!
HOW CAN LABTOPIA HELP WITH MY ORGANIZATIONS' TRANSITION TO ISO 17025:2017?
Our comprehensive assessment focuses on your current documented quality management system and will provide a clear picture of your QMS’ readiness for transition. The gap assessment results in a precise checklist of action items that need to be implemented to meet the new standard’s requirements.
Labtopia's Gap Assessments Include:
- A formal review of existing practices against requirements of the standard and your business application Identification of how you already meet specific new requirements
- Identification of areas where you might be unclear on how requirements apply or whether you meet them
- Highlights any risks and weaknesses based on the new requirements
- Deliverables include a Checklist with the GAPS
Labtopia offers ISO 17025:2017 consulting services geared to supporting existing quality systems in the laboratory or manufacturing environment. Implementing a quality system can drain a company’s resources and can be frustrating and costly if not done properly. Our experts have aided large multi-national, global companies. At the same time, we recognize that small and medium sized businesses must meet the same quality and regulatory requirements as their larger counterparts and some companies may not need full-time support.
Lead or assist your team with a gap assessment, transition planning, and effective documentation development.
Conduct an on-site internal audit of your quality management system. Identify process effectiveness and any process deficiencies found.
CORRECTIVE ACTION REVIEW
Assist with corrective action review and closure.
Deliver internal audit, management overview and requirements training
Conduct on-site pre-accreditation audit prior to the certification body audit to boost confidence of system effectiveness and certification success.