A2LA Today l September 2017 l Number 136
By Tim Osborne, A2LA Senior Director of Training Services
After over two and a half years, 6 Working Group and 2 Drafting Group meetings, ISO/IEC 17025:2017 is about to go live this fall, perhaps in early winter (for those of us in the northern hemisphere). 6,746 comments later, the FDIS was released for ballot on August 14, 2017. Voting on the Standard will conclude on October 9th. Once the votes are tallied, comments collated, and, assuming there were no technical comments, the editors will work diligently on addressing the general and editorial comments by each country’s CASCO mirror committees.
How does this impact my accredited laboratory?
This is the beauty of the new Standard – from a management system perspective, it is easier and less restrictive. From a business management perspective, it is much more liberating. Easier, less restrictive, liberating and an ISO Standard? These words do not belong in the same sentence. I agree, but . . . here is why:
1. Risk Management vs. Managed Risk.
ISO/IEC 17025:2005 managed the laboratories risk by forcing the creation and maintenance of a quality manual, policy, dozens of procedures and supporting policies. Under the new Standard, there are no quality manual requirements, approximately 12 procedural requirements but the laboratory can manage its own risk. Who knows better about running a business than the owner? They know the risks before starting the company. Now they can manage the company to meet the customer’s needs with a lot less administrative burden from a management system perspective.
2. Decision-making at the lowest level possible.
In the previous version, top management had to get involved in the management system decisions as well as the business decisions. Now, through proper coaching, mentoring and training, executive management can push decision-making to the lowest possible level as evidenced through documented authorizations.
3. 9001 Certified?
In Section 8 (Management System) of the new Standard, Option B allows for the implementation of the ISO 9001:2015. While there is some level of reciprocity, assessors must still check that key elements of sections 4-7 of the Standard are still reviewed during the internal audits and management reviews. Option A, for those who have implemented 17025:2005, is strikingly familiar. The only significant addition to this section is 8.5 on managing risks and opportunities.
4. What things do I have to implement, differently?
Spend more time focusing on achieving your customer’s needs and your goals! In a nutshell, the emphasis is on effective leadership and following 9001’s lead on applying requirements and concepts developed over the last 17 years. They will enhance your business and management system processes while demonstrating accuracy and precision in the product you are supplying to your customers and stakeholders. These confidence-building tools include:
• Manage, measure and monitor risks to impartiality;
• Address confidentiality at all levels;
• Manage risks & opportunities through mitigation and contingency plans;
• Implement a process-based approach (PDCA) to ensure all levels of employee engagement;
• Measure the process outcomes (KPIs) to address;
• Act proactivity vs. reactivity for continuous improvement which increases employee engagement; and
• Collaborate with customers to manage risk in conformity decisions.
How do I get more information?
A2LA has booked several venues both nationally and internationally in 2017 and will follow in 2018. We offer two types of classes.
• The 1-day Transition to ISO/IEC 17025:2017 class is designed for those laboratories who are accredited to the current version but desire to gain a clearer perspective of the changes. The course includes activities to help navigate some of the challenges of implementation as well as a crosswalk with the current Standard (ISO/IEC 17025:2005).
• For new laboratories and managers new to management systems, we recommend the 2-day The New Standard for Laboratory Accreditation class. The course provides a cornerstone for the participant to understand process flow and risk management concepts and an exploratory environment to begin building its own solutions in class. From starting a laboratory to producing the final report, this class covers all the key areas affecting the laboratory’s day-to-day activities as well as handling new opportunities and addressing change.
2017 Course Schedule
The most current course dates and availability may be accessed through our public calendar.
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