The decision to pursue and successfully complete ISO/IEC 17025 accreditation should not be made lightly and not without full clarity of support required from management.
To ensure success, the quality department must do some initial groundwork to make sure that the quality department and management have a complete, accurate picture of the current state of the quality management systems. Quality and management must also recognize the extent of change required to convert the existing quality processes and procedures into a system that will pass the assessment process. This is particularly important if the lab has been in business for many years with employees who have become well-established in their ways of working.
Staff will likely have concerns related to changes in historical ways of working.
McCrone Associates, Inc., a laboratory specializing in investigational materials analysis, set a goal of ISO 17025 accreditation, and in August 2012 it began the process of revising the existing quality management system to meet the expectation of the ISO guideline. The decision to pursue ISO accreditation was made, after serious consideration, when McCrone’s largest client made the request as part of their supplier improvement program. The journey to accreditation was planned out as a project with established milestones. Quality and management met monthly to review the plan and discuss progress, challenges and decisions that were needed. Ultimately, McCrone Associates was able to schedule the initial assessment in June 2014 as planned, and was accredited shortly thereafter. This success was largely due to the detailed project plan and support from McCrone management staff.
To successfully reach this type of accreditation goal, laboratory management needs to fully understand the tasks involved from the quality department, time commitment from technical staff, additional resourcing that may be required, support desired in terms of change management and monetary commitments. Management staff must address additional critical functions, including review of documents, discussion and decision making, and needs to consider and understand the client base knowledge of the ISO 17025 standard in order to communicate the relevance and value of the accreditation to clients. This is particularly important if the added quality programs will increase the cost of current services or if management intends to offer accredited and non-accredited services to accommodate smaller clients in non-regulated industries. Putting all tasks and management needs into a well-thought-out project plan will ensure success.
1. Ensure management has a true understanding of the changes and commitment required to achieve and maintain accreditation.
When beginning the internal company assessment of elements necessary to gain ISO/IEC 17025 accreditation, work with an assessment body to obtain a general checklist of requirements and define the scope of accreditation. This will help frame the scale of the project. Using the checklist to perform a gap analysis up front can identify the work that needs to be completed in order to achieve accreditation. The gaps should be segregated into three categories in order to better evaluate what needs to be completed: (1) minor changes to existing systems, (2) major changes to existing systems, or (3) true gaps in need of a system.
From there, a task list can be created with assigned personnel and date requirements, but more is needed to ensure full management commitment and support. Management must be made aware of the work-hours required from all team members — not just the quality department — to address the items on the checklist. Additional short-term resources or subject matter experts may be indispensable to help with change and development systems for gaps. Depending on the complexity of the existing system, it is also possible that the requisite changes will result in hiring additional quality department personnel to administer and maintain the new quality management system. A thorough project plan outlines all human resource considerations, when and where management needs to step in to adjust workloads or bring on additional resources, and any concerns relating to change management.
There is a cost associated with the initial accreditation and annual assessments, but additional funds may be required for human resources, training, upgrading software and systems, instrumentation, and equipment. Quality department members may need to attend training covering certain aspects of the standard for better understanding. Reference materials and standards may need to be purchased. New programs, such as proficiency testing, may require additional monies. Making the monetary impact clear up front ensures a better understanding and commitment from the management team. Management will also need to allocate their own time to review changes to existing documentation and systems and to review proposed new policies and procedures to provide meaningful input. Management may need to set aside regular time for discussion and decision-making activities to keep the team on track and moving toward the intended goal. A roadmap to accreditation with all the major milestones outlined is a helpful tool to facilitate discussions with management to clarify where and when resources, money and management input are essential.
2. Create a comprehensive change management plan for your staff.
Involving personnel in the ISO 17015 journey will create a smooth transition and result in a successful assessment.
Change management involves more than just informing staff of the plan and timeline for ISO accreditation, and scheduling training sessions. Regardless of the size and magnitude of changes involved, changes should be something that staff are a part of, not something done to them. Since changes to existing systems are inevitable, and additions to the quality management system to meet ISO requirements are likely, a plan to secure staff involvement from beginning to end is critical to success. They need to understand not only the benefits of ISO accreditation in terms of streamlining and improving processes related to their own work, but also the benefits to the overall business. Involving them in discussions on proposed changes and inviting their input allows them to be a part of the process, particularly when implementing new components to the quality management system. Keeping them updated and involved during this journey creates a sense of ownership, ensures a smooth transition, and ultimately, a successful assessment and accreditation process. They will likely have concerns regarding changes that could result in increases in workload, changes to existing instrumentation or methods, or changes in historical ways of working. They may be concerned about learning new systems or disrupting service to valued clients. Providing an outlet and feedback mechanism to express and discuss concerns throughout the process will ease change anxiety, resulting in a more comfortable transition.
Training is an important part of change management and should be an ongoing process: a series of sessions prior to the assessment. Training may include new instruction on the standard for some or all of the staff, revised and new policies and procedures, accreditation agency requirements, and possibly a course in representing the accreditation and its benefits to clients.
An initial gap analysis will help determine the tasks that need to be completed and the scope of change management involved.
3. Know your client base awareness and understanding of the value of ISO 17025.
Before launching into the accreditation process, it is important to understand whether the majority of your client base even understands the standard and what it means for the services provided to them. When McCrone Associates first launched into this process, it was assumed that all clients would understand the significance of being accredited to the standard since our largest client requested it. This may not be the case for everyone, though. If a company’s clients truly understand the content of the standard or perhaps even drove the requirement for accreditation, a simple announcement upon accreditation is meaningful and impactful. If the client base is not aware of the standard, marketing efforts should include education about the standard and why it benefits the client. Comparison to existing standards and regulatory commitments is helpful in elucidating the value of an accredited laboratory.
With careful research, planning, and ongoing communication with management and all affected employees regarding tasks and goals, the journey to accreditation can be stable, steady, and smooth.
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