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.įrom there, a task list can be created with assigned personnel and date requirements, but more is needed to ensure full management commitment and support. Using the checklist to perform a gap analysis up front can identify the work that needs to be completed in order to achieve accreditation. This will help frame the scale of the project. 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. Ensure management has a true understanding of the changes and commitment required to achieve and maintain accreditation. Putting all tasks and management needs into a well-thought-out project plan will ensure success.ġ. 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.
Iso 17025 iso#
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. 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. This success was largely due to the detailed project plan and support from McCrone management staff. Ultimately, McCrone Associates was able to schedule the initial assessment in June 2014 as planned, and was accredited shortly thereafter.
Quality and management met monthly to review the plan and discuss progress, challenges and decisions that were needed.
The journey to accreditation was planned out as a project with established milestones. 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. 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. Staff will likely have concerns related to changes in historical ways of working.
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