ISO/IEC 17025:2017 Standard is applicable to all laboratories engaged in Calibration, Verification, Sampling or Testing and applies to all small, medium, large, government or privately-owned Laboratories and other entities engaged in activities of Testing, and Calibration. It is often used in connection with ISO 15189 Medical Laboratories – Requirements for Quality and Competence for companies in the medical sector. The checklist also gives the auditor a specific place to document what they saw that did or did not meet the standard.ISO/IEC 17025:2017 previous revision of ISO 17025:2012 was updated through collaboration with the International Electrotechnical Commission (IEC) and released on November 29, 2017. The checklist provides the auditor with recommendations of what documents to look for, examples of what will meet the requirements and other guidance on auditing to the standard.Where there is a shortfall, it is called a “gap”. The auditor (person conducting the Gap Analysis) will use this list to compare the QMS that is in place with the requirements of the ISO 9001 Standard.This is a list of the requirements in the standard, written in question format. The most important tool for the Gap Analysis is the Gap Checklist.During an audit, the goal is to compare an organization’s policies and procedures to the requirements of the standard, and then look for evidence that they are being followed within the business. The main difference between a gap analysis and an audit is that during a gap analysis your organization will compare your business to the standard. How does a gap analysis differ from an Audit? They have the experience to conduct a successful gap analysis and to ensure areas will not be overlooked. You may also want to consider having assistance from a consultant.Appoint one or more people within your organization to conduct the Gap Analysis it is helpful if they have some quality system experience or audit experience.Recommended steps to be completed before conducting the Gap Analysis: The gap analysis will identify the ‘gaps’, allowing you to produce a more accurate project plan for filling those gaps and achieve ISO 9001 certification. Starting with a gap analysis can be very beneficial as it often saves time and money. An ISO Gap Analysis can be an ideal place to start when implementing a new standard in your organization. ISO 9001 Online Training Course ListingĪn ISO 9001 gap analysis is an objective evaluation of your organization’s current arrangements against the ISO 9001 requirements of the standard.ISO 9001 Internal Auditor Training Courses.ISO 9001:2015 Requirements Online Training.ISO 9001:2015 Online Internal Auditor Training.
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