The audit days cannot be reduced by planning on longer hours per working day. The audit days are based on eight hours per day. The off-site activities should not reduce the total on-site audit duration to less than 80% of the times shown in the tables above. MD 5 states the audit duration for all types of audits includes on-site time at a client’s premises and time spent off-site carrying out planning, performing document review, interacting with client personnel, and writing the report. Note 2: High, Medium, Low, and Limited are complexity categories. Note 1: View number of employees as continuum rather than stepped change. (Compiled from tables in Annexes A and B of MD 5 and Annex D of MD 9) Dependent on the hours worked, the part-time personnel numbers can be converted to an equivalent number of full-time personnel. Non-permanent (seasonal, temporary, and contracted personnel) and part-time personnel who will be present at the time of the audit are included in the numbers. The effective number of personnel indicated in the audit day table below consists of all full-time personnel within the scope of the certification, including those working on each shift.
MD 9:2011 applies to medical device quality management systems (ISO 13485). MD 5:2009 applies to quality management systems (ISO 9001) and environmental management systems (ISO 14001). The International Accreditation Forum (IAF) provides Mandatory Documents (MD 5:2009 and MD 9:2011) to certification bodies that contain mandatory provisions and guidance on the time required to audit their clients. How many audit days would a certification body (registrar) estimate for your initial stage 1 and stage 2 certification audit, ongoing surveillance visits, or re-certification audit?
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