Title

Make an Internal Audit Plan for the coming 12 months

Why

The complete quality management system and all the examinations need to be audited every 12 months. An approach must be developed to achieve this. Moreover, during the audits specific staff members must be available to answer questions from the auditors. These staff members must thus be informed beforehand that an audit is planned in which they are needed so they can adapt their planning.

What

Develop an Internal Audit Year Plan.

How & who

Quality Officer:

  1. Design a schedule in which the complete quality management system is audited in one year. Start by choosing an approach to auditing: will vertical audits be performed in which similar elements in multiple examinations are audited (for example: auditing internal quality control procedures in all the examinations), or will horizontal audits be performed in which one examination procedure is audited by checking all the steps from sample collection to Result Reporting/Archiving? An option is to focus the audits on quality system essentials. There are 12 quality system essentials, so you can schedule one audit per month; each audit focusses on another quality system essential.
  2. Based on the approach chosen, divide the quality management system into pieces so that audits with a logical scope can be planned. Once per year a “System Audit” must be planned. This audit does not include any examination procedures but focuses at the management, organization and planning of everything related to the quality management system.
  3. Make a workable planning. In the right-hand column a template for an audit plan is provided. Assign specific Internal Auditors to perform each audit. An example year planning is also provided to give you an idea of how auditing of the quality management system in one year can be planned (this plan consists of 5 somewhat bigger audits (done by at least two auditors each time).
  4. Distribute the planning to all the Internal Auditors and discuss the planning in a weekly staff meeting.

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This activity belongs to the QSE Assessment
ISO15189:2007: 4.14.1 4.14.2
ISO15189:2012: 4.14.1 4.14.5
ISO15190:2003: