Internal Audit for ISO 17025

Phases, Schedule, and Key Components of an Internal Audit for ISO 17025

ISO 17025 requires an internal audit of a laboratory’s activities. An internal audit aims to confirm that the operations of a laboratory continue to comply with the ISO/IEC 17025 requirements.

Likewise, an audit guarantees that the quality system meets the ISO/IEC 17025 requirements, regulatory bodies, and accreditation that is significant to a certain criteria document.

The audit makes sure that whether or not all levels of work optimize the requirements of a laboratory’s quality manual and related documents.

Hence, an internal audit will locate any non-conformities. A laboratory can use that information to improve its quality system and technical competence.

Key Components of an Internal Audit:

• Procedures
• Planning
• Methods
• Facts
• Controls
• Risks
• Management

Laboratories should design, conduct, and follow up the internal audit. This is especially the case in the lead-up to an external audit.

Note that the recommendations for audit preparation, documentation, performance, and follow-up are written for the audited departments, not for the auditors.

People Involved in an Internal Audit

• Owners – Overall hosts or owners must be defined.
• Quality Managers – They manage internal audits by verifying a laboratory’s conformance to the ISO/IEC 17025 requirements. They also validate whether a laboratory follows policies, procedures, and processes.
• External Auditors – They verify that a laboratory is operating in compliance with ISO/IEC 17025. External auditors could be from accreditation bodies or clients.
• Laboratory Staff – They must follow procedures for responsibilities before, during, and after internal and external audits. Staff must also undergo training.

Phases of an Audit

• Preparation

The preparation begins by assigning an overall host or owner for the audit.

The laboratory will also appoint a technical contact who will have access to review whether all records and documentation are complete.

Preparation also encompasses setting up a work area for the inspectors, reviewing the schedule, and preparing and training staff.

Lastly, this is the right time to inform all those involved in what will happen in the audit.

• Conduct

This phase maintains a continuous log of the audit. A laboratory must provide copies, but shouldn’t give the original ones away.

Remember, protect proprietary information. A laboratory can do this by safekeeping all documents in the work area.

Therefore, it’s advisable to retain duplicates of all information given to auditors.

This stage must accompany the auditor at all times. Be cooperative and courteous by answering questions when asked.

To evaluate the progress, a laboratory could hold daily debriefing meetings. Take immediate corrective action, whenever necessary.

• Close

There are instances where you might not be able to answer questions. In such a case, it’s acceptable to be open to the auditor about being unable to provide answers.

Similarly, this is the chance to clear up any questions or causes for discontent in the exit meeting.

• Follow-up

This covers developing both corrective and preventative action plans. This phase encompasses owners, schedules, tasks, and deliverables. Finally, keep track of the plan.

Internal Audit Schedule

An internal audit must follow a prearranged schedule to finish all activities over a reasonable period.

It must either be a monthly or quarterly audit. In this way, it won’t be troublesome to audit all activities or a quality system’s parts in a single audit.

A horizontal audit inspects every aspect of a single requirement, such as pieces of equipment.

Meanwhile, a vertical audit can assess compliance of a single test through all steps from sampling to record archiving.

Time to Plan for an Internal Audit

An internal audit isn’t meant to make things complicated. It doesn’t aim to frighten your employees.

Its main goal is to prepare your laboratory for an external audit.

QSE Academy wants to support that goal. Our toolkits and ISO 17025 consultants are here to make sure all phases of your internal audit are done with ease.

For further information about ISO 17025 audits, please refer to our packages and other blog posts.