How To Make it ISO/IEC 17025 Audit for Small Laboratories?

To prepare an ISO 17025 Audit is always a challenging task. It takes time and effort from staff when you are in a small laboratory. Where whole processes are more challenging. When “all hands-on deck” isn’t all that many pairs of hands, it’s clear that being a smaller lab offers a different problem than having a larger lab.

There is a Small Lab Case Study:

Michelle Robertson discussed how she prepared her tiny lab for ISO/IEC 17025 audits in another recent webinar. Michelle had a big assignment when she began her role as the Quality Assurance Officer at the Guadalupe-Blanco River Authority (GBRA). GBRA’s documents included over 700 hard copies and over 260 bench sheets – a massive amount by any measure. However, you read it correctly: these records were still document-based, making retrieval difficult and time-consuming.

Handling these documents was challenging due to their disorganized structure, which was managed through a mix of shared drives, manuals, binders, an obsolete electronic archive system, and two overflowing filing cabinets situated separately. This state of disarray was far from optimal for audit readiness.

Michelle had to deal with challenges caused by personnel turnover, which added to the disorganized document management system. Due to a lack of people, information flow and tracking degraded. To make matters worse, updates to the Standard Operating Procedures (SOPs) were not being made on time, producing extra difficulties for the workforce. There were also various issues with equipment and software.

What are the Important Aspects of Achieving Audit Readiness?

There are a few important elements for which you must have robust, efficient processes in place to be audit-ready. As a tiny lab, you will require:

• A method of storing documents in one location while also making them easily retrievable. Having them in a filing area is OK, but if finding specific documents is a time-consuming effort in and of itself, you will be diverted from more vital lab chores.
• Have solid mechanisms in place for managing proficiency testing and lab training. Monitor staff training progress and performance.
• Establish and implement effective processes for SOPs, CARs, workflows, and all other processes. Having all partners in your quality system follow the same processes will greatly improve.
• Establish protocols for managing personnel changes. This should complement your efforts to develop comprehensive proficiency testing and lab training, but it is also critical to have similarly well-established processes for bringing new starting up to speed – or existing personnel up to speed in a new capacity – as rapidly as feasible.
• A method of keeping ISO 17025 Documents up to date and approved by the appropriate parties. The ability to track adjustments, get them signed off on, and have them conveniently available are all hallmarks of audit-ready.
• Create methods for dealing with complaints and feedback. There are few better ways to understand what works and what doesn’t for your lab, and such feedback might be critical for avoiding non-conformances during your next audit.
• Create automated workflows for critical procedures. By introducing automated workflows, you can be extra certain that important procedures, such as equipment calibration and testing, are being carried out precisely and effectively. Know exactly what activities must be taken and when they must be taken.
• Conduct internal audits. Internal auditing is critical for maintaining quality. To understand more, attend our webinar on critical internal auditing skills.

The Outcomes of Putting the Suggestions Above into Action:

• If you implement the procedures outlined above, we know from Michelle at GBRA and many of our other customers that:
• You will have more consistency in the face of employee turnover.
• Greater staff accountability for the entire quality system, particularly the papers contained within it
• There will be no “uncontrolled” documents floating about, and there will be no (or substantially decreased) publication errors when submitting modifications or new documents.
• Documents are easily retrievable, reducing time and making audit preparation easier.
• Fewer errors and blunders as processes govern essential equipment testing
• Error rates are also significantly lower in all other sectors, and personnel bear responsibility and accountability.

ISO 17025 Technical Internal Audits: The Basics

The Testing and Calibration Laboratories are required to have a program of internal audits to assess whether their operations comply with ISO/IEC 17025 requirements on an ongoing basis. This involves auditing both management and technical activities to identify gaps, and to drive improvements.

A positive audit culture is essential to ensure that internal technical audits are effective. Management should encourage an open, fair, collaborative effort between technical auditors and auditees. There are ISO 17025 Auditor Training online courses available on web that specifically designed for those who want to learn auditing techniques based on ISO 17025:2017 as well as to know ISO 17025:2017 requirements in detail.

In this post, you will get information about an overview of the various technical audit techniques and the technical requirements that covered in three types of technical audits.

Are technical audits similar to management audits?

The same professional behaviour, general auditing skills, and good understanding of the ISO/IEC 17025:2017 standard is needed in both technical and management audits to ensure they are unbiased and meet their purpose. The Technical auditors are just like lead management auditors, need to be independent, impartial, observant, perceptive, and focused on assessing the compliance of processes, procedures and documented information against specific audit criteria.

What are the three types of audits?

There are three types of technical audits used to assess technical competence: witnessing, vertical, and horizontal.

a) Witnessing

Witnessing involves observing an auditee performing a particular activity, for example, a specific test method, and assessing the degree of compliance. The auditor must be provided with the documented test method against which compliance is assessed.

During the witnessing, the auditor would assess compliance with applicable clauses, but only as they relate to the specific witnessing. This means, for example, only the witnessed auditee’s training records would be assessed, for the specific activity.

b) Vertical audits

A vertical technical audit involves selecting a single report or reported result and assessing compliance with applicable clauses, but only for the specific laboratory activities to get to the point of reporting the specific result. The auditor would either work systematically backward, from the report to the registration of the particular sample (or sampling, if included), or forward from the sample registration.

c) Horizontal audits

Horizontal audits involve assessing compliance with applicable clauses, but across all test methods or activities within the scope of accreditation – For example, environmental controls or technical competency of personnel. A horizontal audit could involve one or all technical clauses. It would be performed on a sampling basis.

Performing a technical audit

The technical audit involves a process and performance-based approach using suitable techniques to collect and verify supplied information, observation of ISO 17025 documents, and record audit findings against technical audit criteria. The auditor must be able to assess whether the laboratory’s risk-based approach produces valid results for customers and meets ISO/IEC 17025:2017 requirements for technical competence.

Internal auditing techniques include the use of ISO 17025 audit checklist, document review, questioning and listening during interviews, and witnessing of activities.

Note that although certain audit techniques are more suitable for onsite audits, they can be adapted for remote audits. Whether remote or onsite, technical audits should be interactive to allow the auditor to engage with the auditees to develop an understanding of the critical technical issues at hand. The techniques should be chosen and combined based on the audit scope, objectives, and operational activities available for assessment.