Do you want to become a master at conducting an internal audit? Or, on the contrary, do you aim to be the best auditor of all time in your laboratory?
Then you must have a clear guide to carry out this process. If you don’t know where to start, you don’t have to worry about a thing. Today we’ll discuss in general how to conduct an internal audit in the clinical laboratory under ISO 15189.
Let’s get started!
What is an internal audit?
Imagine you’re the quality manager of a clinical laboratory. One ordinary day, you receive an email. The subject line displays a word that may seem intimidating: “Audit.”
After reading that email, many doubts arise: Am I prepared? Can I trust the activities of my staff? Is my management system adequate?
The audit shouldn’t be a source of doubts and worries flowing uncontrollably through your mind. This tool is crucial within the clinical laboratory.
Essentially, the audit is a tool that allows you to identify areas for improvement and, therefore, enhance the management of your clinical laboratory. It can also help you to:
- Comply with the requirements of ISO 15189.
- Identify risks and opportunities within your laboratory processes.
- Strengthen trust among your clients, laboratory staff, and management.
If you wish to conduct an audit, it’s best to be well-prepared. To achieve this, you must know everything related to ISO 15189, plan, and execute a comprehensive audit plan.
If you’re interested in doing this, keep reading. In the following sections, we’ll cover everything necessary to turn the experience of conducting an audit from bitter to a sweet chocolate.
Importance of internal audit under the ISO 15189 approach.
In such a competitive world, quality assurance is key to staying at the right level. ISO standards establish requirements for ensuring quality, among which, of course, the performance of internal audits is included.
ISO 15189, like other standards such as ISO/IEC 17025 and ISO 9001, places great emphasis on internal audits. This is because they are indispensable requirements for accreditation.
Among the requirements related to internal audits are the following general requirements:
Audit program: The laboratory must have an audit program, which must be documented and include a description of the scope, frequency, and resources needed to achieve the audit.
Audit team: Personnel responsible for conducting the audit must not belong to any area of the process being evaluated. This eliminates a potential risk to impartiality.
Audits must be documented and recorded: All findings observed during the audit, such as the identification of improvement opportunities, must be recorded and communicated to the laboratory’s management team, in order to implement the respective action plans.
Corrective actions: If a problem is identified during your audit, you must address it promptly. Once identified, the problem must undergo a corrective action to address the non-conformity and prevent it from recurring.
Conducting laboratory audits allows you to:
- Improve the quality of your services.
- Increase the confidence of both your patients, users, and internal staff.
- Reduce costs, as error identification prevents major problems, which can generate additional costs.
- Foster a culture of quality in your staff.
- Prepare you for accreditation. Which is ultimately the goal of many executives.
Preliminary Steps: Prepare to conduct an audit in your clinical laboratory.
Before implementing an audit, proper planning is necessary. Consider the following preliminary steps when carrying out this process. I assure you everything will flow like water.
Preliminary Step 1: Select Your Audit Team.
This is one of the first preparatory stages. Before selecting the audit team, consider what their main responsibilities are.
Given the above, there are two protagonists in this scenario: the laboratory director and the quality manager. Below, we mention the fundamental responsibilities of each:
Responsibilities of the Laboratory Director.
The laboratory director bears the weight of the audit. Their main responsibilities are:
- Establishing the general policies of the audit program.
- Assigning the person responsible for creating the quality program, who is usually the quality manager.
- Supporting necessary corrective measures.
- Being aware of all results obtained during the audit.
In conclusion, the laboratory director is like the president of a country. They create policies, assign their collaborators, and are aware of everything.
Responsibilities of the Quality Manager.
The quality manager is one of the main architects and executives within the audit program. Their main responsibilities are:
- Organizing and managing the internal audit program of the clinical laboratory.
- Establishing and providing guidelines on the audit schedule.
- Coordinating the audit-related process.
- Managing corrective actions.
- Ensuring that laboratory staff and the director are aware of the audit results.
However, this cast is made up of more than two protagonists. The additional cast consists of a competent audit team. Take into account the following two key points when forming this team:
Availability of personnel and level of technical expertise: Depending on the area to be audited, there may be different types of trained personnel to conduct the audit.
Hiring a consultant: This is still an internal audit: the laboratory plans everything without external restrictions, but consultants or colleagues hired specifically for this audit will assist laboratory personnel in carrying it out.
Preliminary Step 2: Define the Scope of Your Audit.
The audit scope determines which areas, processes, or activities will be evaluated. Its correct determination ensures an effective and efficient process.
When defining this scope, consider:
- The requirements of ISO 15189.
- Assessing risks and identifying areas for improvement in the laboratory.
- Considering available resources.
- Defining the time period during which the audit will take place.
Some examples of areas, processes, or activities that may be evaluated in a typical internal audit include:
Management system: Monitoring policies, objectives, procedures, records, etc.
Technical processes: Assessing the performance of laboratory personnel in executing activities such as sample collection, reception and processing, analysis, and quality controls. Essentially, processes can be evaluated from the pre-analytical to post-analytical stages.
Infrastructure and equipment: Reviewing facilities, maintenance records, and equipment calibration.
Human resources: Evaluating personnel competence. Reviewing results from personnel performance evaluation plans or proficiency testing results, for example.
Preliminary Step 3: Develop an Audit Program.
Taking into account the previous preliminary steps, you should create an audit program. It is a fundamental document that describes, among other things, the activities to be carried out during an audit, as well as the schedule and responsible parties.
In addition to the previous steps, consider the following aspects when creating the audit program:
Define audit stages: Such as planning, execution, monitoring, and closure.
Define activities: Determine what will be done at each stage of the audit.
Assign responsibilities: Select from the audit team the individuals responsible for each of the determined activities.
Define necessary audit resources: Such as information availability, audit team training needs, or budget approval for hiring external personnel.
Preliminary Step 4: Information Gathering.
Information gathering is a crucial stage of the internal audit. It involves obtaining relevant information about the areas, processes, and activities that will be evaluated.
Various techniques can be used to gather information:
Document review: Procedure manuals, records, reports, etc.
Interviews: Laboratory personnel, area managers, clients, etc.
Direct observation: Observing processes in the laboratory.
It’s important to select the most appropriate information gathering techniques for each case.
The collected information should be:
- Accurate: It should be precise and reliable.
- Relevant: It should be related to the audit objectives.
- Sufficient: It should be enough to allow for a comprehensive evaluation.
The collected information will be used as a basis for evaluating compliance with ISO 15189.
The Moment Has Come: How to Conduct an Internal Audit?
Now that you have a structure for the audit program, you have defined responsibilities, as well as the scope of the audit, you are facing the challenging adventure of executing the audit.
At this stage, you must evaluate each of the areas, processes, or activities determined in the scope.
To make it easier, it is advisable to follow this series of steps:
Step 1: Opening Meeting.
The audit opening meeting defines the start of the process. All involved parties should attend, including the laboratory director, quality manager, audit team, and the auditees.
During this meeting, the following should be done:
- The lead auditor, usually the quality manager, introduces the audit team and provides instructions on the audit objective.
- Necessary documentation and resources to be implemented during the process are reviewed.
- Possible questions from the auditee team are addressed.
Step 2: Document Review.
During this stage, relevant information about the management system and its compliance with ISO 15189 is obtained. Consider the following activities:
- Relevant documents for the audit, such as the quality manual, procedures, records, and reports, are reviewed.
- It is verified that documents are complete, accurate, and up-to-date.
- It is ensured that documents comply with ISO 15189.
Step 3: Activity Observation.
The objective of activity observation is to verify that the activities performed in your laboratory are carried out according to documented procedures.
There are three methods you can implement when conducting these observations:
Direct observation: The auditor directly observes the performance of an activity. For example, how a sample collection is carried out by a technician.
Record review: The auditor examines records made about an activity, ensuring they are completed correctly and the information is consistent.
Personnel interviews: The audit team can meet with relevant staff and ask pertinent questions to obtain information on how activities are performed.
When applying one of these methodologies, the audit team should consider the following aspects:
Procedure compliance: Verify that activities related to pre-analytical, analytical, and post-analytical phases are carried out according to established procedures.
Personnel competence: Ensure that personnel have adequate competence to perform activities.
Safety and biosecurity: Verify compliance with safety and biosecurity standards.
Effectiveness of the management system: Verify that the management system is effective in ensuring the quality of test results.
Step 4: Audit Closure.
The audit closure should involve the laboratory director, the quality manager, and the audit team. During this session, audit findings are presented, and necessary recommendations for improving the management system are made.
During this meeting, agreements are reached between the laboratory head and the quality area manager to address identified non-conformities.
Keep the following in mind during this meeting:
- Maintain clear and concise communication.
- When establishing action plans, set realistic goals and determine deadlines for achieving them.
- Assign responsibility for implementing these action plans.
- Document all agreements made during these types of meetings.
When you reach this meeting, it is crucial to be prepared and to have the necessary tools to ensure an effective process.
For this purpose, one of the best implementations is to prepare a clear and concise report containing all findings and improvement recommendations.
Tips for Conducting an Effective Audit.
If you don’t want to cut corners halfway through, consider these general recommendations on the road to executing a successful audit. These are cross-cutting throughout the audit process, so keep them in mind during each stage:
- Focus on critical areas of the laboratory, such as customer complaints or quality control.
- Conduct short and frequent audits instead of an overwhelming annual effort.
- ISO 15189 recommends auditing the management system at least once a year. This does not mean a complete annual audit, but rather that all areas of the laboratory should be inspected at least once a year.
- Establish a policy of periodic audits by sections or specific processes.
- Audit frequency can vary based on findings.
By following these recommendations, the laboratory can conduct simple, effective internal audits that contribute to continuous quality improvement.
In conclusion:
Internal audits are a fundamental tool for clinical laboratories seeking to improve the quality of their services and comply with the requirements of ISO 15189:2022.
By conducting internal audits effectively, laboratories can:
Identify areas for improvement: Internal audits allow laboratories to identify areas where their processes or systems do not meet the requirements of ISO 15189:2022.
Prevent non-conformities: By identifying areas for improvement, laboratories can take measures to prevent non-conformities from occurring.
Improve result quality: Internal audits help laboratories improve the quality of their results and increase customer confidence.
Prepare for accreditation: Internal audits are an essential part of the accreditation process for ISO 15189:2022.
