Accreditation, Auditing and Requirements

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Table of Contents

Introduction
Performance Indicators and Benchmarking
Internal and External Auditing
Accrediting Body Selection
Applications and Requirements
Conclusion
References

Introduction

To ensure that customers will be provided with high-quality services that align with all international or regional standards accepted, organizations in different spheres need to apply for accreditation. This process involves many stages, and this is why specialists supposed to be responsible for the current status of an organization have to consider a wide range of details related to documentation and performance of a company. Speaking about the accreditation of a clinical laboratory organization, it is necessary to state that there are a number of tasks that need to be fulfilled during the preparatory stage that precedes submission of an application to get a new accreditation certificate. These tasks include measuring performance indicators and juxtaposition of the particular statements, solving problems related to external and internal auditing, choosing the accrediting body, and submitting an application (“Frequently asked questions,” 2014). Besides, members of teams handling such issues have to be aware of the requirements that have to be met for the renewal of the accreditation certificate.

Performance Indicators and Benchmarking

Measuring performance indicators remains an important part of the preparation process before the accreditation of an organization. A performance indicator is a measure that helps to make a conclusion concerning the success rate of a company or of the particular task fulfilled by members of an organization. Speaking about this measure, it is necessary to consider that it is closely interrelated with such notions as defect percentage that should be as low as possible and the company’s tendency to achieve important goals within short periods of time (Micheli & Mari, 2014).

More importantly, in reference to organizations related to medicine and healthcare, it needs to be stated that feedback received from customers should be taken into consideration as well. In general, there is a variety of ways to define the given measure. Nevertheless, in order to choose the method that would be the best for a particular organization, for example, a clinical laboratory, it is necessary to rely on the basic values of a company and the most important aspects related to its work. Thus, as for such an organization, it may be necessary to consider the integrity of laboratory equipment, the percent of laboratory tests that have been conducted successfully, or periods of time needed in order to implement new types of equipment and start providing customers with additional services (Plebani, 2017). Importantly, measuring performance indicators can provide specialists with additional information on tasks related to the company’s activity that need to be redesigned and performance weaknesses in general.

As for benchmarking, this term usually refers to a process that involves comparing different measures and evaluating the level of success of a certain project or organization in general. Also, it may include comparing the company’s performance to one of the other organizations working in the field. Thus, there is such type of benchmarking as internal that involves making a comparison between operations performed by a company (for instance, different types of clinical tests). Although such a process helps to improve performance, it is much more effective to compare the resulting quality of operations performed by a company and level of customer satisfaction to the ones reported by a leading competitor of the given organization.

Internal and External Auditing

In reference to the process of accreditation, auditing needs to be paid increased attention to because its results have a significant influence on application processing. As for external auditing, it is conducted by a specialist who is not related to the organization being accredited. Such a specialist is required to keep track of financial and organizational operations related to the performance of a company in order to make a conclusion concerning its current financial position (Turpen & Dyer, 2015). In the case of laboratories, external auditors have to review operations used to conduct tests and define if operations and materials used during the work align with standards of the country or international standards. Internal auditing, as is clear from the term itself, involves a check run by one of the specialists from the company. In fact, internal auditing often precedes the external one and helps to prepare for independent checking. There is no doubt that the positive result of external auditing significantly increases the company’s chances of success; nevertheless, it also involves certain risks such as leak of data on unique laboratory assessments.

Accrediting Body Selection

The selection of accrediting bodies is an important task as the goodwill of the body is extremely significant because it often defines perceptions of the accredited organization. In the majority of countries, there are special bodies responsible for accrediting organizations related to particular spheres. Nevertheless, such an option as international accreditation becomes more popular. In reference to laboratories, there is a particular standard known as ISO/IEC 17025 defining the rules of their accreditation. Meeting this set of standards could be regarded as a mark of distinction, and this is why it is more appropriate to choose international accrediting organizations such as IAS or UKAS located in the United Kingdom. Also, choosing the accrediting body, one has to familiarize himself with the information on requirements and application processing to estimate the chances of success.

Applications and Requirements

To submit an application, our organization needs to contact representatives of the accrediting body chosen and ask them to provide additional information. A lot of such bodies provide clients with an opportunity to submit an application on official websites. Usually, submitting an application, organizations provide accrediting bodies with access to data on their management systems and inspection results reported by external and internal auditors (“UKAS online application,” 2017).

As for additional requirements for certificate renewal, all the files and folders attached to the application form should be organized and scanned for viruses. Information that needs to be reported during filling in the application form includes the status of an organization, address, contacts, financial metrics, documents confirming previous inspections, reports, and information on managers and representatives of a company (“Requirements for renewal of accreditation,” 2016). Importantly, nothing should be omitted as it may lead to an extension of application processing time. Another detail that is relevant to the given case is that specialists from accrediting body chosen should be provided with all the information that is actual; therefore, if certain facts change (for instance, there are different organizational practices implemented into the work of laboratory), the organization is supposed to inform the accrediting body as soon as possible and provide new documents if necessary.

Conclusion

In the end, accreditation procedure requires companies to use different resources including financial ones as this service can sometimes be costly (“Facts about laboratory accreditation,” 2016). Accreditation involves a lot of advantages as it encourages the improvement of customer service quality, increases the level of trust in the laboratory, and has a positive influence on its competitive ability. Despite that, there are certain drawbacks related to paperwork, service cost, and possible delays in processing applications. To simplify the process and guarantee positive outcomes, our organization is recommended to apply the method of competitive benchmarking, invite an independent specialist to conduct auditing, and prepare necessary documentation in advance.

References

Facts about laboratory accreditation. (2016). Web.

Frequently asked questions related to the A2LA ISO 15189 clinical laboratory accreditation program. (2014). Web.

Micheli, P., & Mari, L. (2014). The theory and practice of performance measurement. Management Accounting Research, 25(2), 147-156.

Plebani, M. (2017). Quality in laboratory medicine: 50 years on. Clinical Biochemistry, 50(3), 101-104.

Requirements for renewal of accreditation. (2016). Web.

Turpen, R., & Dyer, H. (2015). Working with external auditors: A successful relationship between internal and external auditors depends on collaboration and open communication to achieve the shared goal of effective audit service. Internal Auditor, 72(1), 17-19.

UKAS online application (2017). Web.

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