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ISO 15189 Certification Standard

ISO 15189 Certification Standard for Quality and Competence Management

Do you own a medical laboratory? Enhance the quality of your service management with the ISO 15189 certification standard! Get accredited in just 30 days with Compliancehelp Consulting LLC!

The ISO 15189 Information Security Management Standard

ISO 15189 is the global benchmark that provides comprehensive guidelines for maintaining the quality and competence level of services offered by medical laboratories. The set of requirements it provides helps companies with process management. From pre-analytical to post-analytical phases, the standard ensures each stage cooperates to achieve the bigger goal – increasing the customer satisfaction level. With an effective implementation of ISO 15189 clauses, medical laboratories can produce reliable and accurate test results for health monitoring, medical treatment, and diagnosis.

Why Achieve the ISO 15189 Certification for Your Business?

The fundamental design and purpose of the standard align with the original ISO 17025 standard, which is the service management standard for testing/calibration centers. However, ISO 15189 precisely focuses on the laboratory firms that work with medical devices, treatment facilities, and pathological diagnosis. The focus of the standard is solely on enhancing quality for competence and clinical support.

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Best practices that the ISO 15189 Certification Standard promotes are:

  • Quality management through continuous risk management and documentation
  • Meticulous sample handling, equipment management, and external quality assessment
  • Staff competency through an awareness campaign and training
  • Ethical conduct of performing tests
  • Unbiased test results
  • Transparency on roles and responsibilities

To get the ISO 15189 certification standard, your business needs to consider the following aspects:

  • Personal data regarding qualifications, training, professional development, and competence assessment should be kept with utmost priority.
  • The management must focus on the environmental conditions and facility maintenance essentials. There should be a specifically designed list of record-keeping for staff health and maintenance manual.
  • The management must ensure that each equipment is technologically advanced and functions efficiently to produce reliable results.
  • Pre-examination procedures like sample collections, transportation of patients, and their preparations should be done with due diligence.
  • Appropriate methods should only be applied for each examination. Interlaboratory comparisons are often suggested to small and new laboratories.
  • Information management to maintain the privacy of patient data is crucial. Laboratories must implement a comprehensive data security management system.
  • Ethical practices to maintain confidentiality and ensure continuous improvement are strongly required. For enhancing the competency level, ethical practices are vital.

By attaining the ISO 15189 certification, your business may see the following potential benefits:

Builds trust among the target segment

A certified laboratory represents itself as a committed body for providing reliable test results. The stringent control measures designed by the benchmark ensure dependable and precise test results. Therefore, both the medical professionals and the patients start relying on the firm.

A steady revenue margin

To ensure a steady revenue and market hold, medical laboratories need to maintain their commitment towards serving results that can be trusted without a second opinion. Quality is the key to keeping customer loyalty, and that drives revenue.

Brand image and market exposure

With the certification in hand and a loyal and niche customer segment, a laboratory establishes and subsequently strengthens its brand image. It opens the door for more business opportunities, both domestically and internationally.

Competitive edge

As quality is paramount in the industry of medical laboratories, ISO certification is a strategic move to stay competitive in the market. When quality and consistency are met, laboratories obtain loyal customers who hardly shift to other vendors.

Credibility and cost-effective operations

A certified laboratory always adheres to the regulatory obligations. The due compliance is met, and that ensures a strong bond with the stakeholders and the regulatory bodies. On the other hand, ISO 15189 ensures effective optimization of relevant resources that gradually reduces waste and unnecessary costs.

Risk management

Like other ISO standards, ISO 15189 is no less in enhancing management’s capability in managing risks. From detecting to aggregating and mitigating the likelihood of potential disruptions, the ISO standard minimizes failures that often occur in the testing process.

Patient care is improved

If we can look at the bigger picture, then the ISO 15189 certification standard is an indispensable aspect when it comes to patient care. Reliable test results help with correct diagnosis, which leads to proper and timely treatment of the patients.

Getting started with the ISO 15189 certification procedure might seem complex to you, but our expert ISO 15189 consultants will make it easier for you with trouble-free steps.

Consultation

In the first step, we would discuss with you the details of the ISO 15189 requirements and provide consultation to help you understand their relevance in your business and processes. Our consultants would then help you plan the next steps to meet the criteria for successful certification within a decided timeframe.

Document Your Information Security Management System

Our consultants will help you determine the scope and objectives of your management system. Following that, they would evaluate your existing processes to determine how they will interact with the management system. Subsequently, they would help you to prepare a document of the processes, as required by the standard. The document establishes how your employees should execute the processes to adhere to the standard’s requirements.

Implementation of the management system

Once the documentation is complete, you need to provide training to the employees to ensure the system is practically put into place. Training is necessary to ensure the system is efficiently integrated throughout your organization and there is consistency in the roles of employees.

Internal Audit

Our team also has expert auditors who will analyze your processes and management system to find out any inconsistencies and nonconformities. They would then provide recommendations to correct or fix those identified issues to ensure your business is fully compliant and certification-ready.

Certification

You need to apply for certification to a certification body. They would perform an external audit and get your business certified after affirming the compliance of your management system. Our consultants will help to maintain your certification in the long run by periodically following up and performing surveillance audits.

Benefits illustration

Why Hire the ISO 15189 Certification Consultants from
Compliancehelp Consulting LLC?

Lowest cost

We deliver a lean, custom fit ISO compliant management system, saving significantly on the often-overlooked, but usually most expensive part of ISO compliance- the implementation stage.

Speed

Everybody knows how lengthy an ISO certification process is! It is difficult to be motivated and focused if certification takes too long. Don’t worry! We can help you gain certification within 30 days, or often in less time than that!

Resources to obtain and maintain certification

ISO compliance does not need to cost a lot to maintain! We minimize the need for internal resources with a lean and compliant ISO quality consulting approach.

Ongoing support

Compliancehelp Consulting LLC can help you manage ongoing compliance on your own, or you can team up with us. Our personalized ISO certification services include monitoring and internal audits as well. Our experts can monitor your Quality Management System to ensure consistency, improvement, and compliance. We can also help in making it compliant with future updates to the ISO standard a cinch.

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Frequently Asked Questions

What is the ISO 15819 certification standard?

It is the quality and competence management standard designed for medical laboratories across the globe. It comes with a predefined set of clauses that provide comprehensive guidance for service management.

Are ISO 15189 and ISO 17025 the same?

Though both of the standards focus on the quality of service management for the laboratories, ISO 15189 focuses only on medical labs. It also sheds light on enhancing competence, unlike ISO 17025.

Can I improve my brand’s presence with the ISO 15189 certification standard?

If you are new to the medical laboratory industry, then yes, you can enhance the presence of your brand by being ISO 15189 certified.

Do I need ISO consultancy for getting certified?

If you think your system has recurring problems and is unable to meet the clauses, then calling professional consulting services is a wise idea.