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ISO certification requirements

What Is ISO?

ISO is an independent non-governmental International Organization for Standardization founded on 23 February 1947. It works in 167 countries as of 2022 and has a headquarters in Geneva, Switzerland. The importance of ISO standards is simple: safeguarding consumers and end-users by ensuring conformance to their requirements.

ISO standards for clinical laboratories are developed with a strong emphasis on quality management, occupational health and safety management, environmental management, and information security management in mind. The product entering any market will be examined in light of basic consumer needs as well as the aforementioned factors.

ISO has developed more than 20,000 standards to date. From agriculture to food safety and information security to healthcare these standards have improved product quality in practically every industry. Every industry and product has to follow specific standards and regulations along with many generic standards to get ISO certificates.

Let’s look at the most important ISO certification for medical laboratory.

Essential ISO Certification – For Medical LaboratoryImportant ISO certifications for medical laboratories

ISO 9001:2015: This standard affirms that the quality management system which required is complete. This standard & timely ISO audit ensures that the company is capable of consistently providing products and that services meet customer statutory and regulatory needs. The purpose is to improve customer satisfaction through effective product or service offerings. These requirements apply to organizations of any form or size.

ISO 15189:2012: Quality and competence of ISO medical laboratory are audited under this standard. This is one of the most important certifications for medical laboratories as it has dedicated regulations. It assesses personnel, accommodation, and environmental conditions.

In personnel condition, the ISO audits qualifications documentation, job descriptions, personal introduction to the organizational environment program, training provision, competence assessment per person & reviews of staff performance. It also ensures continuing education and professional development, alongside personal records of relevant skills.

In accommodation and environmental conditions, it ensures that the laboratory and office facilities provide environmentally appropriate duties. It also ensures proper storage facilities, staff services, patient sample collection facilities, facility maintenance, and environmental conditions.

It covers auditing of reagents, laboratory equipment, and consumables as well. Review of pre-examination and review processes ensures the best quality of test process results, accurate post-examination processes, results reporting, disseminating results and achieving information management in the laboratory.

ISO/IEC 17025: This certification is important for international trade. This standard streamlines communication between governing bodies and laboratories. ISO accredited Lab can enhance its testing results and get a platform to demonstrate its global service-providing capability with this certification.

ISO 10012:2003: It is a general standard that demonstrates the quality management requirements of measurement management systems. For the management of measurement processes and metrological compliance of measuring equipment, these guidelines.

ISO 19011: These sets of ISO standards are considered guidelines for auditing management systems. It applies to firms that are responsible for planning and managing audit programs. Whether it is internal, or external audits of the management system, it helps regulatory bodies and individuals manage audits, auditors, and auditing teams.

ISO 15190:2003 Updated to 15190:2020: ISO 15190:2003 was created considering the safety of lab employees and patients. However, in 2020, after the COVID outbreak, many alterations were made to the regulation and now the regulation for safety requirements is 15190:2020. 

The regulation determines the requirements for ISO certification to create and promote a safe working environment in a medical lab. It also explains the role of the laboratory safety officers in making sure that all employees take ownership of their safety at work, and that of others too.

These guidelines also cover patient care and information safety. It mainly defines the role of clinical personnel responsible for patient care.

How Does ISO Work?

Importance of ISO standards and regulations considering consumer needs and safety. International Accreditation Firm (IAF) is an international forum that works with ISO and provides accreditation to regulatory bodies in their respective countries. The IAF establishes mutual recognition agreements, otherwise known as Multilateral Agreements (MLA).

IAF oversees Accreditation Bodies (AB) around the world. These bodies ensure that companies do not need to be certified in every country they are selling products.

The main job of the accreditation body is to ensure all Certification Bodies (CB) are following ISO standards. There are around 120 accreditation bodies in the world and each country usually has only one accreditation body (AB).

Certification bodies perform audits and provide ISO certifications to an organization. CB separately determines requirements for each company and also makes sure that the companies fulfill all requirements. Thus, the ISO does not issue certificates directly. It only creates standards and CB issues certificates.

If we take the example of India, there are multiple certification bodies in every state, NABCB is an accreditation body that administers such certification bodies. IAF and MLA are international forums that work collaboratively with NABCB. These forums ensure all new standards are conveyed & being followed by governing bodies.

ISO governing bodies

How To Become An ISO-Certified Lab With ISO Certification Process?

There is a misconception in the business world that the certification process is complex. Requirements for ISO certification process are simple. Below is the stepwise guide obtains ISO lab certification.

The first step is to identify which ISO standards are essential for your organization. Once the information has been verified, companies must find a certification body that meets their requirements.

The second step is to create an application and thereby a contract with the certification body. After agreeing to the terms and conditions, CB appoints an ISO auditor that reviews essential documents and suggests changes according to the standards.

In the third step, the company is required to make recommended amendments. The auditor shares the final report after checking companies have resolved the non-conformities. CB then issues an ISO certificate to the company.

The last step is a surveillance audit. CB usually conducts surveillance audits once a year to ensure the ISO-certified company is consistently following standards. CB renews its ISO certifications after the completion of the surveillance audit.

ISO certification process

What Are The Benefits Of ISO Certification?

The International Organization for Standards has established unwavering trust amongst consumers and end-users. In the global market, any company with an ISO certificate is considered credible and gets a huge advantage over the competition in national and international trades.    

Following the benefits of ISO certification, saves a notable amount of time and costs as it fortifies processes and timelines. With improved productivity and process efficiency, companies can make sure that customer satisfaction is achieved.

ISO also delivers a strategic advantage. It specifies how companies can get more value from all resources. It also ensures that the employee and organizational health is safeguarded with safety standards. Create a standard with an eye to the needs of consumers. Thus, customer satisfaction and trust will always be remarkable with compliance.

Challenges Faced By Laboratories During ISO Certification

In March 2020, NCBI conducted a survey of medical laboratory staff in pursuit to understand the challenges faced by them during ISO lab certification. Participating members will assess their overall experience on a scale of 1-10 and engage in 16 major adversities.

The most non-conformities are observed in laboratory safety measures, documentation, reagent unavailability, and laboratory management support. Very few of the participants faced challenges in terms of communication, staff apathy, and workload throughout the ISO certification process.

Governing organizations suggest having technical assistance that can provide proper training or mentorship is the best possible way to resolve these bottlenecks.

Cost & Other Factors

ISO-accredited lab cost varies from company to company. It is dependent on multiple factors. Consider the number of processes and employees within the organization, the potential for risk and complexity while identifying the cost. It takes usually more than 6 months to complete the process. However, it can take up to 1 year if non-conformities are not resolved properly.

ISO makes amendments to its standards and regulations frequently. These changes take into account industrial trends and consumer behaviour globally. For example, ISO has made multiple changes in its molecular lab standards post-COVID. Companies must be aware of such factors. 

Know More: How Automated Audit Tool Helps with Major NABL Challenges

ISO certifications are not mandatory. However, numerous benefits of following their standards can be observed in every aspect of your business. Global leaders have always recommended ISO certifications as they make the brand credible and have definite en-cashing advantages. 

Know how our lab automation solution can redefine your laboratory business with remarkably reduced costs. 


ISO 15189:2012 Medical laboratories – Requirements for quality and competence

ISO/IEC 17025 – Testing and calibration laboratories

Guidelines for auditing management systems

ISO 10012:2003: Measurement management systems — Requirements for measurement processes and measuring equipment

ISO 9001:2015: Quality management systems — Requirements

Challenges with the pursuit of ISO 15189 

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