Who within the healthcare industry benefits from ISO standards?

Everyone including the industry, the regulator and the consumers greatly benefit from the creation and implementation of the ISO standard. It would be tedious for organisations to comply with different regulations and multiple requirements, therefore ISO health standards help organisations alleviate burnout by ensuring consistency. They form strategic tools that allow organisations to gain a competitive advantage through the provision of products and services that are trustworthy, reliable and safe.

Similarly, regulators can rely on these solutions which are internationally harmonised to improve their technical foundations, so that they continuously meet citizens’ expectations and market-friendly regulations. ISO standards provides the necessary instruments to assess and evaluate conformity, so that a solid foundation can be created for health legislation.

Consumers benefit of ISO certification in the healthcare industry

Consumers benefit the most from the creation of ISO standards as they ensure that their interests are preserved by providing good quality care through safe and reliable products or services. ISO standards seek to harmonise the entire sector to increase efficiency, facilitate access and reduce costs. In addition, the ISO for manufacturing companies also has many benefits for consumers’ healthcare.

ISO certification in the healthcare industry

Listed below are a selection of ISO standards that are dedicated to improving the quality and safety of healthcare organisations across the globe:

ISO 9001 in the healthcare industry

This standard can help healthcare industries to conduct periodic management reviews and internal audits to measure any possible lapses in the system. Additionally, the healthcare company can apply corrective actions to ensure that the effectiveness of their Quality Management System (QMS) is not only maintained, but enhanced. Moreover, as ISO 9001 focuses on risk management and continual improvement, it can help the healthcare organisation meet the changing demands of their patients. For more information, you can read the ISO 9001 benefits article.

ISO 14001 for the healthcare industry

This standard can help healthcare organisations implement an Environmental Management System (EMS) that can significantly reduce their environmental impact. With the help of an effective EMS, companies can show reduction of wastage and compliance to environmental laws, helping them gain a reputation in the market for being environmentally responsible. To implement ISO 14001, you must first be familiar with the requirements of ISO 14001.

ISO 45001 for the healthcare industry

This standard will help the organisation avoid healthcare hazards by identifying risks before they escalate to bigger issues and perform preventive interventions.

ISO 27001 for the healthcare industry

This standard will help the organisation secure information about their patients or customers by implementing an effective Information Security Management System (ISMS). The ISMS will protect the privacy of patients by ensuring that the data is protected against any potential breaches or losses. If you are thinking of implementing ISO for your IT company, ISO 27001 is one of your most important options.

ISO consultant for the healthcare industry

Since the healthcare industry is vast, there is a plethora of ISO standards that are available for consumption. An ISO consultant will help your organisation select the standard which will provide the maximum number of benefits.

For example, if your company focuses on laboratory testing and in-vitro diagnostic test systems, the consultant will recommend the ISO/TC 212 standard. Similarly, if your company produces small connectors that are utilised to connect medical devices such as syringes, tubing or gases, the ISO consultant will suggest ISO/TC 210 that provides quality management and product manufacturing specifications related to the general aspects of medical devices.

On your own, you will never be able to select the most appropriate ISO standard for your company, simply because you do not have the experience, knowledge base, and training of an ISO consultant. Additionally, they also help you review your documents, assess your management system, apply corrective actions, conduct a reassessment and finally apply for the certification.

Cost of ISO certification for the healthcare industry

The cost of the ISO certificate depends upon the exact size of your organisation. Size is the most important factor for calculating the cost as it is directly proportional to the number of documents, the number of processes, and the complexity of your management system. Having said that, the majority of the accreditation bodies charge $15,000 per annum if your organisation is medium sized.