How ISO Certification helpful for Healthcare Industry?
All institutions that safeguard people's health and safety are included in the healthcare industry. It includes pharmaceutical companies, hospitals, pharmacies, and the medical device industry, among others. In this industry, product and service quality, as well as process efficiency, are critical. The International Organization for Standardization (ISO) produces a set of ISO Certification for Healthcare Industry for this purpose, which can assist firms in the healthcare sector in showing their market credibility.
Which standards or ISO certificates are required for the Healthcare Industry?
The International Organization for Standardization (ISO) develops standards that aid in the implementation of systematised management systems for the delivery of quality assured products and services, as well as enabling compliance with the relevant standard.
ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO 27001and ISO 50001 are the most prevalent ISO standards for all types of Healthcare Industry. However, ISO 13485 certification is the most significant and required ISO standard for the Healthcare Industry.
Let's have a look at these ISO standards in more detail:
ISO 9001 Standard
ISO 9001 is a global standard that establishes a framework for establishing Quality Management Systems (QMS) in businesses. As a result, ISO 9001 assures that the quality of your products or services fulfils client expectations, which is extremely advantageous to the prosperity of your country.
ISO 14001 Standard
By providing the basis for the construction of Environmental Management Systems, the internationally renowned ISO 14001 standard assists you in enhancing your contact with the environment (EMS). It also aids you in resource management and waste reduction in order to make your activities more environmentally friendly.
ISO 45001 Standard
The ISO 45001 accreditation is critical for ensuring the occupational safety of healthcare personnel. It assists in the prevention of healthcare hazards by recognising risks early and taking preventative measures.
ISO 50001 Standard
By effectively implementing ISO 50001 for energy management systems, healthcare organisations can lower their operational costs and increase their overall efficiency.
ISO 27001 Standard
The healthcare sector's organisations are the custodians of personal information about their patients or clients. It is their responsibility to preserve the privacy of their customers. As a result, these firms may ensure that their data is safeguarded against any breach or loss by implementing the ISO 27001 standard for Information Security Management Systems.
ISO 13485 Standard
This standard aids in the implementation of medical device quality management systems. Any medical equipment, whether external or implantable, must be safe to use because it has a direct impact on the patient's life. This standard guarantees that medical equipment are of the highest possible quality and are fully safe to use.
Benefits of ISO certification for Healthcare Industry Industry
- Assures buyers of the product's quality and safety.
- Enhances the organization's reputation and aids in the acquisition of bids
- Makes organisations comply with applicable laws.
- Reduced premiums assist in cost reductions.
- By continuously refining the system, it aids in satisfying the needs of customers.
ISO Certification process for Healthcare Industry
- Application & contract
- Audit team Assignment
- Document view
- Certification Audit Independent review
- Notification of Certification
- Surveillance audit
- Re-Assessment
The certification process goes further. click here to view the next steps to ISO certification Process