Md. Towhidur Rahman :
Accreditation is a process of assessing conformity assessment services (Testing, Calibration & Medical Laboratories, Certification Bodies, Inspection Bodies, Training Institutes etc.) against relevant International, regional and national standards, to identify what is being done well and what needs to be improved. In other words, accreditation acknowledges a level of organizational competence that is comparable to other organizations accredited by the same or mutually recognized other accrediting body. It also identifies areas in need of improvement and provides suggestions on how those improvements could be made. When you see the provider is accredited, it means the provider is taking that extra step, investing time and resources to meet rigorous standards. These providers have put policies, processes, and practices in place to help minimize risk and deliver safer care.
The successful provision of health and social care is one of the greatest challenges today and will only grow in its magnitude and complexity. Whether caused by expanding global population growth, or increased life expectancy, the need to provide reassuring, consistent, cost-effective health and social care grows every day. Accreditation provides a key tool for health and social care providers in this delivery.
Accreditation is emerging as a preferred framework for building quality medical laboratory systems in resource-limited settings. Accredited laboratories can become more accountable and less dependent on external support. Efforts made to achieve accreditation may also lead to improvements in the management of laboratory networks by focusing attention on areas of greatest need and accelerating improvement in areas such as supply chain, training, and instrument maintenance. Laboratory accreditation may also have a positive influence on performance in other areas of health care systems by allowing laboratories to demonstrate high standards of service delivery. Accreditation may, thus, provide an effective mechanism for health system improvement yielding long-term benefits in the quality, cost-effectiveness, and sustainability of public health programs.
Laboratory results are required for making a large proportion of medical decisions. In developed countries, an estimated 60% to 80% of patient management decisions are based on laboratory data. Laboratories that achieved accreditation are recognized for superior test reliability, operational performance, quality management, and competence. Accreditation is most effective when it is rooted in a policy framework for evaluating laboratory quality and patient safety. In some countries, accreditation is a mandatory requirement for testing operations, while in other countries, accreditation is voluntary and driven by market incentives. Governments may stipulate that laboratories functioning below the accreditation standard be required to submit detailed improvement plans and take timely action to demonstrate compliance, with continued failure to comply resulting in penalties, service limitations, and prohibitions against further testing.
International and/or national quality standards are the backbone of accreditation. Standards provide the guiding framework within which laboratory performance is evaluated. ISO 15189, a laboratory standard from the International Standards Organization (ISO), specifies quality management system and competency requirements for medical & clinical testing. Based on ISO/IEC 17025 and ISO 9001, it has gained widespread recognition as a reference standard for accrediting clinical laboratories. Adherence to such quality standards-and participation in accreditation programs that certify this adherence-can improve operational efficiency and customer service and reduce rates of laboratory errors.
Among different accredited ISO certifications, ISO 9001 is receiving an increased level of attention by a growing number of healthcare institutions. According to the American Society for Quality, about half a dozen hospitals and clinics have already registered to the standard and several hundred other healthcare organizations are in the process of preparing for ISO 9001 registration. Benefits of accredited certification are clear. Perhaps the most obvious is that an organization that takes on the challenge of ISO 9001, it essentially guarantees itself of being in a constant state of readiness; ready for change, ready for the future and ready to grow.
If a health & Social care provider is certified to ISO 9001, any other survey process for healthcare quality certifications will be much simpler and less costly regarding both preparation and compliance demonstration.
Systemic breakdowns are recognized and addressed.
Development of “Best practice” hospital-wide processes, with reference to supporting documentation.
Ensures conformance to and effectiveness of documented processes.
Focuses on Patient Care, Satisfaction, and Safety.
Reduce errors associated with “hand-offs”.
Improve documentation and records.
Improve employees’ understanding of roles and responsibilities within the healthcare quality management system.
Strengthen customer/community confidence and relationships.
Alignment of Hospital-wide, Departments, Individual objectives.
Foundation for on-going improvement initiatives.
Security is an ongoing concern for most health & social care providers. There is growing acceptance that electronic records will play a more important role in health & social care service delivery. So a formal information security management system becomes necessary. There is, however, a set of standards available to IT professionals looking to formalize their information security process: ISO 27001. These standards provide the framework for an organization to systematically protect itself by managing risk, comply with relevant legislation, and have a mechanism to validate, that their supply chain and business partners have secure systems.
Accredited inspection for social care drives up standards, and provides assurance and confidence to customers and the public that the care provider has been independently inspected in their specific fields of expertise in social care such as dementia, learning difficulties, nursing, mental health, and domiciliary care, and is compliant with the rigorous standards used by the accredited inspection body.
Granting healthcare practitioners access to medical devices that are made in another country is critical to all healthcare systems. Indeed, most countries import more medical devices than they export. Each country must sensibly regulate access to medical devices in order to protect their citizens from unsafe devices. Regulators are increasingly realizing the benefit of recognizing the quality management system standard ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. This international standard provides the basis for medical device regulations to be harmonized around the world. The regulating bodies of our country may remember this while monitoring the health & social care service. By becoming certified in the ISO 13485 standard the company will increase the probability of making safe and effective medical devices, meet regulatory requirements, meet customer expectations & help monitor the effectiveness of the supply chain. Additional Benefits of ISO 13485 certification includes increased efficiency, cost savings, more effective risk management and quality assurance and improved ability to respond to Customer Requirements.
With expanding global markets, especially for medical devices, the systems of the IAF Multilateral Recognition Arrangement (MLA) and ILAC’s Mutual Recognition Arrangement (MRA) help all patients, regulators and other stakeholders understand the credentials of health and social care providers which holds accreditation or accredited certification. Regardless of geography, those organizations which are linked to the IAF MLA and ILAC MRA systems, demonstrate a commitment to excellence and assurance vital in health and social care. In addition to delivering assurance, this system also delivers efficiency. The stated and verified equivalence gained through the global MLA and MRA systems allows health and social care providers to use manufacturers and suppliers which have tested products once, rather than multiple times, both in the process of seeking regulatory approvals and moving it across borders.
Accreditation of laboratories, inspection bodies and certification bodies ultimately provides assurance of good service to patients and all stakeholders. Through the standardization and regulatory process, coupled with accreditation, health and social care is provided at the right quality, efficiently and using the most appropriate resources from home & around the world.
