ISO 7101
Certification
Quality Management Systems in Healthcare Organizations
ISO 7101 is an international standard that establishes requirements for quality management systems in healthcare organizations, enabling the delivery of high-quality healthcare through processes that ensure safe, effective, efficient, timely, equitable, and people-centered care.
Improved Quality and Patient Safety
Strategic and Sustainable Management of Healthcare Organizations
Promotion of a Positive Organizational Culture
Strengthened Trust and Institutional Reputation
Focus on Innovation and Continuous Improvement
Why should your organization obtain ISO 7101 certification?
ISO 7101 – Quality Management Systems in Healthcare Organizations certification is essential for healthcare services seeking to enhance their market credibility, improve patient and user experience, and highlight the quality and safety of services provided through a process-based and risk management approach.
- Creating a culture of quality and safety involving all professionals, starting with top management
- Adopting a healthcare quality management system based on person-centered care, respect, compassion, user engagement, equity, and dignity
- Identifying and addressing risks associated with healthcare delivery
- Monitoring and evaluating clinical and non-clinical performance, including care and administrative processes, ensuring organizational reliability
- Controlling service delivery through documented, implemented, and monitored processes
ISO 7101 Certification with QMS
Continuous Improvement of Healthcare Quality
The standard establishes principles to ensure patient safety, clinical efficiency, and patient-centered care, promoting a culture of quality and excellence in healthcare delivery.
Increased Trust and Organizational Reputation
Adoption and certification to ISO 7101 demonstrate a commitment to best practices in healthcare management, which can attract more patients, strengthen partnerships, and facilitate national and international accreditations.
Greater Organizational Resilience and Sustainability
The standard provides guidance on strategic planning, risk management, and efficient resource use, making organizations more adaptable to change and better prepared to face crisis situations.
How to obtain ISO certification?
ISO does not certify organizations. To obtain certification to the standard, you need to contact a third-party certification body, such as QMS, for example, which will carry out an audit of your organization and determine whether your management system meets the criteria of the ISO standard.
Step 1
Working with a consultant
Some companies decide to hire a consultant to help them with the process of implementing a management system. Through their expertise, this consultancy can guide them through the requirements of the ISO Standards and help them develop the necessary tools. Please note that hiring a consultant for this purpose is optional and this service is not offered by QMS.
Stage 2
Pre-audit
Once you have completed the implementation of your management system and before the certification audit, you can request a pre-audit if you feel it is necessary. In this process, a certification body such as QMS will carry out a prior, independent assessment of your management system in order to check that all the requirements comply with the criteria of the ISO standard you have adopted. It is important to note that this step is optional for any organization that has applied for certification and that the pre-audit can be offered by QMS.
Stage 3
Suitable for ISO certification
At this stage, you need to apply for ISO certification through a third-party certification body. The certification body will conduct an audit of your company’s documents and management system against the requirements of the standard and determine whether it is ready for certification. During the audit, it is essential to demonstrate the effectiveness of your management system. If you wish, you can contact QMS for a no-obligation quote.
Stage 4
ISO recertification
Each certification is valid for 3 years. However, every year, the certification body carries out a surveillance audit to ensure that your management system continually adheres to the requirements of the ISO standard.
What is ISO certification?
ISO is the International Organization for Standardization. It was created with the aim of facilitating international coordination and the unification of industrial standards that contribute to the development of trade.
Standards are made up of documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for purpose.
Each standard represents a different good, service or process, and it is up to the company to decide which standard best meets its needs.
What are the benefits of being certified to an ISO standard?
Among the numerous benefits, certification can help you win contracts. If you are looking to bid for and win tenders, for example, being certified can increase your chances of being chosen as a supplier, especially for work in the public sector. In addition, certification adds credibility to your business, boosting customer satisfaction and confidence in your brand. Other benefits include cost savings and increased market share.
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