To study quality manual and standards required for ISO-9001-2008 of a hospital?
1. Quality Manual
The quality manual is the central document of a hospital's quality management system (QMS) and provides an overview of the hospital's quality policies, objectives, and procedures. It should be written in a clear and concise manner and be easily understood by all employees.
The following are some of the key elements that should be included in a quality manual:
* Introduction: This section should provide a brief overview of the hospital, its mission, and its vision.
* Scope: This section should define the scope of the QMS, including which departments and processes are included.
* Quality Policy: This section should state the hospital's quality policy, which is a statement of the hospital's commitment to providing high-quality care.
* Objectives: This section should list the hospital's quality objectives, which are specific, measurable, achievable, relevant, and time-bound (SMART) goals related to quality.
* Procedures: This section should describe the procedures that the hospital has in place to achieve its quality objectives.
* Responsibilities: This section should outline the roles and responsibilities of all employees in relation to quality.
* Internal Audits: This section should describe the hospital's internal audit process, which is used to assess the effectiveness of the QMS.
* Management Review: This section should describe the hospital's management review process, which is used to review the QMS and make necessary improvements.
2. Standards
In addition to the quality manual, a hospital must also comply with a number of standards in order to achieve ISO 9001:2008 certification. These standards include:
* ISO 9001:2008: This is the international standard for quality management systems.
* ISO 13485:2016: This is the international standard for quality management systems specific to medical devices.
* The Joint Commission: This is a non-profit organization that accredits hospitals and other healthcare organizations.
* The National Patient Safety Goals (NPSGs): These are a set of national goals that are designed to improve patient safety.
By adhering to these standards, hospitals can demonstrate their commitment to providing high-quality care and improve patient safety.
Conclusion
The quality manual and standards required for ISO 9001:2008 certification are essential for hospitals that want to provide high-quality care and improve patient safety. By implementing these requirements, hospitals can create a culture of quality and continuous improvement and ensure that they are meeting the needs of their patients.