2011年3月9日 星期三

How can ISO 9001: 2000 used for health care?


Definition of ISO:

ISO means "all sides". To date, more than ½ a million organizations in 149 countries have implemented the ISO standards.
ISO 9001: 2000 is a basic standard of quality management system requires an organization to identify, define, document, implement (follow), monitor/measure and continuously improve the efficiency of its processes. It is a user to customize the system, which requires the Organization to identify and treat all introduced a requirement; as well as improve as its organisational performance by changing the systemic issues (e.g. those traditionally associated with "hand-offs").
Use of ISO in the health sector:

Use the ISO family of standards, your organization can establish a comprehensive quality/Business Management System such as:
Provide a solid basis for all introduced a requirement (e.g. JCAHO, AABB, Federal & State regulations) must be respected.
Makes all other certification & accreditation processes easier and less costly.
Facilitates a better understanding of the roles & responsibilities among employees; and improved communication/coordination between departments.
Requires the creation of improvement of measurable objectives and accountability to these objectives through monitoring/measurement and reporting.
Results in improved systems, processes and results.
The structure of ISO 9001: 2000 standard:

ISO: 9001 2000 Standard consists of 8 clauses. 1St 3 is introductory in nature. The following 5 clauses include the requirements your organization must solve. They are:

Clause 4-Quality Management System
Process management, documentation requirements, records control
Clause 5-responsibility
Customer/Patient focus, policy objectives, planning, responsibility & authority
Clause 6-resource management
Human resources, infrastructure, health and safety at work
Clause 7-product/Service realization
Planning of new products & services, Customer Interface/communication management, Design, procurement/supplier, production/Service operations, calibration
Clause 8-measurement, analysis and improvement

Internal audits, customer/Patient satisfaction monitoring/measurement of products and services and processes, handling of deviations, corrective & preventive action, continuous improvement

Process/method

While the standard does not provide for the procedure or method to be used by an organization, we recommend the following.


Obtain management commitment to support, understanding, commitment, the provision of resources
Training management & staff of ISO 9001: 2000 standard, scope of work, organisational consequences
Define key improvement objectives
Identify and map key organisational processes, as well as support. Address all introduced a requirement.
Develop your organization's quality policy and quality Manual
Establish approach to document management and access.
Develop, review/revise and incorporate all the necessary supporting documentation (e.g. Department policies/procedures, forms).
Educate staff on QMS documentation
Establish and implement monitoring/measurement for each process
Train internal auditors. Implement an internal audit process.
Carry out a review of the QMS.
Subjected to a Pre-Assessment or "Mock study" to assess system implementation, preparedness
Make necessary corrections
Send document revision to the Registrar (quality Manual, processes)
Subject to certification review
The Key improvement objectives
Improve patient satisfaction

Target: improved to 70th percentile
Department objectives: reducing latency for outpatient registration to improve patient safety
Goal: Reduce medication error rates to goal: reduce the rate of decline to Note: organisational/Hospital-wide goal is then translated into related departmental, process, individual objectives/goals

Process interaction example chart

Se =http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html>Test quality policy

We strive to be the leading provider of health services in Southern Ohio. We will achieve this through




Consistent compliance with all established requirements;
Our focus on patient safety and satisfaction and continuous improvement of our products, services and processes.

Innovative quality solutions company is a full service training and consulting company focused on total customer satisfaction, improvement of performance and organizational objectives. Innovative quality solutions provides all aspects of support to organizations seeking certification and compliance to ISO 9001, ISO 14001, as 9100 and ISO/TS 16949 (TS 16949) standards. The company has since 1995, more than 250 organizations lead to successful first time certification/registration.

Innovative quality solutions is located in Akron, Youngstown, Cleveland and Columbus. Renee Mallett, Deputy Director, health care Division, can be contacted at 614-855-0008 or email reneem@iqsconsulting.net:


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