IS 15551 : 2003 Quality Management Systems - Guidelines for Process Improvements in Health Service Organizations

1 Scope

This Indian Standard provides guidelines beyond the requirements given inIS/ISO 9001 in order to consider both the effectiveness and efficiency ofa quality management system, and consequently the potential forimprovement of the performance of an organization. When compared to IS/ISO9001, the objectives of customer satisfaction and product quality areextended to include the satisfaction of interested parties and theperformance of the organization.

This Indian Standard is applicable to the processes of the organizationand consequently the quality management principles on which it is basedcan be deployed throughout the organization. The focus of this IndianStandard is the achievement of ongoing improvement, measured through thesatisfaction of customers and other interested parties.

This Indian Standard consists of guidance and recommendations and is notintended for certification, regulatory or contractual use, nor as a guideto the implementation of IS/ISO 9001.

This standard provides additional guidance for any health serviceorganization involved in the management, delivery, or administration ofhealth service products or services, including training and/or research inthe life continuum process for human beings, regardless of type, size andthe product or service provided.

Note - ISO 13485 and IS/ISO/IEC 17025 provide specific information formedical device organizations and commercial laboratory facilities.ISO 15189 provides specific information for medical (clinical) -laboratories. Other organizations, such as manufacturers/distributors ofpharmaceuticals, medical supplies, etc. are regulated and have to complywith other specified criteria. This standard could be viewed as avoluntary supplement to those organizations should they choose toimplement the guidance of this standard.

The definitions of terms such as patient/client, client, primary,ancillary, and specialty care vary by region within the health servicecommunity. The organization's processes for addressing these activitiesshould be included in the quality management system. The recommendationsand guidance in this standard apply to anyone in the organizationaffecting quality, including necessary support services.

Each section of this standard is tied to its counterpart inIS/ISO 9004 : 2000 including text boxes containing all the requirements ofIS/ISO 9001 : 2000.

2 References

IS 397 Method for statistical quality control during production

     Part 0 : 2003 Part 0 Guidelines for selection of control charts

     Part 1 : 2003 Part 1 Control charts for variables

     Part 2 : 2003 Part 2 Control charts for attributes

     Part 3 : 2003 Part 3 Special control charts by variables

     Part 4 : 2003 Part 4 Special control charts by attributes

IS 7200 : Part 1 : 1989 Presentation of statistical data: Part 1 Tabulation and summarization

IS 7200 : Part 2 : 1975 Presentation of statistical data: Part 2 Diagrammatic representation of data

IS 10427 : Part 1 : 1982 Designs for industrial experimentation: Part 1 Standard Design

IS 10427 : Part 2 : 1986 Designs for industrial experimentation: Part 2 Orthogonal arrays

IS 12801 : 1989 Pareto diagram and cause and effect diagram

IS/ISO 9000 : 2000 Quality management systems - Fundamentals and vocabulary

IS/ISO 9001 : 2000 Quality management systems - Requirements

IS/ISO 9004 : 2000 Quality management systems - Guidelines for Performance Improvements

IS/ISO 19011 : 2002 Guidelines for quality and/or environmental management systems auditing

IS/ISO 10012 : 2003 Measurement management systems requirements for measurement processes and measuring equipment (First revision of IS/ISO 10012-1 : 1992 and IS/ISO 10012-2 : 1997)

IS/ISO/TR 10013 : 2001 Guidelines for quality management system documentation

IS/ISO/TS 16949 : 2002 Quality management systems - Particular requirements for the application of IS/ISO 9001 : 2000 for automotive production and relevant service part organizations

IS/ISO/IEC 17025 : 1999 General requirements for the competence of testing and calibration laboratories

SP 68 : 2000 Guidance on statistical techniques for ISO 9001 : 1994 (Identical to ISO/TR 10017)