ISO 9000 FOR HOSPITAL

JINSON GEORGE

ISO 9000

In the year 1987,composed of representative from national standards bodies of 91 nations, adopted a series of written quality standards, to standardize quality requirement of European countries within the common market and those who wishing to do business with those countries These standards, were revised in 1994, and again (significantly)in the year 2000

The ISO 9000 is a quality assurance protocol that was created to increase and maintain quality standards in businesses or organizations. The protocol consists of a set of quality management guidelines that are recognized internationally to improve efficiency and customer satisfaction

ISO is an international agency consisting of 156 member countries including Kenya

ISO was formed in 1947 and is based in Geneva, Switzerland

It develops international standards to foster increased trade of products and services

By July 2005, ISO had published over 15,000 standards

ISO 9000

• Most widely known and successful series of standards

• Gaining wider interest in new management of Public administrations

• Represents an international consensus on good management practices

• Is a tried and tested framework of managing your business process

ISO 9000

ISO 9000 FOR HOSPITALS

Hospital performance statistics and articles about services falling short of expectations are rarely out of the news these days, its just because of the various standards

Hospitals are asked to perform quality measures, is it not strange that each individual hospital will try and attain these objectives so they will try to various quality accrediction

ISO 9000 FOR HOSPITALS

The generalized implementation of ISO 9000 quality management systems by health care establishments is seen as a means of rationalizing client-supplier relationships and an opportunity to improve the quality of health care while reducing the costs.

The document provides a framework for the design and improvement of process-based quality management systems by health care organizations. The guidelines are voluntary and they are not intended for certification or accreditation.

ISO 9000 FOR HOSPITALS

Guidelines for implementing ISO 9000 quality management systems in the health care sector were published by ISO (International Organization for Standardization) on 20 September 2001 as its first "International Workshop Agreement" (IWA).

ISO 9000's purpose is to ensure that suppliers design, create, and deliverproducts and services which meet predetermined standards

The ISO 9000 quality standards are broken down into three model sets—ISO 9001, ISO 9002, and ISO 9003.

ISO 9001 is the most wide-ranging, for it specifies the various operating requirements in such areas as product design and development, production, installation, and servicing. ISO 9002 is concerned with quality assurance at the production and installation stages. ISO 9003 covers testing and inspections.

Establishment of ISO 9000 IN hospital

Acceptable quality care at affordable prices.Timely care.Clear communication to the patients.Best practices for fixing appointment and service

delivery.Reliable diagnostic and laboratory support.Reliable support services like canteen, ambulance,

pharmacySafe and pleasant environment.Technical competence, courtesy and attitude of

staff.

THE BENEFITS OF IMPLEMENTATION

Uniformity of objectives and methodologiesCosts: shared processes and methods allow

staff to transfer and work at other sites seamlessly with a minimum of training.

Staff costs: it could be strongly argued that if a standardized quality management process existed within hospitals, that considerable administrative and expensive management costs could be eliminated, given that standard processes, training, objectives, and goals would exist.

THE BENEFITS OF IMPLEMENTATION

Improved customer satisfaction: the absolute goal of any ISO implementation process. Measuring, review, and action versus the respective clauses of the standard should ensure the continual improvement cycle and provide better service and effective lessons learned for the benefit of the end user, the patient.

Information sharing: standardized processes across multiple hospitals would allow data and knowledge to be shared, ensuring greater efficiency and lower costs in pursuit of objectives.

FOLLOWING PROCEDURE

Periodic management reviews: all organizations using the same formats and sharing targets and objectives.

Internal audits all hospitals would have to perform these as standard practice.

Measurement and control of suppliers: this would allow consistency and assurance that taxpayer money was utilized efficiently.

Customer feedback: the ISO 9000 requirement to solicit customer feedback would help to ensure that preventive measures would be more prominent than corrective actions.

FOLLOWING PROCEDURE

Corrective action: a standardized and formal corrective action process that could be shared across different sites could be a huge advantage to hospital managers.

Risk assessment: again, this is obviously performed within most work environments, but a standardized and regular format that is recognized across multiple sites could bring improved synergy and reduced costs to the service provided.

Continual improvement: as the recurring theme of the 9001 standard, the above processes, when undertaken correctly, can drive real improvement within a hospital environment similarly to any business.

 ELEMENTS AND THEIR APPLICATION FOR HEALTH CARE PROVIDERS

Management responsibility. This applies to both administrative and clinical operations. The purpose is to provide the leadership, structure and resources, and establish the quality policy for the entire health care quality system

Quality system. As with other ISO 9000 applications, health care providers must establish a quality manual; create a documented quality management system (QMS); and determine how the organizational structure, procedures and processes will satisfy quality objectives. 

Contract review. The purpose of this requirement is to ensure that all written materials creating patient expectations are accurate

ELEMENTS AND THEIR APPLICATION FOR HEALTH CARE PROVIDERS

Design control. It defines the steps that must be taken by the hospital when new or additional services are considered for implementation.

Document and data control. This clause requires that the quality system provide timely access to approved instructions for the accurate and timely provision of patient care and support functions.

Purchasing. It is necessary that the QMS ensure the accurate and timely purchase of materials and supplies from approved vendors

Product identification and traceability.  Patient records and patient activities are generally connected to a particular patient through the use of unique identification numbers. 

ELEMENTS AND THEIR APPLICATION FOR HEALTH CARE PROVIDERS

Inspection and testing. This clause involves the objective monitoring of the accuracy and timeliness of patient care and all supporting functions that affect that care. 

Handling, storage, packaging, preservation and deliveryInternal quality audits. An ISO 9000 QMS is audited regularly.

Audits can be internal (first party), insurance underwriters (second party) or qualified health care registrars (third party).

Statistical techniques. It can provide significant insight to the efficacy of the system and areas that should be addressed.

COST AND CERTIFICATION

Contracting a Registrar - The registration audit is performed by a Registrar and the cost will depend on how big and how complex the organization is. They will charge depending on how many audit days they spend at the organization. 

Auditor's feesAuditor's Travel and living expensesApplication feeRegistration feeInitial assessment (optional)Certification audit (Year 1)Surveillance audits (Year 2 and 3)Reassessments (optional)

COST AND CERTIFICATION

Internal Cost - The time the employees will need to spend building and implementing the system. • Learn about ISO 9001• Graph Analysis• Plan the project• Train Employees• Document your Quality Management System (QMS)• Quality Manual• Procedures/Work Instructions/Flowcharts• Forms/Records

• Implementation of the Quality Management System• Audit the QMS• Registration

COST AND CERTIFICATION

Outside help - This is either consultant fees or the purchasing of tools to help with the project.

1-25 Employees, no quality system in place yetEstimated costs of doing the implementation in the hospital using

iso authority, All-in-One Documentation & Training Package, and by hiring a consultant

Cost in Dollars for All-in-One Package or Consultant

Cost in terms of your company's employee hours spent

All in one $997 96

consultant $4800 48

DISADVANTAGES OF ISO 9000

Owners and managers do not have an adequate understanding of the ISO 9000 certification process or of the quality standards themselves

Funding for establishing the quality system is inadequate

Heavy emphasis on documentationLength of the process

THANK YOUUUUUUUUUUUU……….