Obtain Management commitment to support, understanding, involvement, provision of resources

Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact

Define Key Improvement Objectives

Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.

Develop the organization’s Quality Policy and Quality Manual

Establish approach to document control and access.

Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).

• ISO means “all sides being equal”. To date, more than ? a million organizations in 149 countries have implemented the ISO Standards.
• ISO 9001:2000 is a fundamental quality management system standard that requires an organization to identify, define, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address all imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

Application of ISO in Healthcare:

Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

• Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
• Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
• Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
• Results in improved systems, processes, and outcomes.

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

• Clause 4 – Quality Management System
Process Management, Documentation Requirements, Records Control
• Clause 5 – Management Responsibility
Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
• Clause 6 – Resource Management
Human Resources, Infrastructure, Work Environment
• Clause 7 – Product / Service Realization
Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
• Clause 8 – Measurement, Analysis, and Improvement

  Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

Obtain Management commitment to support, understanding, involvement, provision of resources
Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
Define Key Improvement Objectives
Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
Develop the organization’s Quality Policy and Quality Manual
Establish approach to document control and access.
Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).
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Application of ISO in Healthcare:

Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

• Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
• Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
• Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
• Results in improved systems, processes, and outcomes.

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

• Clause 4 – Quality Management System
Process Management, Documentation Requirements, Records Control
• Clause 5 – Management Responsibility
Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
• Clause 6 – Resource Management
Human Resources, Infrastructure, Work Environment
• Clause 7 – Product / Service Realization
Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
• Clause 8 – Measurement, Analysis, and Improvement

  Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

Obtain Management commitment to support, understanding, involvement, provision of resources
Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
Define Key Improvement Objectives
Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
Develop the organization’s Quality Policy and Quality Manual
Establish approach to document control and access.
Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).
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g/measuring and reporting.
• Results in improved systems, processes, and outcomes.

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

• Clause 4 – Quality Management System
Process Management, Documentation Requirements, Records Control
• Clause 5 – Management Responsibility
Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
• Clause 6 – Resource Management
Human Resources, Infrastructure, Work Environment
• Clause 7 – Product / Service Realization
Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
• Clause 8 – Measurement, Analysis, and Improvement

  Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

Obtain Management commitment to support, understanding, involvement, provision of resources
Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
Define Key Improvement Objectives
Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
Develop the organization’s Quality Policy and Quality Manual
Establish approach to document control and access.
Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).
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All customers have certain expectations about what good service should be. It is the personal responsibility of every employee to provide exceptional customer service. Customer expectations differ from one person to another but, basically, they all expect the same things.Customers expect:♦ Value - Fair Prices ♦ Quality ♦ Variety ♦ Pleasant Atmosphere ♦ Friendly Service ♦ Interested Employees Who Care ♦ Attentiveness To Their NeedsThere are six keys to excellent customer service.Key 1: Competence People who enjoy
esources, Infrastructure, Work Environment
• Clause 7 – Product / Service Realization
Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
• Clause 8 – Measurement, Analysis, and Improvement

  Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

Obtain Management commitment to support, understanding, involvement, provision of resources
Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
Define Key Improvement Objectives
Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
Develop the organization’s Quality Policy and Quality Manual
Establish approach to document control and access.
Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).
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following is recommended.
Obtain Management commitment to support, understanding, involvement, provision of resources
Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
Define Key Improvement Objectives
Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
Develop the organization’s Quality Policy and Quality Manual
Establish approach to document control and access.
Develop, review/revise, and incorporate all required support 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.
Conduct a Management Review of the QMS.
Undergo a Pre-Assessment or “Mock Survey” to assess system implementation, readiness
Make required corrections
Submit Document Review to Registrar (Quality Manual, Processes)
Undergo the Certification Audit

Sample Key Improvement Objectives

• Improve Patient Satisfaction
Goal: Improve to 70th Percentile
Department Goal: Reduce Wait time for Outpatient Registration to < 4 minutes
• Improve Patient Safety
Goal: Reduce Medication Error Rate to < .3%
Goal: Reduce fall rate to < 2.6 per 1,000 patient days
Note: Organizational/Hospital-wide objectives are then translated to related departmental, process, individual goals/objectives

Sample Process Interaction Diagram
See =>http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html

Sample Quality Policy

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

• Consistent compliance with all imposed requirements;
• Our focus on Patient Safety and Satisfaction; and
• Continual improvement of our products, services, and processes.