Implementation of an ISO 9001 Business/Quality Management System (B/QMS) into Sterile Processing Services (SPS)

Presented by Veterans Integrated Service Network (VISN) 4Sterile Processing Services Veterans Healthcare Administration

0

1

The ISO Consultation Division of the Veteran’s Health Administration is working with Sterile Processing Services across the US to implement ISO 9001

VISN 4 Sterile Processing Services (SPS)

VISN 4 is an integrated network providing comprehensive health care services to Veterans at 10 VA Medical Centers and 43 community-based outpatient clinics. It is divided into Eastern and Western markets - each with 5 medical centers, serving Veterans in 104 counties in Pennsylvania, West Virginia, Delaware, New Jersey, New York, and Ohio.

VISN 4 SPS provides, supports, and oversees extensive services, including: Decontamination (cleaning and disinfection), Preparation/Packaging, Sterilization, High Level Disinfection, Critical and Semi-critical RME Storage and RME Transportation /Distribution.

2What is ISO 9001? 3

ISO 9001 is an International Standard that provides the structure to manage interrelated systems and processes with a focus on the CUSTOMER!

● seeks the most effective way to produce the best product ● identifies consistent methods to produce reliable products with

fewer errors

ISO 9001 supports improvement frameworks such as Lean and Six Sigma and performance excellence frameworks such as the Malcolm Baldrige National Quality Program criteria.

The Foundation Blocks of ISO 9001The Three “Cs”

4

Customer Satisfaction

Consistent Processes

ContinualImprovement

When ISO 9001 is fully implemented…

Ultimately, it’s a WIN-WIN for Veterans, SPS, and the Organization!

ISO 9001 Implementation 6

5 Key areas include

Quality Management

Management Responsibility

Managing Resources

Product Realization

MeasurementAnalysis

Improvement

How we do our job and how we keep track of what we have done.

Leadership support and involvement is critical to team success.

Discusses the resources needed to smoothly manage and maintain SPS.

Addresses the core business processes for SPS. What things are required to meet the need of the SPS customer.

Focuses on measuring and monitoring what we do in SPS including customer satisfaction, processes, conformity, or audits to provide consistency.

7

What ISO 9001 does for the SPS

• Focuses on the system and TEAM

• Seeks the most effective way/best product

• Streamlines work

• Delivers consistent methods and fewer errors by standardizing processes

• Ensures right instructions for the job

• Provides an environment for motivated staff and satisfied customers – the formula for lasting success!

8

VISN 4 SPS Quality Policy

Right productRight timeRight conditionReady for today

- regulatory complianceReady for tomorrow

- continual improvement

9

VISN 4 Sterile Processing Service ISO 9001Journey

5

ISO 9001 Quality Manual

Record Control

Control of Defects

Corrective Action

Preventive Action

Internal Audits

Document Control

Quality Policy and Quality Objectives

2012 Pilots (Including Pittsburgh VA Healthcare System) Lessons learned related to Logistics/support, purpose, participants, preparation, curriculum, and follow-up

2013 Series of Workshops (4)/ Self Assessments Built the Foundation of a successful business/quality management system

2014 Gap Assessments/Work Plans Completed assessments to identify areas that did not meet requirements and developed/implemented work plans

2015 Internal Audit and Continual ImprovementFurther Development of Internal Audit Plans and Sustainment/Continual Improvement

The Quality Manual & the 6 Procedures