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VHA ISO 9001 Implementation Initiative and Synergy with

Baldrige Criteria

Washington, DCOctober 2010

Christopher LoGrasso MCPM, PMP, CMQOE, Regional Director for the National Office of Clinical

Consultation and Compliance

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“You can’t have healthy patients without having

healthy healthcare systems” –Robert L. Jesse, MD, PhD

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ISO 9001 as the Foundation

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Regulatory Compliance

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Baldrige Criteria and Known Performance Benefits

• The Baldrige Criteria provide an integrated, results-oriented framework for designing, implementing, and assessing the management of all operations– Leadership– Strategic planning– Customer Focus– Measurement, Analysis, and Knowledge Management– Workforce Focus– Process Management– Results

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ISO 9001 Background

• The International Organization for Standardization (ISO)– ISO, founded in 1947, is a non-governmental, non-profit

organization based in Geneva, Switzerland – ISO’s mission is to promote the development of standardization

for related activities in the world

• ISO 9000 Family of Quality Management System (QMS) Standards– ISO 9000:2005 – Fundamentals and Vocabulary– ISO 9001:2008 – Requirements (subject for audit)– ISO 9004:2009 – Guidelines for Performance Improvements

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Constructs of ISO 9001

• Plan – Do – Check – Act• Quality Management Principles

– Customer Focus– Leadership– People Involvement– Process Approach– System Approach to Management – Continual Improvement– Factual Approach to Decision Making – Mutually Beneficial Supplier Relationship

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ISO 9001 QMS Structure

Clause 4 – Quality Management System (QMS)– Process Management, Documentation, and Records

Clause 5 – Management Responsibility– Policy, Objectives, Planning, Responsibility and Authority,

Documentation, Communications, and Management Review

Clause 6 – Resource Management– Human Resources, Infrastructure, and Work Environment

Clause 7 – Product Realization– Customer Requirements, Design, Purchasing, Production and

Service Operations, and Calibrations

Clause 8 – Measurement, Analysis and Improvement– Audit, Satisfaction, Inspection and Testing, Nonconformity,

Corrective and Preventive Action, and Continuous Improvement

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ISO 9001 and Healthcare

• Why is healthcare embracing ISO9001?– Healthcare organizations recognize the value of a system that

combines all criteria for management including:• Business Management

• Compliance Management

• Quality Management

– Physicians’ Clinic of Iowa (PCI) and the U.S. Department of State Medical Services (MED)

CURRENT NEW SYSTEM

Copyright © 2010 ISO Consultants for Healthcare, LLC

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Synergy Between ISO 9001 and Baldrige

• Implementation and use: – Series (sequentially)– Parallel (simultaneously)

• Quality system methodology – Structure– Purpose

• Performance improvement– Measures– Corrective/Preventive Action

• Customer focus

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Synergy Between ISO 9001 and Baldrige (cont’d)

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 Baldrige Criteria

   1.Leadership  2. Strategic Planning  3. Customer Focus

4. Information Analysis 

5. Human Resources 6. Process

Management 7. Business Results 

 ISO 9001:2000              

4Quality Management System              

5.1Management Commitment              

5.2Customer Focus              

5.3Quality Policy              

5.4Planning              

5.5Resp., Authority & Communication              

5.6Management Review              

6.1Provision of Resources              

6.2Human Resources              

6.3Facilities              

6.4Work Environment              

7.1Planning of Product Realization              

7.2Customer Related Processes              

7.3Design and/or Development              

7.4Purchasing              

7.5Production and Service Operations              

7.6Control of Measuring and Monitoring Devices              

8.1General              

8.2Measurement and Monitoring              

8.2.1Customer Satisfaction              

8.2.2Internal Audit              

8.2.3Measurement and Monitoring of Processes              

8.2.4Measurement and Monitoring of Product              

8.3Nonconforming Product              

8.4Analysis of Data              

8.5Improvement              

8.5.2Corrective Action              

8.5.3Preventive Action              

Aligned 

Somewhat Aligned  

Not Aligned 

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Office of Clinical Consultation and Compliance

• Conceived from Secretary Shinseki T-21 initiative (SPD/ISO 9001 RME Action Plan) related to:– Vulnerabilities with reprocessing reusable medical equipment

(RME) can expose patients to infectious diseases– Public nature of topic– Need to reduce the variation in the way we do business

• Aligned within the Office of the Principal Deputy Under Secretary for Health

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OCCC Vision and Mission

• Vision: – Provide Veteran-centric care (Veteran is the customer)– Be forward thinking/proactive– Assist with the ability to provide reduced variation in the quality

of care we provide

• Mission:– Implement the ISO 9001 Quality Management System across

VHA– Begin by supporting RME initiatives– Provide on site consultation and education– Chair iQMS consortium for document control

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OCCC Initiatives

• Stand up National Office and 7 Regional Offices• Standardize knowledge tools and processes through

Internationally recognized programs (ISCHMM)• Support SPD with development of standardized

SOPs and Competencies• Provide education to stakeholders on our ISO 9001

QMS

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OCCC Initiatives (cont’d)

• Integrate ISO 9001 standards within SPD/RME through educating, consulting, and supporting stakeholders

• Work synergistically with existing auditing teams to streamline and reduce audits, surveys, and inspections (SPD, SOARS, OIG, OMI, Pt. Safety…)

• Assist facilities in readiness for inspections and consistency with ISO 9001

• Support rollout of oneSOURCE• Chair iQMS Consortium

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oneSOURCE

• Extensive database of clinical instrument documents • Easy to access, view, and print • Continuously updated as new clinical equipment

come to market • Documents will be added to oneSOURCE by request• No more file drawers full of documents in a remote

location • No more personnel time spent accumulating and

maintaining these files • No more wasted time searching for lost or misplaced

documents when needed

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Integrated Quality Management System (iQMS)

• A system that will strategically unite and align quality and business processes, streamline the access and utilization of data repositories, and analytical systems

• The iQMS Consortium is an ad-hoc, integrated project team (IPT) committee of VHA inter-program subject matter expert representatives accountable for the procurement process for the software and initial design, implementation, and use of the system

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References

Burney, R., Levett, J., Dolan P., (2009, January).  Iso-lating the problem.  Quality Progress,42(1), 36-40.

The Elsmar Cove Website. (2010). ISO 9001-QS-9000 (now TS 16949) Information Exchange: An Alignment Matrix. Retrieved October 19, 2010, from http://elsmar.com/level2/baldrige.html.

Folkerts, T. J., (2007, May). The quality diet:  Building a healthy business. Quality Progress, 40(5), 21-25.

oneSOURCE Document Site. (2010). Retrieved October 21, 2010, from http://onesourcedocs.com/index.html.

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QUESTIONS

We look forward to partnering with you to improve the care of our Nation’s Veterans!

Chris LoGrasso

christopher.lograsso@va.gov

202-603-4487

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