Services

ISO 9001:2008 Service Description

Many hospitals are turning to ISO 9001 to attain DNV accreditation. Some find it helps realize efficiencies, cost savings, and improved quality of care.

Others, though, are still grappling with ways to make ISO work for them. They want a system that does more than just deliver accreditation. They want a system that helps them achieve a culture of excellence and continuous improvement. A system that’s flexible, transparent, and nimble. A system that’s not bogged down in paperwork.

A system that’s not about procedures—it’s about results.

Sound impossible? We know it’s not. Chapman Medical Quality (CMQ) has developed a lightweight but powerful framework that lets hospitals achieve their quality goals—and surpass them—without the usual friction and headaches.

CMQ’s quality framework is fully ISO 9001 compliant and enables hospitals to meet DNV’s requirements. But it moves beyond simply delivering compliance by serving as a powerful management tool, one that truly rationalizes process improvement.

The system lets hospitals codify their business objectives and transform them into practical, pragmatic, and effective improvement projects. Because you can’t monitor what you can’t measure, and you won’t measure anything if the system’s not usable.

What’s more, CMQ’s quality framework incorporates best-practice elements of Lean, Six-Sigma, Balanced Scorecard, business intelligence, and a host of CMQ proprietary tools. In management’s hands, it’s a powerful toolkit. We built the toolkit running our own companies, and refined the tools in actual practice.

You could call it an “ISO 9001 Quality Compliance Management Engine, Powered by Lean.” We just call it “Lean ISO.” Here’s how it works:

  • We partner with your hospital’s C-suite and key stakeholders to clarify your quality goals.
  • We work with your staff to use our proprietary tools to rationalize the document system underlying – “Leaning it out” and focusing it on risk.
  • Using your strategic objectives, we identify traceable metrics, and develop a Balanced Scorecard to chart your organization’s progress.
  • We audit your existing CAPA system and integrate it into your existing management and project management systems – streamlining data collection, monitoring, and reporting to make all processes agile—and sustainable.
  • We integrate your internal audit and management review functions into and around the CAPA and document system – management review should be the essence of all of your ISO efforts.
  • If desired, we install a Metric Compliance System to give clinicians, management, the quality team, and other stakeholders a real-time view into compliance, quality improvements, and realized savings.

ISO 9001 isn’t just a tool for quality improvement and cost savings. It’s a complete business management tool that can boost quality at every level and in every department. It eliminates risk, letting hospitals focus on what they do best—delivering excellent patient care.

How we can help:

First, Let’s Talk

We’re happy to spend an hour understanding your stage of ISO system development, the goals that you currently have for your system, your current use internal audit and Process Improvement (PI) tools (Lean & Six Sigma), your current accreditation and the current status of your Policies and Procedures (P&Ps). We do not offer a “one-size-fits-all” solution, and we need to understand how you are currently operating and what you want to accomplish before we can determine how we can be helpful.

Document and System Review: 2-4 Days

A thorough review of your document and quality systems is a critical first step. We recognize that what we recommend has to be in keeping with your existing practices, leveraging on what has been done in the past. We do a one day review of documents, quality systems, internal audit practices, PI practices and systems, IT systems and existing P&Ps. This will normally include a review of ISO documents if they exist, and a review of 5-20 existing P&Ps, for discussion with your team. We then typically spend a full day on site, going through our work with your team, and answering any additional questions that you may have. Finally, we prepare a detailed GAP analysis and recommendations, which we deliver in written and oral form. The whole process takes about 2-4 days.

Next – Document Re-work: Time Varies According to Assignment

We have never seen a situation where the conversion to ISO 9001:2008 did not offer the potential for tremendous reduction and restructuring of P&Ps. We feel strongly that accomplishing this is vital to get value from ISO. We use a proprietary set of tools to do this, and we’re happy to come in and train your team for a few days, or spend time over several months getting this right in a team environment.

We feel strongly that integrating your 6 required ISO procedures with the P&P restructuring process is a key element of future QMS success and utility, and we are happy to help make these documents as lean and useful as possible.

Finally, integrating your PI efforts with the corrective and preventive procedures (CAPA system) as well as your internal audit is fundamental to getting value from an ISO 9001 QMS. We are dedicated to helping you in that regard as well.