How to develop and manage your hospital’s quality manual

You can achieve DNV hospital accreditation by creating a quality manual that follows the DNV NIAHO and ISO 9001 standards.

June 24, 2024

Article Highlights

The DNV NIAHO standards are some of the most complex and stringent standards in the healthcare field. Hospitals that seek to meet those standards undergo a multi-year process that includes the adoption of a new policy and procedures manual based on ISO 9001 standards.

This manual, called a quality manual, includes several factors that help hospitals set new performance standards, monitor the performance of those standards, and provide plans to bring staff's performance up to required expectations. 

The ISO 9001 process involves a few new philosophies for hospitals, such as risk-based thinking or using checklists and similar tools to reduce the number of medical, surgical, lab, and support errors. 

This article will discuss what a quality manual is in healthcare, the ideal format for a hospital's quality manual, and how the 24/7 online availability of the manual can help with DNV hospital accreditation.

What is a quality manual in healthcare?

A quality manual is an extensive document that details the quality management system of a hospital or healthcare facility in clear and simple language. The purpose of the quality manual is to provide the framework of the quality system requirements.

It's the how-to document, written to ISO 9001 standards, that dictates the hospital's operational processes in providing the level of care and what steps they will take to provide it. In many ways, it can serve as a hospital's policy and procedures manual, especially if the hospital is trying to meet DNV NIAHO standards.

Finally, a quality manual is also a commitment from top leadership that these are the performance levels they will hold all staff members accountable to.

The quality management system manual has to be reviewed and approved on an annual basis. For larger hospitals especially, this is usually done by an interdisciplinary team consisting of a combination of the following stakeholders: senior leadership, medical staff, nursing, quality/risk management, safety, pharmacy services, and ancillary services. Together, this dedicated team keeps the hospital quality management plan up to date.

What should a quality manual include?

According to the Accreditation Requirements, Interpretive Guidelines & Surveyor

Guidance For Hospitals from NIAHO every healthcare organization seeking NIAHO accreditation shall be able to demonstrate each of these standard requirements:

Risk-based thinking

Risk-based thinking is a system where hospital staff determine the risk of any potential treatment plan, find a way to avoid the risks, and then determine whether they were successful. It's present in every one of NIAHO's accreditation standards, and it pushes healthcare systems to see risk as something more than just patient care. For example, hospitals have used this as a way to reduce medication and surgical errors by using medical checklists and surgical safety checklists.

The primary components of risk-based thinking include:

  • Determine the risks and opportunities of a treatment or procedure
  • Create a plan that weighs and addresses those risks
  • Execute the plan within a quality management system framework
  • Measure and evaluate the effectiveness of the plan
  • Use what you've learned to find a way to improve and prepare for the next treatment.

In many ways, this is similar to the military's use of the OODA loop, Observe, Orient, Decide, Act. First developed by Colonel John Boyd of the U.S. Air Force, the decision-making process goes like this.

  • Observe your situation and surroundings.
  • Orient on possible options and solutions.
  • Decide the appropriate course of action.
  • Act on that decision.
  • Repeat the process again, based on the results of your action.

Documented information

Your organization needs to structure and maintain all documents needed for the QMS so they are available for use when and where needed. This can be a healthcare policy management solution, which lets you: store all of your ISO 9001 standards and policy manual; map your policies to the standards; and access them on any kind of device, any time, anywhere. Hospitals can (and have) used this as a way to keep their policy manuals updated and to share those updates with their staff.

Internal surveys (internal audits)

The hospital should regularly conduct internal reviews of its policies and procedures, comparing it to the latest information from their accrediting agencies and professional associations, and then making the appropriate updates. They should also make updates to their processes and/or training based on the abilities of their staff to meet those performance standards.

After all, a quality manual is a living document that's always changing, growing, and adapting to new technologies, practices, methods, and ideas. Internal DNV hospital surveys and audits help you future-proof your organization so you're always up on the latest techniques in patient care. 

Nonconformity and corrective action

When a procedure fails, or when people fail to meet the performance standards of those policies, the organization needs to be able to determine whether it's a training issue or competency issue, and then provide additional training as needed or further corrective action to address improvement.

If there's a pattern of errors in a particular procedure, the appropriate training methods should be updated, fleshed out, and staff should retake the training and assessments to ensure they understand the new materials.

Hospitals and healthcare organizations that are working toward DNV hospital accreditation for the first time, or have found a pattern of nonconformity, may want to avail themselves of a hospital performance improvement plan template.

Measurable quality objectives

An organization also needs to establish measurable quality objectives based on policies and procedures, and then analyze and address those results. This can help improve patient care and organizational effectiveness.

For example, a hospital might create a hygiene policy with the aim of reducing hospital-related infections by 30 percent over the next year. Setting this objective lets management know if they were effective and if the policy had its desired effect. If not, they can determine the effectiveness of the policy.

Determination of effectiveness

Appropriate information and results need to be submitted to the Quality Management Oversight group for determination of effectiveness. If a policy is found to be ineffective, or the team did not meet its stated objective, they can figure out how to improve the policy and procedures or create a more realistic objective.

The World Health Organization has a 19-item surgical safety checklist. One item asks whether the surgical site has been marked. A measurable objective might seek 100% compliance with the rule. 

The WHO checklist helped McLeod Regional Health System in SC reduce mortality rates by nearly one third while increasing the productivity of surgical teams and saving millions annually.

The World Health Organization has a quality manual template available on its website to help you get started in creating your own quality manual.

How are you currently managing your quality manual?

How are you gathering your information? Who is responsible for assembling and maintaining it? How should it be formatted? If you've ever tried to manage a massive multi-chapter document, you know there are a few ways to amass all of the information – two of them are inefficient, time consuming, and require a large team just to manage the unwieldy mass. But one of them uses automation and electronic tracking to simplify the efforts.

  • Paper processes. This was the system for managing policy manuals as little as 20 years ago. Manuals were kept in large 3-ring binders, printed out for each person within the organization. If you had a 2,000 person organization, this could get extremely expensive and time consuming. And if you updated a policy, you had to make sure every employee got the new update, but it was never a 100% guarantee that everyone read the new policy or updated their old policy in the binder.
  • Email / Shared Drive / Intranet. In this model, everything is stored on a central drive, like Google Drive or Microsoft OneDrive. Each document is labeled so it can be published and read in order, and new updates overwrite old ones. Once updates are sent out to staff, they would often email back that they had read the new update. Tracking all of this often meant creating a spreadsheet or even tracking on an employee log, whether everyone had responded or not. Reminders to read and respond would have to be emailed out to everyone, or they would have to be sent a few at a time to batches of people.
  • Policy Management Software. Policy management software has done away with the worst parts of managing the details of a policy manual. An entire manual can be stored in a central location, which is password-protected. Because it's cloud based, it's accessible to employees 24/7 on any device they choose, whether it's a laptop, tablet, or mobile phone. Updates can be made, notifications can be sent out automatically, and responses automatically tracked. Reminder emails are then sent out automatically only to those people who have not read and signed off on the new updates. This can save several people several days because all the tracking and collecting of information is automated and done in seconds.

With the right policy management software, it's possible to create a hospital quality assurance manual PDF so people can review it in case they don't have wifi access where they're located or need to store it for later offline reading. You can load the PDF into an ebook reader like Amazon Kindle or other mobile app.

Final thoughts

PowerDMS is a policy management platform and can incorporate your quality manual template and content into the system. We help hospitals and healthcare organizations achieve and maintain DNV accreditation by equipping you to:

  • Simplify document control
  • Meet ISO 9001 requirements
  • Map policies and proofs of compliance to DNV NIAHO standards and DNV ISO 9001 standards
  • Incorporate updates and changes to DNV NIAHO standards and allow you to track staff signatures acknowledging updates.
  • Reduce DNV survey prep time by 60%
  • Make manuals available in PowerDMS (1. Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance for Hospitals; 2. Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance for Critical Access Hospitals)

PowerDMS is a platform that is built for policy management, information storage, workflow management, training management, and accreditation compliance. Learn how we help hospitals and healthcare facilities achieve DNV accreditation.

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