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Why ISO 9001:2015 is Critical for Compliance Excellence

March 9, 2020

When it comes to health care, quality matters. One of the hallmarks of quality control is the ability to identify problems and solve them efficiently without disruption to the customer or end-user.

However, these processes aren’t necessarily easy to put into place or even to identify. That’s where ISO 900:2015 comes in.

The International Standard for Organization (ISO) is an international, independent, non-government entity that writes standards for nearly every industry, from health care to agriculture and data privacy. Nearly every organization on the globe can benefit from implementing the standards they create to minimize waste, increase productivity, and protect consumers.

What is ISO 9001:2015?

ISO 9001:2015 is the most widely implemented ISO standard. Over one million companies in over 170 countries have earned the certification. It can be used by any organization of any size or type. Its framework addresses nearly every key process and allows leadership to have a holistic view and gives ownership to individual employees for their processes.

ISO does not individually accredit or perform certifications of individual organizations. There are many independent companies called registrars that can complete audits, but they are not required. However, undergoing an external audit is common, and many countries and industries have governing bodies that can help guide which registrars to use.

An audit consists of three parts: internal, external, and certification. The internal audit is completed first. This is when organizations evaluate and pressure test their own processes. These audits are conducted by people independent of the processes they are auditing. These audits allow organizations to go through some of the rigorous checklists before spending their own money to bring in an external or certification auditor.

An external audit is conducted by existing and potential customers or suppliers, depending on your industry and organization.

A certification audit is done in two stages: survey and on-site. During the survey process, the auditor an organization has chosen reviews the documentation provided and gives suggestions for improvement. This saves the cost of travel and the expense of doing an on-site evaluation, only to have to repeat it.

Later, an on-site survey takes place over the course of several days. An auditor dives deep into organizational processes and interviews staff and leadership.

Using a checklist and making a detailed gap analysis is key to making the external and certification audits as seamless as possible and to avoid wasted resources or budget to redo an audit.

When can organizations benefit from a quality management system?

Nearly every organization can benefit from the ISO 9001:2015 audit. ISO has created guidance for many different industries, including medical devices and clinical and business processes.

The ISO 9001:2015 revision is generic and fits a variety of different needs. According to ISO, organizations can benefit from a quality management system when they:

  1. Need to demonstrate their ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
  2. Aim to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Given the demand that consumers today have for quality products and services, as well as the intense competition in the marketplace, ISO 9001:2015 makes sense for any organization that wishes to solidify their commitment to customers and quality.

What are the benefits of ISO 9001?

ISO 9001:2015 is the gold standard in quality management systems. It’s often required by organizations when entering into new partnerships or evaluating vendors. It demonstrates a commitment to customer satisfaction, efficiency, and continued improvement.

Beyond that, there are many other reasons why an ISO 9001:2015 certification is valuable, particularly in the health care space:

  • It establishes standards of quality and safety for patient treatment
  • It identifies and manages risk to the organization, staff, and patients
  • It allows a holistic view of complex processes
  • Many international and national standards include the same requirements
  • It identifies areas of improvement and informs best practices and procedures for all areas of business
  • It provides peace of mind for all stakeholders that an organization has undergone serious effort to improve and prioritize quality

Verisys successfully completed its ISO 9001:2015 certification in March 2018 and expects to be assessed to renew this certification in 2021. However, this certification doesn’t end at the audit, and systems and performance will continue to improve.

The ISO 9001:2015 certification included a rigorous onsite evaluation and performance evaluation to ensure delivery of quality services and to employ methods for improvement. The scope of products and services certified included credentialing software and background screening.

Taking compliance frameworks such as ISO 9001:2015 seriously is key to Verisys’ mission of delivering high-quality products and services to our partners and protecting patients, organizational reputation, and managing risk.

Heather Lynn Gillman Written by Heather Lynn Gillman
Director of Healthcare Communications
Problem Solver. Designer. Wine Maker. Writer.
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