In my previous installments, I’ve given an overview of quality in healthcare, provided some common obstacles to implementing a compliant ISO 9001:2015 QMS in a healthcare environment, and listed high-level responsibilities by leadership that will help ensure a successful QMS implementation.  

In this installment, we’ll review how an organization can support the QMS policy as well as develop operational guidelines for execution of those policies.  


Decide How You Will Execute Your QMS Plan  

Once you’ve defined the leadership and planning components, the organization must develop how they will support and execute those goals and objectives; these are the “Do” portion of the “Plan\Do\Check\Act” process. As you progress through a QMS implementation, you should notice that no one QMS component is more important than another, and each is dependent on the other.

There are many pieces to the support component (Clause 7) of a QMS. In general, the organization must identify and provide the resources needed to create, implement, maintain, and improve the QMS program. In doing so, you must look at:

  • Capabilities of and constraints on existing internal resources, as well as those of external resources (7.1.1)
  • People (who’s available and who’s needed to effectively implement and operate the QMS) (7.1.2)
  • Infrastructure (buildings & related utility needs; equipment (hardware, software, assets, etc.); transportation resources; communication & information needs) (7.1.3)
Figure 1: Resource status identification
Figure 1: Resource status identification 

Be sure to consider resources as more than just people.  

Additionally, and possibly more critical in today’s workplace environment, are the needs to ensure the workplace is conducive for the QMS to flourish. What does this mean? Well, you must look at the work environment and make sure that it’s not working against your team. Consider these aspects:

  • Social. Do people know they can be candid (yet professional) with suggestions and criticism? Is leadership approachable? Are all stakeholders given a chance to voice ideas and concerns? Is the team broad (diverse in roles, leadership levels, etc.)?
  • Psychological. Is the process calm, low-stress, non-confrontational? Has it been designed to eliminate (or reduce) burnout?
  • Physical. Are the meeting spaces comfortable? Are they within a reasonable travel distance from workplaces? Is the meeting place layout setup to promote equality of members (no “head of the table”)? Will the meetings be away from noisy environments?


Other areas to consider from a support perspective surround monitoring and measurement (staff, equipment, metrics, documentation) and organizational knowledge (competence, intellectual property, standards, regulations). Organizational knowledge (7.1.6) can be derived from a multitude of sources

Figure 2: Organizational knowledge
Figure 2: Organizational knowledge 

You must also foster awareness of the QMS, develop and conduct a communications plan, and ensure all necessary documentation of the QMS program.

All of these activities come together to develop how the QMS will operate (Clause 8). Here you will:

  • Develop operational planning and control mechanisms (requirements of your product\service, determine the resources needed to achieve those requirements, exercise controls of the processes that meet the criteria, produce and maintain documentation to show compliance)
  • Document communications, regulations, customer requirements, contract needs, and auditing results
  • Create controls for the design and development of the product\service (nature, stages, verification\validation needs, control interfaces, customer involvement, customer involvement, inputs, outputs, external requirements and controls)
  • Identify production and service provisions (unique identifiers (serial numbers), work and production instructions, monitoring\measuring equipment, release of the product\service)
  • Control of non-conforming outputs

Producing a comprehensive program that identifies how the product\service will be identified, developed, produced, measured, audited, delivered, and followed-up on dramatically increases the ability to deliver the product\service the customer is expecting, while also defining how improvements are made where deficiencies are found.  

An organization that provides proper support of the QMS will reap the benefits in the delivery of their product\service while also increasing employee satisfaction through workplace improvements. The cumulative QMS process continues to manifest itself as higher patient satisfaction, lower cost, and improved outlook for the healthcare organization.

About The Author

For more than 23 years, Rick Joslin IRCC, Senior Advisor, Healthcare Strategy at Accruent, has helped hundreds of healthcare systems navigate the ins and outs of managing service missions within their organizations. He has 35+ years in the maintenance management industry, including roles such as technician, inspector/compliance surveyor, and director. He is known for promoting continuous improvement, driving operational efficiency, increasing resource utilization, and ensuring regulatory success by identifying gaps and inefficiencies in business processes. Rick leverages LEAN thinking and Six Sigma processes to guide customers in the development of short and long-term goals. His broad knowledge of healthcare operations and regulatory requirements, coupled with an intimate knowledge of CMMS systems, allow him to assist customers in developing easily implemented solutions to unique, and changing, business needs.