By: Rick Joslin, Senior Advisor, Healthcare Strategy
In this final installment on implementing a compliant ISO 9001:2015 QMS in a healthcare environment, we tackle how an organization will measure the success of the QMS and identify ways to improve the quality of the product\service they provide. These topics are found within Clause 9 and Clause 10, and it is crucial that an organization take the time to define how, when, and where specific processes are to be monitored, measured, analyzed, and evaluated. This is crucial if organizations hope to determine if the QMS is effective and if the goals are being met. Generally, these steps fall under the “Check” (Clause 9) and “Act” (Clause 10) portions of the Plan\Do\Check\Act cycle.
A QMS has many components where the organization must determine its own destiny, and Clause 9 is no different. The organization must set the standards, then define how they will know the program is working. There are four key areas for consideration in the initial Clause 9 Section 9.1.1:
- Identify what needs to be monitored and measured
- Define the methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results
- Determine when the monitoring and measuring shall be performed
- Specify when the results from monitoring and measurement shall be analyzed and evaluated
Inherent in these requirements are supporting needs, such as ensuring you have adequate and correct resources to execute these requirements. Also included is the need to gather and present evidence that the activities were completed, as well as evidence of any considered and executed changes to the QMS process.
ISO 9001:2015 then gives you specific examples of what to do. Since a primary purpose of a QMS is to meet or exceed customer’s expectations (customer satisfaction), having a means to identify if you’ve met those expectations is almost as important as the process itself. Clause 9 is all about making sure you’re getting it done by evaluating those activities and identifying areas for continual improvement. Here are some general activities to accomplish contained within Section 9.1:
- Determine and publish the schedule for collecting data (9.1.1)
- Monitor customer perceptions on how their needs and expectations have been met (9.1.2)
- Surveys, feedback, meetings, market-share analysis, compliments, warranty activity, dealer reports
- Delivery results (on time, order accuracy)
- Complaint management
- Generate appropriate data for review (9.1.3)
- Conformity\non-conformity of products and services
- Degree of customer satisfaction
- How well the QMS performs and its effectiveness
- Performance of external providers (contractors)
- Identify areas needed for improvement
Once the data has been collected, reviewed, and processed, it must be audited. But you should not simply audit your outputs, but instead the whole QMS program, since the goal of these audits are to ensure the QMS program is compliant with both ISO 9001:2015 and the organizations QMS program as written. The audit process is about identifying what’s going well and what could use some improvement; it’s not about finding fault with individuals or teams. The expectations found within Clause 9.2 are:
- Ensure compliance with internal QMS documents as well as local and international standards (9.2.1)
- Develop, implement, and maintain an auditing program (9.2.2(a))
- Determine and publish the schedule for auditing data and processes (9.2.2(a)). To be compliant, audits must be planned, established, and maintained
- Define the frequency and the methods to be used (at least once a year)
- Put them on (and publish) a schedule of audits (recommended)
- Define criteria and scope (9.2.2(b))
- What is the scope (an overview of the whole area, or focused on specific process\system)
- Identify the focus (governmental regulations, quality standards, internal processes)
- Identify the auditors (9.2.2(c))
- Get them trained in doing audits
- Grant them the authority necessary to perform the audits
- Keep them independent of the audited area (helps to increase cooperation)
- Presentation of findings (9.2.2(d))
- Identify relevant management
- Present\report results
- Make changes by taking necessary corrective actions immediately (9.2.2(e))
- Document everything, and keep it for reference and evidence (9.2.2(f))
Once the audits are completed and sent to the appropriate management team(s) for action, they take over and complete the auditing process. Section 9.3 covers the Management Review requirements of a compliant QMS program. There are specific activities required by “top management” geared toward supporting the QMS program and ensuring the results and recommendations of the audits are reviewed and implemented. Key activities of Section 9.3 Management Review are:
- Develop, schedule, conduct, and document management review activities related to the QMS and ensure the QMS is suitable, adequate, effective, and in align with organizational goals (9.3.1)
- Look over all available information, considering (9.3.2)
- previous reviews
- changes to reported issues
- the effectiveness and performance of the QMS
- resource allocation
- improvement opportunities
- Develop feedback and decisions on needed improvements, QMS updates, and resources (9.3.3)
Once you’ve completed all these steps, you must execute on identified areas for improvement. Remember, a core component of a QMS is constant improvement, and it should be a rare occurrence when a review does not uncover something that can be improved. Clause 10 gives you guidance on how to identify and implement improvements.
- Improving products and services to meet current and future needs, addressing undesired effects of processes or procedures, and improving the QMS program (10.1)
- Accept, address, and implement needed changes to correct any nonconformity that occurred. This also includes reviewing if the change eliminated the nonconformity, as well as updating risk and QMS programs accordingly (10.2)
- After completing a complete QMS cycle and considering all results from that review, identify and implement changes that will improve the product, service, process, or procedure involved in the QMS.
Understanding that a compliant ISO 9001:205 QMS program’s primary goal is to achieve (or improve) customer satisfaction, the efforts expended in developing and executing a QMS program will result in an institutional drive toward self-reflection and continual improvement. The resulting certification can increase increased revenue, higher employee satisfaction, and increased reputation within your industry. As stated in earlier posts, the cumulative QMS process continues to manifest itself as higher patient satisfaction, lower cost, and improved outlook for the healthcare organization.
