As this year comes to a close and organizations move forward with their business planning for the new year, it’s important to remember that the Quality Management System (QMS) requires a review of the suitability and effectiveness to meet the organization’s quality objectives. This usually takes place at the annual Management Review Meeting which is required under FDA's QSR Part 820.20(c) and ISO13485:2016 5.6.
The Management Review Meeting must occur at a minimum annually; however, it may occur more frequently. Your quality management approach and the size of your business will help determine the need for meetings. The frequency of audits and any significant problems that need to be addressed will require a meeting. Major changes in your business such as new technology, your business model, quality concepts, market strategies, and resources can also affect the frequency of these meetings.
Schedule your meeting with ample time for participants to prepare for the meeting. This preparation may include gathering of all of the documents, reports, records, audit findings, and past meeting minutes that will support the agenda items.
Decide who must attend. The members should be management with executive responsibility which would include those senior employees who have authority to establish or make changes to the quality policy and quality system. Designate someone to take minutes of the meeting, prepare them in written form, and distribute them to all participants. The minutes must show the date, time, location, names of attendees, and the agenda.
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An agenda must be set and included in the QMS documentation. This agenda can be expanded upon to include any other items that are important to bring before this meeting. The minutes that are taken must detail the discussions and all decisions made to improve the QMS. Remember that the purpose of this meeting is to help you evaluate the effectiveness of your quality system so the more detail you include in the minutes the more it will help the Management Representative to document the improvements committed to by management.
Here’s a suggested agenda that can be used to measure the effectiveness of your QMS:
- Results of Quality Audits
- Follow-up actions from previous management reviews
- New or revised regulatory and statutory requirements
- Process performance and product conformity
- Customer Complaints and CAPA
- Supplier and Subcontractor Performance
- Staff training
- Effectiveness of Quality System to meet quality objectives
- Continuous improvement actions taken over the past year and in the coming year
- Any changes made during year and future changes to Quality System due to new technology and/or processes
- Changes that could affect quality management system including resource requirements
Top management must ensure that the quality policy is appropriate to the purpose of the organization and that the QMS is effective to provide a framework for establishing and reviewing quality objectives. Use your Management Review Meeting to establish measurable goals for continuous improvement.
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We address your business needs whether they are a basic quality system to meet FDA compliance or an expanded quality system to improve good business practices. We provide customized programs specific to your business model.
SafeLink Consulting offers dental labs the whole package on quality systems, safety programs, patient security and chairside services plus compliance with FDA, OSHA & HIPAA. For over 25 years SafeLink has been helping the dental industry with compliance. Our staff, including CDT’s and former lab owners, has over 100 years of combined experience in the dental environment. SafeLink also has Authorized OSHA Outreach Trainers on staff, DAMAS certification auditors, and third-party quality auditors on staff who are ASQ certified.
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Our clients also benefit from our broad experience with Quality System development for other medical device manufacturers. We also offer risk assessments, cloud-based data management programs, ISO registration and FDA 510k submission assistance. We are one of the premier FDA consulting firms in the dental industry assisting labs with medical device US import requirements. Our FDA compliance consultants are knowledgeable of the dental environment. Learn more about specific quality/FDA topics by taking any of our educational, online courses available 24/7 when it’s convenient for you.
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