Under the title of Quality Management Systems (QMS), we have listed the forms that are commonly used and required in QMS for you. These forms are critical to demonstrating the effectiveness and suitability of an organization's quality management system.
The basic record forms that should be included in a quality certification software are generally aimed at meeting the requirements of standards such as ISO 9001. Here are the main form categories and examples that can be evaluated in this context:
1. Forms Related to Document and Record Control:
- Document Request and Distribution Form: Record of requests for new document publication, revision or cancellation and their controlled distribution.
- External Document Tracking Form: Tracking of documents such as standards, specifications, and customer documents coming from outside the organization.
- Records Retention and Destruction Form: Records in which the retention periods, locations and destruction methods of records are determined and implemented.
2. Internal Audit and External Audit Records:
- Annual Internal Audit Plan Form: The form in which the internal audits to be conducted during the year are planned.
- Internal Audit Question List Form: A form containing control questions to be used during the audit.
- Internal Audit Report Form: Report containing audit findings, nonconformities and observations.
- Internal Audit Nonconformity Follow-up Form: Follow-up of the closure processes of detected nonconformities.
- External Audit Records: Plans, reports and tracking of nonconformances related to certification or customer audits.
3. Corrective and Preventive Activities (CPA) / Improvement Activities Records:
- Corrective Action Request Form (Non-Conformity Report): A form that includes the description of a detected non-conformity, root cause analysis, planned corrective actions and determination of those responsible.
- Preventive Action Request Form: A record of actions taken to prevent a potential nonconformity or risk.
- Corrective/Preventive Action Tracking and Closure Form: Record of the progress and effectiveness of initiated CPAs and their closure.
- Improvement Suggestion Form: The form in which improvement suggestions from employees or interested parties are collected and evaluated.
4. Management Review (MRR) Records:
- Management Review Meeting Agenda Form: Form that specifies the agenda items of the YGG meeting.
- Management Review Meeting Minutes/Report: A form in which the topics discussed at the meeting, decisions taken, actions determined, and those responsible are recorded.
- YGG Decisions Follow-up Form: Follow-up of the implementation status of the decisions taken at the YGG meeting.
5. Equipment, Measurement and Monitoring Devices Records:
- Equipment List and Identification Form: List of all critical equipment in the organization, their identification and status.
- Calibration Tracking Plan and Record Form: Record of calibration plans of measuring devices, results of calibrations, their dates and next calibration dates.
- Maintenance Plan and Record Form: The form in which the periodic maintenance plans of the equipment and the details of the maintenance performed are recorded (including incidental maintenance records).
- Verification Record Form: Records of tests and controls performed to verify measurement systems or processes.
6. Human Resources and Training Records:
- Personnel Competency Matrix/Evaluation Form: The competencies that employees must have according to their positions and the evaluation of their current situation.
- Training Needs Analysis Form: Form in which the training needs of employees are determined.
- Annual Training Plan Form: List of planned trainings, dates and participants.
- Training Participation Form and Evaluation Records: List of participants in the training provided and records for evaluating the effectiveness of the training.
- Orientation Training Record Form: Record of orientation training given to new employees.
7. Purchasing and Supplier Management Records:
- Approved Supplier List Form: List of approved suppliers that the organization works with.
- Supplier Evaluation and Selection Form: Records of the selection of new suppliers or periodic performance evaluations of existing suppliers.
- Purchase Request Form: Form in which material or service requests from departments are recorded.
- Input Control Record Form: Records that control the conformity of purchased products or services to quality standards.
8. Records of Customer-Related Processes:
- Customer Complaints and Feedback Record Form: Form where complaints, suggestions and satisfaction/dissatisfaction notifications from customers are recorded and tracked.
- Customer Property Tracking Form: Tracking of materials, equipment or information belonging to the customer and under the organization's control.
- Order/Contract Review Form: Records that evaluate the organization's ability to meet customer demands and contract terms.
9. Product and Service Realization Records:
- Production/Service Delivery Plan Form: Record of plans for the production of products or the delivery of services.
- Process Control Record Forms: Forms in which critical parameters in production or service delivery stages are monitored and recorded (e.g. temperature, pressure, time, etc.).
- Product/Service Non-Conformity Record Form (Internal Error Notification Form): Form in which non-standard products or services detected during production or service provision are recorded, evaluated and how they will be handled (repair, rework, scrap, etc.) is determined.
- Release Records: Records that show that the product or service has undergone final checks and is suitable before being released to the customer.
- Traceability Records: Records that enable the tracking of all stages of the product or service and the inputs used (batch number, serial number, etc.).
10. Risk and Opportunity Assessment Records:
- Risk and Opportunity Assessment Form: The form in which risks and opportunities related to QMS processes are identified, analyzed, evaluated and actions are planned for them.
- Risk and Opportunity Monitoring and Review Form: Records in which the status of identified risks and opportunities and the effectiveness of the actions taken are monitored and periodically reviewed.
11. Other Potential Forms:
- Meeting Minutes Form: Records of various meetings held regarding the QMS (quality circle, project meetings, etc.).
- Change Management Request and Approval Form: Record of the request, evaluation and approval processes for any change (process, document, equipment, etc.) that may affect the QMS.
- Data Analysis and Performance Monitoring Reports Form: Forms in which QMS performance indicators (KPIs) are analyzed and reported with the collected data.
Important Notes:
- This list provides a general outline. Depending on your organization's size, complexity, industry, and specific quality standards it implements (e.g., ISO 13485, AS9100, etc.), some of these forms may not be required or additional forms may be required.
- It is important that these forms are created digitally in your software, filled out, approved, distributed, stored and easily accessible when needed.
- Features such as version control and authorization of forms will also increase the usability of the system when you want to transfer these processes to software.
