ISO 9001 is an international quality management standard. Under this standard, various data can be measured to evaluate and improve an organisation's processes and performance. Some of the data commonly measured under ISO 9001 include:
- Customer satisfaction: Organisations can measure customer satisfaction through surveys, customer feedback and evaluations to ensure that products or services meet customer expectations.
- Employee Satisfaction: Employee satisfaction is key to ensuring a positive working environment. Organisations can measure this through internal surveys and organisational climate assessments.
- Performance Indicators: Performance Indicators (KPIs) such as product yield rate, scrap rate, customer satisfaction rate, etc., are measured to assess the effectiveness of processes and the achievement of objectives.
- Failures and non-conformities: Organisations measure failures and non-conformities to identify weaknesses in processes and take corrective action.
- Supplier Performance Rates: Supplier performance is assessed to ensure that raw materials or external services meet the required quality standards.
- Process Efficiency: Process efficiency is measured through data such as time taken to complete a task, resources used, etc.
- Data Analysis: Organisations carry out data analysis to identify trends, opportunities for improvement and to make evidence-based decisions.
- Equipment Performance: Equipment maintenance and performance is monitored to minimise downtime and maximise operational efficiency.
It is important to note that the data measured may vary depending on the type of organisation, its activities and its specific objectives in accordance with the requirements of ISO 9001.
As part of the ISO 9001 standard, production-related data is essential for guaranteeing product quality and the efficiency of manufacturing processes. Some of the data measured specifically for production under ISO 9001 include:
- Overall Equipment Efficiency (OEE): This measures the overall efficiency of the equipment and assesses the percentage of actual production time compared to the total planned production time.
- Product yield rate (PRR): This measures the percentage of finished products that meet quality specifications in relation to the total number of products manufactured.
- Reject Rate: This represents the percentage of products or components that do not meet quality standards and are rejected during the manufacturing process.
- Production Downtime: This measures the total time that production is interrupted due to equipment breakdowns, production changes or other reasons.
- Machine Efficiency: Measures the optimum use of production machines and equipment, taking into account uptime and unplanned downtime.
- Cycle Time: This represents the time taken to complete a production cycle, from start to finish, and is used to assess process efficiency.
- Raw Material Quality Indicators: Data on the quality of raw materials, including compliance tests and inspections, is crucial to guaranteeing the quality of the final product.
- Number of Non-Conformities Detected Internally: This measures the number of errors or defects identified during internal quality controls, enabling corrective measures to be applied internally before the product reaches the customer.
- Non-Quality Costs: This measures the costs associated with production errors, including repair costs, scrap, and costs associated with customer complaints.
This data is analysed regularly to identify trends, implement corrective and preventive actions, and continuously improve production processes, in accordance with the requirements of ISO 9001.
ISO 9001 focuses primarily on quality management, but it can also include aspects relating to equipment maintenance, particularly in the context of product quality. Maintenance indicators that can be used in the context of ISO 9001 may include:
- Equipment Availability Rate: Measures the time during which production equipment is operational in relation to the total time.
- Equipment Efficiency Ratio (EER): Evaluates the efficiency of equipment, taking into account actual production time compared with planned production time.
- Breakdown Rate: Measures the frequency of equipment breakdowns, which is essential for assessing machine reliability.
- Mean Time Between Breakdowns (MTBF): This represents the average length of time an item of equipment operates before breaking down.
- Repair Time (MTTR): Measures the average time taken to repair equipment after a breakdown.
- Maintenance Costs: Evaluates the total costs associated with the preventive and corrective maintenance of equipment.
- Preventive Maintenance Rate: Measures the frequency with which preventive maintenance is carried out in relation to the total number of maintenance interventions.
- Number of Maintenance-Related Non-Conformances: Measures the number of maintenance-related incidents that have led to quality or production problems.
- Spare Parts Quality Indicators: Measures the quality of spare parts used for maintenance, which can have an impact on product quality.
- First Time Fix Rate: Evaluates the effectiveness of maintenance interventions by measuring the frequency with which equipment is correctly repaired at the first intervention.
These indicators help to monitor equipment maintenance performance, identify areas for improvement and ensure that equipment is in good working order to produce ISO 9001-compliant products. Effective maintenance helps to prevent non-conformities and ensures customer satisfaction by guaranteeing product quality.