Investing in quality assurance and preventing defects from reaching the end user is a smart business decision. It can minimize legal liabilities, preserve reputations and reduce production costs.
Quality control methods vary by industry. For example, the food and drug manufacturing industry may require a scientific approach such as Six Sigma. Below we will find more difference between quality assurance vs quality control.
Purpose
QA encompasses all planned and systematic activities that are designed to ensure that the processes used to create products and services meet their desired outcomes. This includes training, documentation, monitoring, and audits. It also involves using tools like Six Sigma and other project management or process improvement strategies to save time and money while improving quality.
The main difference between QA and QC is that QA focuses on the processes while QC focuses on the product. QA can use methods like the Gemba Walk or SIPOC to help improve the processes by identifying what needs to be improved. This helps prevent defects from reaching the QC stage and eventually customers.
QC can use tools like the 8D Report to help find the root cause of a problem and fix it in a timely manner. This will result in fewer defects, higher customer satisfaction, and reduced operational costs. In addition, a proper QC process should include methods for gathering feedback from customers.
Operation
The operation of quality control consists of monitoring and identifying product defects, assessing performance and reliability, documenting results and taking corrective action. Quality control systems use process-monitoring tools such as SPC (Statistical Process Control) to distinguish natural variations from abnormal ones. Data from these tools help determine when a process is out of control.
When a company releases a defective product, it can lead to costs related to customer support, engineering hours to fix the issue and shipping costs to rework the product. A robust quality assurance system can reduce these expenses by catching problems earlier in the manufacturing process.
QC typically occurs after development, but QA is ongoing throughout the production process. QA engineers test products to ensure they meet standards and are ready for mass production. They can also find the root cause of issues and prevent them from recurring in the future. In this way, they can save money and improve customer experience.
Objectives
No company wants to release a faulty product, so it’s important for the business to have effective quality control processes. These include Statistical Process Control (SPC) and Total Quality Management (TQM).
QC involves performing inspections and tests of raw materials, components, and finished products to ensure they meet quality standards. This also includes identifying causes of poor quality, such as defects, in order to improve the process and reduce waste.
Ideally, good QA practices and collaboration among teams will result in fewer defects making it through to the QC stage and reaching customers. QC is a critical part of the overall quality management system and helps reduce costs by minimizing issues and reducing scrapping, recalls, and customer complaints. The key to successful QC is keeping records of all the processes and responsibilities in place to help employees quickly identify problems when they arise. Keeping a documented, consistent approach to the work process also reduces confusion and ambiguity for employees.
Conclusions
In conclusion, quality assurance and quality control are pivotal components of a robust Quality Management System (QMS). While it may be easy to confuse these two terms, understanding their roles in a business helps you ensure that your products and services meet the standards set by your industry.
For example, QC processes might include inspections and tests to identify issues in a finished product. It might also involve reviewing and documenting the results of these tests to maintain traceability and accountability. Ideally, QC issues should trigger a review by QA to uncover and address the root cause of the issue.
Effective quality assurance is proactive and preventive and should precede Quality Control. For instance, QA might involve quality efforts during the design stage to help avoid defects rather than after the fact. QA can include things like establishing standard operating procedures and quality assurance audits. It can also involve the use of a quality improvement model such as statistical process control (SPC) or total quality management (TQM).
ISO 13485 Vs 9001 for Medical Devices
Here you will know about iso 13485 vs 9001. Getting ISO 13485 certification helps your business develop a world-class Quality Management System. With the right digital tools, you can also automate document and change control processes to accelerate workflows and de-risk your path to certification.
While ISO 9001 is a general standard that can be applied to any type of organization, ISO 13485 is tailored to companies that design and manufacture medical devices. Understanding the differences and similarities between these two standards is critical to making the best choice for your company.
What is ISO 13485?
ISO 13485 is an international quality standard that helps you build a comprehensive Quality Management System. Its requirements are specifically designed to help you design, produce, store and distribute medical devices and related services while consistently meeting customer and applicable regulatory requirements.
While similar to ISO 9001, ISO 13485 takes a more in-depth approach to ensuring the safety and quality of your products. The standard provides a more granular definition of the types of improvement activities that medical device manufacturers need to implement in order to produce safe and effective products.
Medical devices are potentially life-saving, so establishing and maintaining a world-class QMS is crucial to your success as a manufacturer. It also allows you to earn the trust of regulators and customers, as well as speed up your route to market. To learn more, read our complete guide to ISO 13485 certification. It includes everything you need to get started on your ISO 13485 journey, including best practices for document control, complaint handling, and more.
What is ISO 9001?
ISO 9001 is an international standard that helps companies meet their clients’ expectations by following quality management rules. It focuses on improving customers’ satisfaction and is applicable to all industries. It also emphasizes planning and control of the processes needed for product realization and requires validation of those that affect final products.
In contrast, ISO 13485 is an international standard that applies only to organizations that design and manufacture medical devices. It is based on the ISO 9001 quality management system requirements and places more emphasis on risk management and regulatory requirements for medical device manufacturers.
Medical devices are highly regulated and have an impact on patients’ lives. So, it’s important that they follow the best practices to ensure patient safety. The right digital QMS software can automate document and change management to improve compliance with both standards. This helps de-risk the development and launch of medical devices to meet client expectations. It also helps meet the specific requirements of ISO 13485 and other industry standards like IATF 16949 and AS9100.
What is the Difference between the Two Standards?
While the general scope of ISO 9001 applies to any organization, ISO 13485 is specific for medical devices. It requires a more comprehensive Quality Management System and a stronger focus on regulatory compliance.
For example, the requirements for a medical device QMS include defining processes to ensure that purchased goods and materials meet specifications. These purchasing procedures must consider the impact of the purchased goods on your company’s products, as well as the risks involved in using these materials.
Traceability is also a major component of ISO 13485, which mandates that medical devices be traceable down to the batch, lot or unit level. This allows for effective product recalls and the monitoring of potential safety issues.
Companies often implement both standards to gain the advantages of each. For instance, they may leverage a fully integrated electronic Quality Management System (eQMS) to meet the needs of both ISO 9001 and ISO 13485. This approach reduces the need for manual workarounds, streamlines documentation and speeds up time to certification.
Which is better for Your Business?
Choosing which standard to follow depends on your internal processes and improvement aims. ISO 9001 offers a flexible framework that can be applied across many industries and product lines. ISO 13485 is more rigorous and focuses on specific requirements for the medical device industry. It also requires that organizations launch an investigation into any nonconformities and create long-term preventive and corrective actions.
Whether you choose to get certified for ISO 13485 or opt for the more general ISO 9001, it’s crucial that your organization has the right tools to manage these processes effectively. A digital eQMS that is designed to support medical device manufacturing can help de-risk your journey to certification and provide the automated workflows needed for data capture, document control, and regulatory compliance throughout your entire production process.
ETQ’s eQMS solution Qualio helps businesses in the pharma and life sciences industries meet both ISO 9001 and ISO 13485 standards. Request a demo today to see how Qualio can accelerate your time to ISO 13485 certification and help you meet the stringent requirements of the medical device industry.
