What Do Quality Certifications Mean for Diagnostic Device Manufacturing?
Quality management in diagnostic development is paramount to the health and safety of patients. Should a batch of diagnostics be defective and give false negative results, patients and healthcare professionals may act on incorrect information. This can be disastrous for patients, and, in turn, their caregivers.
Manufacturers of diagnostic devices must establish and carefully adhere to robust quality management systems to ensure that patients and healthcare professionals receive the highest quality, defect-free diagnostics. CorDx is certified under EN ISO 13485:2016 and has multiple well-established quality management systems across its research, development, and production facilities in San Diego and overseas. This blog outlines the process by which a diagnostic device manufacturer develops, implements, and receives a quality management certification.
What Is “Quality” (And How Is It Standardized)?
Quality and quality management systems are defined according to ISO 9001:2015. ISO 9001 also informs the way in which quality is standardized for medical devices (including diagnostic devices) in ISO 13485:2016. In these contexts,
“quality” is the degree to which a set of inherent characteristics of an object fulfills the requirement, anda quality management system” is part of a management system that concerns quality. Regulatory bodies often use international quality standards as the basis for approval processes. ISO 9001 describes that a quality management system should cover three fields:
Management Activities: project management, laboratory management, and meeting management.R&D and Product Activities: scientific research, requirements engineering, design and development, measurement and testing, product release and maintenance, and publication and dissemination.Quality Management: risk management, documentation, and feedback and change.
An effective quality management system encompasses quality assurance (QA), quality control (QC), and other documentation processes. QA involves the inspection of manufacturing processes for potential flaws in various steps. It’s also a continuous improvement and flaw mitigation process for product development and quality management. On the other hand, QC controls the final product and tests for defects in production batches. It’s one of the last processes in diagnostic manufacturing. It involves comprehensive inspections for potential flaws to ensure the safety and efficacy of the device.
The FDA’s Quality System Regulation Part 820 is harmonized with ISO 13485:2000 (based on ISO 9001). However, the FDA has proposed a new rule to harmonize 820 with the current iteration of the standard (i.e., ISO 13485:2016). The current iteration of the standard contains additional guidance regarding risk management in quality management, so it’s expected that the FDA may also heighten its requirements for risk management.
Many other regulatory bodies around the world also rely on ISO standards to develop a quality system. This helps to simplify the process and allows regulatory bodies to rely on each other’s inspections and exchange information more readily.
The current iteration of ISO 13485 has placed increased importance on risk management and planning. An effective quality management system (according to ISO 13485:2016) must incorporate a risk-based approach to comply with the standard. The risk-based approach primarily applies to the safety and performance of a medical (or diagnostic) device. It should also consider product and applicable regulatory requirements. Risk is covered in more detail in the ISO 14971:2019 standard.
Common Quality System Certifications
ISO 13485:2016: “Medical devices — Quality management systems — Requirements for regulatory purposes”The ISO 13485 standard details the requirements for the quality management system of a medical device manufacturer. The requirements are necessary to prove that a manufacturer can produce safe and effective medical devices that meet user needs and comply with all applicable regulations. ISO 13485 is commonly used in the medical device industry. It allows potential clients to see proof that the company complies with industry best practices and regulatory requirements.
ISO 9001:2015: “Quality management systems — Requirements”The ISO 9001 standard describes the requirements a company must maintain in its quality management system to achieve the standard. These requirements outline a quality management system that helps companies to improve, streamline operations, and reduce costs. The standard is generalized and often used in many different industries. It also serves as the basis for the ISO 13485 standard.
ISO 14971:2019: “Medical devices — Application of risk management to medical devices”ISO 14971 details the risk management principles required to effectively identify, assess, control, and monitor the risks associated with medical device manufacture. Device manufacturers may benefit from the inclusion of risk management principles that cover quality, design, manufacturing, and supply chain operations. This allows medical device manufacturers to identify, quantify, and mitigate potential hazards more easily.
The ISO 13485:2016 Certification Process
1. Planning
In this stage, a company plans to establish and align its quality management system to that standard’s quality planning requirements. It starts with a thorough review of the ISO 13485 standard. A quality manual should be established to contain standardized processes and necessary document records. The quality manual should also contain a procedure for implementing changes to the quality management system.
Standardized processes are first identified as relevant quality processes. These are then established and assigned to internal auditors and teams (with ISO 13485 training or experience). Each process requires a gap analysis, schedule, and detailed workflows and guidelines. Once optimized and finalized, the standardized processes go into the quality manual along with other necessary document records (e.g., Gantt charts and spreadsheets).
2. Internal Audit
An internal audit is a process that verifies whether a company’s quality management system is effective prior to a third-party audit. This allows the company to identify gaps/non-conformities and their root causes.
3. Corrective Actions
Following the internal audit, corrective actions are taken to identify, resolve, and prevent quality non-conformity issues. In this stage, Corrective and Preventive Actions (CAPA) are applied. A CAPA may be necessary to collect and analyze information; investigate product and quality problems; and take corrective/preventative action to prevent reoccurrences. This helps to identify and eliminate any issues or non-conformities, thereby making the quality management system and team more effective.
4. Management Review
This may be the final stage before applying for ISO 13485 certification by a third-party auditor. An organization’s top management reviews and audits the organization’s quality objectives, system, and processes before applying for certification. Top management identifies a list of actionable items for the quality management team to address. This may lead to additional corrective actions and internal audits before the next management review. Once fully approved, the organization can then move on to the certification audit.
5. ISO 13485 Certification Audit
A third-party ISO 13485 certification organization should be identified to conduct the certification. After the application and contract signing has been completed, the process moves on to two stages.
5.1. Documentation Survey
The auditor investigates how a company organizes and documents quality management processes. This includes the CAPA process, top management review, and the overall quality management system. Several documents need to be prepared for inspection, including:
Quality manual
Organizational chart
Internal auditing processes and schedules
CAPA protocols and logs
Management review process and corrective actions
5.2. Primary Audit
In the primary audit, the auditor reviews any relevant regulatory requirements that need to be met (including those recognized in international markets). The auditor also assesses the efficacy of the quality management system by reviewing records from every process. Finally, a schedule for surveillance audits and reassessment will be established for the company.
CorDx is ISO 13485-Certified
CorDx received an EN ISO 13485 certification by TÜV Rheinland for its US-based facilities in August 2022. This certification is essential to support CorDx’s proprietary diagnostic supply chain development and continues to enable CorDx’s source of diagnostics in the US market.
The ISO certification provides tangible assurance that CorDx’s diagnostic manufacturing supply conforms to the latest quality process standards set by ISO. CorDx’s certified quality management system maintains consistency and quality across all of our products, services, and systems. CorDx continually strives to improve our quality assurance processes to bring our customers reliable and effective diagnostics.
This means that all CorDx- and Core Tests-branded diagnostic products manufactured to these guidelines. Further, all contract and OEM manufacturing clients’ products are manufactured using the same quality management system.
Choose a quality diagnostics manufacturer—choose CorDx. Contact CorDx to discuss your next project.
From its headquarters in Atlanta, Ga., CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. Through its product realization partnerships with leading pharmaceutical companies, CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health. Its proprietary line of diagnostics solutions is recognized by families and medical professionals for reliability, affordability, and rapid results.
CorDx is a member of the CorDx Union, a biotechnology organization that delivers medical device solutions to healthcare industries and over a billion users in more than 170 countries.
original source: https://cordx.com/blog/what-do-quality-certifications-mean-for-diagnostic-device-manufacturing/
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