Achieve ISO 13485:2016 certification with BioBoston Consulting. Discover the benefits, certification process, and best practices for ensuring quality and compliance in medical device manufacturing.
ISO 13485:2016 certification is the key to best medical device manufacturing and a quality compliant lighthouse.
ISO 13485:2016 certification benefits
It is a standard with international recognition, defined for the requirements of quality management system of any medical equipment manufacturing company. This certification is not just a badge of honor but is an ongoing dedication to the responsibility that medical devices should be safe, efficient and compliant with regulatory requirements globally.
Why is ISO 13485:2016 certification so important?
1. Global Acceptance
International acceptance – ISO 13485:2016 is an internationally recognized standard that pays to claim as it facilitates manufacturers of medical devices to enter global markets easily. This certification is a proof to show that you want to align your company with international standards of quality.
2. Enhanced Product Quality
Compliance with ISO 13485:2016 helps manufacturers to make medical devices that can be consistently manufactured with high quality and without defects thereby preventing recalls.
3. Regulatory Compliance
Organizations across the globe, including FDA in United States refer to ISO 13485:2016 standard as one of the benchmarks for quality management systems. For this you need to be certified which will fast track your app on the regulatory process.
4. Greater Operational Efficiency
ISO 13485:2016 focuses on efficiency in processes, more consistent practices, better waste management and improves overall operational performance.
5. Risk Management
ISO 13485:2016 places a heavy emphasis on risk assessment, requiring manufacturers to carefully consider and control any risks related to their products.
How ISO 13485:2016 is Explained
There are several aspects of ISO 13485:2016 that you must comprehend before you get certified.
1. QMS stands for Quality Management System
It mandates a well-structured quality management system which needs to be developed and sustained. In other terms, leverage this system for good practices to be followed while creating a new product.
2. Keep Good Records of Everything
Detailed documentation is key to ISO 13485:2016. Manufacturers must document every process, procedure, and quality record to ensure traceability.
3. Risk Management
Risk management is a critical aspect of the standard. Manufacturers are required to complete thorough risk assessment, identify and mitigate risks associated with their products.
4. Regulatory Compliance
ISO 13485:2016 is harmonized with many regulatory requirements, helping manufacturers easily satisfy the expectations of regulatory authorities such as the FDA and the European Medicines Agency (EMA).
5. Continual Improvement
ISO 13485:2016 is all about continual improvement. Their processes need to be continuously monitored and improved in order for manufacturers to produce the safest and highest quality product possible.
ISO 13485:2016 Certification Procedure
Getting ISO 13485:2016 certification is basically a step-by-step process, some of which are as follows:
1. Gap Analysis
Begin with a gap analysis to evaluate your existing quality management system versus the requirements from ISO 13485:2016. Locate the improvements or misalignments.
2. Quality Management System
Develop or improve your quality management system to align with ISO 13485:2016 after identifying the gaps based on what you harvest from the gap analysis. This means recording processes, procedures, and quality records.
3. Training and Awareness
Make certain that your group is trained along with awareness regarding the brand-new quality handling system. Training needs to address what the criteria are and how those play a role in everyday operation.
4. Internal Auditing
Internal audits should verify the effectiveness of your quality management system. Find Out Nonconformities and corrective actions
5. Certification Body Selection
Select an ISO 13485:2016 accredited certification body. An external audit will be performed by the certification body to verify your return to compliance with the standard.
6. External Audit
Auditors from the certification body would verify your quality management system. Should you pass the audit, you will be certified as ISO 13485:2016.
7. Ongoing Monitoring
Certification requires a series of surveillance audits to be established by the certification body to ensure your quality management system continues to conform to the standard.
ISO 13485:2016 Certification – Best Practices
Some of the best practices to streamline this certification process and succeed in the long run are:
1. Start Early
For gap analysis, development of the system and training, start certification well before.
2. Engage Experts
You may also want to consult with knowledgeable ISO 13485:2016 consultants. Their experience can speed up the process and avoid possible stumbles.
3. Foster a Culture of Quality
This has to be part of your organizational culture. Motivate everyone in the team to become owners of quality and compliance.
4. Documentation is Key
Keep detailed notes and records. This not only aids in compliance, but it also helps meet the requirements of continuous improvement.
5. Stay Informed
Keep yourself updated on ISO 13485:2016 changes and updates. As a core thing in the standard, it is possible that this evolves. so be sure to stay updated.
Conclusion
ISO 13485:2016 certification is a declaration of quality, safety, and regulatory compliance by a medical device manufacturer. Certification may require a long runway, but the pay-off from certification in quality product, global market access and operational efficiencies have been well worth it.
BioBoston Consulting offers a unique portfolio of regulatory consulting services to the life science sector.
Our team of ISO 13485:2016 certified professionals have decades of experience in leading organizations to successful certification and will help you get certified, without having any impact on your existing quality management systems.
Get in touch with BioBoston Consulting here or visit our website to get more information on how we can help your company.
