ISO 15189:2022 Certification – Medical Laboratory Quality & Competence | Accredify Global
Evolution of ISO 15189:2022 Certification
ISO 15189 was first published in 1996 and is based on the ISO 9001 Quality Management System. It was developed to address specific regulatory requirements for medical device manufacturers, suppliers, and service providers.
The latest version, ISO 15189:2022, aligns with global medical device regulations (FDA, MDR, IVDR) and includes risk-based thinking, documentation controls, and enhanced regulatory compliance.
What is ISO 15189 - Medical Laboratory Quality & Competence?
ISO 15189 is an international quality management standard for the medical device industry, ensuring:
- Regulatory compliance with global medical standards.
- Risk management & patient safety assurance.
- Consistent product quality & traceability.
- Streamlined manufacturing & supply chain processes.
Who Needs ISO 15189 Certification?
ISO 15189 is essential for companies involved in:
- Medical device manufacturing & design.
- Component & material suppliers for medical devices.
- Sterilization & packaging service providers.
- Healthcare & diagnostic equipment companies.
- Medical software & technology providers.
- Distributors & regulatory consultants.
Importance of ISO 15189 Certification
With medical device recalls costing companies billions, ISO 15189 helps:
- Reduce product defects by 50%.
- Improve compliance with FDA & EU MDR regulations.
- Enhance patient safety & device reliability.
- Increase global market access & supplier approvals.
- Continuous improvement using the PDCA cycle.
ISO 15189 and Its Major Aspects in Business
ISO 15189 provides a structured framework for Medical Laboratory Quality & Competence, covering:
- Risk-based quality control & product safety.
- Medical device design, production & testing.
- Regulatory compliance (FDA, MDR, IVDR, etc.).
- Supplier & subcontractor quality management.
- Post-market surveillance & corrective actions.
The Principles of ISO 15189 Certification
The principles of ISO 15189 include:
- Regulatory Compliance – Aligning with global medical device laws.
- Risk-Based Approach – Ensuring patient safety & product effectiveness.
- Process Efficiency – Reducing waste & optimizing quality control.
- Customer Focus – Meeting patient & healthcare provider needs.
- Continuous Improvement – Enhancing product lifecycle & performance.
Checklist for ISO 15189 Certification
- Develop a Medical Laboratory Quality & Competence System (QMS)
- Implement risk assessment & design control measures
- Establish traceability & documentation compliance
- Conduct internal audits & supplier quality checks
- Train employees on ISO 15189 best practices
- Implement emergency response plans
- Maintain records and documentation
Is ISO 15189 Certification mandatory or a legal requirement?
ISO 15189 is not legally required but is essential for compliance with:
- FDA Quality System Regulations (QSR)
- European Union Medical Device Regulation (EU MDR/IVDR)
- Health Canada & international medical device laws
Services
Benefits of ISO 15189 Certification
50% fewer product defects & compliance failures
30% faster regulatory approval for medical devices.
Increased trust with healthcare providers & suppliers.
Reduced risk of costly product recalls & legal issues.
Improved market access in the USA, EU, and global markets.
Requirements of ISO 15189 Certification
Implement a QMS tailored to medical device regulations.
Ensure traceability & documentation for all products.
Conduct risk-based assessments & patient safety evaluations.
Train staff in quality control & regulatory compliance.
Undergo internal & external certification audits.
Cost of ISO 15189 Certification
The cost of ISO 15189 certification varies depending on the size and complexity of the organization. However, the investment can lead to significant energy cost savings and improved energy efficiency.
On average, ISO 15189 certification costs range from $10,000 to $50,000, including auditing and consultation fees.
PDCA Cycle | Accredify Global
- Plan – to think that what do we need to achieve in our organization
- Do – to execute a planned action which will help us achieve the required objective
- Check – monitor against the standards) (policies, objectives, requirements)
- Action – finally implementing what has been rechecked.
ISO CERTIFICATION. 3 STEPS. 30 DAYS. DONE !! | ACCREDIFY GLOBAL
Accredify Global, we follow a structured and transparent ISO certification process to help businesses achieve international compliance efficiently. Our streamlined approach ensures a hassle-free experience from initial consultation to final certification..
3. Audit Review & Certification
- Objective: Validate your management system through an external audit and achieve certification.
- Actions:
- Conduct an internal audit to ensure readiness for the certification audit, utilizing Accredify Global's auditing tools and resources.
- Schedule and undergo an external audit with Accredify Global's accredited certification body.
- Address any non-conformities identified during the audit with support from Accredify Global's consultants.
- Outcome: Successful certification and ongoing compliance with the ISO standard, with continuous support and guidance from Accredify Global.