What is ISO 13485:2016?
ISO 13485 is a quality management system standard for medical devices & equipment. The standard requires an organization to implement in one or more stages of the life cycle of a medical device that helps it fulfill the Medical Device Regulatory Compliances. The standard specifies the requirements of medical devices to be free from contaminants, sterilized, and maintain cleanliness in their entire life-cycle.
ISO 13485 gives guidance to the organization to implement the quality management system effectively in medical device manufacturing or medical service-related organizations. The ISO 13485 standard ensures the consistent design, development, production, installation, and delivery of safe medical devices for their intended purposes. ISO 13485 certification ensures organizations that provide medical devices are meeting high quality and safety requirements.
Benefits of ISO 13485 Certification for Businesses
- Improves customer satisfaction
- Improve safety in using medical devices
- Increase in productivity, profitability, and quality of products
- Global recognition of your business
- Provides an effective quality management system for medical devices
- Meets applicable statutory and regulatory requirements
Who Can Apply for ISO 13485 Certification?
The ISO 13485 certification standards apply to all companies/industries that produce and distribute medical devices and equipment, regardless of their size. Furthermore, ISO 13485 certification applies to sectors that provide related services as well.
Why Choose IAS for ISO 13485 Certification?
Although the International Organization for Standardization (ISO) establishes and publishes the ISO 13485 standards, they do not perform ISO 13485 certification. Therefore, organizations turn to third-party certification bodies to obtain ISO 13485 certification such as IAS. Integrated Assessment Services (IAS) is a leading globally recognized ISO 13485 Certification Body, operating in the United Kingdom, which is accredited by Universal Quality Accreditation Services (UQAS). We provide ISO 13485 certification in the UK and also in various countries across the world. Incorporated in 2006, we have two decades of professional experience in auditing and providing ISO 13485 certification and various product and ISO process certifications.
We are independent experts in auditing and the most trusted ISO 13485 certification body in ensuring the conformity and requirements of international management standards. We effectively support our clients to implement the management system for their growth and development.
Procedure to Obtain ISO 13485 Certification through IAS:
- Initially, make an inquiry on our global website or contact us directly through mail or telephone, based on your country/region.
- Download and fill the application form which is available for free on our website.
- After reviewing the application, IAS will contact you for further certification procedures.
- Our auditors will form a customized plan to perform the ISO 13485 certification audit.
- Our ISO 13485 Certification audit includes 2 major stages:
- Evaluation of your organization – Readiness Audit
- Verifying objective evidence and conformity to the ISO 13485:2016 standard requirements – Implementation Audit
- IAS will convey the audit findings, any non-conformities, and any necessary observations found during the audit to your organization.
- The time duration for effective non-conformity closure is between 30 to 60 days.
- Verification and validation of non-conformity closure and also follow-up visits will be conducted by our IAS team for ISO 13485 certification.
- Finally, IAS will issue ISO 13485 certification with a validity of three years.
- IAS also conducts a surveillance audit every 12 months throughout the ISO 13485 certification validity period.
- IAS will also conduct a re-certification audit after the validity of the initial ISO 13485 certification.
ISO 13485 Certification Cost
IAS provides competitive pricing for ISO 13485 certification. The ISO 13485 Certification cost depends on the size and nature of your organizational structure. ISO 13485 certification cost also depends on your organization’s knowledge and preparedness in implementing an ISO 13485 quality management system. The total cost includes service charges, auditor fees, audit reports, site visits, certification issuance, etc.
IAS offers a free quotation service to help you understand the cost of ISO 13485 Certification and all the associated fees such as consultancy, training, documentation, re-certification audits, etc. Please get in touch with us to get a free quotation!
For more details about ISO 13485 certification, ISO 13485 certification cost, other ISO management standards & product certification, and audit procedures, kindly contact us at [email protected]