What is ISO 13485?
ISO 13485 is a popular international standard for quality management systems (QMS) of medical device manufacturing and related services. The standard ISO 13485 requirements follow a process-based approach that enables the organization to carry out each and every process using the PDCA cycle. The ISO 13485 certification specifies the requirements in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device.
It empowers the organization’s risk assessment, decision making, the involvement of top management, resources, competency in an effective manner. ISO 13485 Certification is applicable to any medical device manufacturers and its related services who want their QMS to be effectual and to meet their objectives and quality policy in a strategic direction for continual improvement.
Benefits ISO 13485 certification
- Improves customer satisfaction
- Improve safety in using medical devices
- Increase productivity, profitability, and quality of products
- Global recognition of your business
- Effective quality management system
- Better workplace improves communications between employees
- Good leadership practices
- Integrated Assessment Services (IAS) is the most trusted certification body, prominent in providing various ISO management certification and product certification in Netherlands, accredited by Universal Quality Accreditation Services (UQAS).
- We have qualified auditors and technical expertise to support our clients for their certification process and assist them in meeting the ISO 13485 requirements for successful certification.
- Other than Netherlands, IAS is also successfully operating in other countries such as Asia, Gulf, Middle East, Africa, and USA.
- IAS also expertise in providing IRCA certified training on various ISO standards. We offer product certifications such as Green, Kosher, Halal, CE Marking, etc.
ISO 13485 certification procedure
- Initially, make an enquiry in our global website or contact us through mail or telephone-based on your country/ region.
- Download and fill the application form which is available for free in our website and send email to: firstname.lastname@example.org
- After reviewing the application, we will contact you to discuss further certification procedures.
- IAS submit audit findings, no of NC’s (if found any), and following observations found during the audit.
- The time duration for effective NC closure is between 30 to 60 days.
- Finally, after the successful implementation, IAS will provide the ISO 13485 certificate which has a validity of 3 years.
- Also, IAS conducts a surveillance audit for every 12 months.
- Logo usage, suspension, withdrawal, or termination of contract comes under IAS terms and conditions.
Further, to know more details about ISO 13485 certification and kindly contact us – email@example.com.