ISO 13485 Certification: Quality Management System for Medical Devices
By obtaining ISO 13485 Certification in Saudi, you can raise the quality of your medical devices.
What is ISO 13485 Certification?
ISO 13485 Certification was established by ISO (International Organization for Standardization) and revised in the year 2016 to authenticate Quality Management systems and security in medical devices. The medical field is witnessing continuous development in its technologies and equipment. It is also important for the world to secure safety measures for it.
ISO 13485 Certification can be applied by any size of medical service provider throughout the life- cycle of the device. It is entitled in every stage of device life, from planning, production, supply, distribution, storage, installation, controlling, monitoring, maintain, and even post-production. It is not obligatory but still a necessity for medical service providers to be trusted by consumers, stakeholders, and all the parties concerning them.
ISO 13485 Certification can be adopted by any organization manufacturing medical devices irrespective of its shape, size, age, and geographical location.
ISO has adopted the process approach which follows the PDCA act (Plan – Do – Check – Act) cycle which brings in a drive for continued perfection in the process of the organization.
Benefits of ISO 13485 Certification
ISO 13485 Certification enables the establishment of the Quality management system in medical device production, maintenance, and life-cycle process by:
- Improve the process of production and maintenance of medical devices.
- Enhances the effectiveness of medical devices
- Ensures safety in medical devices.
- Reduces operational cost.
- Continuous Improvement in medical devices
- Increase trust in stakeholders and customers
- Validate customer satisfaction and wellbeing.
- Encouragement of staff and employee training in medical service providers.
Requirements of ISO 13485 Certification
The standards for a Quality Management System for Medical Devices are outlined in ISO 13485:2016 in order to satisfy both customer and applicable regulatory requirements. A company can apply requirements consistently to related services it offers with the use of an ISO 13485 certificate.
- Define adequate quality of design and development plan for medical devices.
- Identification of Quality management process in medical device production and further process.
- Consider customer’s requirements throughout the process.
- Production of sterile medical devices.
- Proper maintenance, control, and repair of medical devices.
- Review quality of design and development in medical devices.
- Meet documentation requirements fundamental to ISO 13485.
- Safe distribution of medical devices.
- An internal audit of the organization.
Which organization need ISO 13485 Certification?
An organisation that is involved in the design, development, production, storage, distribution, installation, servicing, and eventual decommissioning and disposal of medical equipment, as well as the design, development, or provision of related operations, may use it (e.g. technical support). Suppliers and other outside parties who provide these organizations with products (such as medical devices, raw materials, components, subassemblies, sterilisation services, calibration services, distribution services, and maintenance services) can also use the requirements in this International Standard.
Why you need ISO 13485 Certification?
ISO 13485 Certification is needed to help manufacturer of medical devices in manufacturing quality devices that follows a quality management system (QMS) that develops and maintains the efficiency of their processes. It guarantees that medical devices are consistently designed, developed, produced, installed, and delivered before being disposed of in a manner that is safe for their intended use.
Strength of Ascent SAUDI
- Ascent experts guide you through the proper documentation process of ISO 13485 Certification without adding the burden of unnecessary documents on your organization in all parts of Riyadh, Jeddah, al-khobar, and Dammam.
- Ascent Saudi provides complete understanding and proper training for personnel regarding the quality of the medical device that can solve quality issues easily. Ascent provides training based on the need of the organization and not unnecessary ones.
- Ascent helps by imparting the right education regarding coordination and motivation of management and employees to help you achieve ISO 13485 standard
- Ascent provides required training, education and confidence to employees thus making QMS a regular habit for them which eradicates fear and dopes confidence.
- Ascent experts guide you about the inadequate resources that will resolve various problems in the failure of ISO 13485 conformity.
- The Ascent Solutions Architect guides you through the entire ISO 13485 compliance and implementation till the achievement of certification which will give you a sigh of relief.
- Ascent facilitates in-depth and professional auditing services that are significantly more stringent than the audits done by certification bodies. This ensures no failure during external audits.
- Ascent works 24X7, to cater to the needs of its customers all over the world. This gives you ample opportunity to demand our services even during the odd hours and holidays.
- Ascent has a general practice of complete analysis before an offer is given. It is extremely improbable that the total expenditure goes beyond the budgeted figures unless there are special requirements from the client’s end. “Not a single penny extra”, is a general motto that each Ascent employee abides by.
Frequently Asked Questions
What is the cost of applying for ISO 13485 Certification in the Saudi?
The cost of this standard is a little higher than the cost of other standards related to quality management as it is a very crucial standard dealing with the safety of medical devices and consumers’ life. It depends on the type of device you are dealing with and the need to acquire Certification.
IS ISO 13485 Certification mandatory?
ISO 13485 is mandatory in some countries for some of the kinds of products. Nevertheless, obtaining ISO 13485 Certificate is safer and effective to deal with medical products.
How long does it take to acquire ISO 13485 Certification?
Depending upon the strength of an organization it approximately takes 3-6 months for companies.
What is the validity of the ISO 13485 certificate?
ISO 13485 certification is valid for 2 (Three) years from the date of issue of the certificate, subject to a successful annual surveillance audit at the end of the first and second year.
What are class 1, 2, 3 medical devices?
Medical devices according to FDA or as per EU Regulations are divide into various Categories based on Product Risks ex. CAT 1 / CLASS I (Devices with low-moderate risk to the consumer requires general control; CAT 2 / Class II (Devices with moderate-high risk requires special controls); CAT 3 / Class III( Device with high risk supporting life or sustaining life).
What is the difference between ISO 9001 and ISO 13485?
ISO 9001 Certification is an international standard for Quality Management systems for all types of industries whereas ISO 13485 Certification is a Quality Management System for medical devices.
Is it necessary for an organization to have ISO 13485 if they want to apply for the CE mark of any medical device?
ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices. CE Marking is the product Certification and ISO 13485 is the basic requirement for an organization.
What does obtaining ISO 13485 Certificate mean?
A) Obtaining and maintaining ISO Certification is but a section of the whole business plan.
B) Focuses on the practices the business employs to maintain quality within the company.
C) Set the structures within which the operations function.