Quality and Safety can not be negotiable at any cost in the medical devices industry, that’s why ISO 13485 was developed .The main objective of ISO 13485 was to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standard. This certification process reflects an Innovations that give commitment to quality during the production, manufacturing and distribution of medical devices.
ISO 13485 standard includes specific manufacturing, installation and servicing requirements provided below
1. Implementation of a system for quality management with several improvements.
2. Approach to risk management in product development and product realization
3. Validate the procedures.
4. Compliance with legal and regulatory requirements.
5. Effective traceability of products and recall systems.
As an internationally recognized quality and safety standard for the manufacture of medical devices, having ISO 13485 certification helps companies to be recognized as more reputable and trustworthy suppliers. On every five years, ISO 13485 is reviewed and revised according to updation recorded in industry to fulfill requirements and needs
Steps to obtain ISO 13485 certification
- Create a quality plan structure
- Identify target markets and work towards compliance
- Build a CAPA system
- Establish document controls
- Schedule audits with Notified Bodies
Benefits of ISO 13485:2016
- It shows that the process of medical device manufacturing is safest and hygenic.
- It will increase business goodwill .
- It ensures to meet expectations for customers.
- Certification helps to grow in business, especially where certification require in a highly regulated sector as a condition for supply.
- Establish brand confidence in manufacturing of medical devices in india.
- Provide healthcare services with appropriate quality in medical devices which are manufactured in a certified facility.
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Step 1: Visit our ISO Certificate Registration Website.
Step 2: Fill out the Registration Form of the ISO 13485:2016 Certification.
Step3:Complete application online payment.
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Step5: You will get your ISO 13485 certificate in your registered email address within 2-3 working days.
ISO 9001 is described as the International Standard that Specifies requirements for a quality management system (QMS). Organizations use the standard to determine the ability to consistently provide products and services that meet customer and regulatory requirements.
ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and better customer satisfaction.
While no company needs a certification to manage, many companies will find significantly greater success if they are certified. The ISO 9001 is applicable in both production and service industries. Quality management can be very useful in manufacturing and customer-based companies.
ISO 9001 is simply a standard that sets out the requirements for consistent and effective management. It helps businesses and organizations to become more efficient and improve customer satisfaction.
ISO 9001:2005 is a quality management system standard that specifies the requirements for an organization to establish, implement, maintain, and continually improve its quality management system.
ISO 9001:2005 can be used by any organization, regardless of its size, type, or industry. The standard is applicable to both product and service-oriented organizations.
The benefits of implementing ISO 9001:2005 include increased customer satisfaction, improved product and service quality, better process efficiency, and enhanced credibility and reputation.
The certification process for ISO 9001:2005 involves the following steps:
(1) preparing the quality management system documentation,
(2) conducting a pre-assessment or internal audit,
(3) selecting a certification body,
(4) undergoing an external audit by the certification body, and
(5) receiving the ISO 9001:2005 certification.
ISO 9001:2015 is the latest version of the ISO 9001 quality management system standard and has several differences from ISO 9001:2005, including a stronger focus on risk-based thinking, a greater emphasis on leadership and engagement, and a simplified structure and language.