ISO 13485:2016 (MDQMS)Medical Devices Quality Management System.

ISO 13485:2016 (MDQMS)Medical Devices Quality Management System.

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​The benefits of ISO 13485 Medical device – Quality Management System certification include demonstration of regulatory compliance and better risk assessment.

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Description

​ISO Certificate 13485:2016 : The benefits of ISO 13485 Medical device – Quality Management System certification include demonstration of regulatory compliance and better risk assessment. Certification helps to comply with regulatory requirements. It also ensures to consumers, suppliers or other stakeholders that the organization established a standard procedures for its processes. Other benefits of ISO certificate 13485:2016 includes: Better competency in global market. Assurance that appropriate regulatory requirements are implemented within your organizational processes. Increased access to more market. Increased efficiency.

Documents required for ISO 13485:2016

  • INCORPORATION CERTIFICATE
  • GST NUMBER CERTIFICATION
  • MSME CERTIFICATION
  • SALE & PURCHASE BILL COPY
  • ELECTRICITY BILL
  • OWNER ID PROOF COPY
  • LETTER HEAD
  • VISITING CARD
  • EMAIL ID / PHONE NUMBER
  • PAN CARD
  • AADHAR CARD
  • PHOTO
  • ELECTRICITY BILL
  • SIGN WITH COMPANY
  • STAMP/SIGN
  • WITHOUT STAMP
  • PRODUCT LIST / INFORMATION
  • CANCEL CHEQUE
  • MAIL ID / CONTACT NO.

Section 8 of ISO 13485:2016 gives the requirements for measurement analysis and improvements of these processes including:

8.1  General
8.2  Monitoring and Measurement
8.3  Control of nonconforming product
8.4  Analysis of data
8.5  Improvement

8.1  General

All business organisations are instructed to create a plan which is applicable to the monitoring, measurement, analysis and improvement processes needed, in order to meet the conformity requirements of the product, to ensure the conformity of the QMS, and maintain the QMS effective.

Monitoring and Measurement

As part of the needs each organization is required to mange and measure a variety of data in order to improve their method and meet customer needs:

  • Customer Feedback
  • Complaint Handling
  • Reporting to Regulatory Authorities
  • Internal Audit
  • Monitor and Measure processes and products

8.3 Control of nonconforming product

Business Organizations needs to react to any product that is not conforming to product needs. Organizations required to identify and manage these products to ensure that they are not used and distributed further. This method needs to be documented and maintained.

8.4 Analysis of Data

The business firms needs to collect and analyze the data to determine the efficiency of the QMS. The ways to determine this need to include data collection and analysis, including statistics to help understand the extent of the QMS productivity.

8.5 Improvements

Improvements are a important part of the quality management system. ISO 13485:2016 requires all business  organizations to focus on continually enhancing. Overall, the firm needs to identify and implement any changes important to maintain the effectiveness of the QMS, and the medical device security and performance.

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