GRC’s MDR Certification Process
1. Pre-application : Pre-application – Initial, expedited review phase for a preliminary proposal
– Fill out the product information receipt form and send it (M.RF.23.03)
2. Application : For formal quotation and contract
step
– Application form ( M.Fr.07.01 )
– Business registration certificate (English)
3. MDR Contract: MDR Contract
4. Project application form : Submit progress documents
5. Assignment : Designation of person in charge of technical documents/QMS, etc.
6. TCF assessment: TCF (Technical Construction File, technical document) review
7. Site assessment : QMS audit
8. Issuance EC Certificate : Certificate issuance
The international standard ISO 13485:2016 was published on 25 February 2016.
ISO 13485:2016 maintains the existing eight-clause system, unlike ISO 9001:2015.
GRC Certification Institute is comprised of auditors qualified to ISO 13485:2016 and can issue certificates accordingly.
The following clauses have additional requirements compared to the existing ISO 13485:2003 in ISO 13485:2016. For more detailed information, please refer to the standard and related training.
4.1 General requirements for quality management system
4.2 Documentation Requirements
5.6 Management Review
6.2 Human Resources
6.3 Infrastructure
6.4 Working Environment and Pollution Control
7.1 Product Realization Planning
7.2 Customer-related processes
7.3.2 Design Development Planning
7.3.3 Design Development Inputs
7.3.5 Design Development Review
7.3.6 Design Development Verification
7.3.7 Design Development Validation
7.3.8 Design Development Transfer
7.3.9 Design Development Change Management
7.3.10 Design Development File
7.4.1 Purchasing Process
7.4.2 Purchase Information
7.4.3 Verification of Purchased Products
7.5.1 Management of production and service provision
7.5.2 Cleanliness of the product
7.5.4 Service Activities
7.5.6 Validation of processes for production and service provision
7.5.7 Special requirements for validation of processes for sterilization and sterilization barrier systems
7.5.8 Identification
7.5.11 Preservation of Products
8.2.1 Feedback
8.2.2 Complaints Handling
8.2.3 Reporting to the competent authorities
The international standard ISO 9001:2015 was published on September 22, 2015.
In the ISO 9001:2015 standard, the existing 8-item system was changed to a 10-item system, the High Level Structure.
GRC Certification Center has auditors who can audit ISO 9001:2015 and issue certificates accordingly.
The following clauses have additional requirements compared to the existing ISO9001:2008 in ISO 9001:2015. For more detailed information, please refer to the standard and related training.
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of stakeholders
4.3 Determining the scope of application of the quality management system
4.4 Quality Management System and Process
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer Focus
5.2.2 Communication of Quality Policy
5.3 Roles, responsibilities and authorities of the organization
6.1 Actions to address risks and opportunities
6.3 Planning for Change
7.1.5.2 Measurement Traceability
7.1.6 Organizational Knowledge
7.3 Recognition
8.3.2 Design and Development Planning
8.4.2 Type and scope of management
8.4.3 External Provider Information
8.5.6 Change Management
9.1.3 Analysis and Evaluation
9.3 Management Review
10 Improvements
You can check the GRC certification center under Our partners at the bottom of http://www.erca-academy.com .
You can check the GRC certification logo on the 4th line of the 3rd line.
