ISO 13485-2016 Accreditation
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Meeting EUMDR Accreditation
MD-SAP Accreditation
Quality Assurance for Medical Devises
Our Quality Services Team have over 3 decades of experience in developing and managing Quality Assurance System used in the Medical Equipment Manufacturing Industry, if you are buying or manufacturing equipment from Chinese sources then you will already know about EU-MDR and MDSAP but does your supplier actually work to this standard and what is your risk, SMC-Compliance was born out of this necessity. our services include writing quality systems to meet the joint requirements under one QMS , supplier evaluation and validation, inspections and reviews and production oversight.
Risk Management Check Sheet
This sheet will help you to define GAP and Requirement to meet the standard.
Personnel Requirement Guidance Action Checked
Clause 6.2
Methodology used to check effectiveness is proportional to risk associated with the work for which the training or other action is being provided
HR shall provide all training documents for all personnel to be deployed on this project. Risk Shall be Assessed using COTO document, this shall be submitted with this form to Quality for review.
Assess risk if NOT adequately performed.
Supporting documentation shall be submitted for management review
Product Safety ☐
Supporting Document Numbered ☐
Performance ☐
Supporting Document Status ☐
Compliance Known ☐
HR records and Training matrix.
Training records ☐
Education Records ☐
On the Job Training ☐
Risk Awareness Training ☐
Quality Objectives ☐
Suppliers Clause 4.1.5
Outsourced processes –
Controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements
Assess risk of the supplier not being able to meet the standards required and risk to processes of OUR QMS
The Supplier Quality Management Document must be submitted as supporting documentation to meet this selection criteria NCR Record ☐
Quality Control Process ☐
Production Inspection ☐
Supplier Clause 7.4.1
Supplier selection and evaluation shall be proportionate to the risk associated to the manufacture of medical devices and statute regulatory requirements. Documentary evidence shall be presented that meeting requirements of EUMDR 2017-745
FDA 21CFR802
ISO 13485-2016 Certification Documents Checked
GB/T9001-2015 ☐
ISO 9001-2015 ☐
EUMDR 2017-745 ☐
ISO 13485-2016 ☐
FDA 21CFR802 ☐
QSP-SQM ☐
Traceability Records ☐
Supply Chain
Suppliers shall operate a quality management system that meets the same requirements Up Stream Supplier Check
Traceability Records ☐
Production Quality Control ☐
Certification ☐
Audited to 13485-2016 ☐
Supplier legal
Quality Requirements
Written standards of quality and accountability shall be enacted with all suppliers
Agreements Documented Checked
Critical to Quality ☐
Acceptable Quality Levels ☐
SPC data units ☐
Test ratio ☐
Purchased Products Clause 7.4.3
Verification –
Extent of verification activities shall be based on Supplier evaluation results and proportionate to the risk associated to the purchased product and the final product. Assess risk to product, quality, compliance.
The QMS and quality objectives.
Establish quality controls and production quality controls that establish ratio of inspections.
Quality Records Checked
% of customer complaints ☐
Time to Rectify CC ☐
NCR Numbers ☐
Product Quality Records ☐
Recall Records ☐
Product Compliance ☐
DFMEA ☐
PFMEA ☐
Performamace ☐
Software Validation Clause 4.16,7.5.6,7.6
Software used in the QMS, production, product, service provision, monitoring, and measurement –
The specific approach and activities associated with software validation and re-validation shall be proportionate to the risk associated with the use of the software.
Assess risk to final product, quality, and compliance
Risk based selection criteria shall be used.
Consult ISO8002-2
ISO 10012
Records and processes for the management of software shall be maintained Documents and Process Checked
ISO 8002-2 ☐
ISO 10012 ☐
GDDP ☐
Penetration Test ☐
IP ☐
Licenses ☐
Performamace ☐
Validation ☐
Evaluation ☐
Security ☐
CTO Sign off ☐
You can see from the short form check sheet compliance to each standard is challanging, that is why we can help you.
it is worth noting that in China most suppliers will tell you they have a ISO13485-2016 but it in most cases is the Chinese GB/t13485-2016 note both the EU-MDR nor the FDA recognises this standard.