FUSION CONSULTANT REGULATORY AFFAIRS

CHECKLIST FOR ISO 1485: 2016

Mandatory document Clause of ISO Available
13485:2016 Yes / No
Document the role(s) undertaken by the organization 4.1.1
Written quality agreements with outsource partners 4.1.5
Procedure for the validation of the application of computer software 4.1.6, 7.5.6, 7.6
Quality manual 4.2.1
Quality policy 4.2.1
Quality objectives 4.2.1
Procedure for document control 4.2.4
Procedure for record control 4.2.5
Responsibilities and authorities 5.5.1
Procedure for management review 5.6.1
Procedure for competence, training and awareness 6.2
Requirements for the infrastructure 6.3
Requirements for the maintenance activities 6.3
Requirements for the work environment 6.4.1
Procedure to monitor and control the work environment 6.4.1
Requirements for health, cleanliness and clothing of personnel 6.4.1
Arrangements for the control of contaminated or potentially 6.4.2
contaminated product
Requirements for control of sterile medical device contamination 6.4.2
Processes for risk management in product realization 7.1
Arrangements for communicating with customers 7.2.3
Procedure for design and development 7.3.1
Procedure for purchasing 7.4.1
Procedure and methods for the control of production 7.5.1
Requirements for cleanliness of product 7.5.2
Requirements for medical device installation and acceptance criteria 7.5.3
Procedure for servicing activities of medical devices 7.5.4
Procedures for validation of processes 7.5.6
Procedure for the validation of processes for sterilization 7.5.7
Procedure for product identification 7.5.8
Procedure for traceability 7.5.9.1
Procedure for preserving the conformity of product 7.5.11
Procedure for monitoring and measuring equipment 7.6
Procedure for customer feedback gathering 8.2.1
Procedure for complaint handling 8.2.2
Procedure for internal audit 8.2.4
Procedure for control of nonconforming product 8.3.1
Procedure for issuing advisory notices 8.3.3
Procedure for rework 8.3.4
Procedure for analysis of data 8.4
Procedure for corrective actions 8.5.2

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 FUSION CONSULTANT REGULATORY AFFAIRS
CHECKLIST FOR ISO 1485: 2016
Procedure for preventive actions 8.5.3

Mandatory records Clause of ISO Available

13485:2016 Yes / No
Records of software validation activities 4.1.6, 7.6
Medical device file 4.2.3
Records of management review 5.6.1
Records of education, training, skills and experience 6.2
Records of the maintenance activities 6.3
Records of risk management activities 7.1
Outputs of product realization planning 7.1
Records of the results and actions arising from review of 7.2.2
Records of product requirements changes
requirements 7.2.2
Design and development planning documents 7.3.2
Design and development inputs 7.3.3
Design and development outputs 7.3.4
Records of design and development review 7.3.5
Records of the results and conclusions of the design and 7.3.6
Design and development validation plans
development 7.3.7
Records of the results and conclusion of design and 7.3.7
Results and conclusions of the design and development transfer
development 7.3.8
Records of design and development changes 7.3.9
Design and development file 7.3.10
Records of the results of evaluation, selection, monitoring 7.4.1
Records
and re- of the purchased product verification 7.4.3
Record for each medical device or batch of medical devices 7.5.1
Records of medical device installation and verification of 7.5.3
Records of servicing activities
installation 7.5.4
Records of the sterilization process parameters 7.5.5
Records of the results and conclusion of validation 7.5.6
Records of the results and conclusion of sterile medical device 7.5.7
Records
validationof traceability 7.5.9.2
Records of the name and address of the shipping package consignee 7.5.9.2
Report to the customer about changes on his property 7.5.10
Records of the results of calibration and verification of 7.6
Customer
monitoringfeedback
and report 8.2.1
Complaint handling records 8.2.2
Records of reporting to regulatory authorities 8.2.3
Internal audit plan 8.2.4
Internal audit report 8.2.4
Evidence of conformity of products with the acceptance criteria 8.2.6
Identity of the person authorizing release of product 8.2.6

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 FUSION CONSULTANT REGULATORY AFFAIRS
CHECKLIST FOR ISO 1485: 2016
Identity of personnel performing any inspection or testing of 8.2.6
Record of nonconformity
implantable 8.3.1
Records of the product acceptance by concession and the identity 8.3.2
Records
of the of actions relating to the issuance of advisory notices 8.3.3
Records of rework 8.3.4
Records of the results of data analyses 8.4
Records of corrective actions 8.5.2
Records of preventive actions 8.5.3

These are the documents and records that are required to be maintained for the ISO 13485
Quality Management System, but you should also maintain any other records that you
have identified as necessary to ensure your management system can function, be maintained,
and improve over time.

Commonly used non-mandatory documents

ISO 13485 does not require that you document all of the procedures, but there are a lot of
mandatory processes that must be established in order to generate the required records that
are outlined in the first section.

Non-mandatory documents Clause of ISO Available

13485:2016 Yes / No
Procedure for measuring customer satisfaction 5.2
Procedure for identification of regulatory and customer requirements 5.2
Procedure for internal communication 5.5.3
Procedure for planning product realization 7.1
Quality plan 7.1
Sales procedure 7.2

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