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Chapter
Checklist for changes by revision of the Implementation
EN ISO 13485:2016 Yes/No
No Name
Has a possible application of the standard to organisations involved in phases of the
medical device lifecycle been taken into account?
Has a possible application of the standard to service providers and suppliers been taken
into account?
1 Scope
Has the monitoring, maintenance and control of outsourced processes been
implemented?
Is there a possible exclusion of requirements of sections 6 and 8 with the indication "not
applicable" and a justification?
Has the redefinition of the term "document" been implemented by creating,
implementing, maintaining and documenting?
Have all roles in the company been documented and the corresponding processes
defined?
4.1 General requirements
Has a risk-based approach been used for required processes in the QMS?
Are outsourced processes subject to monitoring?
Are there written quality agreements for outsourced processes?
Has the computer software used in the QM system been validated?
Has a process for controlling recordings been implemented?
Have the listed documents been included in the medical device file?
Documentation
4.2 Have the requirements for the protection of confidential health information been taken
requirements
into account in records?
Have the requirements for archiving documents been taken into account?
5.2 Customer focus Are applicable regulatory requirements determined and is it ensured that they are met?
Were the requirements of the management evaluation procedures and their
5.6 Management review implementation implemented in "documented and planned intervals"?
Have the enhancements in the lists of inputs and results been taken into account?
Has the requirement to document the procedures for ensuring the qualification, training
6.2 Human resources
and quality awareness of personnel been implemented?
Is the avoidance of product mix-up and ensuring the proper handling of the product
ensured by suitable infrastructure?
6.3 Infrastructure
Has the documentation of maintenance activities of equipment in production, work
environment control, monitoring and measurement been implemented?
Have the additional documentation requirements for the work environment been taken
Work environment and into account?
6.4
control of contamination Has the additional requirement to control contamination by particles or micro-organisms
been taken into account in the manufacture, assembly or packaging of sterile products?
Have the infrastructure and work environment been included in the list of resources to be
Planning of product provided?
7.1
realization Have the infrastructure and work environment been included in the list of resources to be
provided?
Have the additional requirements in the list been taken into account?
Customer-related
7.2 Has the new requirement for communication with authorities been implemented?
processes
Has the possible impracticable formal verification of an order been deleted?
Have the additional requirements in the list been taken into account?
Design and development
7.3.2 Has the requirement to manage and control the interfaces between groups involved in
planning
development been removed?
Design and development Have the additional requirements in the list been taken into account?
7.3.3
inputs Has the additional verification and validation of requirements been taken into account?
Design and development
7.3.5 Have the additional details on the content of records been taken into account?
review
Have the additional requirements for the documentation of verification plans been taken
Design and development into account?
7.3.6
verification Has the documentation of interface considerations been taken into account?
Has the requirement been implemented for recording verification records?
Has the additional requirement for documentation of validation plans been taken into
account?
Have the additional requirements for products intended for validation been taken into
Design and development
7.3.7 account?
validation
Has the additional requirement of documenting the validation of interface considerations
been taken into account?
Has the requirement been implemented for recording validations?
Design and development Has the requirement to document procedures for transferring development results to
7.3.8
transfer manufacturing been implemented?

Valicare GmbH
Eschborner Landstraße 130 – 132 Wir helfen Ihnen gerne bei der Umsetzung der neuen Anforderungen.
60489 Frankfurt Nehmen Sie mit uns Kontakt auf:
Dr. Ellen Sons-Brinkmann, Tel. 069 7909-350
Firma Straße

Ansprechpartner PLZ/Ort

Telefon Email

Chapter
Checklist for changes by revision of the Implementation
EN ISO 13485:2016 Yes/No
No Name
Have the additional details to be taken into account when determining the significance of
developmental changes been taken into account?
Control of design and
7.3.9 Has the requirement been implemented that the assessment of the change effect on the
development
products to be processed and the results of risk management and product realization
processes should be carried out?
Design and development Has a process for maintaining a development file for a medical device or medical device
7.3.10
files group been implemented?
Were the criteria for selecting the supplier focused on the supplier's performance impact
on the quality of the medical device, the risk associated with the medical device and the
fulfilment of applicable regulatory requirements by the product?
7.4.1 Purchasing process
Were the new requirements for monitoring and re-evaluation of suppliers and measures
to be taken if procurement criteria are not met implemented?
Have the additional details regarding the content of the records been taken into account?
Has the requirement for a written agreement been implemented that the supplier informs
of any changes to the suitability of the purchased product to meet the specified
7.4.2 Purchasing information
procurement requirements prior to its implementation?
Have the other procurement details been included in the list?
Have the new requirements on the extent of verification activities been implemented?
Verification of purchased
7.4.3 Were the requirements with regard to the measures to be taken implemented when the
product
organisation becomes aware of changes to the purchased product?
Control of production and Have the details of production and service provision been taken into account?
7.5.1
service provision Has the new requirement been included in the list?
7.5.2 Cleanliness of products Has the new requirement been included in the list?
7.5.4 Service provision Has the requirement to analyze records of service provision been implemented?
Have the additional requirements in the list been taken into account?
Validation of processes
Have the details of cases requiring procedures been taken into account?
7.5.6 for production and
Has the approach of risk-based software validation been taken into account?
service provision
Have the requirements for validation records been implemented?
Special requirements for
the validation of
7.5.7 sterilization processes Has the additional requirement for sterile barrier systems been taken into account?
and sterile barrier
systems
Has the additional requirement for unique identification of a device been taken into
account?
7.5.8 Identification
Has the requirement for a documented process for product identification and
identification and product status during production been implemented?
7.5.11 Preservation of product Have the further details of how preservation can be achieved been taken into account?
Has it been implemented that feedback should come from manufacturing activities and
post-production activities?
8.2.1 Feedback
Has the requirement that feedback for risk management processes should be used to
monitor and maintain product requirements been taken into account?
Has the establishment of a procedure on requirements and responsibilities, record
8.2.2 Complaint handling
maintenance and information exchange with external parties been implemented?
Reporting to regulatory Has the process of reporting complaints, adverse events or issuing recommendations for
8.2.3
authorities action been implemented?
Monitoring and Has the requirement to identify the test equipment used to perform measurements been
8.2.6
measurement of product taken into account?
Have the further details on the types of control that need to be documented been taken
into account?
Has the generalisation of the requirement regarding the opening of an investigation and
Control of nonconforming the justification for the decisions been taken into account?
8.3
product Have the additional requirements regarding acceptance by concession been taken into
account?
Have the additional requirements for the records on the preparation of advisory notice
been taken into account?
Have account been taken of the requirement as regards the definition of appropriate
8.4 Data analysis methods, including statistical methods and the extent to which they are used?
Have the new details been taken into account in the list of entries?
Has the requirement regarding verification of corrective actions been implemented that
they have no undesirable effect?
8.5.2 Corrective action
Has the additional requirement to take corrective action without undue delay been taken
into account?
Has the additional requirement regarding the verification of preventive actions taken into
8.5.3 Preventive action
account that they have no undesirable effect?

Valicare GmbH
Eschborner Landstraße 130 – 132 Wir helfen Ihnen gerne bei der Umsetzung der neuen Anforderungen.
60489 Frankfurt Nehmen Sie mit uns Kontakt auf:
Dr. Ellen Sons-Brinkmann, Tel. 069 7909-350