ser Standard Clause Title Clause Standa Clause No.

Clause Standa Clause No. Title Clause Process Question Objective Evidence Actual on System Actual Implementation
Productio
ISO-
1 ISO-13485 7 n 8 Operation
9001
Realizatio The organization shall plan and develop
the processes needed for product The organization shall plan, implement and control the
realization. Planning of product processes (see 4.4) needed to meet the
realization shall be consistent with the requirements for the provision of products and services, and to
requirements of the other processes of implement the actions determined in Clause 6, by:
the quality management system. a) determining the requirements for the products and services;
The organization shall document one or b) establishing criteria for:
more processes for risk management in 1) the processes;
product realization. 2) the acceptance of products and services;
Records of risk management activities c) determining the resources needed to achieve conformity to
shall be maintained (see 4.2.5). the product and service requirements;
In planning product realization, the d) implementing control of the processes in accordance with
Producti Has the organization identified Documented
Planning organization shall determine the Operational the criteria;
ISO- on and documented the procedure outlining
2 ISO-13485 7.1 of product following, as appropriate: 8.1 planning and e) determining, maintaining and retaining documented Production Planning Process
9001 Planning processes necessary for the processes for
realization a) quality objectives and requirements control information to the extent necessary:
Process product realization? product realization.
for the product; 1) to have confidence that the processes have been carried out
b) the need to establish processes and as planned;
documents (see 4.2.4) and to provide 2) to demonstrate the conformity of products and services to
resources specific to the product, their requirements.
including infrastructure and work The output of this planning shall be suitable for the
environment; organization’s operations.
c) required verification, validation, The organization shall control planned changes and review the
monitoring, measurement, inspection consequences of unintended changes,
and test, handling, storage, distribution taking action to mitigate any adverse effects, as necessary.
and traceability activities specific to the The organization shall ensure that outsourced processes are
product together with the criteria for controlled (see 8.4).
product acceptance;
Planning of product realization shall be Are the requirements of the Flowcharts or
Planning
consistent with the requirements of the quality management system diagrams that
3 ISO-13485 7.1 of product Flow chart in technical File
other processes of the quality integrated into the product illustrate process
realization
management system. realization process? interactions.
The organization shall document one or Records of risk
Planning more processes for risk management in What methodologies are used assessments,
4 ISO-13486 7.1 of product product realization. for identifying, assessing, and including identified
realization Records of risk management activities mitigating risks? risks and mitigation
shall be maintained plans.
Planning How are risk management Methods of
5 ISO-13487 7.1 of product activities recorded and maintenance of logs
realization maintained? or databases of risk
In planning product realization, the
How does the organization Evidence of how
Planning organization shall determine the
ensure that the quality quality objectives are
6 ISO-13488 7.1 of product following, as appropriate: Objectives Initiatives
objectives are measurable measured (e.g.,
realization a) quality objectives and requirements
and achievable? metrics, KPIs).
for the product;
b) the need to establish processes and What resources have been Resource allocation
Planning documents (see 4.2.4) and to provide allocated specifically for the records, including Work environment and
7 ISO-13489 7.1 of product resources specific to the product, product, including infrastructure and infrastructure procedure,
realization including infrastructure and work infrastructure and work work environment but no process
environment; environment? specifics.
Assessments or
How does the organization
Planning audits of the work
ensure that the work
8 ISO-13490 7.1 of product environment to TAB Assessments
environment is suitable for the
realization ensure compliance
product's requirements?
c) required verification, validation, with product
monitoring, measurement, inspection Documented
Planning Have the required verification
and test, handling, storage, verification and
9 ISO-13491 7.1 of product and validation activities for IO Matrix, Validation Plan
distribution and traceability activities validation plans for
realization the product been defined?
specific to the product together with the the product.
criteria for product Records of
What monitoring,
Planning monitoring and
measurement, inspection,
10 ISO-13492 7.1 of product measurement OMS
and testing methods are in
realization activities, including
place for the product?
inspection and
 Handling Procedure,
Procedures for
Warehouse Procedure,
Planning Are handling, storage, and handling, storage,
Distribution Process
11 ISO-13493 7.1 of product ` distribution procedures and distribution
No procedure for
realization documented for the product? specific to the
Distribution, No Processes
product.
for Handling

Documented criteria
Planning What acceptance criteria have for product
12 ISO-13494 7.1 of product been established for the acceptance, Quality Plan, Test Methods
realization product? including any
applicable standards
Are there specific records that Records of
d) records needed to provide evidence
Planning confirm compliance of inspections, tests,
that the realization processes and QC Inspections, Quality
13 ISO-13495 7.1 of product resulting product and product and validations that
resulting product meet requirements Plan, Customer Inquiry
realization realization processes with the show compliance
(see 4.2.5).
requirements? with requirements.

Planning The output of this planning shall be Examples of

Is the output of the planning
14 ISO-13496 7.1 of product documented in a form suitable for the documented Planning Reports
documented ?
realization organization’s method of operations. planning outputs
the methodology
Planning Is the output in a format that used to ensure the
15 ISO-13497 7.1 of product aligns with the organization’s suitability of the Work Standards, Testing
realization operational methods? output to the method
of operation.
Customer- Requirements for
ISO-
16 ISO-13485 7.2 related 8.2 products and
9001
processes services
The organization shall determine:
Marketin
a) requirements specified by the
When determining the requirements for the products and g
customer, including the requirements
services to be offered to customers, the Require
Determina for delivery and post-delivery activities; Records of customer
organization shall ensure that: ments What methods are used to
tion of b) requirements not stated by the Determining the feedback or
a) the requirements for the products and services are defined, Docume gather customer
requireme customer but necessary for specified or ISO- requirements for requirements- Customer Inquiry form, No
17 ISO-13485 7.2.1 8.2.2 including: nt requirements, including
nts intended use, as known; 9001 products and gathering sessions Customer Inquiry Process
1) any applicable statutory and regulatory requirements; Creation delivery and post-delivery
related to c) applicable regulatory requirements services (e.g., surveys,
2) those considered necessary by the organization; Process activities?
product related to the product; interviews).
b) the organization can meet the claims for the products and Custome
d) any user training needed to ensure
services it offers. r Inquiry
specified performance and safe use of
Process
the medical device;
Determina
Records of Customer Inquiry process
tion of
b) requirements not stated by the What processes are in place assessments or add R&D section that if the
requireme
18 ISO-13485 7.2.1 customer but necessary for specified or to assess and document these analyses conducted requirements are not
nts
intended use, as known; implicit requirements? to determine these specified than will be
related to
requirements. specified by the R&D
product
Determina
tion of Has the organization identified Documented list of
Improve by adding list of
requireme c) applicable regulatory requirements and documented all applicable regulatory
19 ISO-13485 7.2.1 regulatory bodies and their
nts related to the product; applicable regulatory requirements for the
requirements
related to requirements for the product? product.
product
Determina
Is there a system for
tion of Processes for
monitoring changes in
requireme monitoring and
20 ISO-13485 7.2.1 regulatory requirements and Check in the quality manual
nts updating regulatory
updating internal
related to compliance status.
documentation accordingly?
product
Determina
Has the organization identified
tion of Documented training
d) any user training needed to ensure the training needs for users to
requireme needs assessment Add any training needed in
21 ISO-13485 7.2.1 specified performance and safe use of ensure the specified
nts specific to the the operator manual
the medical device; performance and safe use of
related to medical device.
the medical device?
product
 Determina
Training materials
tion of
What methods are used to (e.g., manuals,
requireme Training Material, traning
22 ISO-13485 7.2.1 develop and deliver user presentations) used
nts programs
training programs? in user training
related to
programs.
product
Determina
tion of Records of training
Is there a process for
requireme sessions, including Add any training needed in
23 ISO-13485 7.2.1 evaluating the effectiveness of
nts attendance and the operator manual
the training provided?
related to feedback.
product
Determina
tion of Evaluation reports
How is the training
requireme showing the Add any training needed in
24 ISO-13485 7.2.1 documented and
nts effectiveness of the operator manual
communicated to users?
related to training programs.
product
Determina
tion of What process is used to
Process used to
requireme e) any additional requirements determine and document
25 ISO-13485 7.2.1 establish these Customer Inquiry Process
nts determined by the organization. these additional
requirements.
related to requirements?
product The organization shall review the The organization shall ensure that it has the ability to meet the
requirements related to product. This requirements for products and
review shall be conducted prior to the services to be offered to customers. The organization shall
organization’s commitment to supply conduct a review before committing to supply
product to the customer (e.g. products and services to a customer, to include:
submission of tenders, acceptance of a) requirements specified by the customer, including the
contracts or orders, acceptance of requirements for delivery and postdelivery
changes to contracts or orders) and activities;
shall ensure that: b) requirements not stated by the customer, but necessary for
a) product requirements are defined the specified or intended use, when
and documented; known;
Review of the
b) contract or order requirements c) requirements specified by the organization;
ISO- requirements for
differing from those previously 8.2.3 d) statutory and regulatory requirements applicable to the
Review of 9001 products and
expressed are resolved; products and services;
requireme services Revies records or Customer Inquiry Procedure
c) applicable regulatory requirements e) contract or order requirements differing from those Sales Are product requirements
26 ISO-13485 7.2.2 nts Signatures by the to be documented,
are met; previously expressed. Process reviewed?
related to reviewers. Customer Inquiry Process
d) any user training identified in The organization shall ensure that contract or order
product
accordance with 7.2.1 is available or requirements differing from those previously
planned to be available; defined are resolved.
e) the organization has the ability to The customer’s requirements shall be confirmed by the
meet the defined requirements. organization before acceptance, when the
Records of the results of the review and customer does not provide a documented statement of their
actions arising from the review shall be requirements.
maintained (see 4.2.5). NOTE In some situations, such as internet sales, a formal review
When the customer provides no is impractical for each order. Instead, the review can cover
The organization shall ensure that relevant documented
documented statement of requirement, Changes to
information is amended, and that relevant
the customer requirements shall be ISO- requirements for
8.2.4 persons are made aware of the changed requirements, when
confirmed by the organization before 9001 products and
the requirements for products and
acceptance. services
services are changed.
When product requirements are Records of reviews
This review shall be conducted prior to conducted before
Review of
the organization’s commitment to Are reviews of product commitments are
requireme Customer Inquiry Procedure
supply product to the customer (e.g. requirements conducted prior made, including
27 ISO-13485 7.2.2 nts to be documented,
submission of tenders, acceptance of to contract acceptance or notes, approvals, or
related to Customer Inquiry Process
contracts or orders, acceptance of changes to contracts/orders? checklists indicating
product
changes to contracts or orders) the review of product
Review of shall ensure that: Are product requirements requirements.
Specifications, Customer Inquiry Procedure
28 ISO-13485 7.2.2 requireme a) product requirements are defined clearly defined and standards, or to be documented,
nts and documented; documented? requirements Customer Inquiry Process
 Records of identified
Review of Are differences between
discrepancies and
requireme b) contract or order requirements contract or order Customer Inquiry Procedure
the resolution
29 ISO-13485 7.2.2 nts differing from those previously requirements and previously to be documented,
process, including
related to expressed are resolved; expressed requirements Customer Inquiry Process
communications and
product documented and resolved?
Review of agreements on
requireme Are all regulatory requiements List of regulatory Customer Inquiry Procedure
c) applicable regulatory requirements
30 ISO-13485 7.2.2 nts met for the product requirements for the to be documented,
are met;
related to requirements? product. Customer Inquiry Process
product
Review of d) any user training identified in Are there documented plans training materials, Customer Inquiry Procedure
31 ISO-13485 7.2.2
requireme accordance with 7.2.1 is available or or schedules for providing registration lists, or to be documented,
Documentation of
resources (e.g.,
Review of equipment,
Are there assessments or
requireme personnel) and Customer Inquiry Procedure
e) the organization has the ability to evaluations in place to verify
32 ISO-13485 7.2.2 nts processes that to be documented,
meet the defined requirements. the organization's ability to
related to ensure the Customer Inquiry Process
fulfill the requirements?
product organization can
meet the defined
Review of requirements,
Records of the results of the review and Are the records of the review Customer Inquiry Procedure
requireme
33 ISO-13485 7.2.2 actions arising from the review shall be and arising actions Maintained records to be documented,
nts
maintained maintained? Customer Inquiry Process
related to Records of
Are customer requirements
Review of When the customer provides no communications or
confirmed through other
requireme documented statement of requirement, informal Customer Inquiry Procedure
means, such as verbal
34 ISO-13485 7.2.2 nts the customer requirements shall be documentation used to be documented,
communication or informal
related to confirmed by the organization before to confirm customer Customer Inquiry Process
documentation, before
product acceptance. requirements, such
accepting the order?
as meeting notes,
Review of When product requirements are Records showing
Are changes to product Customer Inquiry Procedure
requireme changed, the organization shall ensure that relevant
35 ISO-13485 7.2.2 requirements communicated to be documented,
nts that relevant documents are amended personnel were
to relevant personnel? Customer Inquiry Process
related to and that relevant personnel are made notified of the
*Documented
Review of procedures outlining
Is there a process in place for
requireme how changes to Customer Inquiry Procedure
amending documents when
36 ISO-13485 7.2.2 nts product to be documented,
product requirements
related to requirements are Customer Inquiry Process
change?
product managed
The organization shall plan and *Updated versions of
document arrangements for
communicating with customers in Communication with customers shall include:
relation to: a) providing information relating to products and services;
Customer Inquiry Procedure
a) product information; b) handling enquiries, contracts or orders, including changes; Has the organization
Documented to be documented,
Communi b) enquiries, contracts or order ISO- Customer c) obtaining customer feedback relating to products and Sales established and documented
37 ISO-13485 7.2.3 8.2.1 procedure for Customer Inquiry Process,
cation handling, including amendments; 9001 communication services, including customer complaints; Process a procedure for
communication. Post Market-Surveillance
c) customer feedback, including d) handling or controlling customer property; communication ?
Process
complaints; e) establishing specific requirements for contingency actions,
d) advisory notices. when relevant.
The organization shall communicate
with regulatory authorities in Records of
What methods are used for
communications
Communi customer communication
38 ISO-13485 7.2.3 with customers,
cation (e.g., meetings, emails,
including emails,
surveys)?
meeting minutes,
Evaluation reports on
How does the organization
the effectiveness of
Communi ensure that customer Post Market-Surveillance
39 ISO-13485 7.2.3 customer
cation communication is timely and Process
communication
effective?
strategies.
What specific types of product
information are provided (e.g., Samples of product
Communi Post Market-Surveillance
40 ISO-13485 7.2.3 a) product information; specifications, usage information
cation Process
instructions, safety documents
information)?
 How is product information Methods used to
Communi communicated to customers distribute product Distribution of Information
41 ISO-13485 7.2.3
cation (e.g., manuals, websites, information to Procedure missing
labels)? customers.

Does the organization have

Procedures for Customer Inquiry Procedure
Communi b) enquiries, contracts or order documented procedures for
42 ISO-13485 7.2.3 enquiry, contract, to be documented,
cation handling, including amendments; handling customer enquiries,
and order handling. Customer Inquiry Process
contracts, and orders?
Samples of contracts
Is there a process for or order forms, Customer Inquiry Procedure
Communi
43 ISO-13485 7.2.3 managing amendments to including to be documented,
cation
contracts or orders? documentation of Customer Inquiry Process
any amendments.
Has the organization
procedures for
established a documented Customer Complaints
Communi c) customer feedback, including managing customer
44 ISO-13485 7.2.3 process for collecting and Procedure, Post- Market
cation complaints; feedback and
handling customer feedback Surveillance Process
complaints.
and complaints?
How is customer feedback Records of customer Customer Complaints
Communi
45 ISO-13485 7.2.3 tracked and analyzed for feedback received, Procedure, Post- Market
cation
trends or recurring issues? including complaints Surveillance Process
Is there a defined process for Analysis reports
Communi
46 ISO-13485 7.2.3 responding to customer showing trends in Data Analysis Process
cation
complaints? customer feedback
What criteria are used to Records of advisory
Communi Add in customer inquiry
47 ISO-13485 7.2.3 d) advisory notices. determine when an advisory notices issued,
cation procedure
notice is necessary? including the context
Communication logs
Communi How are advisory notices Add in customer inquiry
48 ISO-13485 7.2.3 showing how
cation communicated to customers? procedure
advisory notices
The organization shall communicate What specific regulatory List of regulatory
Communi
49 ISO-13485 7.2.3 with regulatory authorities in requirements dictate the requirements that To be documented
cation
accordance with applicable regulatory communication process? dictate
Is there a record-keeping Records of
Communi system in place for communications
50 ISO-13485 7.2.3 No records
cation communications with with the regulatory
regulatory authorities? authorities.
Design
ISO-
51 ISO-13485 7.3 and
9001
Developm
The organization shall document
procedures to control design and
development changes. The organization
shall determine the significance of the
change to function, performance,
usability, safety and applicable
regulatory requirements for the medical
device and its intended use. Design and The organization shall review and control changes for
Control of development changes shall be
production or service provision, to the extent necessary to Procedure outlines
design identified. Before implementation, the Change Have procedures been
ensure continuing conformity with requirements. the process for
and changes shall be: ISO- Control of Manage documented for controlling Design Change Management
52 ISO-13485 7.3.9 8.5.6 The organization shall retain documented information controlling design
developm 9001 changes ment design and development Process
describing the results of the review of changes, the person(s) and development
ent a) reviewed; Process changes?
authorizing the change, and any necessary actions arising from changes.
changes
the review.
b) verified;

c) validated, as appropriate;

d) approved.

The review of design and development

changes shall include evaluation of the
 Control of The organization shall determine the
Is there a defined Methodology or
design significance of the change to function,
methodology or criteria for criteria for assessing
53 ISO-13485 7.3.9 and performance, usability, safety and CAR/CCR System
assessing the impact of the impact of
developm applicable regulatory requirements for
changes? changes
ent of
Control the medical device and its intended
design Are risk management
and activities conducted to assess
54 ISO-13485 7.3.9 risk assessment CAR/CCR System
developm potential risks associated with
ent proposed changes?
changesof
Control
process for
design
Are changes classified based identifying and
55 ISO-13485 7.3.9 and CAR/CCR System
on their nature ? documenting
developm
proposed changes
ent Design and development changes shall
Control of
be identified. Before implementation, Are reviews conducted by Reviewers include
design
the changes shall be: appropriate personnel to personnel with List of document codes, for
and
56 ISO-13485 7.3.9 a) reviewed; evaluate the impact on design appropriate improvement roles and
developm
b) verified; inputs, requirements, and expertise and responsibility matrix
ent
c) validated, as appropriate; other aspects? responsibilities.
changes
Control of d) approved.
design Are changes verified to ensure
and they are implemented
57 ISO-13485 7.3.9 Verification methods CAR/CCR System
developm correctly and achieve their
ent intended purpose?
changes
Control of For significant changes
design affecting product
and performance or regulatory
58 ISO-13485 7.3.9 Validation activities CAR/CCR System
developm compliance, is there a
ent validation process in place?
changes (revalidation)
Control of
Are responsibilities assigned
design
for approving changes based Hierarchy of
59 ISO-13485 7.3.9 and CAR/CCR System
on their impact and approvals
developm
significance?
ent of
Control The review of design and development
design changes shall include evaluation of the
Are changes assessed for
and effect of the changes on constituent Compatibility need to research if bio
60 ISO-13485 7.3.9 compatibility with existing
developm parts and product in process or already assessments compatibility is needed
components and materials?
ent delivered, inputs or outputs of risk
changesof
Control management and product realization Assessment
design Is there an assessment of how considering how Need to add in the car
and proposed changes affect proposed changes system if the changes will
61 ISO-13485 7.3.9
developm products that are currently inaffect products affect work standard in the
ent the manufacturing process? currently in the manufacturing of the device
changesof
Control manufacturing
Considerations for
design Are considerations made for
products already Add status of products in
62 ISO-13485 7.3.9 and products already delivered to
delivered are servicing procedure
developm customers?
documented.
ent
Control of
Purchasin ISO-
63 ISO-13485 7.4 8.4 externally
g 9001
provided
 The organization shall document
procedures (see 4.2.4) to ensure that
purchased product conforms to
The organization shall ensure that externally provided
specified purchasing information. The
processes, products and services conform to requirements.
organization shall establish criteria for
The organization shall determine the controls to be applied to
the evaluation and selection of
externally provided processes, products and services when:
suppliers. The criteria shall be:
a) products and services from external providers are intended
for incorporation into the organization’s own products and
a) based on the supplier’s ability to
services;
provide product that meets the
b) products and services are provided directly to the
organization’s requirements;
ISO- customer(s) by external providers on behalf of the organization;
8.4.1 General
9001 c) a process, or part of a process, is provided by an external
b) based on the performance of the
provider as a result of a decision by the organization.
supplier;
The organization shall determine and apply criteria for the
evaluation, selection, monitoring of
c) based on the effect of the purchased
performance, and re-evaluation of external providers, based on
product on the quality of the medical
their ability to provide processes or products and services in
device;
accordance with requirements. The organization shall retain
documented information of these activities and any necessary
d) proportionate to the risk associated Purchasi Has the organization Documented
Purchasin actions arising from the evaluations.
64 ISO-13485 7.4.1 with the medical device. The ng documented a procedures for procedure for
g Process
organization shall plan the monitoring Process purchasing ? purchasing
and re-evaluation of suppliers. Supplier
performance in meeting requirements The organization shall ensure that externally provided
for the purchased product shall be processes, products and services do not
monitored. The results of the monitoring adversely affect the organization’s ability to consistently deliver
shall provide an input into the supplier conforming products and services to
re-evaluation process. its customers.
The organization shall:
Non-fulfilment of purchasing a) ensure that externally provided processes remain within the
requirements shall be addressed with control of its quality management
the supplier proportionate to the risk ISO- Type and extent system;
8.4.2
associated with the purchased product 9001 of control b) define both the controls that it intends to apply to an external
and compliance with applicable provider and those it intends to apply to the resulting output;
regulatory requirements. c) take into consideration:
1) the potential impact of the externally provided processes,
Records of the results of evaluation, products and services on the
selection, monitoring and re-evaluation organization’s ability to consistently meet customer and
of supplier capability or performance applicable statutory and regulatory
and any necessary actions arising from requirements;
these activities shall be maintained 2) the effectiveness of the controls applied by the external

How does the organization

Purchasin ensure that the purchased Methods to ensure
65 ISO-13485 7.4.1
g Process product conform to specified the conformity.
purchasing information.
The organization shall establish criteria
for the evaluation and selection of Established criteria
suppliers. The criteria shall be: Have criteria been established based on the
Purchasin
66 ISO-13485 7.4.1 for the evaluation and organizational and
g Process
a) based on the supplier’s ability to selection of suppliers? regulatory
provide product that meets the requirements.
organization’s requirements;
What are the methods used to
Supplier
Purchasin determine the suppliers ability
67 ISO-13485 7.4.1 Qualification
g Process to meet organization's
Records
requirements ?
Are the criteria based on the
Purchasin b) based on the performance of the supplier’s performance, Supplier
68 ISO-13485 7.4.1
g Process supplier; including quality, delivery, and Performance Metrics
reliability metrics?
c) based on the effect of the purchased Are risk assessments Records of risk
Purchasin
69 ISO-13485 7.4.1 product on the quality of the medical conducted for purchased assessments for
g Process
device; products? purchased products.
 risk assessments
Are higher-risk products
Purchasin d) proportionate to the risk associated categorizing
70 ISO-13485 7.4.1 subject to more stringent
g Process with the medical device. products by risk
supplier evaluations?
level.
A documented plan
The organization shall plan the Is there a documented plan for outlining the process
Purchasin
71 ISO-13485 7.4.1 monitoring and re-evaluation of the monitoring and re- and frequency of
g Process
suppliers. evaluation of suppliers? supplier monitoring
and re-evaluation.
Clearly defined and
Supplier performance in meeting tracked metrics for
Purchasin Are metrics for supplier
72 ISO-13485 7.4.1 requirements for the purchased supplier
g Process performance clearly defined
product shall be monitored. performance (e.g.,
and tracked?
defect rates,
Records of delivery
Are corrective actions taken corrective actions
Purchasin
73 ISO-13485 7.4.1 when supplier performance taken when supplier
g Process
does not meet requirements? performance falls
short of from
Reports
The results of the monitoring shall Are decisions made during re- supplier re-
Purchasin
74 ISO-13485 7.4.1 provide an input into the supplier re- evaluation based on the evaluations that
g Process
evaluation process. monitoring results? reference monitoring
Non-fulfilment of purchasing results and inform
Documentation of
Are non-fulfilments of
requirements shall be addressed with non-fulfilments
purchasing requirements
Purchasin the supplier proportionate to the risk addressed with
75 ISO-13485 7.4.1 addressed in relation to the
g Process associated with the purchased product suppliers, including
risk level of the purchased
and compliance with applicable risk assessment and
product?
regulatory requirements. regulatory
Records of
Are actions taken for non- corrective actions
Purchasin fulfilments documented and taken, showing
76 ISO-13485 7.4.1
g Process proportionate to the impact on alignment with the
regulatory compliance? risk associated with
the product
Evidence and
of actions
Is there evidence that
taken to ensure that
corrective actions are
Purchasin non-fulfilments meet
77 ISO-13485 7.4.1 implemented in accordance
g Process applicable regulatory
with the risk and regulatory
requirements and
requirements?
Records of the results of evaluation, are proportionate to
selection, monitoring and re-evaluation
Purchasin Are records maintained for the
78 ISO-13485 7.4.1 of supplier capability or performance Documented records
g Process mentioned specifications ?
and any necessary actions arising from
these activities
Purchasing shall be shall
information maintained
describe
or reference the product to be
purchased, including as appropriate:

a) product specifications; The organization shall ensure the adequacy of requirements

prior to their communication to the
b) requirements for product external provider.
acceptance, procedures, processes The organization shall communicate to external providers its
and equipment; requirements for:
a) the processes, products and services to be provided;
c) requirements for qualification of b) the approval of:
Purchasin Purchase orders or
supplier personnel; Information for 1) products and services; Purchasi Is there a reference or a clear
g ISO- contracts that
65 ISO-13485 7.4.2 8.4.3 external 2) methods, processes and equipment; ng description to the product in
Informatio 9001 include Product
d) quality management system providers 3) the release of products and services; Process the purchasing information?
n details.
requirements. c) competence, including any required qualification of persons;
d) the external providers’ interactions with the organization;
The organization shall ensure the e) control and monitoring of the external providers’ performance
adequacy of specified purchasing to be applied by the organization;
requirements prior to their f) verification or validation activities that the organization, or its
communication to the supplier. customer, intends to perform at the external providers’
premises.
Purchasing information shall include,
as applicable, a written agreement that
the supplier notify the organization of
changes in the purchased product prior
 Purchase orders or
Purchasin
including as appropriate: Are the product specs contracts that
g
66 ISO-13485 7.4.2 mentioned with the include detailed
Informatio
a) product specifications; purchasing information. descriptions or
n
references to the
Purchasin Does the purchasing Purchase orders or
b) requirements for product
g information include contracts that
67 ISO-13485 7.4.2 acceptance, procedures, processes
Informatio requirements for product specify acceptance
and equipment;
n acceptance? criteria
Documentation
Are procedures, processes,
Purchasin outlining the
and equipment related to
g procedures and
68 ISO-13485 7.4.2 product acceptance
Informatio processes for
referenced in the purchasing
n product acceptance,
information?
including
Agreements equipment
or
Are there documented contracts that detail
Purchasin
procedures detailing how the requirements for
g
69 ISO-13485 7.4.2 product acceptance product acceptance
Informatio
requirements are and reference the
n
communicated to suppliers? associated
procedures,
Documents
Purchasin Are there documented criteria
specifying the
g c) requirements for qualification of or standards for the
70 ISO-13485 7.4.2 qualifications
Informatio supplier personnel; qualification of personnel that
required for supplier
n suppliers must meet?
personnel involved
Documentation thatin
details the quality
Purchasin Are there documented
management system
g d) quality management system standards or guidelines for the
71 ISO-13485 7.4.2 requirements,
Informatio requirements. QMS that the supplier must
including relevant
n adhere to?
standards or
guidelines the
Purchasin The organization shall ensure the Are purchasing requirements Methods for
g adequacy of specified purchasing validated for completeness validation for
72 ISO-13485 7.4.2
Informatio requirements prior to their and accuracy before sending completeness such
n communication to the supplier. to suppliers? as validation reports.
Written agreements
Purchasing information shall include,
Does the purchasing specifying that
as applicable, a written agreement that
information include a written suppliers must
Purchasin the supplier notify the organization of
agreement requiring the inform the
g changes in the purchased product prior
73 ISO-13485 7.4.2 supplier to notify the organization of any
Informatio to implementation of any changes that
organization of any changes to changes that could
n affect the ability of the purchased
the purchased product prior to affect the product’s
product to meet specified purchase
their implementation? ability to meet
requirements.
specifiedof
Records
To the extent required for traceability
Purchasin purchasing
given in 7.5.9, the organization shall
g Are records of purchasing information
74 ISO-13485 7.4.2 maintain relevant purchasing
Informatio information maintained? maintained
information in the form of documents
n according to the
(see 4.2.4) and records (see 4.2.5).
The organization shall ensure that externally provided organization’s
processes, products and services do not
adversely affect the organization’s ability to consistently deliver
conforming products and services to
its customers.
The organization shall:
a) ensure that externally provided processes remain within the
control of its quality management
ISO- Type and extent system;
8.4.2
9001 of control b) define both the controls that it intends to apply to an external
provider and those it intends to apply
The organization shall establish and to the resulting output;
implement the inspection or other c) take into consideration:
activities necessary for ensuring that 1) the potential impact of the externally provided processes,
purchased product meets specified products and services on the
purchasing requirements. The extent of organization’s ability to consistently meet customer and
verification activities shall be based on applicable statutory and regulatory
the supplier evaluation results and requirements;
 the supplier evaluation results and
The organization shall ensure the adequacy of requirements
proportionate to the risks associated
prior to their communication to the
with the purchased product.
external provider.
The organization shall communicate to external providers its Has the organization
Verificatio When the organization becomes aware
requirements for: established procedures for
n of of any changes to the purchased Purchasi
a) the processes, products and services to be provided; inspecting purchased Inspection
75 ISO-13485 7.4.3 Purchase product, the organization shall ng
Information for b) the approval of: products to ensure they meet procedure.
d determine whether these changes ISO- Process
8.4.3 external 1) products and services; specified purchasing
Product affect the product realization process or 9001
providers 2) methods, processes and equipment; requirements?
the medical device. When the
3) the release of products and services;
organization or its customer intends to
c) competence, including any required qualification of persons;
perform verification at the supplier’s
d) the external providers’ interactions with the organization;
premises, the organization shall state
e) control and monitoring of the external providers’ performance
the intended verification activities and
to be applied by the organization;
method of product release in the
f) verification or validation activities that the organization, or its
purchasing information.
The organization shall implement planned arrangements, at
Records of the verification shall be appropriate stages, to verify that the
maintained (see 4.2.5). product and service requirements have been met.
The release of products and services to the customer shall not
proceed until the planned arrangements
Release of have been satisfactorily completed, unless otherwise approved
ISO-
8.6 products and by a relevant authority and, as
9001
services applicable, by the customer.
The organization shall retain documented information on the
release of products and services. The
documented information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.

Verificatio Are there records showing that

The extent of verification activities shall
n of verification activities are Risk/Supplier
be based on the supplier evaluation
76 ISO-13485 7.4.3 Purchase adjusted based on supplier evaluation-Based
results and proportionate to the risks
d performance and product Verification Records
associated with the purchased product.
Product risk?
Verificatio When the organization becomes aware Is there a process in place to Documented
n of of any changes to the purchased assess the impact of changes procedures outlining
77 ISO-13485 7.4.3
Purchase product, the organization shall to purchased products on the how changes to
d determine whether these changes product realization process or purchased products
Verificatio Are assessments conducted
Records of
78 ISO-13485 7.4.3 n of when changes to purchased
assessments
Purchase products are identified?
Verificatio When the organization or its customer Is the intention to perform Purchase orders or
79 ISO-13485 7.4.3 n of intends to perform verification at the verification at the supplier’s contracts that
Purchase
Verificatio supplier’s premises, the organization premises
Are clearlyverification
the specific stated in the explicitly state
Purchase ordersthe
or
n of activities and methods of contracts that
80 ISO-13485 7.4.3
Purchase product release described in contain detailed
d the purchasing descriptions of the
Verificatio
Records of the verification shall be Are the records of verification Records of
81 ISO-13485 7.4.3 n of
maintained (see 4.2.5). maintained? verification.
Purchase
Productio
ISO- Production and
82 ISO-13485 7.5 n and 8.5
9001 service provision
service
 -Production and service provision shall The organization shall implement production and service
be planned, carried out, monitored and provision under controlled conditions.
controlled to ensure that product Controlled conditions shall include, as applicable:
Pre-
conforms to specification. As a) the availability of documented information that defines:
Assembly
appropriate, production controls shall 1) the characteristics of the products to be produced, the
Process
include but are not limited to: services to be provided, or the activities
Assembly
a) documentation of procedures and to be performed;
Process
methods for the control of production 2) the results to be achieved;
Calibrati Approved work
Control of (see 4.2.4); b) the availability and use of suitable monitoring and measuring
on instructions, training
productio b) qualification of infrastructure; Control of resources; Are work instructions
ISO- Process records, and
83 ISO-13485 7.5.1 n and c) implementation of monitoring and 8.5.1 production and c) the implementation of monitoring and measurement available and accessible to OMS
9001 Performa acknowledgment of
service measurement of process parameters service provision activities at appropriate stages to verify that relevant personnel?
nce personnel access to
provision and product characteristics; criteria for control of processes or outputs, and acceptance
Testing procedures
d) availability and use of monitoring and criteria for products and services,
Process
measuring equipment; have been met;
Labeling
e) implementation of defined d) the use of suitable infrastructure and environment for the
and
operations for labelling and packaging; operation of processes;
Packagin
f) implementation of product release, e) the appointment of competent persons, including any
g Process
delivery and post-delivery activities. required qualification;
-The organization shall establish and f) the validation, and periodic revalidation, of the ability to
maintain a record (see 4.2.5) for each achieve planned results of the processes
Approved production
control procedures
and work
Are documented procedures instructions
a) documentation of procedures and
and methods established for Documented
ISO-13485 7.5.1 methods for the control of production OMS
controlling production methods detailing
(see 4.2.4);
processes? process steps,
controls, and
acceptance criteria
Version-controlled
Infrastructure
qualification
protocols and
reports (e.g., IQ, OQ,
PQ for equipment
and facilities)
Environmental
Has the infrastructure used
monitoring records
for production been qualified
ISO-13485 7.5.1 b) qualification of infrastructure (if applicable) TAB Assessments
to ensure it meets required
Preventive
specifications?
maintenance and
calibration records
for production
equipment
Facility layout plans
demonstrating
compliance
Documentedwith
procedures for
process monitoring
and measurement
Process control
plans defining
Are process parameters and critical process
c) implementation of monitoring and
product characteristics parameters and
ISO-13485 7.5.1 measurement of process parameters OMS
monitored and measured to acceptance criteria
and product characteristics;
ensure conformity? Records of in-
process and final
product inspections
(Test Method)
Calibration records
of measuring
instruments used for
 Inventory list of
monitoring and
measuring
Need intermediate checks
equipment used in
Is monitoring and measuring for equipments add in
production OMS ( difference betweeen
d) availability and use of monitoring and equipment available and used procedure and process.
ISO-13485 7.5.1 Calibration and equipment list and measuring
measuring equipment; appropriately to ensure
maintenance tool)
product conformity? Trainning record of
records of measuring
measuring tools.
instruments
Equipment
qualification reports
Approved
procedures and work
instructions for
labeling and
packaging processes
Label design and
Are labeling and packaging
approval records, Packaging and labeling
e) implementation of defined operations defined,
ISO-13485 7.5.1 ensuring compliance procedure, process,
operations for labelling and packaging; controlled, and implemented
with regulatory Technical File
to ensure product conformity?
requirements
Verification records
confirming correct
labeling (e.g.,
barcode scanning,
visual inspection)
Documented
product release
procedures
Are defined procedures Batch/lot release
f) implementation of product release, implemented to ensure that records with
ISO-13485 7.5.1
delivery and post-delivery activities only conforming products are approval signatures
released? Final inspection and
test records
Certificates of
Conformance (CoC)
Documented
procedures for
product handling,
Procedure of handling,
Are delivery processes storage, and
warehouse and distribution,
controlled to maintain product transportation
processes, No records of
integrity and traceability? Shipping records
shipping
with traceability
(e.g., tracking
numbers, lot
Procedures for post-
market surveillance
and customer
Are post-delivery activities, complaint handling
including customer feedback Complaint records Post Market-Surveillance
and complaint handling, and trend analysis Process
implemented? reports
Returned product
investigation reports
Records of
 Documented
procedures for batch
record management
The organization shall establish and and traceability
Does the organization OMS ( Data can be traced back
maintain a record (see 4.2.5) for each Batch manufacturing
maintain records for each to each device, Work order, work
medical device or batch of medical records (BMR) or
medical device or batch, instruction, QC and validation of
devices that provides traceability to the Device History
ISO-13485 7.5.1 ensuring traceability and the last test conducted, who
extent specified in 7.5.9 and identifies Records (DHR)
documenting the amount conducted the assembly
the amount manufactured and amount containing:
manufactured and approved process, when and duration
approved for distribution. The record Lot/batch number
for distribution? conducting the operation)
shall be verified and approved. Amount
manufactured
Amount approved for
-The organization shall document distribution
requirements for cleanliness of product
or contamination control of
product if:
a) product is cleaned by the
organization prior to sterilization or its
Cleanline
Cleanline use;
ISO- ss of
15 ISO-13485 7.5.2 ss of b) product is supplied non-sterile and is No Clauses Instruction for use
9001 Product
product to be subjected to a cleaning process
Process
prior to sterilization or its use;
c) product cannot be cleaned prior to
sterilization or its use, and its
cleanliness is of significance in use;
d) product is supplied to be used non-
sterile, and its cleanliness
-The organization is of
shall document
requirements for medical device
installation and acceptance criteria for
verification of installation, as Operator
Installatio
appropriate. ISO- Manual
16 ISO-13485 7.5.3 n No Clauses Operator Manual
-If the agreed customer requirements 9001 Creation
activities
allow installation of the medical device process
to be performed by an external party
other than the organization or its
supplier, theof
-If servicing organization
the medicalshall provide
device is a
specified requirement, the organization
shall document servicing
procedures, reference materials, and
reference measurements, as
necessary, for performing servicing
activities and verifying that product
Servicing requirements are met. ISO- Servicing
17 ISO-13485 7.5.4 No Clauses Servicing procedure
activities -The organization shall analyse records 9001 Process
of servicing activities carried out by the
organization or its
supplier:
a) to determine if the information is to
be handled as a complaint;
b) as appropriate, for input to the
improvement process.
 -The organization shall validate any The organization shall implement production and service
processes for production and service provision under controlled conditions.
provision where the resulting output Controlled conditions shall include, as applicable:
cannot be or is not verified by a) the availability of documented information that defines:
subsequent monitoring or 1) the characteristics of the products to be produced, the
measurement and, as a consequence, services to be provided, or the activities
deficiencies become apparent only to be performed;
after the product is in use or the service 2) the results to be achieved;
has been delivered. b) the availability and use of suitable monitoring and measuring
-Validation shall demonstrate the resources; List of the processes
Validation
ability of these processes to achieve c) the implementation of monitoring and measurement identified as
of
planned results consistently. activities at appropriate stages to verify that What processes require requiring validation, Process for validation of
processes
-The organization shall document Control of criteria for control of processes or outputs, and acceptance validation because their including rationale processes (mentioning
for ISO- Vigilance
19 ISO-13485 7.5.6 procedures for validation of processes, 8.5.1 production and criteria for products and services, output cannot be verified by for why their output either appearing in the
productio 9001 Process
including: service provision have been met; subsequent monitoring or cannot be verified by servicing activity or in the
n and
a) defined criteria for review and d) the use of suitable infrastructure and environment for the measurement? subsequent post market surveillance)
service
approval of the processes; operation of processes; monitoring or
provision
b) equipment qualification and e) the appointment of competent persons, including any measurement.
qualification of personnel; required qualification;
c) use of specific methods, procedures f) the validation, and periodic revalidation, of the ability to
and acceptance criteria; achieve planned results of the processes
d) as appropriate, statistical techniques for production and service provision, where the resulting output
with rationale for sample sizes; cannot be verified by subsequent
e) requirements for records (see 4.2.5); monitoring or measurement;
f) revalidation, including criteria for g) the implementation of actions to prevent human error;
revalidation; h) the implementation of release, delivery and post-delivery
Validation g) approval of changes to the activities.
Is there evidence that
of
deficiencies in these
processes *Examples of Past
processes would only become Risk Evaluation in Process
ISO-13485 7.5.6 for Deficiencies
apparent after the product is for validation of processes
productio *Risk Assessments
in use or the service has been
n and
delivered?
service
Validation Is there a documented plan for
ISO-13485 7.5.6 of validating these identified Validation procedure Validation of Processes
processes processes?
Validation Reports showing the
What documentation or
of results of the
records do you maintain to
processes Validation shall demonstrate the ability validation activities,
demonstrate that process
ISO-13485 7.5.6 for of these processes to achieve planned such as: OMS (QC and KPI's)
validation has been
productio results consistently. *Test Data: Evidence
successful in achieving
n and from tests or trials
planned results?
service that verify the
Validation
of What criteria do you establish
ISO-13485 7.5.6 processes to define the planned results Quality Metrics, …. OMS (Quality Plan)
for for process validation?
productio
Validation What actions are taken if
ISO-13485 7.5.6 of validation results indicate that Corrective Actions CAR/CCR System
processes processes are not consistently
Validation What procedures do you have
The organization shall document
ISO-13485 7.5.6 of documented for the validation Validation procedure Validation of Processes
procedures for validation of processes
processes of processes? Validation process
Validation
containing:
of
*Review/Approval
processes Does the plan/procedure for
including: matrix
for validating these processes
ISO-13485 7.5.6 a) defined criteria for review and *Tests and Methods Validation of Processes
productio include defined criteria for
approval of the processes; for Review and
n and review and approval?
Approval, such as:
service
Installation
provision
Validation What are the equipment Qualification
List of required
b) equipment qualification and
ISO-13485 7.5.6 of qulaifications required for the equpment
qualification of personnel;
processes validation processes? qualifications.
 Validation *Calibration
of How to maintain the certificates
Calibration Certificates,
ISO-13485 7.5.6 processes conformity of these *Schedueled
Intermediate Checks
for qualifications? assessments and
productio maintenance.
Validation Detailed job
What are the Personnel
of descriptions
ISO-13485 7.5.6 qulaifications required for the
processes outlining the
validation processes?
for responsibilities and
Validation *Training Records
of *Competency
How to maintain the
processes assessments, this
ISO-13485 7.5.6 conformity of these
for can include tests,
qualifications?
productio practical
n and
Validation evaluations, and
Which specific methods used *Methods
c) use of specific methods, procedures
ISO-13485 7.5.6 of for process validation are Documentation OMS
and acceptance criteria;
processes
Validation documented? *Method
Procedures Selection
outlining
What are the procedures used
of the steps and
ISO-13485 7.5.6 for conducting the process OMS
processes requirements for
validation?
for conducting the
Validation Performance
What acceptance criteria are
ISO-13485 7.5.6 of Standards, Quality
used?
processes Metrics, Pass/Fail
Validation How to determine the Regulatory and
ISO-13485 7.5.6 of acceptance criteria for the Standard
processes process validation? Requirements.
Validation What statistical techniques do Types of Statistical
d) as appropriate, statistical techniques
ISO-13485 7.5.6 of you use, if applicable, for Tests: Specific tests Process for Sample size
with rationale for sample sizes;
processes process validation? and methods used
*Explanation of the
Validation statistical basis for
of determining sample
processes sizes (e.g.,
What rationale do you provide
for confidence intervals,
ISO-13485 7.5.6 for the sample sizes chosen in
productio power analysis,
your process validation?
n and population
service variability)
provision *Reference to any
Validation What information do your relevant regulatory or
of records contain to
ISO-13485 7.5.6 e) requirements for records (see 4.2.5); Records' contents
processes demonstrate compliance with
for process validation
Validation What methods do you use to Unique
ISO-13485 7.5.6 of ensure the integrity and Identification,
processes traceability of records related Version Control, …....
Validation
of
processes Are there documented
f) revalidation, including criteria for Revalidation
ISO-13485 7.5.6 for procedures for conducting CAR/CCR System
revalidation; Procedure
productio revalidation?
n and
service
Validation Detailed
of documentation
Has the organization
processes specifying the
established and documented
ISO-13485 7.5.6 for criteria that trigger
criteria for revalidation of
productio revalidation, such
processes?
n and as:
service
Validation Does the organization have a *Scheduled
of g) approval of changes to the documented procedure for Change Control
ISO-13485 7.5.6 Responsibility Matrix
processes processes. managing and approving Procedure
for changes to processes?
 Validation Change Request
of Forms, including:
processes *Description of
How are the changes
ISO-13485 7.5.6 for Change
handled?
productio *Rationale
n and *Impact
service Assessment.
Validation Are all changes to processes Sigantures on the
ISO-13485 7.5.6 of reviewed and approved before Change request
processes implementation? form, …......
Validation
What procedures are
of The organization shall document CAR/CCR System
documented for the validation Computer Software
processes procedures for the validation of the OMS
ISO-13485 7.5.6 of computer software used in Validation
for application of computer software used ERA
production and service procedure.
productio in production and service provision. ERP
provision?
n and
Validation
of What are the computer List of computer
ISO-13485 7.5.6
processes softwares used? softwares.
for
Validation Description of
of specific methods
processes and approaches
Which methods are used for
for used for software
ISO-13485 7.5.6 the computer software
productio validation, including:
validation?
n and *Test types, such as:
service (e.g., unit tests,
provision
Validation integration tests,
of Such software applications shall be CAR/CCR System
*Licenses
processes validated prior to initial use and, as what are the evidences used OMS
ISO-13485 7.5.6 *Test reports
for appropriate, after changes to such to ensure the validation? ERA
etc…..
productio software or its application. ERP
n and
Validation Is there a documented Revalidation for
ISO-13485 7.5.6 of procedure for re-validating computer software
processes software applications after procedure.
Validation Are records available showing
Change Request
ISO-13485 7.5.6 of re-validation activities for
Forms
processes software following changes?
Validation The specific approach and activities
CAR/CCR System
of associated with software validation and
Is a risk assessment Risk Assessment OMS
ISO-13485 7.5.6 processes revalidation shall be proportionate to
performed for the software? Document ERA
for the risk associated with the use of the
ERP
productio software, including the effect on the
Validation Tailored based on
Are re-/validation activities
ISO-13485 7.5.6 of risk level (high,
scaled according to risk?
processes medium, low).
-The organization shall document
procedures for product identification
The organization shall use suitable means to identify outputs
and identify product by suitable means
when it is necessary to ensure the
throughout product realization.
conformity of products and services.
-The organization shall identify product Decvice
The organization shall identify the status of outputs with respect
status with respect to monitoring and Unique Is there a documented
Identificat ISO- Identification and to monitoring and measurement Identification Unique Identification
21 ISO-13485 7.5.8 measurement requirements throughout 8.5.2 Identifica procedure for product
ion 9001 traceability requirements throughout production and service provision. procedure Process, Labeling procedure
product realization. Identification of tion identification?
The organization shall control the unique identification of the
product status shall be maintained Process
outputs when traceability is a
throughout production, storage,
requirement, and shall retain the documented information
installation and servicing of product to
necessary to enable traceability.
ensure that only product that has
passed the required inspections and
Steps for tracking
OMS ( Data can be traced back
product status, such
to each device, Work order, work
The organization shall identify product How is the Product status as:
instruction, QC and validation of
Identificat status with respect to monitoring and identified and Is it tracked *In Design and
ISO-13485 7.5.8 the last test conducted, who
ion measurement requirements throughout throughout the realization Development
conducted the assembly
product realization. process? *In Production
process, when and duration
*In Inspection
conducting the operation)
*In testing
 Are monitoring and *Pending OMS ( Data can be traced back
Identificat
ISO-13485 7.5.8 measurement requirements Inspection/Testing to each device, Work order, work
ion
specified for product status? *Validated instruction, QC and validation of
Identification of product status shall be
Records showing
maintained throughout production,
Are product statuses tracked product status at
storage, installation and servicing of
Identificat to ensure only products that each stage to ensure OMS
ISO-13485 7.5.8 product to ensure that only product that
ion passed inspections and tests compliance with PMS
has passed the required inspections
are dispatched or used? inspection and test
and tests or released under an
requirements.
authorized concession is dispatched, *Non-Conformance
impact, such as:
Minor cosmetic
defects that do not
affect functionality.
*Risk Assessment;
Evaluate the risk
Identificat Is there a criteria for issuing
ISO-13485 7.5.8 associated with the
ion authorized concessions?
non-conformance
and its impact on
safety, performance,
and reliability.
*Ensure that issuing
a concession will not
violate regulatory
*Concession
request forms
containing the
justification.
Identificat How are authorized
ISO-13485 7.5.8 *Approval process
ion concessions handled?
for concessions,
including signatures
from authorized
personnel.
Unique Device
If required by applicable regulatory Identification System
Is there a documented system
requirements, the organization shall Procedure,
Identificat for assigning unique device Unique Identification
ISO-13485 7.5.8 document a system to assign unique containing
ion identification (UDI) to medical Process,
device identification to the medical description of the
devices?
device. UDI system, and
methods for
Does the UDI system comply Evidence that the
Identificat
ISO-13485 7.5.8 with applicable regulatory UDI system meets
ion
requirements? applicable
The organization shall document Is there a documented Steps for receiving,
Identificat
ISO-13485 7.5.8 procedures to ensure that medical procedure for handling identifying, and
ion
devices returned to the organization are returned medical devices? segregating returned
Methods used to tag
Does the procedure include
or mark returned
methods for identifying and
Identificat devices to OMS
ISO-13485 7.5.8 distinguishing returned
ion differentiate them PMS
devices from conforming
from conforming
products?
products.
Process for
inspecting and
evaluating the
Is there a process for
Identificat condition of returned
ISO-13485 7.5.8 assessing and addressing the
ion devices; checklist or
condition of returned devices?
form used to assess
the condition of
returned devices,
ISO- Identification and
22 ISO-13485 7.5.9 Tracebility 8.5.2
9001 traceability
The organization shall document The organization shall use suitable means to identify outputs
procedures for traceability. These when it is necessary to ensure the
procedures shall define the extent conformity of products and services.
ISO- Identification and
23 ISO-13485 7.5.9.1 General of traceability in accordance with 8.5.2 The organization shall identify the status of outputs with respect QMS
9001 traceability
applicable regulatory requirements and to monitoring and measurement
the records to be maintained requirements throughout production and service provision.
(see 4.2.5 The organization shall control the unique identification of the
 The organization shall identify, verify, The organization shall exercise care with property belonging to
protect, and safeguard customer customers or external providers while it is under the
property provided for use or organization’s control or being used by the organization.
incorporation into the product while it is Property The organization shall identify, verify, protect and safeguard
under the organization’s control or belonging to customers’ or external providers’ property provided for use or Is there a documented Procedure for
Customer ISO-
25 ISO-13485 7.5.10 being used by the organization. If any 8.5.3 customers or incorporation into the products and services. N/A procedure for handling handling Customer
property 9001
customer property is lost, damaged or external When the property of a customer or external provider is lost, customer property? Property.
otherwise found to be unsuitable for providers damaged or otherwise found to be
use, the organization shall report this to unsuitable for use, the organization shall report this to the
the customer and maintain records (see customer or external provider and retain documented
4.2.5) information on what has occurred.
Security protocols,
Are there measures in place to
storage conditions,
protect and safeguard
Customer and access controls
ISO-13485 7.5.10 customer property while
property to ensure customer
under the organization's
property is
control?
If any customer property is lost, protected.
Emails or letters sent
Are records maintained for
damaged or otherwise found to be to customers
Customer incidents involving customer
ISO-13485 7.5.10 unsuitable for use, the organization informing them of
property property that is lost, damaged,
shall report this to the customer and the incident and
or unsuitable?
maintain records proposed
An internalsolutions
tracking
system or
Is there a process for
Customer spreadsheet used to
ISO-13485 7.5.10 documenting and tracking
property monitor the status of
these incidents?
reported incidents
The organization shall document Raw and ensure
procedures for preserving the Material
conformity of product to requirements Warehou
during processing, storage, handling, se
and distribution. Preservation shall Process
apply to the constituent parts The organization shall preserve the outputs during production Finished Are there documented
of a medical device. and service provision, to the extent Goods procedures for preserving Written procedures Procedure for warehouse,
Preservati
ISO- necessary to ensure conformity to requirements. Warehou product conformity detailing how handing and distribution,
26 ISO-13485 7.5.11 on of 8.5.4 Preservation
The organization shall protect product 9001 NOTE Preservation can include identification, handling, se throughout processing, product conformity need to add product
product
from alteration, contamination or contamination control, packaging, storage, transmission or Process storage, handling, and is preserved conformity requirement
damage when exposed to transportation, and protection. Material distribution?
expected conditions and hazards during Inspectio
processing, storage, handling, and n
distribution by: Process
a) designing and constructing suitable Material
packaging and shipping containers; Preperati Records showing
Do these procedures how each
risk requirement for
Preservati Preservation shall apply to the constituent specifically address the constituent part is
packaging, storing and
ISO-13485 7.5.11 on of parts preservation of each preserved, including
handling each medical
product of a medical device. constituent part of the handling
device
medical device? instructions, storage
conditions, and
Documented
Do the documented
procedures outlining
The organization shall protect product from procedure mention how to
how to protect
Preservati alteration, contamination or damage when protect products from
products from
ISO-13485 7.5.11 on of exposed to expected conditions and alteration, contamination, or
alteration,
product hazards during processing, storage, damage during processing,
handling, and distribution contamination, or
storage, handling, and
damage, including
distribution?
controls for
Records of handling
assessments
Do the procedures address
Preservati identifying expected
specific expected conditions
ISO-13485 7.5.11 on of conditions and
and hazards that could affect
product hazards, and how
the product?
protective measures
are implemented to
 Records such as
inspection logs,
condition reports, or
Preservati Are records maintained that
maintenance
ISO-13485 7.5.11 on of demonstrate the effectiveness
records
product of these protective measures?
demonstrating
adherence to
protective measures
Documented
procedures for
Are there documented
designing and
Preservati by: procedures for designing and
constructing
ISO-13485 7.5.11 on of a) designing and constructing suitable constructing packaging and
packaging and
product packaging and shipping containers; shipping containers suitable
shipping containers,
for protecting the product?
detailing materials,
construction or
Specifications
Do the packaging and shipping drawings of the
container designs address packaging and
Preservati
specific needs related to the shipping containers
ISO-13485 7.5.11 on of
product’s protection during showing how they
product
processing, storage, handling, are designed to
and distribution? protect the product
from alteration,
Records of testing or
validation of
Are there records of the design
packaging and
Preservati and construction processes
shipping containers
ISO-13485 7.5.11 on of for packaging and shipping
to ensure they meet
product containers, including any
the requirements for
testing or validation?
protecting the
product, including
Documented
Are there documented requirements or
b) documenting requirements for special
Preservati requirements specifying guidelines outlining
conditions needed if packaging alone
ISO-13485 7.5.11 on of special conditions needed special conditions
cannot provide
product when packaging alone cannot (e.g., temperature
preservation.
ensure product preservation? control, humidity
control) needed
Instructions if
detailing
Do the documented
additional
Preservati requirements include details
preservation
ISO-13485 7.5.11 on of on the additional measures or
measures to be
product conditions required for
implemented when
preserving the product?
packaging
Records does not
showing the
application of
special conditions,
Are there records showing that
Preservati such as temperature
these special conditions are
ISO-13485 7.5.11 on of logs, environmental
applied or managed when
product monitoring reports,
necessary?
or documentation of
additional protective
measures used.
Documented
procedures outlining
Are there procedures in place
Preservati how special
If special conditions are required, they shall to control special conditions
ISO-13485 7.5.11 on of conditions (e.g.,
be controlled and recorded required for product
product temperature,
preservation?
humidity) are
controlled
Records andas
such
Are records maintained of the temperature logs,
Preservati special conditions applied to humidity logs, or
ISO-13485 7.5.11 on of ensure they meet the monitoring reports
product necessary criteria for that demonstrate the
preservation? control and
management of
 Documentation of
Is there evidence that these
compliance with
special conditions are
Preservati special conditions,
monitored and controlled
ISO-13485 7.5.11 on of including corrective
throughout processing,
product actions taken if
storage, handling, and
conditions deviate
distribution?
from required
Monitorin
g and ISO-
27 ISO-13485 8.2
measure 9001
ment
As one of the measurements of the
effectiveness of the quality The organization shall meet requirements for post-delivery
management system, the organization activities associated with the products
shall gather and monitor information and services.
relating to whether the organization has In determining the extent of post-delivery activities that are
met customer requirements. The required, the organization shall consider:
methods for obtaining and using this a) statutory and regulatory requirements;
information shall be documented. b) the potential undesired consequences associated with its Customer Inquiry, Sales
ISO- Post-delivery products and services; Sales order, MRD, Customer
28 ISO-13485 8.2.1 Feedback 8.5.5 OMS
The organization shall document 9001 activities c) the nature, use and intended lifetime of its products and Process feedback, PMS,Production
procedures for the feedback process. services; Report
This feedback process shall include d) customer requirements;
provisions to gather data from e) customer feedback.
production as well as post-production NOTE Post-delivery activities can include actions under
activities. warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as
The information gathered in the recycling or final disposal.
feedback process shall serve as
The organization shall meet requirements for post-delivery
activities associated with the products
If applicable regulatory requirements
and services.
require notification of complaints that
In determining the extent of post-delivery activities that are
meet specified reporting criteria of
required, the organization shall consider:
Reporting adverse events or issuance of advisory
a) statutory and regulatory requirements;
to notices, the organization shall Regulator
ISO- Post-delivery b) the potential undesired consequences associated with its
29 ISO-13485 8.2.3 regulatory document procedures for providing 8.5.5 y Affairs PMS
9001 activities products and services;
authoritie notification to the appropriate Process
c) the nature, use and intended lifetime of its products and
s regulatory authorities.
services;
Records of reporting to regulatory
d) customer requirements;
authorities shall be maintained (see
e) customer feedback.
4.2.5).
NOTE Post-delivery activities can include actions under
The organization shall monitor and warranty provisions, contractual obligations such as
measure the characteristics of the The organization shall implement planned arrangements, at
product to verify that product appropriate stages, to verify that the
requirements have been met. This shall product and service requirements have been met.
be carried out at applicable stages of The release of products and services to the customer shall not
Monitorin Control
the product realization process in proceed until the planned arrangements have been
g and Release of of Non-
accordance with the planned and ISO- satisfactorily completed, unless otherwise approved by a
30 ISO-13485 8.2.6 measure 8.6 products and Conformi OMS
documented arrangements and 9001 relevant authority and, as applicable, by the customer.
ment of services ng
documented procedures. The organization shall retain documented information on the
product Process
Evidence of conformity to the release of products and services. The
acceptance criteria shall be documented information shall include:
maintained. The identity of the person a) evidence of conformity with the acceptance criteria;
authorizing release of product shall be b) traceability to the person(s) authorizing the release.
recorded (see 4.2.5). As appropriate,
Control of
ISO-
31 ISO-13485 8.3 nonconfor 8.7
9001
ming
 The organization shall ensure that outputs that do not conform
The organization shall deal with to their requirements are
nonconforming product by one or more identified and controlled to prevent their unintended use or
of the following ways: delivery.
a) taking action to eliminate the The organization shall take appropriate action based on the
detected nonconformity; nature of the nonconformity and its effect
Actions in
b) taking action to preclude its original on the conformity of products and services. This shall also apply
response
intended use or application; to nonconforming products and
to Control
c) authorizing its use, release or services detected after delivery of products, during or after the
nonconfor Control of of Non-
acceptance under concession. ISO- provision of services.
32 ISO-13485 8.3.2 ming 8.7 nonconforming Conformi OMS
The organization shall ensure that 9001 The organization shall deal with nonconforming outputs in one
product outputs ng
nonconforming product is accepted by or more of the following ways:
detected Process
concession only if the justification is a) correction;
before
provided, approval is obtained and b) segregation, containment, return or suspension of provision
delivery
applicable regulatory requirements are of products and services;
met. Records of the acceptance by c) informing the customer;
concession and the identity of the d) obtaining authorization for acceptance under concession.
person authorizing the concession shall Conformity to the requirements shall be verified when
be maintained (see 4.2.5). nonconforming outputs are corrected.
The organization shall ensure that outputs that do not conform
to their requirements are
identified and controlled to prevent their unintended use or
When nonconforming product is
delivery.
detected after delivery or use has
The organization shall take appropriate action based on the
started, the organization shall take
nature of the nonconformity and its effect
action appropriate to the effects, or
Actions in on the conformity of products and services. This shall also apply
potential effects, of the nonconformity.
response to nonconforming products and
Records of actions taken shall be
to services detected after delivery of products, during or after the Control
maintained (see 4.2.5).
nonconfor Control of provision of services. of Non-
The organization shall document ISO-
33 ISO-13485 8.3.3 ming 8.7 nonconforming The organization shall deal with nonconforming outputs in one Conformi
procedures for issuing advisory notices 9001
product outputs or more of the following ways: ng
in accordance with applicable
detected a) correction; Process
regulatory requirements. These
after b) segregation, containment, return or suspension of provision
procedures shall be capable of being
delivery of products and services;
put into effect at any time. Records of
c) informing the customer;
actions relating to the issuance of
d) obtaining authorization for acceptance under concession.
advisory notices shall be maintained
Conformity to the requirements shall be verified when
(see 4.2.5).
nonconforming outputs are corrected.

The organization shall retain documented information that:

Actual Implementation
OMS

OMS

OMS

OMS
OMS

OMS
 QC and KPI on OMS

Quality Plan on OMS

PRE, During, POST

How is CAR integrated

with OMS
 Test Method

QC

Revalidation according
to the risk assessment
external from the
assessment of the
design change or can be
added in the pilot
process
NO validation for any of
these softwares

NO validation for any of

these softwares

NO risk assessment for

any of these softwares

OMS, QR CODES
 QR Code

QR Code

History of all systems

 Production Report

QC, Report of rejected

manufactured products
with the person
responsible for
assembly, list of
equipment used during
the assembly step,
Work Order for reword
and connected to the
previous work order
conducted