Gap Analysis ISO 13485 2016 - IsO 9001 2015 Template

GAP Analysis QMS to (EN) ISO 13485:2016
CLIENT: <<Client organzations name>> DEKRA
EN ISO
13485:2
13485:2
016
ISO Gap assessment of (EN) ISO 13485:2016 Implementation Off site assessment On site assessment
003 CLAUSE assessment GAP Assessment Evidence that demonstrates implementation of requirements effectiveness of implementation
Clause(s) Clause(s) Description New/additional requirements ISO 13485:2016 If GAP = Y Requirement(s) Release date
GAP Document ID Document Description Version Assessed Acceptable Remark Assessed Acceptable Evidence assessed / Remark
Indicate your action implemented? dd-mm-yyyy
1 1 Scope The processes required by this International Standard that are
applicable to the organization, but are not performed by the
organization, are the responsibility of the organization and are
accounted for in the organization’s quality management
system by monitoring, maintaining, and controlling the
processes.
3 3 Definitions Several new definitions added and some existing definitions

refined.
4 4 Quality management System

4.1 4.1 General requirements
4.1 4.1.1 QMS - general The organization shall establish, implement and maintain any
requirements requirement, procedure, activity or arrangement required to
be documented by this International Standard or applicable
regulatory requirements.
4.1 4.1.1 QMS - general The organization shall document the role(s) undertaken by the
requirements organization under the applicable regulatory requirements.
NOTE Roles undertaken by the organization can include
manufacturer, authorized representative, importer or
distributor.
4.1 4.1.2 - b) apply a risk based approach to the control of the

appropriate processes needed for the quality management
system;
4.1 4.1.3 - e) establish and maintain records needed to demonstrate

conformance to this International Standard and compliance
with applicable regulatory requirements (see 4.2.5).
4.1 4.1.4 - The organization shall manage these quality management

system processes in accordance with the requirements of this
International Standard and applicable regulatory
requirements. Changes to be made to these processes shall
be:
a) evaluated for their impact on the quality management
system;
b) evaluated for their impact on the medical devices produced
under this quality management system;
c) controlled in accordance with the requirements of this
International Standard and applicable regulatory
requirements.
4.1 4.1.5 - When the organization chooses to outsource any process that
affects product conformity to requirements, it shall monitor
and ensure control over such processes. The organization shall
retain responsibility of conformity to this International
Standard and to customer and applicable regulatory
requirements for outsourced processes. The controls shall be
proportionate to the risk involved and the ability of the
external party to meet the requirements in accordance with
7.4. The controls shall include written quality agreements.
4.1 4.1.6 - The organization shall document procedures for the validation
of the application of computer software used in the quality
management system. Such software applications shall be
validated prior to initial use and, as appropriate, after changes
to such software or its application.
The specific approach and activities associated with software
validation and revalidation shall be proportionate to the risk
associated with the use of the software.
Records of such activities shall be maintained (see 4.2.5).
4.2 4.2 Documentation requirements

4.2.1 4.2.1 General -
4.2.2 4.2.2 Quality manual -
© DEKRA Certification B.V. 23-March-2017 Page 1 of 36

EN ISO
13485:2
13485:2
016
- 4.2.3 Medical device file For each medical device type or medical device family, the
organization shall establish and maintain one or more files
either containing or referencing documents generated to
demonstrate conformity to the requirement of this
International Standard and compliance with applicable
The content of the file(s) shall include, but is not limited to:
a) general description of the medical device, intended
use/purpose, and labelling, including any instructions for use;
b) specifications for product;
c) specifications or procedures for manufacturing, packaging,
storage, handling and distribution;
d) procedures for measuring and monitoring;
e) as appropriate, requirements for installation;
f ) as appropriate, procedures for servicing.
4.2.3 4.2.4 Control of documents g) prevent deterioration or loss of documents;
4.2.4 4.2.5 Control of records - Addition of: "security and integrity"

- The organization shall define and implement methods for
protecting confidential health information contained in
records in accordance with the applicable regulatory
requirements.
4.2.4 4.2.5 Control of records Changes to a record shall remain identifiable.

5 5 Management responsibility
5.1 5.1 Management commitment
5.1 5.1 Management -
commitment
5.2 5.2 Customer focus

5.1 5.1 Customer focus -
5.3 5.3 Quality policy
5.1 5.1 Quality policy -
5.4 5.4 Planning
5.4.1 5.4.1 Quality objectives -
5.4.2 5.4.2 Quality management -
system planning
5.5 5.5 Responsibility, authority and communication

5.5.1 5.5.1 Responsibility and -
authority
5.5.2 5.5.2 Management c) ensuring the promotion of awareness of applicable
representative regulatory requirements and quality management system
requirements throughout the organization.
5.5.3 5.5.3 Internal -

communication
5.6 5.6 Management review

5.6.1 5.6.1 General The organization shall document procedures for management
review.
5.6.2 5.6.2 Review input b) complaint handling
c) reporting to regulatory authorities;
l) applicable new or revised regulatory requirements.
5.6.3 5.6.3 Review output The output shall be recorded and include input reviewed
c) changes needed to respond to applicable new or revised

regulatory requirements;
6 6 Resource management
6.1 6.1 Provision of resources
6.1 6.1 Provision of -
resources
6.2 6.2 Human resources

6.2 6.2 Human resources The organization shall document the process(es) for
establishing competence, providing needed training, and
ensuring awareness of personnel.
The methodology used to check effectiveness is proportionate

to the risk associated with the work for which the training or
other action is being provided.
6.3 6.3 Infrastructure

EN ISO
13485:2
13485:2
016
6.3 6.3 Infrastructure The organization shall document the requirements for the
infrastructure needed to achieve conformity to product
requirements, prevent product mix-up and ensure orderly
handling of product.
The organization shall document requirements for the

maintenance activities, including the interval of performing
the maintenance activities, when such maintenance activities,
or lack thereof, can affect product quality. As appropriate, the
requirements shall apply to equipment used in production,
the control of the work environment and monitoring and
measurement.
6.4 6.4 Work environment and contamination control

6.4 6.4.1 Work environment -
6.4 6.4.2 Contamination For sterile medical devices, the organization shall document
control requirements for control of contamination with
microorganisms or particulate matter and maintain the
required cleanliness during assembly or packaging processes.
7 7 Product realization
7.1 7.1 Planning of product realization
7.1 7.1 Planning of product The organization shall document one or more processes for
realization risk management in product realization.
Records of risk management activities shall be maintained
(see 4.2.5).
b) the need to establish processes and documents (see 42A)

and to provide resources specific to the product, including
infrastructure and work environment;
c) required verification, validation, monitoring, measurement,

inspection and test, handling, storage, distribution and
traceability activities specific to the product together with the
criteria for product
acceptance;
7.2 7.2 Customer-related processes

7.2.1 7.2.1 Determination of d) any user training needed to ensure specified performance
requirements related and safe use of the medical device;
to product
7.2.2 7.2.2 Review of c) applicable regulatory requirements are met;

requirements related
to product d) any user training identified in accordance with 7.2.1 is
available or planned to be available;
7.2.3 7.2.3 Communication The organization shall communicate with regulatory

authorities in accordance with applicable regulatory
requirements.
7.3 7.3 Design and development

7.3.1 7.3.1 General -
7.3.1 7.3.2 Design and During design and development planning, the organization
development shall document:
planning e) the methods to ensure traceability of design and
development outputs to design and development inputs;
f) the resources needed, including necessary competence of
personnel.
7.3.2 7.3.3 Design and a) functional, performance, usability and safety requirements,
Development inputs according to the intended use;
- Requirements shall be complete, unambiguous, able to be

verified or validated, and not in conflict with each other.
7.3.3 7.3.4 Design and -

development outputs
7.3.4 7.3.5 Design and At suitable stages, systematic reviews of design and
Development review development shall be performed in accordance with planned
and documented arrangements to:
Records of the results of the reviews and any necessary

actions shall be maintained and include the identification of
the design under review, the participants involved and the
date of the review (see 4.2.5).

EN ISO
13485:2
13485:2
016
7.3.5 7.3.6 Design and The organization shall document verification plans that
Development include methods, acceptance criteria and, as appropriate,
verification statistical techniques with rationale for sample size.
If the intended use requires that the medical device be

connected to, or have an interface with, other medical
device(s), verification shall include confirmation that the
design outputs meet design inputs when so connected or
interfaced.
Records of the results and conclusions of the verification and

necessary actions shall be maintained
(see 42A and 4ZS).
7.3.6 7.3.7 Design and - The organization shall document validation plans that
Development include methods, acceptance criteria and, as appropriate,
validation statistical techniques with rationale for sample size.
- Design validation shall be conducted on representative

product. Representative product includes initial production
units, batches or their equivalents. The rationale for the
choice of product used for
validation shall be recorded (see 4.2.5).
- As part of design and development validation, the

organization shall perform clinical evaluations or performance
evaluations of the medical device in accordance with
applicable regulatory requirements. A medical device used for
clinical evaluation or performance evaluation is not
considered to be released for use to the customer.
- If the intended use requires that the medical device be

connected to, or have an interface with, other medical
device(s), validation shall include confirmation that the
requirements for the specified
application or intended use have been met when so
connected or interfaced.
Records of the results and conclusion of validation and

necessary actions shall be maintained (see 42A
and4).
- 7.3.8 Design and The organization shall document procedures for transfer of
Development design and development outputs to manufacturing. These
transfer procedures shall ensure that design and development outputs
are verified as suitable for manufacturing before becoming
final production specifications and that production capability
can meet product requirements.
Results and conclusions of the transfer shall be recorded (see
4.2.5).
7.3.7 7.3.9 Control of design and The organization shall document procedures to control design
development and development changes. The organization shall determine
changes the significance of the change to function, performance,
usability, safety
and applicable regulatory requirements for the medical device
and its intended use.
- The review of design and development changes shall include

evaluation of the effect of the changes on constituent parts
and product in process or already delivered, inputs or outputs
of risk management and product realization processes.
- 7.3.10 Design and The organization shall maintain a design and development file
Development files for each medical device type or medical device family. This file
shall include or reference records generated to demonstrate
conformity to the requirements for design and development
and records for design and development changes.

EN ISO
13485:2
13485:2
016
7.4.1 Purchasing process The organization shall establish criteria for the evaluation and
selection of suppliers. The criteria shall be:
a) based on the supplier’s ability to provide product that
meets the organization’s requirements;
b) based on the performance of the supplier;
c) based on the effect of the purchased product on the quality
of the medical device;
d) proportionate to the risk associated with the medical
device.
The organization shall plan the monitoring and re-evaluation
of suppliers. Supplier performance in meeting requirements
for the purchased product shall be monitored. The results of
the monitoring
shall provide an input into the supplier re-evaluation process.
Non-fulfilment of purchasing requirements shall be addressed
with the supplier proportionate to the risk associated with the
purchased product and compliance with applicable regulatory
requirements. Records of the results of evaluation, selection,
monitoring and re-evaluation of supplier capability
orperformance and any necessary actions arising from these
activities shall be maintained (see 4.2.5).
7.4 7.4 Purchasing

7.4.1 7.4.1 Purchasing process The organization shall establish criteria for the evaluation and
selection of suppliers. The criteria shall be:
a) based on the supplier’s ability to provide product that
meets the organization’s requirements;
b) based on the performance of the supplier;
c) based on the effect of the purchased product on the
quality of the medical device;
d) proportionate to the risk associated with the medical
device.
The organization shall plan the monitoring and re-evaluation

of suppliers. Supplier performance in meeting requirements
for the purchased product shall be monitored. The results of
the monitoring
shall provide an input into the supplier re-evaluation process.
Non-fulfilment of purchasing requirements shall be addressed

with the supplier proportionate to the risk associated with the
purchased product and compliance with applicable regulatory
requirements.
7.4.2 7.4.2 Purchasing a) product specifications;

information b) requirements for product acceptance, procedures,
processes and equipment;
- Purchasing information shall include, as applicable, a written

agreement that the supplier notify the organization of
changes in the purchased product prior to implementation of
any changes that affect the ability of the purchased product to
meet specified purchase requirements.
7.4.3 7.4.3 Verification of The extent of verification activities shall be based on the
purchased product supplier evaluation results and proportionate to the risks
associated with the purchased product.
When the organization becomes aware of any changes to the

purchased product, the organization shall determine whether
these changes affect the product realization process or the
medical device.
7.5 7.5 Production and service provision

7.5.1 7.5.1 Control of production b) qualification of infrastructure;
7.5.1.1 and service provision c) implementation of monitoring and measurement of process
parameters and product characteristics;
7.5.1.2.1 7.5.2 Cleanliness of c) product cannot be cleaned prior to sterilization or its use,
product and its cleanliness is of significance in use;
7.5.1.2.2 7.5.3 Installation activities -

EN ISO
13485:2
13485:2
016
7.5.1.2.3 7.5.4 Servicing activities The organization shall analyse records 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.
7.5.1.3 7.5.5 Particular -

requirements for
sterile medical
devices
7.5.2 7.5.6 Validation of The organization shall validate any processes for production
processes for and service provision where the resultingoutput cannot be or
production and is not verified by subsequent monitoring or measurement
service provision and, as a consequence, deficiencies become apparent only
after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to

achieve planned results consistently.
The organization shall document procedures for validation of

processes, including:
d) as appropriate, statistical techniques with rationale for
sample sizes;
g) approval of changes to the processes.
The organization shall document procedures for the validation

of the application of computer software used in production
and service provision. Such software applications shall be
validated prior to initial use and, as appropriate, after changes
to such software or its application. The specific approach and
activities associated with software validation and
revalidation shall be proportionate to the risk associated
with the use of the software, including the effect on the
ability of the product to conform to specifications.

necessary actions from the validation shall be maintained
(see 4.2.4 and 4.2.5).
7.5.2.2 7.5.7 Particular The organization shall document procedures (see 42A) for the
requirements for validation of processes for sterilization and sterile barrier
validation of systems.
processes for
sterilization and Processes for sterilization and sterile barrier systems shall be
sterile barrier validated prior to implementation and following product or
systems process changes, as appropriate.
Records of the results and, conclusion of validation and

necessary actions from the validation shall be maintained
(see 42A and 4.2.5).
7.5.3 7.5.8 Identification The organization shall identify product status with respect to
7.5.3.3 monitoring and measurement requirements throughout
product realization. Identification of product status shall be
maintained
throughout production, storage, installation and servicing of
product to ensure that only product that has passed the
required inspections and tests or released under an
authorized concession is dispatched,
used or installed.
If required by applicable regulatory requirements, the

organization shall document a system to assign unique device
identification to the medical device.
7.5.3.2 7.5.9 Traceability -

7.5.3.2.1 7.5.9.1 General The organization shall document procedures for traceability.
These procedures shall define the extent of traceability in
accordance with applicable regulatory requirements and the
records to be maintained (see 4.2.5).
7.5.3.2.2 7.5.9.2 Particular -

requirements for
implantable medical
devices
7.5.4 7.5.10 Customer property -

EN ISO
13485:2
13485:2
016
7.5.5 7.5.11 Preservation of The organization shall protect product from alteration,
product contamination or damage when exposed to expected
conditions and hazards during processing, storage, handling,
and distribution by:
a) designing and constructing suitable packaging and shipping
containers;
b) documenting requirements for special conditions needed if
packaging alone cannot provide preservation.
If special conditions are required, they shall be controlled and
recorded (see 4.2.5).
7.6 7.6 Control of b) be adjusted or re-adjusted as necessary: such adjustments

monitoring and or re-adjustments shall be recorded (see 4.2.5);
measuring c) have identification in order to determine its calibration
equipment status;
The organization shall document procedures for the validation

of the application of computer software used for the
monitoring and measurement of requirements. Such software
applications shall be validated prior to initial use and, as
appropriate, after changes to such software or its application.
The specific approach and activities associated with software
validation and revalidation shall be proportionate to the risk
associated with the use of the software, including the effect
on the ability of the product to conform to specifications.

necessary actions from the validation shall be maintained (see
4.2.4 and 4.2.5).
8 8 Measurement, analysis and improvement

8.1 8.1 General
8.1 8.1 General -
8.2 8.2 Monitoring and measurement
8.2.1 8.2.1 Feedback The methods for obtaining and using this information shall be
documented.
The organization shall document procedures for the feedback

process. This feedback process shall include provisions to
gather data from production as well as post-production
activities.
The information gathered in the feedback process shall serve

as potential input into risk management for monitoring and
maintaining the product requirements as well as the product
realization or improvement processes.
If applicable regulatory requirements require the organization

to gain specific experience from postproduction activities, the
review of this experience shall form part of the feedback
process.

EN ISO
13485:2
13485:2
016
7.2.3 8.2.2 Complaint handling The organization shall document procedures for timely
8.2.1 complaint handling in accordance with applicable regulatory
requirements.
These procedures shall include at a minimum requirements
and responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback
constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the
appropriate regulatory authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective
actions.
If any complaint is not investigated, justification shall be

documented. Any correction or corrective action resulting
from the complaint handling process shall be documented.
If an investigation determines activities outside the

organization contributed to the complaint, relevant
information shall be exchanged between the organization and
the external party involved.
Complaint handling records shall be maintained (see 4.2.5).
- 8.2.3 Reporting to If applicable regulatory requirements require notification of

regulatory complaints that meet specified reporting criteria of adverse
authorities events or issuance of advisory notices, the organization shall
document procedures for providing notification to the
appropriate regulatory authorities.
Records of reporting to regulatory authorities shall be

maintained (see 4.2.5).
8.2.2 8.2.4 Internal audit a) conforms to planned and documented arrangements,

requirements of this International Standard, quality
management system requirements established by the
organization, and applicable regulatory requirements;
The audit criteria, scope, interval and methods shall be

defined and recorded (see 4.2.5).
8.2.3 8.2.5 Monitoring and The organization shall apply suitable methods for monitoring
measurement of and, as appropriate, measurement of the quality management
processes system processes. These methods shall demonstrate the
ability of the processes to achieve planned i’esults. When
planned results are not achieved, correction and corrective
action shall be taken, as appropriate.
- REMOVED to ensure conformity of the product REMOVED -
8.2.4 8.2.6 Monitoring and As appropriate, records shall identify the test equipment used
8.2.4.1 measurement of to perform measurement activities.
8.2.4.2 product
8.3 8.3 Control of nonconforming product

8.3 8.3.1 General The organization shall document a procedure to define the
controls and related responsibilities and authorities for the
identification, documentation, segregation, evaluation and
disposition of nonconforming product.
The evaluation of nonconformity shall include a determination

of the need for an investigation and notification of any
external party responsible for the nonconformity.
Records of the nature of the nonconformities and any

subsequent action taken, including the evaluation, any
investigation and the rationale for decisions shall be
maintained (see 4.2.5)

EN ISO
13485:2
13485:2
016
8.3 8.3.2 Actions in response The organization shall ensure that nonconforming product is
to nonconforming accepted by concession only if the justification is provided,
product detected approval is obtained and applicable regulatory requirements
before delivery are met. Records of the acceptance by concession and the
identity of the person authorizing the concession shall
bemaintained (see 4.2.5).
8.3 8.3.3 Actions in response Records of actions taken shall be maintained (see 4.2.5).
to nonconforming
product detected The organization shall document procedures for issuing
after delivery advisory notices in accordance with applicable regulatory
requirements. These procedures shall be capable of being put
into effect at any time. Records of actions relating to the
issuance of advisory notices shall be maintained (see 4.2.5).
8.3 8.3.4 Rework After the completion of rework, product shall be verified to
ensure that it meets applicable acceptance criteria and
Records of rework shall be maintained (see 4.2.5).
8.4 8.4 Analysis of data

8.4 8.4 Analysis of data The procedures shall include determination of appropriate
methods, including statistical techniques and the extent of
their use.
e) audits;
f) service reports, as appropriate.
If the analysis of data shows that the quality management

system is not suitable, adequate or effective, the organization
shall use this analysis as input for improvement as required in
8.5.
8.5 8.5 Improvement

8.5.1 8.5.1 General The organization shall identify and implement any changes
necessary to ensure and maintain the continued suitability,
adequacy and effectiveness of the quality management
system as well as medical device safety and performance
through the use of the quality policy, quality objectives, audit
results, postmarket surveillance, analysis of data, corrective
actions, preventive actions and management review.
8.5.2 8.5.2 Corrective actions (..) Any necessary corrective actions shall be taken without
undue delay.
Corrective actions shall be proportionate to the effects of the

nonconformities encountered.
The organization shall document a procedure to define

requirements for:
d) planning and documenting action needed and
implementing such action, including, as appropriate, updating
documentation;
e) verifying that the corrective action does not adversely
affect the ability to meet applicable regulatory requirements
or the safety and performance of the medical device;
8.5.3 8.5.3 Preventive actions Preventive actions shall be proportionate to the effects of the
potential
problems.
The organization shall document a procedure to describe

requirements for:
c) planning and documenting action needed and
implementing such action, including, as appropriate, updating
documentation;
d) verifying that the action does not adversely affect the
ability to meet applicable regulatory requirements or the
safety and performance of the medical device;
END
11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

GAP Analysis QMS to ISO 9001:2015 combined with (EN) ISO 13485:2016

Assessment combination with ISO 9001:2015 Implementation Off site assessment On site assessment
CLAUSE assessment GAP Assessment Evidence that demonstrates implementation of requirements effectiveness of implementation
Clause(s) Description Additional requirements ISO 9001:2015 If GAP = Y Requirement(s) Release date
4. Context of the organization
4.1 Understanding the The organization shall determine external and internal issues that are
organization and its relevant to its purpose and its strategic direction and that affect its
context ability to achieve the intended result(s) of its quality management
system.
The organization shall monitor and review information about these

external and internal issues.
4.2 Understanding the Due to their effect or potential effect on the organization’s ability to
needs and consistently provide products and services that meet customer and
expectations of applicable statutory and regulatory requirements, the organization
interested parties shall:
Determine the interested parties that are relevant to the quality

management system.
Determine the requirements of these interested parties that are

relevant to the quality management system.
The organization shall monitor and review information about these
interested parties and their relevant requirements.
6 Planning
6.1 Actions to address risks and opportunities
6.1.1 Risks and When planning for the quality management system, the organization
opportunities shall consider the issues referred to in 4.1 and the requirements
referred to in 4.2 and determine the risks and opportunities that need
to be addressed to:
a) give assurance that the quality management system can achieve its
intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 Risks and The organization shall plan:

opportunities
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management
system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be

proportionate to the potential impact on the conformity of products
and services.
6.2 Quality objectives and planning to achieve them

6.2.2 Quality objectives When planning how to achieve its quality objectives, the organization
shall determine:
a) what will be done;

b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
7 Support
7.4 Communication
7.4 Communication The organization shall determine the internal and external
communications relevant to the quality management system,
including:
a) on what it will communicate;

b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
5.4.2 Quality management -

system planning
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.2 Customer satisfaction The organization shall monitor customers’ perceptions of the degree
to which their needs and expectations have been fulfilled. The
organization shall determine the methods for obtaining, monitoring
and reviewing this information.
9.3 Management review

GAP Analysis QMS to ISO 9001:2015 combined with (EN) ISO 13485:2016

Assessment combination with ISO 9001:2015 Implementation Off site assessment On site assessment
CLAUSE assessment GAP Assessment Evidence that demonstrates implementation of requirements effectiveness of implementation
Clause(s) Description Additional requirements ISO 9001:2015 If GAP = Y Requirement(s) Release date
9.3.2 Management review The management review shall be planned and carried out taking into
inputs consideration:
d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities
(see 6.1);
END
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4.1 General requirements
Client
ISO 13485:2016
Job - report #
4.1 Understanding the organization
expectations of interested parties

4.2 Understanding the need and
and its context
Remove row in case ISO 9001 is not
Combination with ISO 9001:2015
applicable
Continual Management Dynamics (e.g., 1.03,

1.08, 1.02)
On site audit (Upgrade)
Management Processes
Management System Document Review
Management Involvement and Customer Focus
includes:
- Policy and Objectives
- Quality Planning
- Responsibility, Authority and
Communication
Management Review
Document and Data Control
Resource Management (people, machines,
work areas)
Competence and Qualification
Facilities Control
Calibration and Preventive Maintenance
Computer Systems Management
Customer Processes
Contract Review (Orders Processing)
Returns Goods Handling and Processing
Distributor Control
Post Market Surveillance
Product Realization Processes (should include
training, equipment, data analysis and records
control associated with these processes)
Purchasing & Supplier Management

Receiving/Receiving Inspection
Production Planning
Product Realization – process A
Product Realization – process B
Product Realization – Testing
Final Inspection and Release
Warehousing/ Inventory Control/ Shipping
Improvement Processes
Nonconforming Product
Corrective and Preventive Action
Internal Audits
Complaints, Vigilance, Recall
Post Market Surveillance
Technical Documentation Review

Clinical evaluation
Annex II capability
Certification Update
Medical device licensing for Canada
Taiwanese TCP overview
……………………
0
6.3 Planning of changes
8.5.6 Control of changes 4.1.4 Changes
8.4.3 Information for external

providers 4.1.5 Outsourced processes
8.5.1 Control of production and

service provision 4.1.6 - Software validation QMS
4.2 Documentation requirements

7.5.1 General 4.2.1 General.
4.3 Determining the scope of the

QMS
4.4.1 QMS and its processes 4.2.2 Quality manual
4.4.2 Documented information 4.2.3 Medical device file
7.5.3 Control of documented

information 4.2.4 Control of documents
7.5.3 Control of documented

information 4.2.5 Control of records
5.1 Leadership and commitment 5.1 – management commitment
5.1.2 Customer focus 5.2 – Customer focus

5.2.1 Establishing the quality policy
5.2.2 Communicating the quality
policy
5.3 – Quality policy
6.2 Quality objectives and planning

to achieve them 5.4.1 – Quality objectives
0 0 0 0 0 0 0 0 0 0 0 0
6.1 Actions to adress risks and
opportunities 5.4.2 – QMS planning
4.4.1.e responsibilities and

authorities 5.5.1 – Responsibility and authority
5.3 Organizational roles, 5.5.2 – Management

responsibilities and authorities representative
7.4 Communication 5.5.3 – Internal communication
9.3.1 General (9.3 Management

review) 5.6.1 – Management review
9.3.2 Management review inputs 5.6.2 – Review input
9.3.3 Management review outputs 5.6.3 – Review output
7.1.2 People 6.1 – Provision of resources
7.1.6 Organizational knowledge

7.2 Competence
7.3 Awareness 6.2.1 – Human resources
7.1.6 Organizational knowledge
7.2 Competence 6.2.2 - Competence, awareness
7.3 Awareness and training
7.1.3 Infrastructure 6.3 – Infrastructure
7.1.4 Environment for the

operation of processes 6.4 - Work environment
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operation of processes 6.4.1 Work environment

operation of processes 6.4.2 Contamination control
8.1 Operational planning and 7.1 – Planning of product

control realization
8.2.2 Determining the
requirements for products and 7.2.1 Determination of
services requirements related to product
8.2.3.1 Review of the requirements 7.2.2 Review of requirements

for products and services related to product
7.4 Communication
8.2.1 Customer communication 7.2.3 Communication
8.3.1 Design and development 7.3.1 - Design and development
8.3.2 Design and development 7.3.2 Design and development

planning planning

inputs inputs

outputs outputs

controls review

controls verification

controls validation
0 0 0 0 0 0 0 0 0 0 0 0 0
outputs transfer
8.3.6 Design and development 7.3.9 Control of design and

changes development changes

outputs files
8.4.1 Control of externally

provided processes, products and
services 7.4.1 – Purchasing process
8.4.3 Information for external

providers 7.4.2 Purchasing information
7.4.3 Verification of purchased

8.4.2 Type and extent of control product
8.5.1 Control of production and 7.5.1 Control of production and

service provision service provision

service provision 7.5.2 Cleanliness of product
8.5.5 Post-delivery activities 7.5.3 Installation activities

service provision
8.5.5 Post-delivery activities 7.5.4 Servicing activities
8.5.1 Control of production and 7.5.5 Particular requirements for

service provision sterile medical devices
7.1.5.1 General - 7.1.5 Monitoring

and measurment resources
8.5.1 Control of production and 7.5.6 Validation of processes for
service provision production and service provision
0 0 0 0 0 0 0 0 0 0 0 0
7.5.7 Particular requirements for
validation of processes for
8.5.1 Control of production and sterilization and sterile
service provision barrier systems
8.5.2 Identification and traceability 7.5.8 Identification
8.5.2 Identification and traceability 7.5.9.1 Traceability
7.5.9.2 Particular requirements for

8.5.2 Identification and traceability implantable medical devices
8.5.3 Property belonging to

customers or external providers 7.5.10 Customer property
8.5.4 Preservation 7.5.11 - Preservation of product
7.1.5 Monitoring and measuring 7.6 Control of monitoring and

resources measuring equipment
9.1 Monitoring, measurment, 8.1 Measurement, analysis and

analysis and evaluation improvement
9.1.2 Customer satisfaction 8.2.1 Feedback
9.1.2 Customer satisfaction 8.2.2 Complaint handling
8.5.5 Post-delivery activities 8.2.3 Reporting to regulatory

9.1.2 Customer satisfaction authorities
0 0 0 0 0 0 0 0 0 0 0
9.2 Internal audit 8.2.4 - Internal auditing
9.1 Monitoring, measurment, 8.2.5 Monitoring and

analysis and evaluation measurement of processes
8.6 Release of products and 8.2.6 - Monitoring and

services measurement of product
8.7 Control of nonconforming 8.3 - Control of nonconforming

outputs product
9.1.3 Analysis and evaluation 8.4 - Analysis of data

8.5.6 Control of changes 8.5.1 Improvement
10.2 Nonconformity and corrective

action 8.5.2 Corrective action
0 0 0 0 0 0 0
10.1 General - 10 Improvement
6.1 Actions to address risks and
opportunities 8.5.3 Preventive action
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Version Change Date
0 Initial version 17/Mar/2017
1 Work sheets updated to enable inserting rows and formatting cells that 4/Apr/2017
are not protected. Can be used in case multiple documents require to
be entered to demonstrate compliance to the applicable
requirement(s).
1. Added On site assessment - effectiveness of implementation in

columns N; O and P to enable full assessment within this document for
both sheets Gap assessment ISO13485 and Combination with ISO9001.
2. Added Subclause matrix as separate sheet with row 4 "On site audit
2 (Upgrade)" auto populated. 19/Jul/2017
Updated sheet Subclause matrix to enable adding and deleting rows
3 and columns 15/Aug/2017

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GAP Analysis QMS to (EN) ISO 13485:2016

CLIENT: <<Client organzations name>> DEKRA

3 3 Definitions Several new definitions added and some existing definitions

4 4 Quality management System

4.1 4.1.2 - b) apply a risk based approach to the control of the

4.1 4.1.3 - e) establish and maintain records needed to demonstrate

4.1 4.1.4 - The organization shall manage these quality management

4.2 4.2 Documentation requirements

© DEKRA Certification B.V. 23-March-2017 Page 1 of 36

CLIENT: <<Client organzations name>> DEKRA

4.2.3 4.2.4 Control of documents g) prevent deterioration or loss of documents;

4.2.4 4.2.5 Control of records - Addition of: "security and integrity"

4.2.4 4.2.5 Control of records Changes to a record shall remain identifiable.

5.2 5.2 Customer focus

5.5 5.5 Responsibility, authority and communication

5.5.3 5.5.3 Internal -

5.6 5.6 Management review

c) changes needed to respond to applicable new or revised

6.2 6.2 Human resources

The methodology used to check effectiveness is proportionate

6.3 6.3 Infrastructure

© DEKRA Certification B.V. 23-March-2017 Page 2 of 36

CLIENT: <<Client organzations name>> DEKRA

The organization shall document requirements for the

6.4 6.4 Work environment and contamination control

b) the need to establish processes and documents (see 42A)

c) required verification, validation, monitoring, measurement,

7.2 7.2 Customer-related processes

7.2.2 7.2.2 Review of c) applicable regulatory requirements are met;

7.2.3 7.2.3 Communication The organization shall communicate with regulatory

7.3 7.3 Design and development

- Requirements shall be complete, unambiguous, able to be

7.3.3 7.3.4 Design and -

Records of the results of the reviews and any necessary

© DEKRA Certification B.V. 23-March-2017 Page 3 of 36

CLIENT: <<Client organzations name>> DEKRA

If the intended use requires that the medical device be

Records of the results and conclusions of the verification and

- Design validation shall be conducted on representative

- As part of design and development validation, the

- If the intended use requires that the medical device be

Records of the results and conclusion of validation and

- The review of design and development changes shall include

© DEKRA Certification B.V. 23-March-2017 Page 4 of 36

CLIENT: <<Client organzations name>> DEKRA

7.4 7.4 Purchasing

The organization shall plan the monitoring and re-evaluation

Non-fulfilment of purchasing requirements shall be addressed

7.4.2 7.4.2 Purchasing a) product specifications;

- Purchasing information shall include, as applicable, a written

When the organization becomes aware of any changes to the

7.5 7.5 Production and service provision

7.5.1.2.2 7.5.3 Installation activities -

© DEKRA Certification B.V. 23-March-2017 Page 5 of 36

CLIENT: <<Client organzations name>> DEKRA

7.5.1.3 7.5.5 Particular -

Validation shall demonstrate the ability of these processes to

The organization shall document procedures for validation of

The organization shall document procedures for the validation