NATIONAL STANDARD
TCVN ISO
13485:2017
ISO 13485:2016
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
FOR REGULATORY PURPOSES
Table of contents
Foreword
Introduction
1 Scope
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3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation
requirements
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
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5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and
contamination control
7 Product realization
7.1 Planning of product
realization
7.2 Customer-related
processes
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7.4 Purchasing
7.5 Production and service
provision
7.6 Control of production and
service provision
8 Measurement, analysis and
improvement
8.1 General
Foreword
TCVN ISO 13485:2017 supersedes
TCVN ISO 13485:2004 and TCVN 8331:2010 (ISO/TR 14969:2004)
TCVN ISO 13485:2017 is an
identical adoption of ISO 13485:2016.
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Introduction
0.1 General
This standard specifies
requirements for a quality management system that can be used by an
organization involved in one or more stages of the life-cycle of a medical
device, including design and development, production, storage and distribution,
installation, servicing and final decommissioning and disposal of medical
devices, and design and development, or provision of associated activities
(e.g. technical support).
The
requirements in this standard can also be used by suppliers or other external
parties providing product (e.g. raw materials, components, subassemblies,
medical devices, sterilization services, calibration services, distribution
services, maintenance services) to such organizations. The
supplier or external party can voluntarily choose to conform to the
requirements of this standard or can be required by contract to conform.
Several jurisdictions have
regulatory requirements for the application of quality management systems by
organizations with a variety of roles in the supply chain for medical devices. Consequently,
this standard expects that the organization:
- identifies its role(s) under
applicable regulatory requirements;
- identifies the regulatory
requirements that apply to its activities under these roles;
- incorporates these applicable
regulatory requirements within its quality management system.
The definitions in applicable
regulatory requirements differ from nation to nation and region to region. The
organization needs to understand how the definitions in this standard will be
interpreted in light of the jurisdictions in which the medical devices are made
available.
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The adoption of a quality
management system is a strategic decision of an organization. The
design and implementation of an organization’s quality management system is
influenced by the:
a) organizational environment,
changes in that environment, and the influence that the organizational
environment has on the conformity of the medical devices;
b) organization’s varying
needs;
c) organization’s particular
objectives;
d) product the organization
provides;
e) processes the organization
employs;
f) organization’s size and
organizational structure;
g) regulatory requirements
applicable to the organization’s activities.
It is not the intent of this
Standard to imply the need for uniformity in the structure of different quality
management systems, uniformity of documentation or alignment of documentation
to the clause structure of this standard.
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0.2 Clarification of concepts
In this standard, the
following terms or phrases are used in the context described below.
- When a requirement is
qualified by the phrase “as appropriate”, it is deemed to be appropriate unless
the organization can justify otherwise. A requirement is considered
appropriate if it is necessary for:
- product to meet requirements;
- compliance with applicable
regulatory requirements;
- the organization to carry out
corrective action;
- the organization to manage
risks.
- When the term “risk” is used,
the application of the term within the scope of this standard pertains to
safety or performance requirements of the medical device or meeting applicable
regulatory requirements.
- When a requirement is required
to be “documented”, it is also required to be established, implemented and
maintained.
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- When the term “regulatory
requirements” is used, it encompasses requirements contained in any law
applicable to the user of this standard (e.g. statutes, regulations, ordinances
or directives).
The
application of the term “regulatory requirements” is limited to requirements
for the quality management system and the safety or performance of the medical
device.
In this standard, the
following verbal forms are used:
- “shall” indicates a
requirement;
- “should” indicates a
recommendation;
- “may” indicates a permission;
- “can” indicates a possibility
or a capability.
Information marked as “NOTE”
is for guidance in understanding or clarifying the associated requirement.
0.3 Process approach
This standard is based on a
process approach to quality management. Any activity that receives
input and converts it to output can be considered as a process. Often
the output from one process directly forms the input to the next process.
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When used within a quality management
system, such an approach emphasizes the importance of:
a) understanding and meeting
requirements;
b) considering
processes in terms of added value;
c) obtaining results of
process performance and effectiveness;
d) improving processes based
on objective measurement.
0.4 Relationship with TCVN
ISO 9001
While this is a stand-alone
standard, it is based on TCVN ISO 9001:2008, which has been superseded by ISO
9001:2015. For the convenience of users, Annex B shows the correspondence
between this standard and TCVN ISO 9001:2015.
This standard is intended to
facilitate global alignment of appropriate regulatory requirements for quality
management systems applicable to organizations involved in one or more stages
of the life-cycle of a medical device. This standard includes some
particular requirements for organizations involved in the life-cycle of medical
devices and excludes some of the requirements of TCVN ISO 9001 that are not
appropriate as regulatory requirements. Because of these exclusions,
organizations whose quality management systems conform to this standard cannot
claim conformity to TCVN ISO 9001 unless their quality management system meets
all the requirements of TCVN ISO 9001.
0.5 Compatibility with other
management systems
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MEDICAL DEVICES -
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
1
Scope
This standard specifies
requirements for a quality management system where an organization needs to
demonstrate its ability to provide medical devices and related services that
consistently meet customer and applicable regulatory requirements. Such
organizations can be involved in one or more stages of the life-cycle,
including design and development, production, storage and distribution,
installation, or servicing of a medical device and design and development or
provision of associated activities (e.g. technical support). This
standard can also be used by suppliers or external parties that provide
product, including quality management system-related services to such
organizations.
Requirements of this standard
are applicable to organizations regardless of their size and regardless of
their type except where explicitly stated. Wherever requirements are
specified as applying to medical devices, the requirements apply equally to
associated services as supplied by the organization.
The processes required by this
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.
If applicable regulatory
requirements permit exclusions of design and development controls, this can be
used as a justification for their exclusion from the quality management system. These
regulatory requirements can provide alternative approaches that are to be
addressed in the quality management system. It is the responsibility of
the organization to ensure that claims of conformity to this standard reflect
any exclusion of design and development controls.
If any requirement in Clauses
6, 7 or 8 of this standard is not applicable due to the activities undertaken
by the organization or the nature of the medical device for which the quality
management system is applied, the organization does not need to include such a
requirement in its quality management system For any clause that is
determined to be not applicable, the organization records the justification as
described in 4.2.2.
2
Normative references
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TCVN ISO 9000:2015 (ISO
9000:2015) Quality management systems - Fundamentals and vocabulary
3
Terms and definitions
For the purposes of this
document, the terms and definitions given in TCVN ISO 9000:2015 and the following
apply.
3.1
advisory notice
Issuance of an advisory notice
to organization, subsequent to delivery of the medical device, to provide
supplementary information or to advise on action to be taken in the:
- use of a medical device;
- modification of a medical
device;
- return of the medical device
to the organization that supplied it; or
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NOTE: Issuance of an advisory
notice can be required to comply with applicable regulatory requirements.
3.2
authorized representative
natural or legal person
established within a country or jurisdiction who has received a written mandate
from the manufacturer to act on his behalf for specified tasks with regard to
the latter’s obligations under that country or jurisdiction’s legislation.
[Source: GHTF/SG1/N055:2009,
5.2]
3.3
clinical evaluation
assessment and analysis of
clinical data pertaining to a medical device to verify the clinical safety and
performance of the device when used as intended by the manufacturer.
[Source: GHTF/SG5/N4:2010,
Clause 4]
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complaint
written, electronic or oral
communication that alleges deficiencies related to the identity, quality,
durability, reliability, usability, safety or performance of a medical device
that has been released from the organization’s control or related to a service
that affects the performance of such medical devices.
NOTE 1: This definition of
“complaint” differs from the definition given in TCVN ISO 9000:2015.
3.5
distributor
natural or legal person in the
supply chain who, on his own behalf, furthers the availability of a medical
device to the end user.
NOTE 1: More than one
distributor may be involved in the supply chain.
NOTE 2: Persons in the supply
chain involved in activities such as storage and transport on behalf of the manufacturer,
importer or distributor, are not distributors under this definition.
[Source: GHTF/SG1/N055:2009,
5.3]
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implantable medical device
medical device which can only
be removed by medical or surgical intervention and which is intended to:
- be totally or partially
introduced into the human body or a natural orifice; or
- replace an epithelial surface
or the surface of the eye, and
- remain after the procedure for
at least 30 days.
NOTE 1: This definition of
implantable medical device includes active implantable medical device.
3.7
importer
natural or legal person in the
supply chain who is the first in a supply chain to make a medical device,
manufactured in another country or jurisdiction, available in the country or
jurisdiction where it is to be marketed.
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3.8
labelling
label, instructions for use,
and any other information that is related to identification, technical
description, intended purpose and proper use of the medical device, but
excluding shipping documents.
[Source: GHTF/GS1/N70:2011,
Clause 4]
3.9
life-cycle
all phases in the life of a
medical device, from the initial conception to final decommissioning and
disposal.
[Source: TCVN 8023:2009 (ISO
14971:2007), 2.7]
3.10
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natural or legal person with
responsibility for design and/or manufacture of a medical device with the
intention of making the medical device available for use, under his name;
whether or not such a medical device is designed and/or manufactured by that
person himself or on his behalf by another person(s).
NOTE 1: This “natural or legal
person” has ultimate legal responsibility for ensuring compliance with all
applicable regulatory requirements for the medical devices in the countries or
jurisdictions where it is intended to be made available or sold, unless this
responsibility is specifically imposed on another person by the Regulatory
Authority (RA) within that jurisdiction.
NOTE 2: The manufacturer’s
responsibilities are described in other GHTF guidance documents. These
responsibilities include meeting both pre-market requirements and post-market
requirements, such as adverse event reporting and notification of corrective
actions.
NOTE 3: “Design and/or
manufacture”, as referred to in the above definition, may include specification
development, production, fabrication, assembly, processing, packaging,
repackaging, labelling, relabelling, sterilization, installation, or
remanufacturing of a medical device; or putting a collection of devices, and
possibly other products, together for a medical purpose.
NOTE 4: Any person who
assembles or adapts a medical device that has already been supplied by another
person for an individual patient, in accordance with the instructions for use,
is not the manufacturer, provided the assembly or adaptation does not change
the intended use of the medical device.
NOTE 5: Any person who changes
the intended use of, or modifies, a medical device without acting on behalf of
the original manufacturer and who makes it available for use under his own name,
should be considered the manufacturer of the modified medical device.
NOTE 6: An authorized
representative, distributor or importer who only adds its own address and
contact details to the medical device or the packaging, without covering or
changing the existing labelling, is not considered a manufacturer.
NOTE 7: To the extent that an
accessory is subject to the regulatory requirements of a medical device, the
person responsible for the design and/or manufacture of that accessory is
considered to be a manufacturer.
[Source: GHTF/SG1/N055:2009,
5.1]
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medical device
instrument, apparatus,
implement, machine, appliance, implant, reagent for in vitro use,
software, material or other similar or related article, intended by the
manufacturer to be used, alone or in combination, for human beings, for one or
more of the specific medical purpose(s) of:
- diagnosis, prevention,
monitoring, treatment or alleviation of disease;
- diagnosis, monitoring,
treatment, alleviation of or compensation for an injury;
- investigation, replacement,
modification, or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception;
- disinfection of medical
devices;
- providing information by means
of in vitro examination of specimens derived from the human body; and
does not achieve its primary intended action by pharmacological, immunological
or metabolic means, in or on the human body, but which may be assisted in its
intended function by such means.
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- disinfection substances;
- aids for persons with
disabilities;
- devices incorporating animal
and/or human tissues;
- devices for in vitro fertilization
or assisted reproduction technologies,
[Source: GHTF/SG1/N071:2012,
5.1]
3.12
medical device family
group of medical devices
manufactured by or for the same organization and having the same basic design
and performance characteristics related to safety, intended use and function.
3.13
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assessment and analysis of
data to establish or verify the ability of an in vitro diagnostic
medical device to achieve its intended use.
3.14
post-market surveillance
systematic process to collect
and analyze experience gained from medical devices that have been placed on the
market.
3.15 Product
result of a process.
NOTE 1: There are four generic
product categories, as follows:
- services (e.g. transport);
- software (e.g. computer
program, dictionary);
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- processed materials (e.g.
lubricant).
Many products comprise
elements belonging to different generic product categories. Whether
the product is then called service, software, hardware or processed material
depends on the dominant element. For example, the offered
product “automobile” consists of hardware (e.g. tyres), processed materials
(e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s
manual), and service (e.g. operating explanations given by the salesman).
NOTE 2: Service is the result
of at least one activity necessarily performed at the interface between the
supplier and customer and is generally intangible. Provision
of a service can involve, for example, the following:
- an activity performed on a
customer-supplied tangible product (e.g. automobile to be repaired);
- an activity performed on a
customer-supplied intangible product (e.g. the income statement needed to
prepare a tax return);
- the delivery of an intangible
product (e.g. the delivery of information in the context of knowledge
transmission);
- the creation of ambience for
the customer (e.g. in hotels and restaurants).
Software consists of
information and is generally intangible and can be in the form of approaches,
transactions or procedures.
Hardware is generally tangible
and its amount is a countable characteristic. Processed materials are
generally tangible and their amount is a continuous characteristic. Hardware
and processed materials often are referred to as goods.
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[Source: TCVN ISO 9000:2005,
3.4.2, modified]
3.16
purchased product
product provided by a party
outside the organization’s quality management system.
NOTE 1: The provision of
product does not necessarily infer a commercial or financial arrangement.
3.17
risk
combination of the probability
of occurrence of harm and the severity of that harm.
NOTE 1: This definition of
“risk” differs from the definition given in TCVN ISO 9000:2015.
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3.18
risk management
systematic application of
management policies, procedures and practices to the tasks of analyzing,
evaluating, controlling and monitoring risk.
[Source: TCVN 8023:2009 (ISO
14971:2007), 2.22]
3.19
sterile barrier system
minimum package that prevents
ingress of microorganisms and allows aseptic presentation of the product at the
point of use.
[Source: TCVN 7394-1:2008
(ISO 11607-1:2006), 3.22]
3.20
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medical device intended to
meet the requirements for sterility.
NOTE 1: The requirements for
sterility of a medical device can be subject to applicable regulatory
requirements or standards
4
Quality management system
4.1
General requirements
4.1.1 The
organization shall document a quality management system and maintain its
effectiveness in accordance with the requirements of this standard and
applicable regulatory requirements.
The organization shall
establish, implement and maintain any requirement, procedure, activity or
arrangement required to be documented by this standard or applicable regulatory
requirements.
The organization shall
document the role(s) undertaken by the organization under the applicable
regulatory requirements.
NOTE: Roles undertaken by the organization
can include manufacturer, authorized representative, importer or distributor.
4.1.2 The
organization shall:
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b) apply a risk based approach
to the control of the appropriate processes needed for the quality management
system;
c) determine
the sequence and interaction of these processes.
4.1.3 For
each quality management system process, the organization shall:
a) determine criteria and
methods needed to ensure that both the operation and control of these processes
are effective;
b) ensure the availability of
resources and information necessary to support the operation and monitoring of
these processes;
c) implement
actions necessary to achieve planned results and maintain the effectiveness of
these processes;
d) monitor,
measure as appropriate, and analyze these processes;
e) establish and maintain
records needed to demonstrate conformance to this standard and compliance with
applicable regulatory requirements (see 4.2.5).
4.1.4 The
organization shall manage these quality management system processes in
accordance with the requirements of this standard and applicable regulatory
requirements. Changes to be made to these processes shall be:
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b) evaluated for their impact
on the medical devices produced under this quality management system;
c) controlled in accordance
with the requirements of this standard and applicable regulatory requirements.
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 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.
4.1.6 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
Documentation requirements
4.2.1 General
The quality management system
documentation (see 4.2.4) shall include:
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b) a
quality manual;
c) documented procedures and
records required by this standard;
d) documents, including
records, determined by the organization to be necessary to ensure the effective
planning, operation, and control of its processes;
e) other documentation
specified by applicable regulatory requirements.
4.2.2 Quality manual
The organization shall
document a quality manual that includes:
a) the scope of the quality
management system, including details of and justification for any exclusion or
non-application;
b) the
documented procedures for the quality management system, or reference to them;
c) a description of the
interaction between the processes of the quality management system.
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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 standard and compliance with applicable
regulatory requirements.
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.
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Documents required by the
quality management system shall be controlled. Records are a special type of
document and shall be controlled according to the requirements given in 4.2.5.
A documented procedure shall
define the controls needed to:
a) review
and approve documents for adequacy prior to issue;
b) review,
update as necessary and re-approve documents;
c) ensure that the current
revision status of and changes to documents are identified;
d) ensure
that relevant versions of applicable documents are available at points of use;
e) ensure that documents
remain legible and readily identifiable;
f) ensure that documents of
external origin, determined by the organization to be necessary for the
planning and operation of the quality management system, are identified and
their distribution controlled;
g) prevent deterioration or
loss of documents;
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The organization shall ensure
that changes to documents are reviewed and approved either by the original
approving function or another designated function that has access to pertinent
background information upon which to base its decisions.
The organization shall define
the period for which at least one copy of obsolete documents shall be retained. This
period shall ensure that documents to which medical devices have been
manufactured and tested are available for at least the lifetime of the medical
device as defined by the organization, but not less than the retention period
of any resulting record (see 4.2.5), or as specified by applicable regulatory
requirements.
4.2.5 Control of records
Records shall be maintained to
provide evidence of conformity to requirements and of the effective operation
of the quality management system.
The organization shall
document procedures to define the controls needed for the identification,
storage, security and integrity, retrieval, retention time and disposition of
records.
The organization shall define
and implement methods for protecting confidential health information contained
in records in accordance with the applicable regulatory requirements.
Records shall remain legible,
readily identifiable and retrievable. Changes to a record shall
remain identifiable.
The organization shall retain
the records for at least the lifetime of the medical device as defined by the
organization, or as specified by applicable regulatory requirements, but not
less than two years from the medical device release by the organization.
5
Management responsibility
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Top management shall provide
evidence of its commitment to the development and implementation of the quality
management system and maintenance of its effectiveness by:
a) communicating to the
organization the importance of meeting customer as well as applicable
regulatory requirements;
b) establishing
the quality policy;
c) ensuring
that quality objectives are established;
d) conducting
management reviews;
e) ensuring the availability
of resources.
5.2 Customer focus
Top management shall ensure
that customer requirements and applicable regulatory requirements are
determined and met.
5.3 Quality policy
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a) is
applicable to the purpose of the organization;
b) includes a commitment to
comply with requirements and to maintain the effectiveness of the quality
management system;
c) provides a framework for
establishing and reviewing quality objectives;
d) is
communicated and understood within the organization;
e) is
reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure
that quality objectives, including those needed to meet applicable regulatory
requirements and requirements for product, are established at relevant
functions and levels within the organization. The quality objectives shall
be measurable and consistent with the quality policy.
5.4.2 Quality management
system planning
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a) the planning of the quality
management system is carried out in order to meet the requirements given in
4.1, as well as the quality objectives;
b) the
integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented.
5.5 Responsibility, authority
and communication
5.5.1 Responsibility and
authority
Top management shall ensure
that responsibilities and authorities are defined, documented and communicated
within the organization.
Top management shall document
the interrelation of all personnel who manage, perform and verify work
affecting quality and shall ensure the independence and authority necessary to
perform these tasks.
5.5.2 Management representative
Top management shall appoint a
member of management who, irrespective of other responsibilities, has
responsibility and authority that includes:
a) ensuring that processes
needed for the quality management system are documented;
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c) ensuring the promotion of
awareness of applicable regulatory requirements and quality management system
requirements throughout the organization.
5.5.3 Internal communication
Top management shall ensure
that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of
the quality management system.
5.6 Management review
5.6.1 General
The organization shall
document procedures for management review. Top management shall review
the organization’s quality management system at documented planned intervals to
ensure its continuing suitability, adequacy and effectiveness. The
review shall include assessing opportunities for improvement and the need for
changes to the quality management system, including the quality policy and
quality objectives.
Records from management
reviews shall be maintained (see 4.2.5).
5.6.2 Review input
The input to management review
shall include, but is not limited to, information arising from:
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b) complaint
handling;
c) reporting
to regulatory authorities;
d) audits;
e) monitoring and measurement
of processes;
f) monitoring and measurement
of product;
g) corrective action;
h) preventive action;
i) follow-up actions from
previous management reviews;;
j) changes that could affect
the quality management system;
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l) applicable new or revised
regulatory requirements..
5.6.3 Review output
The output from management
review shall be recorded (see 4.2.5) and include the input reviewed and any
decisions and actions related to:
a) improvement needed to
maintain the suitability, adequacy, and effectiveness of the quality management
system and its processes;
b) improvement
of product related to customer requirements;
c) changes needed to respond
to applicable new or revised regulatory requirements;
d) resource
needs.
6
Resource management
6.1 Provision of resources
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a) implement the quality
management system and to maintain its effectiveness;
b) meet
applicable regulatory and customer requirements.
6.2 Human resources
Personnel performing work
affecting product quality shall be competent on the basis of appropriate
education, training, skills and experience.
The organization shall
document the process(es) for establishing competence, providing needed
training, and ensuring awareness of personnel.
The organization shall:
a) determine the necessary
competence for personnel performing work affecting product quality;
b) provide training or take
other actions to achieve or maintain the necessary competence;
c) evaluate the effectiveness
of the actions taken;
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e) maintain appropriate
records of education, training, skills and experience (see 4.2.5).
NOTE: 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 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. Infrastructure
includes, as appropriate:
a) buildings, workspace and
associated utilities;
b) process equipment (both
hardware and software);
c) supporting services (such
as transport, communication, or information systems).
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.
Records of such maintenance
shall be maintained (see 4.2.5).
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6.4.1 Work environment
The organization shall
document the requirements for the work environment needed to achieve conformity
to product requirements.
If the conditions for the work
environment can have an adverse effect on product quality, the organization
shall document the requirements for the work environment and the procedures to
monitor and control the work environment.
The organization shall:
a) document requirements for
health, cleanliness and clothing of personnel if contact between such personnel
and the product or work environment could affect medical device safety or
performance;
b) ensure that all personnel
who are required to work temporarily under special environmental
conditions within the work environment are competent or supervised by a
competent person.
NOTE: Further information can
be found in TCVN 8664 (ISO 14644) and ISO 14698.
6.4.2 Contamination control
As appropriate, the
organization shall plan and document arrangements for the control of contaminated
or potentially contaminated product in order to prevent contamination of the
work environment, personnel, or product.
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7
Product realization
7.1
Planning of product realization
The organization shall plan
and develop the processes needed for product realization. 5.4.2
Quality management system planning shall be consistent with the requirements of
the other processes of the quality management system.
The organization shall
document one or more processes for risk management in product realization. Records
of risk management activities shall be maintained (see 4.2.5).
In planning product
realization, the organization shall determine the following, as appropriate:
a) quality objectives and
requirements for the product;
b) the need to establish
processes and documents (see 4.2.4) 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;
d) records needed to provide
evidence that the realization processes and resulting product meet requirements
(see 4.2.5).
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NOTE: Further information can
be found in TCVN 8023 (ISO 14971).
7.2
Customer-related processes
7.2.1 Determination of
requirements related to product
The organization shall
determine:
a) requirements specified by
the customer, including the requirements for delivery and post-delivery
activities;
b) requirements not stated by
the customer but necessary for specified or intended use, as known;
c) applicable regulatory
requirements related to the product;
d) any user training needed to
ensure specified performance and safe use of the medical device;
e) any additional requirements
determined by the organization.
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The organization shall review
the requirements related to product. This review shall be conducted
prior to the organization’s commitment to supply product to the customer (e.g.
submission of tenders, acceptance of contracts or orders, acceptance of changes
to contracts or orders) and shall ensure that:
a) product requirements are
defined and documented;
b) contract or order
requirements differing from those previously expressed are resolved;
c) applicable regulatory
requirements are met;
d) any user training
identified in accordance with 7.2.1 is available or planned to be available;
e) the organization has the
ability to meet the defined requirements.
Records of the results of the
review and actions arising from the review shall be maintained (see 4.2.5).
When the customer provides no
documented statement of requirement, the customer requirements shall be
confirmed by the organization before acceptance.
When product requirements are
changed, the organization shall ensure that relevant documents are amended and
that relevant personnel are made aware of the changed requirements.
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The organization shall plan
and document arrangements for communicating with customers in relation to:
a) product information;
b) enquiries, contracts or
order handling, including amendments;
c) customer feedback,
including complaints;
d) advisory notices.
The organization shall
communicate with regulatory authorities in accordance with applicable
regulatory requirements.
7.3
Design and development
7.3.1 General
The organization shall
document procedures for design and development.
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The organization shall plan
and control the design and development of product. As
appropriate, design and development planning documents shall be maintained and
updated as the design and development progresses.
During design and development
planning, the organization shall document:
a) the design and development
stages;
b) the review(s) needed at
each design and development stage;
c) the verification,
validation, and design transfer activities that are appropriate at each design
and development stage;
d) the responsibilities and
authorities for design and development;
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.
7.3.3 Design and development
inputs
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a) functional, performance,
usability and safety requirements, according to the intended use;
b) applicable regulatory
requirements and standards;
c) applicable output(s) of
risk management;
d) as appropriate, information
derived from previous similar designs;
e) other requirements
essential for design and development of the product and processes.
These inputs shall be reviewed
for adequacy and approved.
Requirements shall be
complete, unambiguous, able to be verified or validated, and not in conflict
with each other.
NOTE: Further information can
be found in IEC 62366-1.
7.3.4 Design and development
outputs
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a) meet the input requirements
for design and development;
b) provide appropriate
information for purchasing, production and service provision;
c) contain or reference
product acceptance criteria;
d) specify the characteristics
of the product that are essential for its safe and proper use.
The outputs of design and
development shall be in a form suitable for verification against the design and
development inputs and shall be approved prior to release.
Records of the design and
development outputs shall be maintained (see 4.2.5).
7.3.5 Design and development
review
At suitable stages, systematic
reviews of design and development shall be performed in accordance
with planned and documented arrangements to:
a) evaluate the ability of the
results of design and development to meet requirements;
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Participants in such reviews
shall include representatives of functions concerned with the design and
development stage being reviewed, as well as other specialist personnel.
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).
7.3.6 Design and development
verification
Design and development
verification shall be performed in accordance with planned and documented
arrangements to ensure that the design and development outputs have met the
design and development input requirements.
The organization shall
document verification plans that include methods, acceptance criteria and, as
appropriate, 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
4.2.4 and 4.2.5).
7.3.7 Design and development validation
Design and development
validation shall be performed in accordance with planned and documented
arrangements to ensure that the resulting product is capable of meeting the requirements
for the specified application or intended use.
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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.
Validation shall be completed
prior to release for use of the product to the customer.
Records of the results and
conclusion of validation and necessary actions shall be maintained (see 4.2.4
and 4.2.5).
7.3.8 Design and development
transfer
The organization shall
document procedures for transfer of design and development outputs to
manufacturing.
These
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).
7.3.9 Control of design and
development changes
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Design and development changes
shall be identified.
Before
implementation, the changes shall be:
a) reviewed;
b) verified;
c) validated, as appropriate;
d) approved.
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.
Records of changes, their
review and any necessary actions shall be maintained (see 4.2.5).
7.3.10 Design and development
files
The organization shall
maintain a design and development file 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.
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7.4.1 Purchasing process
The organization shall
document procedures (see 4.2.4) to ensure that purchased product conforms to
specified purchasing information.
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.
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7.4.2 Purchasing information
Purchasing information shall
describe or reference the product to be purchased, including as appropriate:
a) product specifications;
b) requirements for product
acceptance, procedures, processes and equipment;
b) requirements for qualification
of supplier personnel;
d) quality management system
requirements.
The organization shall ensure
the adequacy of specified purchasing requirements prior to their communication
to the supplier.
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.
To the extent required for
traceability given in 7.5.9, the organization shall maintain relevant
purchasing information in the form of documents (see 4.2.4) and records (see
4.2.5).
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The organization shall
establish and implement the inspection or other activities necessary for
ensuring that purchased product meets specified purchasing requirements. The
extent of verification activities shall be based on the 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.
When the organization or its customer
intends to perform verification at the supplier’s premises, the organization
shall state the intended verification activities and method of product release
in the purchasing information.
Records of the verification
shall be maintained (see 4.2.5).
7.5
Production and service provision
7.5.1 Control of production
and service provision
Production and service
provision shall be planned, carried out, monitored and controlled to ensure
that product conforms to specification. As appropriate, production controls
shall include but are not limited to:
a) documentation of procedures
and methods for the control of production (see 4.2.4);
b) qualification of
infrastructure;
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d) availability and use of
monitoring and measuring equipment;
e) implementation of defined
operations for labelling and packaging;
f) implementation of product
release, delivery and post-delivery activities.
The organization shall
establish and maintain a record (see 4.2.5) for each medical device or batch of
medical devices that provides traceability to the extent specified in 7.5.9 and
identifies the amount manufactured and amount approved for distribution. The
record shall be verified and approved.
7.5.2 Cleanliness of product
The organization shall
document requirements for cleanliness of product or contamination control of product
if:
a) product is cleaned by the
organization prior to sterilization or its use;
b) product is supplied non-sterile
and is to be subjected to a cleaning 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;
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e) process agents are to be
removed from product during manufacture.
If product is cleaned in
accordance with a) or b) above, the requirements contained in 6.4.1 do not
apply prior to the cleaning process.
7.5.3 Installation activities
The organization shall
document requirements for medical device installation and acceptance criteria
for verification of installation, as appropriate.
If the agreed customer
requirements allow installation of the medical device to be performed by an
external party other than the organization or its supplier, the organization
shall provide documented requirements for medical device installation and
verification of installation.
Records of medical device
installation and verification of installation performed by the organization or
its supplier shall be maintained (see 4.2.4).
7.5.4 Servicing activities
If servicing of the medical
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 requirements are
met.
The organization shall analyze
records of servicing activities carried out by the organization or its
supplier:
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b) as appropriate, for input
to the improvement process.
Records of servicing
activities carried out by the organization or its supplier shall be maintained
(see 4.2.5).
7.5.5 Particular requirements
for sterile medical devices
The organization shall
maintain records of the sterilization process parameters used for each
sterilization batch (see 4.2.5). Sterilization records shall be traceable to
each production batch of
medical devices.
7.5.6 Validation of processes
for production and service provision
The organization shall
validate any processes for production and service provision where the resulting
output cannot be or is not verified by subsequent monitoring or measurement
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:
a) defined criteria for review
and approval of the processes;
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c) use of specific methods,
procedures and acceptance criteria;
d) as appropriate, statistical
techniques with rationale for sample sizes;
e) requirements for records
(see 4.2.5);
f) revalidation, including
criteria for revalidation;
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.
Records of the results and
conclusion of validation and necessary actions from the validation shall be maintained
(see 4.2.5).
7.5.7 Particular requirements
for validation of processes for sterilization and sterile barrier systems
The organization shall
document procedures (see 4.2.4) for the validation of processes for
sterilization and sterile barrier systems.
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Records of the results and,
conclusion of validation and necessary actions from the validation shall be
maintained (see 4.2.4 and 4.2.5).
NOTE: Further information can
be found in TCVN 7394-1 (ISO 11607-1) and TCVN 7394-2 (ISO 11607-2).
7.5.8 Identification
The organization shall
document procedures for product identification and identify product by suitable
means throughout product realization.
The organization shall
identify product status with respect to monitoring and measurement requirements
throughout product realization. The organization shall identify product status with respect
to 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.
The organization shall
document procedures to ensure that medical devices returned to the organization
are identified and distinguished from conforming product.
7.5.9 Traceability
7.5.9.1 General
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7.5.9.2 Particular
requirements for implantable medical devices
The records required for
traceability shall include records of components, materials, and conditions for
the work environment used, if these could cause the medical device not to
satisfy its specified safety and performance requirements.
The organization shall require
that suppliers of distribution services or distributors maintain records of the
distribution of medical devices to allow traceability and that these records
are available for inspection.
Records of the name and
address of the shipping package consignee shall be maintained (see 4.2.4).
7.5.10 Customer property
The organization shall
identify, verify, protect, and safeguard customer property provided for use or
incorporation into the product while it is under the organization’s control or
being used by the
organization.
If
any customer property is lost, damaged or otherwise found to be unsuitable for
use, the organization shall report this to the customer and maintain records
(see 4.2.5).
7.5.11 Preservation of
product
The organization shall
document procedures for preserving the conformity of product to requirements
during processing, storage, handling, and distribution. Preservation
shall apply to the constituent parts of a medical device.
The organization shall protect
product from alteration, contamination or damage when exposed to expected
conditions and hazards during processing, storage, handling, and distribution
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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
Control of production and service provision
The organization shall
determine the monitoring and measurement to be undertaken and the monitoring
and measuring equipment needed to provide evidence of conformity of product to
determined requirements.
The organization shall
document procedures to ensure that monitoring and measurement can be carried
out and are carried out in a manner that is consistent with the monitoring and
measurement
requirements.
As necessary to ensure valid
results, measuring equipment shall:
a) be calibrated or verified,
or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards: when no such
standards exist, the basis used for calibration or verification shall be
recorded (see 4.2.5);
b) be adjusted or re-adjusted
as necessary: such adjustments or re-adjustments shall be recorded (see 4.2.5);
c) have identification in
order to determine its calibration status;
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e) be protected from damage
and deterioration during handling, maintenance and storage.
The organization shall perform
calibration or verification in accordance with documented procedures.
In addition, the organization
shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements. The organization
shall take appropriate action in regard to the equipment and any product
affected.
Records of the results of
calibration and verification shall be maintained (see 4.2.5).
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..
Records of the results and
conclusion of validation and necessary actions from the validation shall be
maintained (see 4.4.2 and 4.2.5).
NOTE: Further information can
be found in TCVN ISO 10012.
8
Measurement, analysis and improvement
8.1 General
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a) demonstrate conformity of
product;
b) ensure conformity of the
quality management system;
c) maintain the effectiveness
of the quality management system.
This shall include determination
of appropriate methods, including statistical techniques, and the extent of
their use.
8.2 Monitoring and
measurement
8.2.1 Feedback
As one of the measurements of
the effectiveness of the quality management system, the organization shall
gather and monitor information relating to whether the organization has met
customer requirements.
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.
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8.2.2 Complaint handling
The organization shall
document procedures for timely 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.
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Complaint handling records
shall be maintained (see 4.2.5).
8.2.3 Reporting to regulatory
authorities
If applicable regulatory
requirements require notification of complaints that meet specified reporting
criteria of adverse 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)
8.2.4 Internal audit
The organization shall conduct
internal audits at planned intervals to determine whether the quality
management system:
a) conforms to planned and
documented arrangements, requirements of this standard, quality management
system requirements established by the organization, and applicable regulatory
requirements;
b) is effectively implemented
and maintained.
The organization shall
document a procedure to describe the responsibilities and requirements for
planning and conducting audits and recording and reporting audit results.
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Records of the audits and
their results, including identification of the processes and areas audited and
the conclusions, shall be maintained.
The management responsible for
the area being audited shall ensure that any necessary corrections and
corrective actions are taken without undue delay to eliminate detected
nonconformities and their causes. Follow-up activities shall
include the verification of the actions taken and the reporting of
verification results.
NOTE: Further information can
be found in TCVN ISO 19011.
8.2.5 Monitoring and
measurement of processes
The organization shall apply
suitable methods for monitoring and, as appropriate, measurement of the quality
management system processes. These methods shall demonstrate the ability of the processes
to achieve planned results. When planned results are not achieved, correction and
corrective action shall be taken, as appropriate.
8.2.6 Monitoring and
measurement of product
The organization shall monitor
and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at applicable stages of the product
realization process in accordance with the planned and documented arrangements
and documented procedures.
Evidence of conformity to the
acceptance criteria shall be maintained. The identity of the person
authorizing release of product shall be recorded (see 4.2.5). As appropriate,
records shall identify the test equipment used to perform measurement
activities.
Product release and service
delivery shall not proceed until the planned and documented arrangements have
been satisfactorily completed.
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8.3 Control of nonconforming
product
8.3.1 General
The organization shall ensure
that product which does not conform to product requirements is identified and
controlled to prevent its unintended use or delivery. 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).
8.3.2 Actions in response to
nonconforming product detected before delivery
The organization shall deal
with nonconforming product by one or more of the following ways:
a) taking action to eliminate
the detected nonconformity;
b) taking action to preclude
its original intended use or application;
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The organization shall ensure
that nonconforming product is accepted by concession only if the justification
is provided, approval is obtained and applicable regulatory requirements are
met. Records
of the acceptance by concession and the identity of the person authorizing the
concession shall be maintained (see 4.2.5).
8.3.3 Actions in response to
nonconforming product detected after delivery
When nonconforming product is
detected after delivery or use has started, the organization shall take action
appropriate to the effects, or potential effects, of the nonconformity. Records
of actions taken shall be maintained (see 4.2.5).
The organization shall
document procedures for issuing 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).
8.3.4 Rework
The organization shall perform
rework in accordance with documented procedures that takes into account the
potential adverse effect of the rework on the product. These
procedures shall undergo the same review and approval as the original
procedure.
After the completion of
rework, product shall be verified to ensure that it meets applicable acceptance
criteria and regulatory requirements.
Records of rework shall be
maintained (see 4.2.5).
8.4 Analysis of data
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The analysis of data shall
include data generated as a result of monitoring and measurement and from other
relevant sources and include, at a minimum, input from:
a) feedback;
b) conformity to product
requirements;
c) characteristics and trends
of processes and product, including opportunities for improvement;
d) suppliers;
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.
Records of the results of analyzes
shall be maintained (see 4.2.5).
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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 Corrective action
The organization shall take
action to eliminate the cause of nonconformities in order to prevent
recurrence.
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:
a) reviewing nonconformities
(including complaints);
b) determining the causes of
nonconformities;
c) evaluating the need for
action to ensure that nonconformities do not recur;
d) planning and documenting
action needed and implementing such action, including, as appropriate,
updating documentation;
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f) reviewing the effectiveness
of corrective action taken.
Records of the results of any
investigation and of action taken shall be maintained (see 4.2.5).
8.5.3 Preventive action
The organization shall
determine action to eliminate the causes of potential nonconformities in order
to prevent their occurrence. Preventive actions shall be proportionate to the effects of
the potential problems.
The organization shall
document a procedure to describe requirements for:
a) determining potential
nonconformities and their causes;
b) evaluating the need for
action to prevent occurrence of nonconformities;
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;
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Records of the results of any
investigation and of action taken shall be maintained (see 4.2.5).
Annex A
(informative)
Comparison of content between TCVN ISO 13485:2004 and TCVN
ISO 13485:2017
Table A.1 outlines the changes
in this edition of this standard (TCVN ISO 13485:2017) compared with the
previous edition (TCVN ISO 13485:2004).
Table
A.1 - Comparison of content between TCVN ISO 13485:2003 and TCVN ISO 13485:2016
TCVN ISO 13485:2017
Comment
on change compared with TCVN ISO 13485:2004
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0.1 General
- Explains that the
requirements can be used by suppliers or other external parties either
voluntarily or as a result of contract arrangements.
- Alerts organizations about
their obligations related to regulatory requirements focused on quality
management systems.
- Alerts organizations about
differences in local regulation definitions and their obligation to
understand how these definitions will affect their quality management system.
- Adds the obligation to meet
the organization’s own quality management system requirements.
- Specifically calls out the
focus on the necessity to “meet customer and applicable regulatory
requirements for safety and performance”.
- Emphasizes that the product
requirements that are important are those related to safety and performance.
- Adds two influences on the
nature of the quality management system that were not in the original listing
(organizational environment and regulatory requirements).
- Clarifies that the
organization does not have to align its documentation to the clause structure
of this standard.
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- Adds two additional criteria
associated with the description of appropriate requirements:
+ compliance with regulatory
requirements;
+ the requirement is
necessary for the organization to manage risks.
- Limits application of risk
to the safety or performance requirements of the medical device or meeting
applicable regulatory requirements.
- Clarifies that the term
“documented” includes the need to establish, implement and maintain.
- Clarifies that the term
“product” applies to outputs that are intended for, or required by, a
customer, or any intended output resulting from a product realization
process.
0.3 Process approach
Explanation of process
approach extended.
0.4 Relationship with TCVN
ISO 9001
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- Indicates the structural
relationship between TCVN ISO 13485:2017 and TCVN ISO 9001:2015 will be
outlined in Annex B.
- The use of italic text
within standard to indicate changes from TCVN ISO 9001:2008 has been
eliminated.
1 Scope
- Indicates the applicability
of this standard to organizations that are involved in one or more stages of
the life-cycle of a medical device.
- Indicates that this Standard
can also be used by suppliers or external parties that provide product,
including quality management system-related services to medical device
organizations.
- Specifically calls out the
responsibilities for monitoring, maintaining, and controlling outsourced
processes.
- Expands requirements that
can be not applicable to those in Clauses 6 and 8.
- Clarifies that the term
“regulatory requirements” includes statutes, regulations, ordinances or
directives and limits the scope of the “applicable regulatory requirements”
to those requirements for the quality management system and the safety or
performance of the medical device.
3 Terms and definitions
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4. Quality management system
4.1 General requirements
- Added requirement to
document the role(s) of the organization.
- Requires the determination
of processes “taking into account the roles undertaken by the organization.”
- Requires the application of
a “risk based approach to the control of the appropriate processes needed for
the quality management system.”
- Adds requirements related to
changes to processes.
- Added requirements related
to validation of the application of computer software used in the quality
management system.
4.2 Documentation
requirements
- Includes control of records
within the document control requirements.
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- New requirement related to
protection of confidential health information.
- New requirement related to
deterioration and loss of documents.
5.6 Management review
- Includes requirement for the
documentation of one or more procedures for management review and the
requirement for management reviews at “documented planned intervals”.
- Lists of inputs and outputs
of management review have been expanded.
6.2 Human resources
New requirement for
documentation processes of establishing competence, providing needed training
and ensuring awareness of personnel.
6.3 Infrastructure
- Adds requirement that
infrastructure prevents product mix-up and ensure orderly handling of
product.
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6.4 Work environment and
contamination control
- Added documentation
requirements for work environment.
- Added requirement related to
control of contamination with microorganism or particulate matter for sterile
medical devices.
7.1 Planning of product
realization
Added requirements to list.
7.2 Customer-related
processes
- Added requirements to list.
- New requirement related to
communication with regulatory authorities.
7.3.2 Design and
development planning
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- Eliminated the requirement
related to the management of the interfaces between different groups involved
in design and development.
7.3.3 Design and
development inputs
- Added requirements to list.
- Added requirement that the
requirements shall be able to be verified or validated.
7.3.5 Design and
development review
Added details of the
contents of records.
7.3.6 Design and
development verification
- Added requirement for
documentation of verification plans and interface considerations.
- Requirement added for
records of verification.
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Added requirement for
documentation of validation plans, product to be used for validation and
interface considerations. Requirement added for records of validation.
7.3.8 Design and
development transfer
New sub-clause added.
7.3.9 Control of design and
development changes
- Adds the requirement that
the evaluation of the change effect should be made on products in process and
on the outputs of risk management and product realization processes
- Added detail to consider in
the determination of the significance of a design and development changes.
7.3.10 Design and
development files
New sub-clause added.
7.4.1 Purchasing process
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- New requirements added
related to monitoring and re-evaluation of suppliers, and action to be taken
when purchasing requirements are not met.
- Provides addition details
related to the content of the records.
7.4.2 Purchasing
information
New requirement added to
include notification of changes in purchased product.
7.4.3 Verification of
purchased product
New requirements added on
the extent of verification activities and action to be taken when the
organization becomes aware of any changes to the purchased product.
7.5.1 Control of production
and service provision
Adds details related to the
controls for carrying out production and service provision.
7.5.2 Cleanliness of
product
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7.5.4 Servicing activities
New requirement for analysis
of records for servicing activities.
7.5.6 Validation of
processes for production and service provision
- Added requirements to the
list.
- Adds details related to
situations requiring procedures.
- Relates the specific
approach to software validation to the risk associated with the use of the
software.
- Adds requirements related to
the validation records.
7.5.7 Particular
requirements for validation of processes for sterilization and sterile
barrier systems
Added requirements for
sterile barrier systems.
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- Added requirement for unique
device identification.
- New requirement for a
documented procedure for product identification and regarding identification
and product status during production.
7.5.11 Preservation of
product
Adds details as to how
preservation can be accomplished.
8.2.1 Feedback
- Indicates that feedback
should come from production and post-production activities.
- Adds a requirement to
utilize feedback in risk management processes in order to monitor and
maintain product requirements.
8.2.2 Complaint handling
New sub-clause added.
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New sub-clause added.
8.2.6 Monitoring and
measurement of product
Adds requirement to identify
the test equipment used to perform measurement activities.
8.3 Control of
nonconforming product
- Added details related to
kinds of controls that shall be documented.
- Generalized the requirement
to include any investigation and the rationale for decisions.
- Adds requirements related to
concessions.
- Separated requirements for
nonconformities detected before delivery, detected after delivery and rework.
- Adds requirements for
records related to the issuance of advisory notices.
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- Adds the requirement to
include determination of appropriate methods, including statistical
techniques and the extent of their use.
- Adds detail to list of
inputs.
8.5.2 Corrective action
- Adds the requirement to
verify that the corrective action does not have an adverse effect.
- Added requirement for
corrective action to be taken without undue delay.
8.5.3 Preventive action
Adds the requirement to
verify that the preventive action does not have an adverse effect.
Annex B
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Correspondence between TCVN ISO 13485:2017 and TCVN ISO
9001:2015
Tables B.1 and B.2 show the
correspondence between TCVN ISO 13485:2017 and TCVN ISO 9001:2015.
Table
B.1 - Correspondence between TCVN ISO 13485:2017 and TCVN ISO 9001:2015
Clause
in TCVN ISO 13485:2017
Clause
in TCVN ISO 9001:2015
1 Scope
4.1.1 (No title)
1 Scope
4.3 Determining the scope of
the quality management system
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4. Context of the organization
4.1 Understanding the
organization and its context
4.2 Understanding the needs
and expectations of interested parties
4.4 Quality management
system and its processes
4.1 General requirements
4.4 Quality management
system and its processes
8.4 Control of externally
provided processes, products and services
4.2 Documentation
requirements
7.5 Documented information
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7.5.1 General
4.2.2 Quality manual
4.3 Determining the scope of
the quality management system
4.4 Quality management
system and its processes
7.5.1 General
4.2.3 Medical device file
(No equivalent clause)
4.2.4 Control of documents
7.5.2 Creating and updating
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4.2.5 Control of records
7.5.2 Creating and updating
7.5.3 Control of documented
information
5. Management responsibility
5. Leadership
5.1 Management commitment
5.1 Leadership and
commitment
5.2 Customer focus
5.1.2 Customer focus
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5.2 Policy
5.2.1 Establishing the
quality policy
5.2.2 Communicating the
quality policy
5.4 Planning
6. Planning
5.4.1 Quality objectives
6.2 Quality objectives and
planning to achieve them
5.4.2 Quality management
system planning
6. Planning
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6.3 Planning of changes
5.5 Responsibility,
authority and communication
5 Leadership
5.5.1 Responsibility and
authority
5.3 Organizational roles,
responsibilities and authorities
5.5.2 Management
representative
5.3 Organizational roles,
responsibilities and authorities
5.5.3 Internal
communication
7.4 Communication
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9.3 Management review
5.6.1 General
9.3.1 General
5.6.2 Review input
9.3.2 Management review
inputs
5.6.3 Review output
9.3.3 Management review
outputs
6 Resource management
7.1 Resources
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7.1.1 General
7.1.2 People
6.2 Human resources
7.2 Competence
7.3 Awareness
6.3 Infrastructure
7.1.3 Infrastructure
6.4 Work environment and
contamination control
7.1.4 Environment for the
operation of processes
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8 Operation
7.1 Planning of product
realization
8.1 Operational planning
and control
7.2 Customer-related
processes
8.2 Requirements for
products and services
7.2.1 Determination of
requirements related to product
8.2.2 Determining the
requirements for products and services
7.2.2 Review of
requirements related to product
8.2.3 Review of the
requirements for products and services
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7.2.3 Communication
8.2.1 Customer
communication
7.3 Design and development
8.3 Design and development
of products and services
7.3.1 General
8.3.1 General
7.3.2 Design and development
planning
8.3.2 Design and
development planning
7.3.3 Design and
development inputs
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7.3.4 Design and
development outputs
8.3.5 Design and
development outputs
7.3.5 Design and
development review
8.3.4 Design and
development controls
7.3.6 Design and
development verification
8.3.4 Design and
development controls
7.3.7 Design and
development validation
8.3.4 Design and
development controls
7.3.8 Design and
development transfer
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7.3.9 Control of design and
development changes
8.3.6 Design and
development changes
8.5.6 Control of changes
7.3.10 Design and
development files
7.5.3 Control of documented
information
7.4 Purchasing
8.4 Control of externally
provided processes, products and services
7.4.1 Purchasing process
8.4 Control of externally
provided processes, products and services
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8.4.2 Type and extent of
control
7.4.2 Purchasing
information
8.4.3 Information for
external providers
7.4.3 Verification of
purchased product
8.4.2 Type and extent of
control
8.4.3 Information for
external providers
8.6 Release of products and
services
7.5 Production and service
provision
8.5 Production and service
provision
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8.5.1 Control of production
and service provision
7.5.2 Cleanliness of
product
No equivalent clause
7.5.3 Installation
activities
No equivalent clause
7.5.4 Servicing activities
No equivalent clause
7.5.5 Particular requirements
for sterile medical devices
No equivalent clause
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8.5.1 Control of production
and service provision
7.5.7 Particular
requirements for validation of processes for sterilization and sterile
barrier system
No equivalent clause
7.5.8 Identification
8.5.2 Identification and
traceability
7.5.9 Traceability
8.5.2 Identification and
traceability
7.5.10 Customer property
8.5.3 Property belonging to
customers or external providers
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8.5.4 Preservation
7.6 Control of monitoring
and measuring equipment
7.1.5 Control of monitoring
and measuring equipment
8 Measurement, analysis and
improvement
9. Performance evaluation
9.1 Monitoring, measurement,
analysis and evaluation
8.1 General
9.1.1 General
8.2 Monitoring and
measurement
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8.2.1 Feedback
8.5.5 Post-delivery
activities
8.2.2 Complaint handling
9.1.2 Customer satisfaction
8.2.3 Reporting to
regulatory authorities
8.5.5 Post-delivery
activities
8.2.4 Internal audit
9.2 Internal audit
8.2.5 Monitoring and
measurement of processes
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8.2.6 Monitoring and
measurement of product
8.6 Release of products and
services
8.3 Control of
nonconforming product
8.7 Control of
nonconforming outputs
8.3.1 General
10.2 Nonconformity and
corrective action
8.3.2 Actions in response
to nonconforming product detected before delivery
8.7 Control of
nonconforming outputs
8.3.3 Actions in response
to nonconforming product detected after delivery
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8.4 Analysis of data
9.1.3 Analysis and
evaluation
8.5 Improvement
10. Improvement
8.5.1 General
10.1 General
10.3 General
8.5.2 Corrective action
10.2 Nonconformity and
corrective action
8.5.3 Preventive action
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6.1 Actions to address
risks and opportunities
10.1 General
10.3 Continual improvement
Table
B.2 - Correspondence between TCVN ISO 9001:2015 and TCVN ISO 13485:2017
Clause
in TCVN ISO 9001:2015
Clause
in TCVN ISO 13485:2016
1 Scope
1 Scope
4 Context of the
organization
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4.1 Understanding the
organization and its context
4.1 General requirements
4.2 Understanding the needs
and expectations of interested parties
4.1 General requirements
4.3 Determining the scope of
the quality management system
4.1 General requirements
4.2.2 Quality manual
4.4 Quality management
system and its processes
4.1 General requirements
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5 Management responsibility
5.1 Leadership and
commitment
5.1 Management commitment
5.1.1 General
5.1 Management commitment
5.1.2 Customer focus
5.2 Customer focus
5.2 Policy
5.3 Quality policy
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5.3 Quality policy
5.2.2 Communicating the
quality policy
5.3 Quality policy
5.2.3 Organizational roles,
responsibilities and authorities
5.4.2 Quality management
system planning
5.5.1 Responsibility and
authority
5.5.2 Management representative
6 Planning
5.4.2 Quality management
system planning
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5.4.2 Quality management
system planning
8.5.3 Preventive action
6.2 Quality objectives and
planning to achieve them
5.4.1 Quality objectives
6.3 Planning of changes
5.4.2 Quality management
system planning
7 Support
6 Resource management
7.1 Resources
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7.1.1 General
6.1 Provision of resources
7.1.2 People
6.2 Human resources
7.1.3 Infrastructure
6.3 Infrastructure
7.1.4 Environment for the
operation of processes
6.4.1 Work environment
7.1.5 Control of monitoring
and measuring equipment
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7.1.5.1 Measurement
traceability
7.6 Control of monitoring
and measuring equipment
7.1.6 Organizational
knowledge
6.2 Organizational
knowledge
7.2 Competence
6.2 Human resources
7.3 Awareness
6.2 Human resources
7.4 Communication
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7.5 Documented information
4.2 Documentation
requirements
7.5.1 General
4.2.1 General
7.5.2 Creating and updating
7.5.3 Control of documented
information
4.2.3 Medical device file
4.2.4 Control of documents
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7.3.10 Design and
development files
8 Operation
7 Product realization
8.1 Operational planning
and control
7.1 Planning of product
realization
8.2 Requirements for
products and services
7.2 Customer-related
processes
8.2.1 Customer
communication
7.2.3 Communication
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7.2.1 Determination of
requirements related to product
8.2.3 Review of the
requirements for products and services
7.2.2 Review of
requirements related to product
8.2.4 Changes to
requirements for products and services
7.2.2 Review of
requirements related to product
8.3 Design and development
of products and services
7.3 Design and development
8.3.1 General
7.3.1 General
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7.3.2 Design and
development planning
8.3.3 Design and
development inputs
7.3.3 Design and
development inputs
8.3.4 Design and
development controls
7.3.5 Design and
development review
7.3.6 Design and
development verification
7.3.7 Design and
development validation
7.3.8 Design and
development transfer
8.3.5 Design and
development outputs
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8.3.6 Design and
development changes
7.3.9 Control of design and
development changes
8.4 Control of externally
provided processes, products and services
4.1 General requirements
(see 4.1.5)
7.4.1 Purchasing process
8.4.1 General
7.4.1 Purchasing process
8.4.2 Type and extent of
control
4.1 General requirements
(see 4.1.5)
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7.4.3 Verification of
purchased product
8.4.3 Information for
external providers
7.4.2 Purchasing
information
7.4.3 Verification of
purchased product
8.5 Production and service
provision
7.5 Production and service
provision
8.5.1 Control of production
and service provision
7.5.1 Control of production
and service provision
7.5.6 Validation of
processes for production and service provision
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7.5.8 Identification
7.5.9 Traceability
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
8.5.5 Post-delivery
activities
7.5.1 Control of production
and service provision
7.5.3 Installation
activities
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8.2.2 Complaint handling
8.2.3 Reporting to
regulatory authorities
8.3.3 Actions in response
to nonconforming product detected after delivery
8.5.6 Control of changes
7.3.9 Control of design and
development changes
8.6 Release of products and
services
7.4.3 Verification of
purchased product
8.2.6 Monitoring and
measurement of product
8.7 Control of
nonconforming outputs
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9 Performance evaluation
8 Measurement, analysis and
improvement
9.1 Monitoring,
measurement, analysis and evaluation
8 Measurement, analysis and
improvement
9.1.1 General
8.1 General
8.2.5 Monitoring and
measurement of processes
8.2.6 Monitoring and
measurement of product
9.1.2 Customer satisfaction
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8.2.1 Feedback
8.2.2 Complaint handling
9.1.3 Analysis and
evaluation
8.4 Analysis of data
9.2 Internal audit
8.2.4 Internal audit
9.3 Management review
5.6 Management review
9.3.1 General
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9.3.2 Management review
inputs
5.6.2 Review input
9.3.3 Management review
outputs
5.6.3 Review output
10 Improvement
8.5 Improvement
10.1 General
8.5.1 General
10.2 Nonconformity and
corrective action
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8.5.2 Corrective action
10.3 Continual improvement
5.6.1 General
8.5 Improvement
Bibliography
[1] TCVN ISO 9001:2015, Quality
management systems - Requirements
[2] TCVN ISO 10012, Measurement
management systems - Requirements for measurement processes and measuring
equipment
[3] TCVN 7394-1:2008 (ISO
11607-1:2006), Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems
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[5] TCVN 8664 (ISO 14644)
(all parts), Cleanrooms and associated controlled environments
[6] ISO 14698 (all parts), Cleanrooms and
associated controlled environments - Biocontamination control
[7] TCVN 8023:2009 (ISO
14971:2007), Medical devices - Application of risk management to medical
devices
[8] TCVN ISO 19011 (ISO
19011), Guidelines for auditing management systems
[9] IEC 62366-1, Medical device - Part 1:
Application of usability engineering to medical devices
[10] GHTF/SG5/N055:2009, Definition of the
Term “Manufacturer”, “Authorized Representative”, “Distributor”
and “Importer”
[11] GHTF/SG5/N4:2010, Post- Market clinical
follow - up studies
[12] GHTF/GS1/N70:2011, Label and
instructions for use for medical devices
[13] GHTF/SG1/N071:2012, Definition of the
terms “Medical device” and “In vitro diagnostic medical device”
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