A Preface
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ISO 13485-2016 “Medical equipment quality management system management requirements”

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The committee responsible for this document is the Technical Committee ISO/TC 210, Quality management of medical devices and corresponding general aspects.

The third edition of ISO 13485 eliminates and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which has been technically revised. It also incorporates the ISO 13485:2003 / Cor.1:2009 Technical Corrigendum. Annex A Outlines the changes incorporated into this edition as compared to the previous edition.

ISO 13485-2016 “Medical equipment quality management system management requirements”

Introduction
0.1 Overview
The requirements of this international standard specifies the quality management system, the quality management system to participate in medical equipment organization using one or more of the life stages, including medical equipment design and development, production, storage and distribution, installation, maintenance and final decommissioning and disposal, as well as the design and development, or provide related activities (such as technical support). Requirements of this standard can also be provided by to such organizations products (for example, raw materials, components, sub-components, medical equipment, sterilization services, calibration services, distribution services, maintenance services) supplier or other external parties. Suppliers or external parties may voluntarily choose to comply with the requirements of this standard or may require compliance through contracts.

Some jurisdictions have various roles to medical equipment in the supply chain organization application of quality management system with regulatory requirements. Therefore, this international standard requires organizations to:

– to determine its role under the requirements of applicable regulatory regulations;

– Determine the regulatory requirements applicable to the activities under these roles;

– Integrate these applicable regulatory requirements into its quality management system.

ISO 13485-2016 “Medical equipment quality management system management requirements”

Definitions in applicable regulatory requirements vary from country to country and region to region. Organizations need to understand how to interpret the definition in this international standard in terms of the regulatory definition in the jurisdiction where the medical device is supplied.

This international standard can also be used by internal and external parties, including certification bodies, to assess an organization’s ability to meet customer and regulatory requirements applicable to the quality management system, as well as the organization’s own requirements. It is important to emphasize that the quality management system requirements specified in this standard are complementary to the product technical requirements necessary to meet customer and applicable safety and performance regulatory requirements.

Using the quality management system is the organization’s strategic decisions. The design and implementation of an organization’s quality management system is affected by the following factors:

a) The organizational environment, changes in that environment, and the impact of the organizational environment on medical device compliance;

b) the different needs of the organization;

c) specific objectives of the organization;

D) group provides products;

e) processes adopted by the organization;

f) the size and organizational structure of the organization;

g) Regulatory requirements applicable to organizational activities.

ISO 13485-2016 “Medical equipment quality management system management requirements”

This standard is not intended to imply that different quality management systems structures need to be harmonized, documentation harmonized or documentation consistent with the clause structure of this Standard.

There are many types of medical devices, and some special requirements of this standard apply only to designated groups of medical devices. These groups defined in article 3.

0.2 Clarification of concepts
In this INTERNATIONAL standard, the following terms or phrases are used in the following contexts.

– when a requirement to use the language to be qualified “discretionary”, unless the group has other reasons, otherwise, the request is considered appropriate. If necessary, will is considered to be suitable.

– Products that meet the requirements;

– comply with the applicable management regulations;

– the organization that takes corrective action;

– risk management organization.

— When the term “risk” is used, the application of that term within the scope of this standard relates to the safety or performance requirements of medical devices or the fulfillment of applicable regulatory requirements.

— When requirements are “documented,” they also need to be established, implemented, and maintained.

ISO 13485-2016 “Medical equipment quality management system management requirements”

– When the term “product” is used, it can also mean “service”. The product applies to the output expected or requested by the customer, or any expected output resulting from the product realization process.

– When the term “regulatory requirements” is used, it includes requirements contained in any laws (such as statutes, regulations, regulations or directives) applicable to users of this International Standard. The application of the term “regulatory requirements” is limited to requirements for quality management systems and the safety or performance of medical devices.

In this standard, the following oral forms are used:

– “shall” indicates a request;

– “should” indicates a suggestion;

– “May” indicates permission;

– “Can” indicates a possibility or an ability.

ISO 13485-2016 “Medical equipment quality management system management requirements”

Information marked “note” to guide to understand or clarification regarding the requirements.

0.3 Process Approach
This standard based on the process of quality management methods. Any activity that receives an input and transforms it into an output can be viewed as a process. Often, the output of one process directly constitutes the input to the next process.

For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of process systems within an organization, as well as the identification and interaction of these processes, and their management to produce the desired results, can be referred to as the “process approach”.

When used in a quality management system, this approach emphasizes the importance of:

a) Understand and meet the requirements;

b) Considering the process in terms of added value;

C) to obtain the result of the process performance and effectiveness;

d) Improve the process based on objective measurement.

0.4 Relationship with ISO 9001
Although this is an independent standard, it is based on ISO 9001:2008, which has been replaced by ISO 9001:2015. Appendix B for the convenience of users, according to the international standards and ISO 9001:2015.

ISO 13485-2016 “Medical equipment quality management system management requirements”

This standard aims to promote worldwide consistency in the appropriate regulatory requirements for quality management systems that are applicable to organizations involved in one or more stages of the medical device life cycle. This standard includes involving medical equipment life cycle of organization of some special requirements, in addition to the ISO 9001 is not suitable for side by side as some of the requirements of regulatory requirements. Because of these, the quality management system in accordance with this international standard organizations cannot claim that conforms to ISO 9001, unless the meet all the requirements of ISO 9001 quality management system.

0.5 Compatibility with other management systems

This standard does not include requirements specific to other management systems, such as specific requirements for environmental management, occupational health and safety management or financial management. However, this international standard enables organizations to align or integrate their own quality management system with the relevant management system requirements. An organization may adjust its existing management system to establish a quality management system that meets the requirements of this international standard.

ISO 13485-2016 “Medical equipment quality management system management requirements”

1 Scope
This international standard specifies requirements for a quality management system in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. These organizations may be involved in one or more stages of the life cycle, including the design and development, production, storage and distribution, installation or service of medical devices and the design and development or provision of related activities (such as technical support). This standard may also be used by suppliers or external parties that provide products to such organizations, including services related to the quality management system.

Unless explicitly stated, the requirements of this standard apply to organizations regardless of their size and type. As long as the requirements are specified to apply to medical equipment, these requirements are equally applicable to the related services provided by the organization.

The processes required by this standard that are applicable to, but not performed by, an organization are the responsibility of the organization and are described in the organization’s quality management system through monitoring, maintaining and controlling the processes.

If applicable regulations allow the exclusion of the design and development control, it can be used as the reason out of the quality management system. These regulatory requirements can provide alternative approaches to be addressed in the quality management system. It is the responsibility of the organization to ensure that declarations of compliance with this standard reflect any exclusion of control over design and development.

ISO 13485-2016 “Medical equipment quality management system management requirements”

If the any article 6 and 7 or 8 of this standard requirement due to the organization to carry out the activities or the nature of the application of quality management system of medical equipment and is not applicable, the organization need to contain such requirements in the quality management system. For any provision determined to be inapplicable, the Organization will record the reasons stated in 4.2.2.

2 Normative references
The following documents in this document in whole or in part by normative references, is required for its application. For dated references, only the cited version applies. For undated references, the references of the new version (including any amendment) applies.

ISO 9000:20151, Quality management systems-basics and vocabulary

3 Terms and definitions

For the purpose of this document, the ISO 9000:2015 and under the terms of the given terms and definitions apply.

3.1 Notice of Consultation

A notice issued by the organization after the delivery of a medical device to provide supplementary information or make recommendations as to the action to be taken in respect of:

— Use of medical equipment,

— Modification of medical devices,

– Return the medical device to the organization that provided it, or

– Destruction of medical equipment

Note 1: Advisory notices may be required to comply with applicable regulatory requirements.

3.2 Authorized Representatives

A natural or legal person established within a country or jurisdiction has received a written authorization from the manufacturer to perform specific tasks on his behalf in relation to obligations imposed by the legislation of that country or jurisdiction

[source: GHTF/SG1 / N055:2009, 5.2]

3.3 Clinical Evaluation

ISO 13485-2016 “Medical equipment quality management system management requirements”

Evaluate and analyze clinical data related to medical devices to verify the clinical safety and performance of medical devices when used by manufacturers as intended

[Source: GHTF/SG5/ N4:2010, Article 4]

3.4 Complaints

Written, electronic, or oral communications alleging defects related to the characteristics, quality, durability, reliability, availability, safety, or performance of medical devices that are out of the organization’s control or related to services that affect the performance of such medical devices

Note 1: The definition of “complaint” is different from that in ISO 9000:2015.

3.5 Distributor

A natural or legal person in the supply chain, facilitating the supply of medical equipment to end users on their own behalf

Note 1: Multiple distributors may be involved in the supply chain.

Note 2: Persons in the supply chain involved in activities such as storage and transportation on behalf of manufacturers, importers or distributors are not distributors in this definition.

[Source: GHTF/SG1/ N055:2009, 5.3]

3.6 Implantable Medical Devices

Medical equipment that can only be removed by medical or surgical intervention and is intended to:

– wholly or partially introduced into the human body or natural orifice, or

– Replacement of the epithelial surface or eye surface, and

— At least 30 days after surgery

Note 1: the definition of implantable medical devices including active implantable medical devices

3.7 Importers

The first natural or legal person in the supply chain whose medical device is manufactured in another country or jurisdiction and made available in the country or jurisdiction where it is sold

[Source: GHTF/SG1/ N055:2009, 5.4]

3.8 Labels

ISO 13485-2016 “Medical equipment quality management system management requirements”

Labels, instructions for use, and any other information relating to the identification, technical instructions, intended purpose and proper use of the medical device, but excluding shipping documents

[Source: GHTF/SG1/ N70:2011, Article 4]

3.9 life cycle

All stages of the medical device life cycle, from initial concept to final decommissioning and disposal

[Source: ISO 14971:2007, 2.7]

3.10 Manufacturer

A natural or legal person responsible for the design and/or manufacture of the medical device with the intention of making the medical device available for use in his name; Whether such medical device designed by the person himself or on his behalf by others and/or manufacturing

Note 1: the “natural person or legal person” the final legal responsibility, to ensure compliance to provide or sales of medical equipment of country or jurisdiction all applicable regulatory requirements for medical devices, unless the jurisdictions of regulators (RA) with clear put the responsibility to others.

Note 2: Manufacturer’s responsibilities are described in other GHTF guidance documents. These duties include met listed before and after the listed requirements, such as adverse event reporting and corrective action notice.

Note 3: “Design and/or manufacture” as referred to in the above definition may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, re-labelling, sterilisation, installation or remanufacturing of medical devices; Or putting together a range of devices and possibly other products for medical purposes.

Note 4: Any person who assembs or modifies a medical device already provided by someone else for an individual patient in accordance with instructions for use is not a manufacturer, provided that the assembly or modification does not alter the intended use of the medical device.

Note 5: Any person who changes the intended use of a medical device or modifies a medical device without representing the original manufacturer and makes it available for use in his own name shall be deemed to be the manufacturer of the modified medical device.

ISO 13485-2016 “Medical equipment quality management system management requirements”

Note 6: Authorized representatives, distributors or importers are not considered as manufacturers if they only add their own address and contact details to the medical device or packaging without overwriting or changing the existing label.

Note 7: if the parts are in bondage to the regulatory requirements for medical devices are responsible for the design and/or manufacturing the accessories of personnel is regarded as manufacturers.

[Source: GHTF/SG1/ N055:2009, 5.1]

3.11 Medical devices

Instruments, devices, tools, machines, appliances, implants, reagents, software, materials or other similar or related articles for use in vitro by the manufacturer, individually or in combination, for human use for one or more of the following specific medical purposes:

Diagnosis, prevention, monitoring, treatment or reduce the disease;

– diagnosis, monitoring, treatment, or compensation for damage;

– investigation, replacement, modification or support of anatomical structures or physiological processes;

– to support or sustain life;

– control conception;

– Disinfection of medical instruments;

– providing information by performing in vitro examination of specimens from human subjects;

And it cannot achieve its main intended effect in or on the human body by pharmacological, immunological or metabolic means, but it can assist its intended function by these means

Note 1: Products that may be considered medical devices in some jurisdictions but not in others include: – disinfectant substances; – AIDS for persons with disabilities; – contains animal and/or human tissue equipment; – Equipment for in vitro fertilization or assisted reproductive technology.

[source: GHTF/SG1 / N071:2012, 5.1]

3.12 medical equipment series

ISO 13485-2016 “Medical equipment quality management system management requirements”

A group of medical devices manufactured by or for the same organization that share the same basic design and performance characteristics related to safety, intended use, and function

3.13 Performance evaluation

Evaluate and analyze data to determine or verify in vitro diagnostic medical device’s ability to achieve its intended use

3.14 Post-listing supervision

Collection and analysis from the market of medical apparatus and instruments of the experience gained in the system process

3.15 products

The outcome of the process

Note 1: there are four general categories, as follows: – services (such as transport); – software (e.g. computer programs, dictionaries); – hardware (e.g. engine mechanical parts); – processing materials (such as lubricant). Many products contain elements belonging to different general product category. Whether a product is called a service, software, hardware, or processed material depends on the dominant element. Provided products, for example, “car” by the hardware (such as tires), processing materials (e.g., fuel, coolant), software (such as engine control software, drivers manual) and services (for example, the sales staff give instructions).

Note 2: service is the need to perform on the interface between the supplier and customer at least an activity as a result, and is often invisible. For example, can provide service involves the following contents: – to provide tangible products (to repair cars, for example) the activity; – to the activities of customers with intangible products (such as preparing tax returns the profit and loss statement); – delivery of intangible products (for example, the transmission of information in the context of knowledge dissemination); – create atmosphere for customers (such as in hotels and restaurants). Software is composed of information, are often invisible, can be in the form of method, trading or program. Hardware is usually tangible and its quantity is a countable characteristic. The processed material is usually tangible and its quantity is a continuous feature. Is often referred to as commodity hardware and processed materials.

Note 3: The definition of “product” is different from that in ISO 9000:2015.

[source: ISO 9000:2005 2, 3.4.2, revision]

3.16 purchase of products

ISO 13485-2016 “Medical equipment quality management system management requirements”

Provided by one party outside of the organization quality management system of the product

Note 1: The provision of products does not necessarily infer commercial or financial arrangements.

3.17 Risks

The combination of the possibility of injuries and injury severity

Note 1: “risk” and the definition of the ISO 9000:2015 in the definition is different.

2.16] [source: ISO 14971:2007,

3.18 Risk management

The systematic application of management policies, procedures and practices to the task of analyzing, evaluating, controlling and monitoring risks

[Source: ISO 14971:2007, 2.22]

3.19 Sterile barrier system

ISO 13485-2016 “Medical equipment quality management system management requirements”

Minimum packaging that prevents entry of microorganisms and allows aseptic display of the product at the time of use

[Source: ISO 11607-1:2006, 3.22]

3.20 Sterile medical devices

Medical devices designed to meet sterility requirements

Note 1: Sterility requirements for medical devices may be subject to applicable regulatory requirements or standards.

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