Applicable definitions are included in documented procedures and instructions throughout to enhance the understanding of the process. In addition to the terms and definitions listed in ISO, also included are Implementation terms, Auditing terms, AS9100, ISO 13485 🚧 and Other/QMS terms:
ISO
International organization for Standardization
Standards
Benchmarks in quality
Asset Inventory
A compiled list of everything an organization has in it's possession, from it's database and technology to items used in operations.
Management
Control of resources, systems and processes, and other aspects of the organization that require monitoring.
Management System
A process that organizations use to set-up and organize policies, objectives and more.
Management Review Meetings
Required to evaluate the QMS and it's success and areas in need of improvement.
Policy
Documents that include information about a set of standards
Process
Set of tasks that are completed to work towards a goal.
Process Approach
How management plans strategies to improve processes.
Process-Based QMS
Processes integrated within the organization to improve quality.
Quality
Quality is measured both by the time and effort required to accomplish a tasks and the company's ability to meet quality standards.
Quality Management
Any activity being performed to maintain and improve quality. This can include establishing a quality policy, ensuring quality assurance, quality planning, etc.
Quality Management System (QMS)
The system by which an organization implements policies and objectives into the processes to help improve overall quality standards.
Quality Objective
The plan laid out to ensure that quality results are achieved properly.
Quality Policy
A document or statement showing the standards set by the organization to improve and maintain quality for customers, suppliers and employees.
System
Set of processes.
Context or Organization
Everything that is represented by the organization, including customer experience, work environment, values and mission, and performance.
Controlled Document Register
The controlled document register is compiled of all the organizations standard documents such as forms, policies, etc.
Customer Satisfaction
A reflection of the level of pleasure that has been received from a customer during their experience. Both short and long term satisfaction goals are to be achieved.
Defect
A non-conformity or issue that does not meet the established quality standards.
Design & Development
How resources are distributed within the organization
Determination
Finding and identifying values of data and what they represent.
Documentation
Documents that provide data related to systems and processes in addition to procedures related to job or department functions.
Document Control
Ensures only the most updated documents are being used and referred to at any given time.
Effectiveness
Determines how successful a plan or operation has been.
Feedback
Reflects a customer or employee's comments on either a product, service, or work environment.
Function
The role that is filled by a department.
Gap Analysis
An initial assessment into the organization's systems and processes to identify 'gaps' where standards may not be met.
Implement
Putting a system, process, procedure or plan into place.
Improvement
Continually bettering systems and processes to ensure highest quality.
Information Systems
Communication methods embedded in an organization.
Infrastructure
The operations or all departments that are run by the organization. This includes software, hardware, physical location.
Initial Assessment
The current status of an organization on their goals compliance (gap analysis).
Leadership
Top Management, QMS Representative, Management, Supervisors
Monitoring
A check of how processes are operating towards compliance with standards.
Objective
Goal set by the organization that has been planned for, with actionable items.
Operation
The internal and external systems within an organization.
Output
Software, Hardware, Processed Materials, Services
Planning
Creating actionable items within the QMS framework to achieve success.
Record Control
How the organization archives and controls their documents and records to make them available to management, employees and customers or other interested parties.
Regulatory Requirement
Task or action that is required from the organization to gain certification to a quality standard.
Requirements
Typically referred to the quality standards specifically - e.g. product requirements.
Risk
Calculating the difference in negative and positive features of a process.
Risk-Based Thinking
The method to determine how much risk is involved for a certain amount of gain.
Risk Assessment
Analyzes potential risks to the business and it's effects on both customers and employees. Can include a set of possible solutions to mitigate the risk.
Safeguard
A form of protection, specific to risk mitigation.
Scope
The area in which something is applicable .
Standard Form
A standard document used within the organization.
Strategy
How a person or organization plans to reach goals.
Support
Related to clause support - e.g. documentation, personnel, resources, etc.
Audit
An audit is a routine inspection performed by either internal employees or an external third-party auditor. The goal of audits is to ensure that your business is following standard requirements and to ultimately certify the company.
Audit Findings
The findings of an audit (both internal and external) are the outcome or results of an audit following completion.
Audit Evidence
Audit evidence is what is used to support the solutions taken from an audit. This can include documentation such as records, statements, and more.
Audit Criteria
The criteria of an audit is essentially a list of expectations the business must meet to pass the audit.
Audit Program
The audit program lists the details surrounding an audit, such as the time it will take place, frequency, etc. This program is usually developed between the auditor(s) and the QMS representative.
Objective Audit Evidence
This is saved information that is represented in the forms of documentation and records.
Outsource
Outsourcing is the action of requesting the aid of an external organization for specific tasks. As an example, businesses may bring in, or outsource, an auditor from an external source for audits.
Performance
Performance is a measure of how well or poorly a particular subject is doing in an area. An example of this would be how efficiently tasks are being completed based on the time, resources, and finances used.
Performance Indicator
This term refers to a tool that is used for gauging how satisfied customers are, as well as how often the outputs are coming to realization.
Periodic
Periodic refers to a time-frame in which something is done or completed. For example, audits are performed periodically to ensure the long-term success of an organization.
Review
Reviews usually come after assessments and are essentially an overview of how a particular process went. They can be both internal and external.
Accordance
If you are in accordance with the standard, it means that you have adequately or sufficiently conformed to its standards/requirements.
Certification
Gaining certification means that your organization has demonstrated compliance to the standards.
Competence
Competence describes a company that is able to meet the stndard requirements through its QMS or other processes.
Compliance
Similar to competence, compliance describes an organization that has successfully fulfilled a requirement for the standard. Also known as conformity.
Concession
A concession is a type of special approval given to release a nonconforming product or service to a customer.
Continual Improvement
This refers to the activities of a business that are driven towards the constant improvement or betterment of their internal systems and processes.
Corrective Action
This is a term that describes an action that needs to take place to improve processes to meet the standards. Corrective actions are often related to the term, continual improvement.
Non-Conformance
This is a term that is used to describe a process that does not meet a requirement set out by the standard.
Re-Certification Audit
These audits are done to ensure that all requirements are still being met and that there are no arising issues that have come up between audits. Re-certification audits usually take place every three years.
Verification
Verification is the final step in achieving certification, as it acknowledges that your organization has met the proper the standards to be granted accreditation.
Counterfeit Part
An unauthorized copy, imitation, substitute, or modified part such as material, part, component, which is knowingly misrepresented as a specified genuine part of an original or authorized manufacturer.
Critical Items
Those items such as functions, parts, software, characteristics, processes having significant effect on the provision and use of the products and services; including safety, performance, form, fit, function, producibility, service life, etc. that require specific actions to ensure they are adequately managed.
Key Characteristic
An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life, or producibility, that requires specific actions for the purpose of controlling variation.
Product Safety
The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.
Special Requirements
Those requirements identified by the customer, or determined by the organization, which have high risks of not being met, thus requiring their inclusion in the operational risk management process.
Innovation
This term reflects various changes that are made either through the standards and/or the organization. Innovation can be done in just about any area, such as customer service, customer satisfaction, products/services, resources, tools, methods, and more.
Involvement
When a group comes together to distribute ideas and resources to work towards a similar goal.
Interested Party
Interested parties are people that are concerned with helping in a decision or participating in a particular activity.
Knowledge
Knowledge reflects all data/information that has been compiled in a system, documents, or data, or known by a particular group or person.
Maintain
This refers to making sure consistency is in place, whether that be in customer satisfaction, profits, etc.
Measuring Equipment
Measuring equipment refers to all of the tools used by organizations to analyze data, including software, reference materials, and more.
Object - An object can be practically anything available to the organization, including:
Products
Services
Documents
Software
Hardware
Methods
Resources
Preservation
This term refers to keeping something as it was, and not allowing changes to affect it in any way.
Preventive Action
This kind of action is done pro-actively to address potential problems. An example of this is backing up certain files in case of an emergency.
Procedure
Procedures are how certain processes are performed to achieve a desired result, and documents how steps will be completed.
Property
This term refers to what is owned by an organization or an individual.
Product
The product of an organization is what is being sold to the customer. Products can be both tangible and intangible. Many factors make up the success of a product, including location, price, and quality.
Provider
A provider is a supplier of a particular product or service. They can be either external or internal, although external providers are more common. Triad always uses the language SUPPLIER.
Relevant
This is referring to what is important to a particular part of the process at a given time.
Release
This term refers to permission to send out information that aids in a process. This can come in many forms, like documentation and software.
Responsibility
This is a task or role assigned to an individual or department and consists of what they are accountable for.
Retain
This is a term that means “to keep.”
Sequence
A sequence is an order in which events occur.
Service
A service is an actionable task that is provided by an organization—or an external source, such as a supplier.
Supplier
A supplier is an individual or organization who provides businesses with either products, services, or both.
Traceability
This term is referring to the ability to be able to track down locations of products and services. It also refers to how these products or services are distributed.
DBA - Internal
ERP system software purchased and maintained in terms of release changes by a 3rd party provider. Used as 'shop control' and for many facets of product definition and development in conjunction with other systems, controlling raw material through invoicing.
ACCELO - Internal
CRM system software purchased and maintained in terms of release changes and support by 3rd party provider. Used to communicate both internally and externally for all facets of internal and external work and communication. Also controls certain aspects of case management such as non-conformances, unique order management and equipment tracking. Can be engineered to execute tasks and progress steps tailored to Triad's business model.
CalcuQuote - Internal
Quoting software purchased and maintained in terms of release changes and support by 3rd party provider. Used to quote all work.
Advisory Notice
notice issues by the 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
destruction of a medical device
As Appropriate
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 necessary for: requirement compliance, regulatory compliance, to carry out corrective action or to manage risks.
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
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
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
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
there may be more than one distributor in the supply chain
persons in the supply chain that store or transport on behalf of the manufacturer, importer or distributor are not distributors under this definition
Documented
If a requirement is to be 'documented' it is also required to be established, implemented and maintained.
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
this definition of implantable medical device includes active implantable medical device
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
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
Life-Cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
Manufacturer
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)
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 within that jurisdiction
the manufacturer's responsibility 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
'design and/or manufacture' as referred to in the above definition may include specifications 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 productions, together for a medical purpose
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
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
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
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
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, modifications, 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
products which may be considered to be medical devices in some jurisdictions but not in others include:
disinfection substances;
aids for persons with disabilities;
devices incorporating animal and/or human tissues;
devices for in vitro fertilization or assisted reproduction technologies
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
Performance Evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use
Post-Market Surveillance
systematic process to collect and analyze experience gained from medical devices that have been placed on the market
Product
result of a process
services;
service is the result of at lesat one activity necessarily performed at the interface between the supplier and customer and is generally tangible:
an activity performed on a customer-supplied tangible product (repair)
an activity performed on a customer-supplied intangible product (income statement for tax return)
the delivery of an intangible product (information, knowledge transmission)
the creation of ambience for the customer (hotels, restaurants)
software;
software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures
hardware;
hardware is generally tangible and its amount is a countable characteristic;
processed materials;
processed materials are generally tangible and their amount is a continuous characteristic
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 (an automobile contains all said categories)
This 'product' definition differs from the definition given in ISO 9001:2015
Purchased Product
product provided by a party outside the organization's quality management system
Risk
combination of the probability of occurrence of harm and the severity of that harm
the application of the term within the scope of ISO 13485 pertains to safety or performance requirements of the medical device or meeting regulatory requirements.
Risk Management
systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk
Regulatory Requirements
When this term is used, it encompasses requirements contained in any law applicable to the user of the ISO 13485 standard. The application of the term is limited to requirements for the QMS and the safety or performance of the medical device.
Sterile Barrier System
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use
Sterile Medical Device
medical device intended to meet the requirements for sterility