ISO & Management System Glossary
Clear, concise definitions of essential terms to help you speak the language of conformance with confidence.
Access Control
Security measures that restrict access to sensitive data and systems.
Example: A company enforces role-based access control to limit employees' access to confidential files.
Accreditation
Formal recognition by an authoritative body that an organization or individual meets the necessary standards for a specific function.
Example: A laboratory is accredited by a national body to perform chemical analysis, ensuring the reliability and accuracy of its test results.
Action Plan
A plan developed to address identified issues or opportunities for improvement, often resulting from an audit or risk assessment.
Example: After an internal audit reveals areas for improvement, the management team develops an action plan to implement corrective actions and prevent recurrence.
Annex A Controls
A set of security controls that help organizations mitigate information security risks.
Example: A company implements encryption and multi-factor authentication as part of Annex A controls.
Audit
A systematic, independent examination to determine whether activities and related results conform to planned arrangements.
Example: An external audit is performed on a company’s QMS to ensure that it adheres to ISO 9001 standards.
Audit Criteria
The set of policies, procedures, or requirements used as the basis for evaluating audit evidence.
Example: The audit criteria for evaluating a medical device company’s QMS include conformance with ISO 13485 and relevant FDA regulations.
Audit Evidence
Information used to support findings and conclusions during an audit.
Example: During an audit, the audit team examines training records and quality control data as evidence that processes meet the required standards.
Audit Findings
The results of an audit, indicating conformance or nonconformance to audit criteria.
Example: The audit findings show that the company’s internal processes comply with ISO 9001 but need improvement in supplier evaluation procedures.
Audit Plan
A document that outlines the scope, objectives, and procedures of an audit.
Example: The audit plan for the ISO 9001 audit includes the areas to be reviewed, the timeline, and the audit team responsibilities.
Benchmarking
Comparing an organization’s processes or products to industry best practices to identify areas for improvement.
Example: A company compares its customer service response times with those of leading competitors to identify areas for improvement.
Best Practice
A method or technique that has consistently shown superior results compared to other methods.
Example: A company adopts a best practice approach to reduce machine downtime by implementing predictive maintenance techniques.
Calibration
The process of adjusting and verifying measurement instruments to ensure their accuracy.
Example: A thermometer used in a lab is calibrated against a known standard to ensure accurate temperature readings.
Calibration Certificate
A document that provides traceability of a measuring instrument to national or international standards.
Example: A laboratory maintains calibration certificates for all measurement devices used in testing.
CAPA (Corrective and Preventive Action)
Systematic approaches to addressing root causes of nonconformities and preventing recurrence.
Example: After a customer complaint, a corrective action is taken to fix the production process, while a preventive action is implemented to avoid future issues.
Capable Process
A process that is consistently able to meet product or service specifications and quality standards.
Example: A manufacturing process is considered capable if it consistently produces components within the specified tolerances.
Carrying Capacity
The ability of a system (e.g., environmental, process) to handle a certain load without failure.
Example: A factory assesses the carrying capacity of its waste management system to handle increasing production volumes.
Certification
The formal process by which an organization is verified to meet the requirements of a specified standard.
Example: A company receives ISO 9001 certification after successfully completing an external audit confirming that its QMS meets all requirements.
Change Control
The systematic approach to managing changes to processes, products, or systems.
Example: The engineering team follows a change control process when making modifications to the design of a product to ensure that all changes are documented and evaluated.
Clean Room
A controlled environment that limits the introduction of contaminants, often used in industries such as aerospace or medical devices.
Example: A medical device manufacturer uses a clean room to assemble sterile products, preventing contamination during the production process.
Client Satisfaction
A measure of how well an organization’s products or services meet or exceed customer expectations.
Example: After product delivery, the company sends out surveys to gauge customer satisfaction with product quality and delivery time.
Competence
The demonstrated ability to apply knowledge and skills to achieve intended outcomes.
Example: Employees are assessed for competence based on their ability to perform tasks according to company standards and regulations.
Competent Authority
An organization or body authorized to enforce laws, regulations, or standards (MDSAP, FDA QSR).
Example: A competent authority, such as the FDA, may audit a medical device manufacturer to ensure compliance with regulatory requirements.
Compliance
The act of conforming to regulations, standards, and requirements.
Example: A company ensures compliance with ISO 14001 by implementing practices that minimize its environmental impact.
Context of the Organization
The external and internal factors that can impact an organization's ability to achieve its intended results under ISO 9001.
Example: A company evaluates its regulatory environment and market trends as part of its strategic planning under ISO 9001.
Counterfeit Parts Prevention
Processes put in place to ensure that counterfeit or suspected counterfeit parts are not used in aerospace and defense applications.
Example: A supplier requires certificates of authenticity for all aerospace components to prevent counterfeit parts from entering production.
Design History File (DHF)
A compilation of records that describe the design and development process of a medical device, demonstrating compliance with design control requirements.
Example: A medical device manufacturer maintains a DHF that includes design inputs, verification testing, and risk analysis reports.
Device History Record (DHR)
A set of records that demonstrates a medical device was manufactured according to the DMR and meets regulatory requirements.
Example: The DHR contains batch records showing that each product passed final inspection before distribution.
Device Master Record (DMR)
A collection of documents that specify all manufacturing, inspection, labeling, packaging, and maintenance requirements for a finished medical device.
Example: The DMR for a surgical instrument includes sterilization protocols and component material specifications.
Document Control
The process of managing and ensuring the accuracy, availability, and consistency of documents in a quality management system.
Example: A company has a document control system that tracks revisions to its standard operating procedures and ensures employees have access to the most up-to-date documents.
Due Diligence
The process of investigating and verifying information about a product, service, or business before making decisions or entering into contracts.
Example: Before acquiring another company, a firm conducts due diligence to assess the company’s financial health, market position, and compliance with regulations.
Emergency Preparedness and Response
Plans and procedures for responding to workplace emergencies.
Example: A hospital establishes an emergency preparedness plan for handling chemical spills.
Environmental Aspect
An element of an organization’s activities that can interact with the environment.
Example: A factory's emissions are an environmental aspect that could impact air quality.
Environmental Impact
Any change to the environment, whether adverse or beneficial, resulting from an organization’s activities.
Example: A company switching to renewable energy reduces its environmental impact.
Environmental Management System (EMS)
A structured framework that enables an organization to improve its environmental performance through consistent processes.
Example: A manufacturing plant establishes an EMS to monitor waste disposal and reduce energy consumption.
Environmental Performance
Measurable results of an organization's management of its environmental aspects.
Example: A factory tracks its carbon emissions and water usage to measure its environmental performance.
Evidence-Based Decision Making
The process of making decisions based on the analysis of objective data and evidence.
Example: A company uses customer feedback and performance metrics to make decisions about product improvements.
External Audit
An audit conducted by a third-party organization to assess the conformity of an organization’s system to a specific standard.
Example: An external auditor visits a company to verify that it meets ISO 9001 requirements.
FAI (First Article Inspection)
A formal process of verifying that the first product manufactured in a production run conforms to required specifications.
Example: A supplier conducts a First Article Inspection to verify that their first batch of a new component meets all design and specification requirements.
Failure Mode
A defect or failure in a product, process, or system that can lead to an undesired outcome.
Example: A failure mode in a manufacturing process could be a machine malfunction that causes a product to be produced with incorrect dimensions.
Feedback
The process of providing information about the results of a process or action, typically used for continuous improvement.
Example: After an audit, feedback is provided to management on areas where the company’s processes are non-compliant with ISO 9001 standards.
Gap Analysis
The process of comparing an organization’s current processes, systems, or practices to the requirements of a standard, identifying areas of nonconformance or improvement.
Example: A company conducts a gap analysis to identify discrepancies between their current practices and the requirements of ISO 13485 before pursuing certification.
Good Manufacturing Practice (GMP)
A system for ensuring that products are consistently produced and controlled according to quality standards.
Example: A pharmaceutical manufacturer adheres to GMP guidelines to ensure that all products are produced consistently and meet regulatory requirements.
Hazard Identification
The process of identifying potential sources of harm or adverse effects in a process, system, or workplace.
Example: A construction company conducts hazard identification to pinpoint risks associated with heavy machinery on-site.
Health and Safety Management System (HSMS)
A system that ensures an organization’s processes are conducted in a way that minimizes health and safety risks.
Example: A company implements an HSMS to ensure that employees are trained on safety procedures and that hazards are properly controlled in the workplace.
Human Error
A mistake made by an individual or group that can impact the outcome of a process.
Example: Human error occurs when a technician forgets to calibrate a machine, leading to product defects.
Information Security Risk Assessment
The process of identifying, analyzing, and evaluating risks to information security.
Example: An IT department conducts a risk assessment to identify vulnerabilities in the company's network security.
Inspection
The act of examining a product or system to ensure it meets specified criteria or standards.
Example: A quality control team performs an inspection on finished products to ensure they meet the required specifications before shipment.
Interested Party
Any person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity.
Example: Customers, suppliers, and regulatory agencies are considered interested parties when defining the scope of a quality management system.
Job Safety Analysis (JSA)
A technique used to identify and mitigate potential hazards associated with specific jobs or tasks.
Example: A construction team conducts a JSA before beginning work on a new site to ensure that all potential hazards, such as falling objects and machinery malfunctions, are addressed.
Key Performance Indicator (KPI)
A measurable value that demonstrates how effectively an organization is achieving its key objectives.
Example: A manufacturing company uses KPIs to track production efficiency, such as the number of units produced per hour, aiming to optimize operations.
Knowledge Management
The process of capturing, distributing, and using knowledge within an organization to improve decision-making and performance.
Example: A company creates a knowledge base that stores best practices and lessons learned, ensuring that all employees have access to useful resources.
Leadership
The action of guiding and directing an organization or team toward achieving goals.
Example: The CEO’s leadership ensures that the organization’s vision and strategic objectives are clearly communicated and aligned with operational activities.
Lean Manufacturing
A production methodology focused on minimizing waste and improving efficiency.
Example: A company adopts lean manufacturing principles by reducing the time spent on machine setup and increasing throughput without adding additional resources.
Life Cycle Perspective
Considering the environmental impacts of a product or service throughout its entire life cycle.
Example: A packaging company assesses the recyclability of its materials as part of its life cycle perspective.
Lifecycle Management
The management of a product from its inception to its disposal, with a focus on optimizing efficiency and minimizing waste.
Example: A manufacturer adopts lifecycle management to ensure that products are designed for longevity and recyclability.
Management Review
A formal process in which top management evaluates the performance of the QMS and makes decisions for continuous improvement.
Example: At a quarterly management review, senior leadership reviews audit results, customer feedback, and process performance to ensure the QMS remains effective.
Materiality
The significance of an issue or data point, often used in the context of audits or risk management.
Example: In the audit of a financial system, materiality helps auditors determine whether certain discrepancies are significant enough to impact financial statements.
MDSAP (Medical Device Single Audit Program)
A program allowing medical device manufacturers to undergo a single audit that meets the regulatory requirements of multiple countries.
Example: A medical device company participates in MDSAP, allowing it to streamline its certification process for markets in the U.S., Canada, Japan, Brazil, and Australia.
Measurement Uncertainty
A parameter that quantifies the doubt in the result of a measurement.
Example: A laboratory calculates measurement uncertainty to ensure confidence in its test results.
Medical Device File (MDF)
A required collection of records under ISO 13485 that includes device specifications, manufacturing and testing procedures, and risk management documentation.
Example: The MDF for a diagnostic device includes biocompatibility test reports and clinical trial data.
Noise
Unwanted fluctuations or disturbances that interfere with the accuracy or quality of measurements or processes.
Example: A laboratory must ensure that external noise, such as electrical interference, does not distort the results of sensitive measurements.
Nonconformity
A failure to meet a required specification or standard, often identified through audits or inspections.
Example: A nonconformity is identified during an audit when a batch of products fails to meet the agreed-upon dimensions and is deemed unfit for delivery.
NQA-1
A quality assurance standard for nuclear facilities to ensure safety and compliance with regulatory requirements.
Example: A nuclear plant uses NQA-1 guidelines to implement stringent controls over its design and maintenance processes to ensure safety and reliability.
Observation
An audit finding that is not a nonconformity but may indicate a potential issue for improvement.
Example: During an audit, an observation is made that employees are not fully trained on the latest software, suggesting a need for additional training programs.
Occupational Health and Safety (OH&S) Management System
A framework for managing health and safety risks in the workplace.
Example: A construction firm implements an OH&S system to reduce workplace injuries.
Operational Efficiency
The ability of an organization to deliver its products or services in the most cost-effective manner while maintaining quality.
Example: An organization improves operational efficiency by automating key processes, reducing production costs while maintaining product quality.
Outsourcing
The practice of obtaining goods or services from an external provider instead of producing them internally.
Example: A company outsources its IT support to an external firm to ensure better service management and cost-efficiency.
Post-Market Surveillance (PMS)
A systematic process for monitoring and analyzing the safety and performance of a medical device after it has been released to market.
Example: A company collects and analyzes customer complaints as part of its PMS activities.
Process Approach
A systematic approach to managing activities as processes that function as a coherent system.
Example: A manufacturer adopts a process approach by linking production, quality control, and customer feedback into a single workflow.
Process Validation
A documented method of proving that a manufacturing or control process consistently produces a product that meets predetermined specifications.
Example: A medical device company validates its sterilization process to ensure conformance with ISO 13485.
Product Safety
The assurance that a product does not pose unacceptable risks during its intended use.
Example: An aerospace company implements rigorous testing and failure analysis to ensure product safety in aircraft components.
Proficiency Testing
A way of assessing a laboratory’s performance by comparing its results with those of other laboratories.
Example: A lab participates in a round-robin test to verify its accuracy in chemical analysis.
Quality Assurance (QA)
The systematic approach to ensuring the quality of products and services meets specified requirements.
Example: QA processes in a food manufacturing plant ensure that all products are consistently tested and meet health and safety standards.
Quality Control (QC)
Techniques and activities aimed at achieving product quality through inspection, testing, and validation.
Example: A manufacturing company uses QC checks at various stages of production to ensure that all components meet the specified quality standards before final assembly.
Quality Management System (QMS)
A system that defines the policies, processes, and resources needed to ensure an organization’s products or services meet customer and regulatory requirements.
Example: A company implements a QMS to ensure its processes meet customer specifications and comply with industry standards like ISO 9001.
Regulatory Compliance
Ensuring that processes, products, or services adhere to relevant laws, regulations, and standards.
Example: A pharmaceutical company ensures regulatory compliance by following FDA guidelines and conducting regular audits to verify adherence to GMP.
Risk Assessment
The process of identifying, evaluating, and mitigating risks that could impact an organization’s ability to meet its objectives.
Example: A company conducts a risk assessment to identify potential cybersecurity threats to its data management system and implements measures to mitigate those risks.
Risk Management File (RMF)
A collection of documents that provide evidence of a systematic risk management process in conformance with ISO 14971.
Example: The RMF for an implantable device includes failure mode analysis and mitigation strategies.
Root Cause Analysis
The process of identifying the primary cause of a nonconformity or failure, rather than just treating its symptoms.
Example: A manufacturer conducts a root cause analysis after discovering a recurring defect in a product, leading to the identification of a flaw in the production machinery.
Special Requirements
Requirements identified by customers or regulations that are critical for product safety and performance.
Example: A defense contractor establishes additional inspection steps to meet the special requirements of military contracts.
Stakeholder
Any individual or group that has an interest in the outcome of an organization’s activities.
Example: Employees, customers, and shareholders are all stakeholders in a company, each with specific interests in the company’s performance.
Standard Operating Procedure (SOP)
A document that outlines the steps to be followed in specific processes to ensure consistency and conformance.
Example: A hospital develops SOPs for all medical procedures to ensure that staff follow consistent, safe, and effective practices.
Sustainability
The practice of ensuring that activities are conducted in a way that does not deplete resources or harm future generations.
Example: A company adopts sustainability practices by reducing energy consumption in its manufacturing process and increasing the use of recycled materials.
Targeted Risk Assessment
A risk assessment focused on identifying and managing specific risks in a particular area, often used in regulatory and safety-critical industries.
Example: A medical device company might conduct a targeted risk assessment to evaluate the risks associated with a new product’s manufacturing process.
Technical File
A regulatory document that compiles all relevant information about a medical device’s design, development, and compliance with applicable standards.
Example: The technical file for an orthopedic implant includes clinical evaluation reports and product labeling requirements.
Total Quality Management (TQM)
A management approach focused on continuous improvement across all aspects of an organization, emphasizing customer satisfaction and employee involvement.
Example: A manufacturing company implements TQM principles to improve both product quality and worker satisfaction, leading to reduced defects.
Traceability
The ability to trace the history, application, or location of an object or activity through recorded documentation.
Example: A company uses traceability to ensure that each component in their supply chain is linked to specific quality checks and batch records.
Urgent Nonconformity
A nonconformity that requires immediate corrective action due to its critical impact on product safety, quality, or conformance.
Example: A pharmaceutical company identifies an urgent nonconformity when a batch of drugs is found to be contaminated, triggering an immediate recall.
User Requirements
The needs and expectations of the end users or customers that a product or service must meet.
Example: A software company conducts a user requirements analysis to understand the needs of customers who will use their new application, ensuring it meets functionality expectations.
Validation
The process of confirming that a product, service, or system meets predefined specifications and performs as expected under operational conditions.
Example: A company conducts a validation of their production process to ensure that the final product meets all quality standards before being released to customers.
Verification
The process of checking that a product, service, or system meets specific requirements, often during development or manufacturing.
Example: Before launching a new medical device, a manufacturer verifies that it meets all regulatory requirements and design specifications.
Waste Management
The process of managing the disposal, reduction, and recycling of waste materials to minimize environmental impact.
Example: An electronics manufacturer establishes a waste management program to reduce hazardous waste and improve recycling rates, ensuring compliance with environmental standards.
Workplace Hazard
A condition or situation in the workplace that has the potential to cause harm or injury.
Example: In a factory setting, a workplace hazard could include unguarded machinery that poses a risk of employee injury.
X-bar Chart
A type of control chart used to monitor the average value of a process over time, helping to detect variations and ensure consistent quality.
Example: A company uses an X-bar chart to monitor the consistency of a manufacturing process, such as measuring the diameter of a component in a machining operation.
Yield
The percentage of products or services produced that meet quality standards without defects.
Example: A factory calculates the yield of a production run by dividing the number of defect-free products by the total number of units produced, aiming to maximize yield and reduce waste.
Zero Defects
A quality management concept where the goal is to eliminate defects from a product or service entirely, emphasizing the importance of error-free performance.
Example: A company adopts the Zero Defects philosophy, striving to ensure that each item produced passes quality checks with no defects, leading to a significant reduction in rework and customer complaints.