FAQ's

ISO (International Organization for Standardization) is an international organization that develops and publishes International Standards.

ISO 9000 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.

ISO 14001 is an international standard that specifies the requirements to establish, implement, maintain and continually improve an Environmental Management System (EMS). ISO 14001 helps an organization to achieve the intended outcomes of its environmental management system and the value for the environment.

  • Enhances corporate image, credibility and competitiveness to get more business.
  • Improves environmental performance of organization and its supply chain.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Provides an opportunity to negotiate lower insurance premium due to effective management of environmental risks.
  • Improves environmental conditions and motivates employees.
  • Reduces cost associated with environmental accidents, injuries, ill-health and penalties.
  • Helps to conserve the natural resources and potentially reduces the cost associated with utilities, materials and waste.
  • Reduces cost of raw materials and supplies due to recycling programs.
  • Helps to identify environmental aspects, impacts and operational controls.
  • Potentially reduces audit frequency from regulators, customers and other interested parties.
  • Demonstrates “due diligence” to create legally defensible position against possible lawsuits.

 

ISO 45001 is an international standard that specifies the requirements to establish, implement, maintain and continually improve an Occupational Health and Safety Management System. ISO 45001 enables organizations to provide safe and healthy workplaces by improving their Occupational Health and Safety (OHS) performance and preventing work-related injury and ill health, as well as.

 

  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Provides an opportunity to negotiate lower insurance premium due to effective management of risks and hence less chances of accidents, injuries and ill-health.
  • Ensure consultation and participation of workers to create best possible working conditions.
  • Reduces/eliminates cost associated with penalties if implemented effectively.
  • Reduces the cost associated with accidents, injuries, ill-health and penalties.
  • Helps to integrate multiple health and safety programs under one umbrella.
  • Potentially reduces audit frequency from legal authorities and other interested parties.
  • Demonstrates “due diligence” to create a legally defensible position against possible lawsuits.

ISO 22301 is an international standard that specifies the requirements to establish, implement, maintain and continually improve a Business Continuity Management System (BCMS) to protect against, reduce the likelihood of the occurrence of, prepare for, respond to and recover from disruptions when they arise.

 

The purpose of a BCMS is to prepare for, provide and maintain controls and capabilities for managing an organization’s overall ability to continue to operate during disruptions.

 

Any organization, regardless of its type, size, products, and services can implement this standard. The extent of application of these requirements depends on the organization’s operating environment and complexity.

 

This document is applicable to all types and sizes of organizations that:

 

  • implement, maintain and improve a BCMS.
  • seek to ensure conformity with stated business continuity policy.
  • need to be able to continue to deliver products and services at an acceptable predefined capacity during a disruption.
  • seek to enhance their resilience through the effective application of the BCMS.

 

This standard can be used to assess an organization’s ability to meet its own business continuity needs and obligations.

  • Natural disaster
  • Technology failure
  • Utility disruption
  • Intentional sabotage
  • Cyber security attacks
  • Conducting business impact analysis
  • Preparing for potential emergencies
  • Establishing business continuity and recovery plan
  • Establishing security and protocols
  • Managing risk and crisis
  • Developing operational resilience
  •  
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Supports organizational objectives and improves its performance.
  • Improves operations, supply chain and information resilience.
  • Improves organizational capability to remain effective during disruptions.
  • Helps to establish robust response and recovery process.
  • Protects life, property and the environment.
  • Helps to meet the expectations of customers and other interested parties.
  • Addresses operational vulnerabilities and demonstrates effective control of risks.
  • Reduces direct and indirect costs of disruptions.
  • Protects assets, turnover and profits.
  • Potentially reduces insurance premium due to effective management of risk.
  • Reduces legal and financial risk if implemented effectively.
  •  
ISO 27001 certification is an international standard that specifies the requirements to establish, implement, maintain and continually improve an Information Security Management System (ISMS). The information security management system preserves the confidentiality, integrity, and availability of information by applying a risk management process and gives confidence to interested parties that risks are adequately managed. It also includes requirements for the assessment and treatment of information security risks tailored to the needs of the organization.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Satisfies the information security concerns of customers and other interested parties.
  • Demonstrates proactive control of information security risks effectively and efficiently.
  • Addresses information security vulnerabilities.
  • Helps to achieve information security objectives.
  • Provides guidelines to develop policies, procedures and processes on how to secure and exchange confidential information.
  • Demonstrates “due diligence” to create a legally defensible position against possible lawsuits.

ISO 22000 is an international standard that specifies the requirements to establish, implement, maintain and continually improve Food Safety Management System (FSMS). This standard also enables an organization that is directly or indirectly involved in the food chain:

  • To plan, implement, operate, maintain and update FSMS providing products and services that are safe in accordance with their intended use.
  • To demonstrate compliance with applicable statutory and regulatory requirements.
  • To evaluate, assess and comply to mutually agreed customer food safety requirements.
  • To effectively communicate food safety issues to interested parties within the food chain.
  • To ensure that the organization conforms to its food safety policy.
  • To demonstrate conformity to relevant interested parties.
  • To seek certification or registration of its FSMS by an external organization or make a self-assessment or self-declaration of conformity to this document.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Supports strategic objectives of an organization by improving performance of food safety.
  • Satisfies the food safety concerns of customers and other interested parties.
  • Demonstrates proactive control of food safety risks effectively and efficiently.
  • Addresses food safety vulnerabilities.
  • Helps to fulfill the compliance obligations.
  • Develops a culture of food safety.
  • Demonstrates conformity to specified FSMS requirements.
  • Provides the framework for effective communication with internal and external interested parties.
  • Identifies, assesses, and controls food safety hazards.
  • Provides greater consistency in output and traceability of products and services.
  • Customer recognition and approval, as well as the potential to penetrate in new markets.
  • Greater staff awareness about their responsibilities and compliance obligations.
  • Potentially reduces audit frequency from regulators and other interested parties.
ISO 9001 is an international standard that specifies the requirements to establish, implement, maintain and continually improve a Quality Management System (QMS). Organizations implement this standard to demonstrate their ability to consistently provide products and services that meet and exceed customer satisfaction. This is the world’s leading quality management standard and has been implemented by over one million organizations in over 170 countries.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Enhances quality performance by improving efficiency, effectiveness and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Reduces cost associated with defects, re-works, rejection, penalties, and recalls by doing the first time right.
  • Engages and motivates staff by implementing best quality practices.
  • Helps to establish and promote quality culture.
  • Provides guidelines to improve internal and external communications.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluation and management of suppliers.
ISO17025 specifies the general requirements for the competence, impartiality and consistent operation of laboratories to generate valid results.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Enhances quality performance by improving efficiency, effectiveness, and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Reduces cost associated with re-testing by doing the first time right.
  • Engages and motivates staff by implementing best testing/laboratory practices.
  • Helps to establish and promote quality culture.
  • Provides guidelines to improve internal and external communications.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluation and management of suppliers.
  • Demonstrates traceability of measurements and calibration services to international/national standards.

IATF 16949, coupled with the applicable Customer-Specific Requirements (CSRs), defines the quality management system requirements for automotive production, service and/or accessory parts. IATF 16949 requirements are fully aligned with the structure and requirements of ISO 9001. However, it is not a stand-alone document, but is implemented as a supplement to, and in conjunction with, ISO 9001, which must be purchased separately.

 

IATF 16949 was jointly developed by The International Automotive Task Force (IATF) members and the International Organization for Standardization (ISO).

 

IATF 16949 emphasizes the development of a process oriented quality management system that facilitates continual improvement, defect prevention and reduction of variation and waste in the supply chain. The goal is to meet customer requirements efficiently and effectively.

The IATF is a group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide.

All registered organizations are added to the IATF website of recognized organizations, a copy of their certificate information is contained within the site and can be verified at any stage. 

IATF Members

BMW Group

FCA US LLC

FCA Italy Spa

Ford Motor Company

Daimler AG

Renault

PSA Group

General Motors Company

Volkswagen AG

AIAG (US)

ANFIA (Italy)

FIEV (France)

SMMT (UK)

VDA QMC (Germany)

 

 



  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the Customer Specific Requirements (CSRs) of Original Equipment Manufacturer (OEM) and other interested parties.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Helps to achieve continual improvement, defect prevention and reduction of variation and waste in the automotive supply chain.
  • Reduces cost associated with defects, re-works, rejection, penalties, and recalls by doing the first time right.
  • Enhances quality performance by improving efficiency, effectiveness, and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Engages and motivates staff by implementing best quality practices.
  • Helps to establish and promote quality culture.
  • Provides guidelines to improve internal and external communications.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluation and management of suppliers.

 



The AS series of standards are the quality management systems standards applicable to organizations that supply to the aviation, space and defense industries. These standards incorporate ISO 9001 requirements in addition to industry specific requirements of aerospace.

This standard is intended for use by organizations that design, develop, or provide aviation, space, and defense products and services and by organizations providing post-delivery activities, including the provision of maintenance, spare parts, or materials for their own products and services.

 

This standard includes ISO 9001 quality management system requirements and specifies additional aviation, space, and defense industry requirements.

 

Note: Organizations whose products are deliverable software, or contain deliverable software, should use the IAQG-developed 9115 standard when planning and evaluating the software design, development, or management activities of the organization. The 9115 standard provides guidance to the requirements of the 9100 standards when it is desired to add “software” to the 9100 quality management system scope.

This standard is intended for use by organizations whose primary business is providing maintenance or continuing airworthiness management services for civil or military aviation articles and products and original equipment manufacturers with maintenance, repair, and overhaul operations that are operated autonomously, or that are substantially different from their production operations.

 

This standard includes ISO 9001 quality management system requirements and specifies additional aviation, space, and defense industry requirements.

This standard is intended for use by organizations that procure parts, materials, and assemblies and resells these products to a customer in the aviation, space, and defense industry should use. This includes organizations that procure products and split them into smaller quantities, as well as those that coordinate a customer or regulatory controlled process on the product.

 

This standard includes ISO 9001 quality management system requirements and specifies additional aviation, space, and defense industry requirements.

  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the requirements of customers in aviation, space, and defense industry.
  • Helps to meet the requirements of legal authorities and other interested parties.
  • Helps to achieve continual improvement, defect prevention and reduction of variation and waste in the aerospace supply chain.
  • Reduces cost associated with defects, re-works, rejection, penalties, and recalls by doing the first time right.
  • Enhances quality performance by improving efficiency, effectiveness, and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Engages and motivates staff by implementing best quality practices.
  • Helps to establish and promote quality culture.
  • Provides guidelines to improve internal and external communications.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluation and management of suppliers.
ISO 13485 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 (e.g. design and development, production, storage, distribution, installation, servicing, final decommissioning and disposal of medical devices) and design, development or provision of associated activities (e.g. technical support). The requirements of ISO 13485 can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices) and services (e.g. sterilization, calibration, distribution and maintenance services) to such organizations. The supplier or external party can voluntarily choose or as required by contract conform to the requirements of ISO 13485.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Helps to achieve continual improvement, defect prevention and reduction of variation and waste in the medical supply chain.
  • Reduces cost associated with defects, re-works, rejection, penalties, and recalls by doing the first time right.
  • Enhances quality performance by improving efficiency, effectiveness, and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Engages and motivates staff by implementing best quality practices.
  • Helps to establish and promote quality culture.
  • Provides guidelines to improve internal and external communications.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluation and management of suppliers.
ISO 21001 specifies requirements for a Management System for Educational Organizations (EOMS) when such an organization needs to demonstrate its ability to support the acquisition and development of competence through teaching, learning or research and/or aims to enhance satisfaction of learners, other beneficiaries and staff through the effective application of its EOMS, including processes for improvement of the system and assurance of conformity to the requirements of learners and other beneficiaries.
  • Enhances image, credibility and competitiveness of an educational institute.
  • Continually improves education system by stimulating excellence and innovation.
  • Motivates staff for active participation in learning and professional development.
  • Supports the acquisition and development of competence through teaching, learning and research.
  • Enhance satisfaction of learners, other beneficiaries and staff through improvement of processes and conformity to the requirements of learners and other beneficiaries.
  • Provides a framework to establish policies, procedures and processes for social responsibility, ethical conduct, accessibility and equity as a part of educational management system.
  • Provides guidelines for protection of data and information.
  • Enhanced social responsibility by providing inclusive and equitable quality education for all.
  • Demonstrates more personalized learning and effective response to all learners, in particular those with special education needs and distance learners.
  • Demonstrates and increases effectiveness and efficiency through consistent processes and evaluation tools.
  • Provides ability to demonstrate commitment to effective quality management practices.
  • Helps to develop a culture of quality and organizational improvement.
  • Harmonizes regional, national, open and proprietary standards within an international framework.
  • Extended participation of interested parties.
The CSA N299 series of Standards defines quality assurance program requirements for the provision of items and services for nuclear power plants when specified in the contract between the customer and the supplier. This Standard was developed in response to industry’s need for a quality assurance standard for items and services supplied to nuclear power plants.
CSA N299.4 specifies “Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 4.” Z299.4 is appropriate for mass-produced products or high volume services. It includes requirements for inspection, testing, nonconforming items, record retention and control of measurement and testing equipment.
CSA N299. 3 specifies “Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3.” Z299.3 is appropriate for products or services which involve complex processes and failure of the product could cause significant monetary cost or some risk to health and safety. It includes all requirements of Z299.4 plus additional requirements for control of procurement activities, control of documentation, traceability of items, control of packaging & shipping and a manual to document these activities.
CSA N299.2 specifies “Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 2.” Z299.2 is intended for products or services which require complex processes and technology and planning in production and verification of design. Failure of the product could cause high monetary cost or significant risk to health and safety. This standard includes all requirements of Z299.4 and Z299.3 plus additional requirements for control of manufacturing activities, control of handling and storage, a plan to deal with multiple inspections and tests, corrective action program to prevent repetition of errors and procedures to describe these activities.
CSA N299.1 specifies “Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 1.” Z299.1 is suitable for custom designed products or services with a high degree of technology. Failure in service could result in extremely high monetary loss or high risk to health and safety. It includes all requirements of Z299.4, Z299.3, and Z299.2 plus additional requirements of control of design activities through procedures and Independent audits on the quality assurance program.
  • Demonstrates the quality assurance program requirements for the provision of items and services to nuclear power plants.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Enhances quality performance by improving efficiency, effectiveness, and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Reduces cost associated with defects, re-works, rejection, penalties, and recalls by doing the first time right.
  • Helps to establish quality culture and motivates staff by implementing best quality practices.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluate and management of suppliers.

ISO 50001 specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The objective is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance and the EnMS.

 

What are the key benefits of ISO 50001?

  • Strengthens the competitiveness of organizations and reduces their vulnerability with respect to energy price fluctuation and availability of energy.
  • Reduces energy costs and improves profitability.
  • Enhances corporate image and credibility of the organization.
  • Provides a better understanding between predictable energy demand and supply.
  • A significant improvement of the energy performance level from an initial energy baseline.
  • Supports the development of an energy policy and an energy plan to achieve energy targets.
  • Creates awareness and a commitment in the organization about energy (i.e. consumption, use, efficiency, renewable sources).
  • Improves the ability of organizations to manage energy risks concerning possible impacts in an efficient and effective way.
  • Allows organizations to benchmarking processes and gain credible external visibility of energy saving actions.

 

R2 stands for Responsible Recycling and is a standard specifically created for the electronics recycling industry by Sustainable Electronics Recycling International (SERI). The R2 Standard provides a common set of criteria to recognize responsible reuse and recycling practices, all along the used portion of the electronics lifecycle. R2 Certification is the formal program for evaluating and monitoring businesses in meeting the R2 Standard, protecting of the environment, the health and safety of workers, and communities, and positively impacting the movement toward a sustainable circular economy while, enriching the lives of people all around the world.

 

Any organization, regardless of its size in electronics recycling industry can implement this standard to meet the requirements of its customers and other interested parties.

  • Reduces the amount of energy required to manufacture new products.
  • Diminishes the environmental risks associated with creating new products.
  • Produces optimal data destruction.
  • Decreases health risks for recycling specialists as well as the public.
  • Minimizes landfill waste.
  • Promotes safe and effective reuse and recovery of electronic equipment and components.
  • Emphasizes data security and the appropriate management of personal data.
  • Provides a template for standardized labelling, testing protocols, and grading of both functionality and cosmetic condition of used electronics with reuse potential or a verified resale market.
  • Ensures accountability and downstream control of the recycling chain.
  • Minimizes environmental and public health risks.
  • Demonstrates compliance with domestic and international laws.
  • Minimizes liability and encourages reduced insurance costs for recyclers.
  • Assists Original Equipment Manufacturers (OEMs) with due diligence for their end-of-life electronics.
  • Instills public confidence through certified third-party review.

 

COR is an occupational safety and health accreditation program that verifies a fully implemented safety and health management system which meets national standards. The objectives of COR are to provide industry employers with effective tools to develop, implement, assess, and promote continual improvement of their safety and health management system to prevent or mitigate incidents and injuries as well as their associated human and financial costs.

 

COR is nationally registered, trademarked and endorsed by the Canadian Federation of Construction Safety Associations (CFCSA) and is delivered through member associations that have a formal Memorandum of Understanding (MOU) to serve as the authority having jurisdiction to grant COR in their respective province/territory.

Each CFCSA member association grants COR Certification to employers, monitors compliance with program requirements and serve as an employer’s main point of contact for all operational aspects related to COR in their respective province/territory. CFCSA member associations have the flexibility to include additional requirements tailored to their industry, province, or territory within their respective COR accreditation program.

  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Provides an opportunity to negotiate lower insurance premium due to effective management of risks and hence less chances of accidents, injuries and ill-health.
  • Ensure consultation and participation of workers to create best possible working conditions.
  • Reduces/eliminates cost associated with penalties if implemented effectively.
  • Reduces the cost associated with accidents, injuries, ill-health and penalties.
  • Helps to integrate multiple health and safety programs under one umbrella.
  • Potentially reduces audit frequency from legal authorities and other interested parties.
  • Demonstrates “due diligence” to create a legally defensible position against possible lawsuits.
ISO 55000 specifies the requirements for the establishment, implementation, maintenance and improvement of a management system for Asset Management System.
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Improves efficiency, effectiveness and capabilities of an organization to manage assets.
  • Engages and motivates staff by implementing best asset management practices.
  • Helps to define the roles, responsibilities, authorities and accountability for asset management.
  • Provides a framework of consistent, prioritized and auditable risk management.
  • Potentially lowers costs of insurance premium.
  • Improves planning for asset management
  • Helps in development of viable and predictable cash flows.
  • Provides ability to manage lifecycle assets.
  • Supports continual improvement and business growth.
  • Provides ability to ensure that assets fulfill their necessary function.
  • Enhances corporate image, credibility and competitiveness.
  • Helps to prevent, detect and respond to bribery.
  • Helps to comply with anti-bribery laws.
  • Creates awareness on the output of bribery.
  • Enhances aptitude for the prevention of corruption.
  • Demonstrates ethical and legal compliance.
  • Executes significant measures for anti-bribery.
  • Reduces malpractice and other hazards.
  • Protects resources and other capitals.
  • Demonstrates due diligence.

Recognizes and mitigates immediate threats.

ISO 26000 is an international standard providing guidelines for social responsibility. The goal of ISO 26000 is to contribute to global sustainable development by encouraging business and other organizations to practice social responsibility to improve their impacts on their workers, natural environments and communities.
  • Enhances corporate image, credibility and competitiveness.
  • Attracts and retain workers or members, customers, clients and users.
  • Enhances employee morale, commitment and productivity.

Strengthens the relationships with interested parties including community.

ISO 37301 specifies requirements and provides guidelines for establishing, developing, implementing, evaluating, maintaining and improving an effective compliance management system within an organization.
  • Enhances credibility of an organization to meet its compliance obligations.
  • Provides a framework to identify, evaluate, manage and continually improve compliance obligations.
  • Helps to identify, evaluate and manage the risk relevant to compliance obligations.
  • Helps to develop, establish, implement and maintain processes to assess, evaluate, investigate and close reports on suspected or actual instances of noncompliance.
  • Helps to establish processes to ensure fair and impartial decision-making.
  • Ensures independent and conflict free investigation processes by competent personnel.
  • Sets a criterion for reporting compliance obligations.

Ensures performance evaluation of compliance obligations.

ISO 31000 provides principles, a framework and a process for managing risk. ISO 31000 can help organizations to increase the likelihood of achieving objectives, improving the identification of opportunities and threats and effectively allocating and using resources for risk treatment.
ISO 31000 cannot be used for certification purposes because these are Risk Management Guidelines and not a standard.

 

Difference between Policy, Process and Procedure

Term

Definition

Example

Policy

Strategic direction of the organization as decided by senior management.

A policy will lay out a destination but won’t give any direction on how this is to be executed.

Time and attendance will be tracked for all staff and contractors in a clear and consistent way’ but wouldn’t give any indication as to how that should be done.

Process

‘A process is a set of inter-related activities that turn inputs into outputs’

A process sets out what you do, but not how you do it.

 

Complete time and attendance spreadsheet’ 

Procedure

A procedure or work instruction should detail the exact steps an individual would need to go through to complete any activity detailed in a process.

The time and attendance spreadsheet can be found in the HR folder of the network drive. Populate the employee number and hours worked in columns C and D’

 

Improvement

Activity to enhance performance. The activity can be recurring or singular.

Continual Improvement

Recurring activity to enhance performance. e.g. The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means and generally leads to corrective action or preventive action.

 

Quality Improvement

Part of quality management focused on increasing the ability to fulfil quality requirements. The quality requirement can be related to any aspect such as effectiveness, efficiency or traceability.

 

System

 

Set of interrelated or interacting elements.

Management System

 

Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.

A management system can address a single discipline or several disciplines, e.g. quality management, financial management or environmental management.

Quality Management System

 

Part of a management system.

 

Policy

 

Intentions and direction of an organization as formally expressed by its top Management

Quality Requirement

Policy related to quality.

Requirement

Need or expectation that is stated, generally implied or obligatory.

Quality Requirement

Requirement related to quality.

Statutory Requirement

 

Obligatory requirement specified by a legislative body.

 

Regulatory Requirement

 

Obligatory requirement specified by an authority mandated by a legislative body.

 

Efficiency

 

Relationship between the result achieved and the resources used.

 

Effectiveness

 

Extent to which planned activities are realized and planned results are achieved.

 

Data

Facts about an object

Information

Meaningful data

Objective

 

Result to be achieved

·         An objective can be strategic, tactical, or operational.

·         Objectives can relate to different disciplines (such as financial, health and safety, and environmental objectives) and can apply at different levels (such as strategic, organization-wide, project, product and process.

·         An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as a quality objective or by the use of other words with similar meaning (e.g. aim, goal, or target).

·         In the context of quality management systems quality objectives are set by the organization, consistent with the quality policy, to achieve specific results.

 

Objective Evidence

 

Data supporting the existence or verity of something

·         Objective evidence can be obtained through observation, measurement, test, or by other means.

·         Objective evidence for the purpose of audit generally consists of records, statements of fact or other information which are relevant to the audit criteria and verifiable.

 

Document

 

Information and the medium on which it is contained.

Examples: Record, specification, procedure document, drawing, report, standard.

·         The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof.

·         A set of documents, for example specifications and records, is frequently called “documentation”.

·         Some requirements (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) and for records (e.g. the requirement to be retrievable).

 

Record

 

Document stating results achieved or providing evidence of activities performed.

·         Records can be used, for example, to formalize traceability and to provide evidence of verification, preventive action and corrective action.

·         Generally records need not be under revision control.

 

Documented Information

 

Information required to be controlled and maintained by an organization and the medium on which it is contained

·         Documented information can be in any format and media and from any source.

·         Documented information can refer to:

o    the management system, including related processes

o    information created in order for the organization to operate (documentation)

o    evidence of results achieved (records).

 

Requirement

 

Need or expectation that is stated, generally implied or obligatory.

·         “Generally implied” means that it is custom or common practice for the organization and interested parties that the need or expectation under consideration is implied.

·          A specified requirement is one that is stated, for example in documented information.

·          A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement, quality requirement.

·          Requirements can be generated by different interested parties or by the organization itself.

·         It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.

 

Quality Requirement

 

Requirement related to quality.

Specification

 

Document stating requirements. EXAMPLE Quality manual, quality plan, technical drawing, procedure document, work instruction.

·         A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

·         It can be that, by stating requirements, a specification additionally is stating results achieved by design and development and thus in some cases can be used as a record.

 

Verification

 

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

·         The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

·         The activities carried out for verification are sometimes called a qualification process.

·         The word “verified” is used to designate the corresponding status.

 

Validation

 

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

·         The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

·         The word “validated” is used to designate the corresponding status.

·         The use conditions for validation can be real or simulated.

 

Characteristic

 

Distinguishing feature.

·         A characteristic can be inherent or assigned.

·         A characteristic can be qualitative or quantitative.

·         There are various classes of characteristic, such as the following:

a) physical (e.g. mechanical, electrical, chemical or biological characteristics)

b) sensory (e.g. related to smell, touch, taste, sight, hearing)

c) behavioural (e.g. courtesy, honesty, veracity)

d) temporal (e.g. punctuality, reliability, availability, continuity)

e) ergonomic (e.g. physiological characteristic, or related to human safety)

f) functional (e.g. maximum speed of an aircraft)

 

Quality Characteristic

Inherent characteristic of an object related to a requirement.

·         Inherent means existing in something, especially as a permanent characteristic.

·         A characteristic assigned to an object (e.g. the price of an object) is not a quality characteristic of that object.

 

Measurement

 

Process to determine a value. According to ISO 3534-2, the value determined is generally the value of a quantity.

Measurement Process

Set of operations to determine the value of a quantity.

Measuring Equipment

 

Measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process

Inspection

 

Determination of conformity to specified requirements.

·         If the result of an inspection shows conformity, it can be used for purposes of verification.

·         The result of an inspection can shows conformity or nonconformity or a degree of conformity.

 

Testing

 

Determination according to requirements for a specific intended use or application

·         If the result of a test shows conformity, it can be used for purposes of validation.

 

Corrective Action

 

Action to eliminate the cause of a nonconformity and to prevent recurrence

·         There can be more than one cause for a nonconformity.

·         Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.

 

Correction

 

Action to eliminate a detected nonconformity.

·         A correction can be made in advance of, in conjunction with or after a corrective action.

·         A correction can be, for example, rework or regrade.

 

Corrective Action

 

Action to eliminate the cause of a nonconformity and to prevent recurrence

·         There can be more than one cause for a nonconformity.

·         Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.

 

Preventive Action

 

Action to eliminate the cause of a potential nonconformity or other potential undesirable situation

·         There can be more than one cause for a potential nonconformity.

·         Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

 

Rework

 

Action on a nonconforming product or service to make it conform to the requirements. Rework can affect or change parts of the nonconforming product or service.

 

Repair

 

Action on a nonconforming product or service to make it acceptable for the intended use.

·         A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements. It can be that in conjunction with a repair a concession is required.

·         Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.

·         Repair can affect or change parts of the nonconforming product or service.

Combined Audit

 

Audit carried out together at a single auditee on two or more management systems e.g. ISO 14001, ISO 45001 and ISO 9001.

Joint Audit

Audit carried out at a single auditee by two or more auditing organizations e.g. G-Certi and SGS

Vision

 

Aspiration of what an organization would like to become as expressed by top management.

Mission

Organization’s purpose for existing as expressed by top management.

Strategy

plan to achieve a long-term or overall objective.

Competence

ability to apply knowledge and skills to achieve intended results

Qualification

demonstrated competence

A “process” is about “what we do” and a “procedure” is about “how we do something”.

Process

A “process” is about “what we do”.

According to ISO 9000, A process is a set of interrelated or interacting activities that use inputs to deliver an intended result.

Procedure

A “procedure” is a specified way to carry out an activity or a process

Note:

The procedures and processes can be documented or not.

Example

business process for “tracking time and attendance” for staff and contractors may contain an activity such as ‘complete time and attendance spreadsheet’ but doesn’t describe how to perform this task. There is an assumption that the responsible person would know how to perform this task and where to find the appropriate materials to do so. Any further guidance or detail should be set out in a procedure or work instruction.

Quality Assurance

Quality Assurance is part of quality management focused on providing confidence that quality requirements will be fulfilled

Quality Control

Quality Control is a part of quality management focused on fulfilling quality requirements

Management

Management is coordinated activities to direct and control an organization

Quality Management

Quality Management is a management with regard to quality.

Management

Management is coordinated activities to direct and control an organization

Top Management

A person or group of people who directs and controls an organization at the highest level

Example

Management can include establishing policies and objectives, and processes to achieve these objectives. The word “management” sometimes refers to people, i.e., a person or group of people with authority and responsibility for the conduct and control of an organization.

 

Top Management has the power to delegate authority and provide resources within the organization. If the scope of the management system covers only part of an organization, then top management refers to those who direct and control that part of the organization.