ISO 9001:2015 Overview 122

calibrated

To be compared and adjusted to a device with known, standard accuracy. Correctly calibrated machinery and other equipment help eliminate any unwanted variation.

calipers

A handheld measuring instrument with a pair of jaws on one end and a long beam containing a marked scale of unit divisions. Caliper jaws can measure both internal and external features.

certified

Having received validation that a person or company has met the requirements to uphold a certain standard. Certified organizations must undergo a series of audits, corrective actions, and recertification to maintain ISO 9001:2015 certification.

conform

To meet all specified quality requirements. To conform, documents, processes, and outputs must meet all of the requirements from customers or in the standards that apply to them.

conformance

The act of meeting all specified quality requirements. Conformance determines whether an output should be delivered to customers.

context

The circumstances that shape how an organization does business. Context may reflect information about an organization's location, market share, size, needs, mission, and other data.

continual improvement

The practice of constantly measuring the effectiveness of an organization's processes. Continual improvement practices must be included in a quality management system for ISO 9001:2015 certification.

controlled

To be kept under strict conditions. Controlled documented information ensures that information is up to date, accurate, undamaged, and follows ISO requirements for storage, editing, and distribution.

corrective actions

A step taken to address nonconformance. Corrective actions, such as recalibrating machinery or implementing in-line inspection, lead to quality improvement.

documented information

A policy, piece of data, or other evidence that must be retained and controlled by an organization in order for its QMS to be effective. Documented information should be preserved in whatever format best serves the needs of each individual organization.

external auditor

An individual outside of an organization who objectively assesses the effectiveness of the organization's quality management system. External auditors are not allowed to offer consulting or advice as part of an ISO 9001:2015 audit.

external providers

An organization that supplies a product or service to another organization. External providers must be vetted for reliability by companies seeking ISO 9001:2015 certification.

inputs

An action or raw material that enters or contributes to a process. Inputs must be defined during process design tasks to comply with ISO 9001:2015.

interested parties

Any individual or organization that will be affected by a decision, situation, or product. Interested parties may require organizations to implement a QMS or seek ISO 9001:2015 certification.

internal audits

An examination of a company's processes, products, and services conducted by the company's own staff. Internal audits are required by ISO 9001:2015.

International Organization for Standardization

ISO. A non-governmental institution that develops and establishes standards, rules, and guidelines designed to ensure that products, processes, and services are fit for their purposes. The International Organization for Standardization created and maintains the popular quality standard ISO 9001:2015.

ISO

International Organization for Standardization. A non-governmental institution that develops and establishes standards, rules, and guidelines designed to ensure that products, processes, and services are fit for their purposes. ISO created and maintains the popular quality standard ISO 9001:2015.

ISO 9000 series

A series of ISO standards intended to guide an organization in implementing and improving a QMS. ISO 9000 series certification indicates an organization is striving to meet the quality requirements of its customers.

ISO 9000:2015

One of the three main publications of the ISO 9000 series that describes the basics of the ISO series, defines vocabulary, and introduces the ISO quality standard. ISO 9000:2015 is titled "Quality Management Systems-Fundamentals and Vocabulary."

ISO 9001:2015

The core standard of the ISO 9000 series that contains the requirements an auditor uses to verify conformity of a QMS. ISO 9001:2015 is titled "Quality Management Systems-Requirements" and presents the actual material to which an organization must conform for certification.

ISO 9004:2009

One of the three main publications of the ISO 9000 series that describes additional recommendations a company can apply to improve their QMS. ISO 9004:2009 is titled "Managing for the Sustained Success of an Organization-A Quality Management Approach."

management reviews

An examination of a company's leadership, processes, products, and overall functioning conducted by the upper management to identify areas for improvement. Management reviews should identify areas for improvement and areas where the QMS could benefit from changes.

market share analyses

A statistical tool that reveals the percentage of a given industry that a company controls. Market share analyses can be used to measure customer satisfaction since market share grows as customer satisfaction improves.

measuring resources

Any method used to inspect a product or service for adherence to specified requirements. Measuring resources include inspection devices, such as gauges, and processes, such as visual inspection.

nonconforming

Failing to meet one or more specified quality requirements. Nonconforming products and services must be monitored and reduced for successful ISO 9001:2015 certification.

objectives

A measurable outcome toward which an entire organization works in order to fulfill the quality policy. Quality objectives are a requirement outlined in the sixth section of ISO 9001:2015.

outputs

The result of a process, such as a finished part. Outputs are the result of inputs being transformed by production.

plan-do-check-act

PDCA. A four-step, iterative method for implementing and evaluating change. Plan-do-check-act includes identifying areas for change, implementing changes, reviewing results, and fully implementing or revising the changes.

preventive actions

A step taken to eliminate the cause of a potential nonconformity or some other undesirable situation before it becomes an issue. Preventive actions aim to eliminate the impact of nonconformities.

primary standard

A measurement standard with the highest accuracy used in a given nation or industry. Primary standards are usually either national standards or international standards, depending on the nation and the context in which the standard is used.

processes

A set of activities that uses resources to transform inputs into outputs. Processes are used to accomplish tasks, create products, and deliver services.

QMS

Quality management system. A company's collection of objectives and processes that ensure excellence and customer satisfaction. A QMS consists of written documents that reflect the ISO 9001:2015 standard.

quality

Conforming to a set of standards or specifications and, therefore, resulting in customer satisfaction with a product or service. Quality products are free of defects and meet the requirements of their anticipated use.

quality management system

QMS. A company's collection of objectives and processes that ensure excellence and customer satisfaction. A quality management system consists of written documents that reflect the ISO 9001:2015 standard.

quality policy

The documented information in a QMS that reflects an organization's commitment to quality and continual improvement. The quality policy is established by the organization's top management.

records

A type of documented information required for ISO 9001:2015 certification that cannot be edited. Records provide evidence for policies, measurements, audits, and other data related to ISO certification.

requirements

A specific mandate that is contained in a standard. Requirements must be followed for an organization to achieve certification.

risks

A condition or situation that can lead an organization to lose profits or fail. Risks include controllable factors like changes in business strategy and financial management and uncontrollable factors like changes in the economy and new technologies.

standard

An established policy about a particular practice or method. Standards in the ISO 9000 series are used to establish and manage quality systems.

surveillance audits

A periodic audit performed by a certified external auditor to ensure that an organization still meets ISO 9001:2015 requirements. Surveillance audits are conducted every year or two years after certification is awarded.

surveys

A marketing tool that polls customers to determine their satisfaction with a given product or company. Customer surveys provide a way to determine if customer needs have been fulfilled.

upskilling

Training that expands the skill set of the trainee. Upskilling improves employee competence and is one tool for continual improvement.

warranty

A statement guaranteeing a product's ability to function for a specific time and that it will be replaced or repaired by the manufacturer if it fails within that time frame. Warranty claims can help analyze customer satisfaction since an increased number of claims corresponds to an increase in customers seeking refunds or returning products.