3 Definitions T 43

Terms, definitions and books related to quality and audits

The beginning of wisdom is the definition of terms. Socrates

Some terms and definitions currently used in this module:

Advisory notice: notice on the use, modification, return or destruction of a medical device
Audit client: everyone requesting an audit
Audit conclusions: outcome of an audit
Audit criteria: everything against which audit evidence is compared
Audit findings: every deviation from audit criteria
Auditee: everyone who is audited
Auditor: everyone who is trained to carry out audits
Competence: personal skills, knowledge and experiences
Customer: anyone who receives a product
GMP: Good Manufacturing Practices
Interested party: person, group or company affected by the impacts from an organization
Medical device: product or service to be used for purposes of diagnosis, prevention, monitoring, treatment, alleviation of disease or injury
Nonconformity: non-fulfillment of a specified requirement
Organization: a structure that satisfies a need
Product (or service): every result of a process or activity
Quality objective: quality related, measurable goal that must be achieved
Stakeholder: person, group or company that can affect or be affected by an organization
Supplier: an entity that provides a product

Examples of interested partiesperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3): investors, customers, external providers, employees and social, public or political organizations

In the terminology of quality management systems, do not confuse the following:

anomaly, defect, dysfunction, failure, nonconformity, reject and waste
- an anomaly is a deviation from what is expected
- defect is the non-fulfillment of a requirement related to an intended use
- dysfunction is a degraded function which can lead to a failure
- failure is when a function has become unfit
- nonconformity is the non-fulfillment of a requirement in production
- reject is a nonconforming product which will be destroyed
- waste is when there are added costs but no value
audit and inspect
- to audit is to improve the management system
- to inspect is to verify the conformity of a process or product
audit, auditee and auditor
- an audit is a process of evaluating and improving the management system
- an auditee is the one who is audited
- an auditor is the one who conducts the audit
audit program and plan
- an audit program is the annual planning of the audits
- an audit plan is the description of the audit activities
communicate and inform
- to communicate is to pass on a message, listen to the reaction and discuss
- to inform is to give someone meaningful data
control and optimization
- control is meeting the objectives
- optimization is the search for the best possible results
customer, supplier and subcontractor
- a customer receives a product
- a supplier provides a product
- a subcontractor provides a service or a product on which a specific work is done
effectiveness and efficiency
- effectiveness is the level of achievement of planned results
- efficiency is the ratio between results and resources
follow-up and review
- follow-up is the verification of the obtained results of an action
- review is the analysis of the effectiveness in achieving objectives
indicator and objective
- an indicator is the information on the difference between the achieved result and the preset objective
- an objective is a sought after commitment
organization and enterprise, society, company
- organization is the term used in the standard ISO 9001 as the entity between the supplier and the customer
- enterprise, society and company are examples of organizations
organizational chart and process map
- the organizational chart is the graphic display of departments and their links
- the process map is the graphic display of processes and their interaction
procedure, process, product, activity and task
- a procedure is the description of how we should conform to the rules
- a process is how we satisfy the customer using people to achieve the objectives
- a product is the result of a process
- an activity is a set of tasks
- a task is a sequence of simple operations

Remark 1: each time you use the term "improvement opportunity" instead of nonconformity, malfunction or failure, the auditee will gain a little more confidence in you.

Remark 2: the use of definitions from the ISO 19011, ISO 9000 and ISO 22716 standards is recommended. The most important thing is to determine a common and unequivocal vocabulary for everyone in the company.

Remark 3: the customer can also be the user, the beneficiary, the initiator, the client, the prime contractor, the consumer.
Remark 4: ISO 19011 version 2018 uses the terms procedure ( ), record ( rec ) and documented information together. We also use the terms procedure and record together with the term documented information.

For other definitions, comments, explanations and interpretations that you don’t find in this module and in annex 06, you can consult: explications rec