3 Definitions T 43

Terms, definitions and books related to quality and audits

 3

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 deviceproduct 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:

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 (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: explicationsrec

explicationsBooks for further reading on internal auditssystematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives (see also ISO 19011, 3.1):

 smileyMinute of relaxation. Paganini's violin concert performed with facial expressions.

When I think of all the books still left for me to read, I am certain of further happiness. Jules Renard

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