ISO 9001 terms

ISO 9001  has a lot of technical terms. The official definitions are in ISO 9000:2015 , the standard that covers the fundamental principles and terminology. Both standards are available in the Netherlands from NEN . Here you find all terms explained in plain English.

A

Accreditation

Official recognition that a certification body is competent to issue certificates. In the Netherlands, the Raad voor Accreditatie (RvA, Dutch Accreditation Council)  grants this recognition. Without accreditation, a certificate is not recognised.

Audit

A systematic, independent check to determine whether you meet the requirements. There are three types:

• Internal audit: you check yourself (mandatory)
• External audit: a certification body checks you
• Supplier audit: you check your supplier

Auditor

The person who carries out the audit. An internal auditor is someone from your own organisation (or contracted in). An external auditor works for the certification body.

C

Certificate

The document that proves you meet ISO 9001. Issued by an accredited certification body. Valid for three years, with annual checks.

Certification body (CI)

The organisation that carries out audits and issues certificates. Well-known bodies in the Netherlands: Kiwa , TÜV , DEKRA , DNV , Bureau Veritas  and LRQA .

Competence

The ability to apply knowledge and skills to achieve intended results. ISO 9001 requires that you determine which competences are needed and that employees have them.

Conformity

Meeting a requirement. The opposite of a nonconformity.

Context of the organisation

The internal and external factors that affect your organisation. Chapter 4 of the standard asks you to understand and document this context.

Continual improvement

The principle that you are never finished with improving. A core concept in ISO 9001. You keep looking for ways to get better.

Corrective action

An action to remove the cause of a nonconformity and prevent it from happening again. It differs from a correction: a correction only resolves the immediate problem.

Customer focus

One of the seven principles of ISO 9001. The main focus is on meeting customer requirements and striving for customer satisfaction.

D

Deviation (afwijking)

When something does not meet a requirement. This can concern products, services or the management system itself. See also: nonconformity.

Document control

The system for managing documents: who may create, approve and change them? How do you make sure everyone uses the right version? Outdated versions must be identified or removed.

Documented information

Everything you must manage and keep. This replaces the old terms “documents” and “records”. You decide the form yourself: paper, digital, video or anything else.

E

Effectiveness

The extent to which planned activities are carried out and planned results are achieved. Ask yourself: “Are we achieving what we set out to achieve?”

Evaluation

Determining whether something is suitable, adequate or effective. The management review, for example, is the periodic evaluation of the whole quality management system by top management.

Evidence

Records, factual statements or other information that show you do what you say you do. Auditors always ask for evidence.

External provider

A supplier, subcontractor or partner that supplies products or services you need. ISO 9001 requires that you evaluate and control these parties.

G

Gap analysis

An analysis to determine where you stand against the requirements of ISO 9001. You identify the gaps between your current situation and what the standard asks for.

H

High Level Structure (HLS)

The fixed structure that all modern ISO management system standards follow (ISO 9001, ISO 14001 , ISO 27001 , and so on). It makes it easier to combine several standards.

I

Improvement

Increasing performance. It can be corrective (solving problems) or preventive (preventing problems).

Infrastructure

The resources you need: buildings, equipment, software, transport and ICT systems.

Interested party (stakeholder)

Anyone with an interest in what your organisation does, or who can influence it. Think of customers, employees, suppliers, shareholders, government and local residents.

Internal audit

An audit you carry out yourself to check whether your system meets the requirements. The standard makes this mandatory. The auditor may not check their own work.

K

KPI (Key Performance Indicator)

A measurable value that shows how well you perform in a particular area. For example: a customer satisfaction score, delivery reliability or the percentage of rejects.

L

Leadership

One of the seven principles. Top management must take the lead, set a good example and make sure quality management is part of how the business is run.

M

Major nonconformity

A serious nonconformity that jeopardises the effectiveness of the management system. It blocks certification and must be resolved before you receive the certificate.

Management review (directiebeoordeling)

A periodic evaluation of the quality management system by top management. The standard requires it. You check whether the system is still effective and what needs to be improved.

Minor nonconformity

A smaller nonconformity that does not immediately jeopardise the effectiveness of the system. You usually get 90 days to correct it. It does not block certification straight away.

Monitoring

Determining the status of a system, process or activity. You keep track of how things are going.

N

NEN-EN-ISO 9001

The full name of the standard as published in the Netherlands. NEN is the Dutch standards institute, EN is the European standard and ISO is the international standard. The content is identical to ISO 9001.

Nonconformity (nonconformiteit)

The official term for a deviation. It occurs when a requirement is not met.

O

Observation

A finding during an audit that is not a nonconformity but is an improvement point. You are not required to resolve it, but it is sensible to do so.

P

PDCA cycle

Plan-Do-Check-Act. The basic cycle for continual improvement:

• Plan: determine your objectives and how you will achieve them
• Do: carry out the plan
• Check: measure and analyse the results
• Act: take action to improve

Process

A set of activities that turns input into output. ISO 9001 asks for a process approach: you look at your work as a whole of connected processes.

Process owner

The person responsible for a process. They make sure the process is effective and is improved where necessary.

Q

Quality management system (KMS)

The whole of processes, procedures, resources and responsibilities that you use to safeguard quality. In English: Quality Management System (QMS).

Quality manual

A document that describes the quality management system. It has not been mandatory since ISO 9001:2015, but many organisations still have one.

Quality objective

Concrete, measurable goals in the area of quality. They must be consistent with the quality policy and formulated in a SMART way.

Quality policy

A document in which top management records the intentions and direction of the organisation in the area of quality. It must suit the organisation and provide a framework for objectives.

R

Record

Evidence that something has been done or that a result has been achieved. It is now part of “documented information”. Examples: completed checklists, minutes and measurement reports.

Recertification audit

The audit after three years to renew your certificate. It is similar to the initial certification audit, but shorter because your track record counts.

Risk-based thinking

Taking risks and opportunities into account in everything you do. Introduced in ISO 9001:2015. No comprehensive risk management method is required, but awareness of risk is.

Root cause analysis

Investigating why something went wrong. The “5 whys” method is a well-known technique: keep asking until you find the real cause.

RvA

The Raad voor Accreditatie (Dutch Accreditation Council) . The Dutch organisation that accredits certification bodies.

S

Scope

The reach of your quality management system. It describes which activities, locations, products and services fall under the certification.

Standard

A document with agreements, guidelines or specifications. ISO 9001 is a standard for quality management.

Supplier evaluation

Evaluating suppliers to determine whether they meet your requirements. This can be done through audits, questionnaires, performance measurements or certificates.

Surveillance audit

The annual check audit by the certification body. It is shorter than the initial audit and checks whether you still comply.

T

Top management

The highest leadership of the organisation. The Dutch edition of the standard often translates this as “directie”. Top management is responsible for the quality management system.

Traceability

The ability to trace the history, use or location of an item. Important in recalls or quality problems: where does this product come from?

V

Validation

Confirming that a product or service is suitable for its intended use. You test whether it works the way the customer expects.

Verification

Confirming that specified requirements have been met. You check whether it meets the specifications.

W

Work environment

The conditions under which work is carried out: physical (temperature, light, noise), social (atmosphere, workload) and psychological (stress, motivation).

Common abbreviations

More information

• Requirements of ISO 9001: all requirements explained per chapter
• The audit process: what can you expect?
• Frequently asked questions: answers to practical questions