Reference · vocabulary
The terms, stated precisely
Every word in this glossary is defined the way the standard or the regulation uses it, not the way marketing does. They come from the pages where the term appears in context, and from here you can jump straight to them.
Where these definitions come from
This glossary is not a separate list somebody maintains by hand: it gathers the definitions that already live on each page of the site, in its vocabulary section. Correct a definition on its page and it changes here on its own. Where a term is defined on several pages, it appears once and all of them are linked.
- Terms collected
- 26From every product and standard page
A
- Annex SL
- The high-level structure common to ISO management system standards. It is what makes integrating several standards into one system technically feasible. Used in: Quality and standards
- Applicable legal requirement
- A specific obligation arising from a rule that affects this organisation by virtue of its activity, size or location. What matters is not the whole statute but the article that obliges something. Used in: Regulatory compliance
C
- Certificate of analysis (CoA)
- A document recording the test results for one specific batch and comparing them with the specification. It is batch-specific and does not apply to another. Used in: Quality certificates
- Clause
- Each numbered section of the normative body. When an auditor says "nonconformity in 8.5.1", they mean one of these. Used in: Academy
- Compliance function
- The unit with autonomous powers of initiative and control charged with overseeing how the model works. Its real independence is what a court examines. Used in: Regulatory compliance
- Corrective action
- A measure aimed at eliminating the cause of a nonconformity so it does not recur. Distinct from correction, which only repairs the immediate effect. Used in: Quality and standards
D
- Declaration of conformity
- The manufacturer's statement that the product meets a specific standard or regulation. Mandatory for food-contact materials and for CE-marked industrial products. Used in: Quality certificates
- Documented information
- The term ISO 9001:2015 uses for documents and records together. The standard stopped requiring a quality manual, though many organisations keep one out of habit. Used in: Quality and standards
E
- Evaluation of compliance
- Periodic, documented verification of whether a requirement is met. ISO 14001 and ISO 45001 require it expressly, with the evidence retained. Used in: Regulatory compliance
I
- Idempotency
- The property of an operation that can be repeated without duplicating its effect. It is what makes retrying a failed sync safe. Used in: ERP connectivity
- Informative annex
- A part of the document that guides but does not oblige. Mistaking it for the normative body leads to implementing things nobody was going to require. Used in: Academy
- Intermediate database
- An exchange area between two systems that do not speak directly. Less elegant than an API, perfectly valid, and often the only option with a legacy ERP. Used in: ERP connectivity
- ISO 37301
- The international standard for compliance management systems, published in 2021 and certifiable. It replaced ISO 19600:2014, which offered guidelines only. Used in: Regulatory compliance
M
- Management review
- Periodic analysis of the system by top management, with inputs and outputs listed in clause 9.3. It is where most systems come unstuck. Used in: Quality and standards
N
- Nonconformity
- Failure to meet a requirement, whether of the standard, the customer or the system itself. It is not a problem in itself: failing to detect them is. Used in: Quality and standards
O
- Organisation and management model
- The set of supervision and control measures which, under art. 31 bis of the Spanish Criminal Code, can exempt a legal person from criminal liability if effective and supervised. Used in: Regulatory compliance
R
- Reconciliation
- Periodic checking that both systems say the same thing. Every integration eventually drifts; what marks out a good one is that it notices before the user does. Used in: ERP connectivity
- Requirement
- A sentence in the standard containing a "shall". It is the only auditable part: notes and examples guide but do not oblige. Used in: Academy
- REST API
- An interface letting two systems exchange data over HTTP with well-defined operations. It is the preferable route where the ERP offers it, because it needs no database access. Used in: ERP connectivity
- Risks and opportunities
- The approach introduced in 2015 that replaced preventive action: rather than reacting, the organisation must plan what could go wrong in each process and what it will do about it. Used in: Quality and standards
S
- Scope
- The delimitation of which activities, products and sites the certified system covers. It appears on the certificate and it is the first thing a customer asking for it looks at. Used in: Academy
- Specification
- The set of parameters and acceptable ranges agreed with the customer. It is the yardstick against which the certificate declares a batch conforming or not. Used in: Quality certificates
- System of record
- The system that wins when two systems disagree about the same record. Declaring it per entity — customers, items, employees — is the decision that prevents ninety per cent of integration problems. Used in: ERP connectivity
T
- Technical datasheet
- A description of a product's general characteristics: composition, properties, conditions of use and storage. It belongs to the product, not the batch, and has versions. Used in: Quality certificates
- Transition
- The period during which one edition of a standard and its successor coexist. Once it ends, certificates issued against the old edition stop being valid. Used in: Academy
U
- Upstream and downstream traceability
- The ability to know which raw materials a batch came from and which customers received it. The first identifies the source of a problem; the second, its extent. Used in: Quality certificates
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Related pages
Glossary of quality management, ISO standards and compliance
This glossary precisely defines the terms that come up in a management system: nonconformity and corrective action, documented information, competence and the competence matrix, working-time records, geofence, advanced electronic signature, certified digitisation, MTBF, MTTR and OEE, among others.
Each definition comes from the page where the concept is explained in context, so from here you can jump to the section that develops it rather than being left with a stray sentence.