ISO 10005:2018

International

v2018

6 domains

42 controls

Verified

ISO 10005:2018 is a compliance framework from International with 6 domains and 42 controls. The largest domains are Clause 6.1 to 6.8: Content of the quality plan, scope to communication – ISO 10005:2018 (13 controls), Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018 (11 controls), Clause 5: Development of a quality plan – ISO 10005:2018 (8 controls). Every control below carries what it requires and what an assessor expects to see.

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Framework Domains (6)

Clause 4: Using a quality plan – ISO 10005:2018

3 controls

Controls in the Clause 4: Using a quality plan – ISO 10005:2018 domain of ISO 10005:2018 — 3 controls
Code	Title	Description
iso-10005-2018::4.1	Introduction: deciding where quality plans are needed	A quality plan describes how the organization will provide an intended output. With an established management system a q...
iso-10005-2018::4.2	Requesting external provider quality plans	An organization may ask an external or prospective external provider, including a separate division of itself, to submit...
iso-10005-2018::4.3	Managing external provider quality plans	A provider's quality plan gives the organization and the provider a common understanding of how requirements will be met...

Clause 5: Development of a quality plan – ISO 10005:2018

8 controls

Controls in the Clause 5: Development of a quality plan – ISO 10005:2018 domain of ISO 10005:2018 — 7 controls
Code	Title	Description
iso-10005-2018::5.1	Context of the quality plan	Understanding the context of the quality plan and its intended results is the basis for determining the risks and opport...
iso-10005-2018::5.2	Inputs to the quality plan	The organization should determine the inputs to the quality plan, for example customer requirements and statutory, regul...
iso-10005-2018::5.3	Defining the scope of the quality plan	The organization should determine what the quality plan covers, which depends on the requirements of customers and other...
iso-10005-2018::5.4.1	Initiation	In preparing the quality plan the organization should determine roles, responsibilities and authorities within the organ...
iso-10005-2018::5.4.2	Defining the quality plan	The quality plan should show how the required activities will be carried out, directly or by reference to documented inf...
iso-10005-2018::5.4.3	Consistency and compatibility	The content and format of the quality plan should be consistent with its scope, inputs, users' needs and intended output...
iso-10005-2018::5.4.4	Presentation and structure	A quality plan may be formally defined and presented by graphical representations (process maps, flow charts), written w...

Clause 6.1 to 6.8: Content of the quality plan, scope to communication – ISO 10005:2018

13 controls

Controls in the Clause 6.1 to 6.8: Content of the quality plan, scope to communication – ISO 10005:2018 domain of ISO 10005:2018 — 12 controls
Code	Title	Description
iso-10005-2018::6.1	General: what the quality plan should contain	The topics of 6.2 to 6.17 indicate what should be considered for inclusion. Documented information needed by users may b...
iso-10005-2018::6.2	Scope of the quality plan	The scope should be clearly stated in the plan: a simple statement of the purpose and expected output of the specific ca...
iso-10005-2018::6.3	Quality plan inputs and requirements	It can be necessary to list or describe the inputs (5.2) so users can refer to them, consistency with inputs can be revi...
iso-10005-2018::6.4	Quality objectives	The plan should state the quality objectives for the specific case and how they will be achieved, set for example in rel...
iso-10005-2018::6.5	Quality plan responsibilities	The plan should identify the people responsible for ensuring the activities and resources for the plan or contract are p...
iso-10005-2018::6.6	Control of documented information	For documented information applicable to the case the plan should state how it will be identified, by whom reviewed and...
iso-10005-2018::6.7.1	Provision of resources	The plan should specify the type and amount of resources needed for successful implementation, provided internally or ex...
iso-10005-2018::6.7.2	Materials, products and services	Where required materials, products and services have specific characteristics, the specifications or standards they need...
iso-10005-2018::6.7.3	People	The plan should specify, where applicable, the competence required for defined roles or activities, and define any speci...
iso-10005-2018::6.7.4	Infrastructure and environment for the operation of processes	The plan should state the specific case's requirements for buildings and utilities, workspace, tools and equipment, info...
iso-10005-2018::6.7.5	Monitoring and measuring resources	The plan should specify the resources needed for valid and reliable results when monitoring or measuring to verify confo...
iso-10005-2018::6.8	Customers and other interested parties communication	The plan should state or reference who is responsible for communication with customers and other interested parties, the...

Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018

11 controls

Controls in the Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018 domain of ISO 10005:2018 — 10 controls
Code	Title	Description
iso-10005-2018::6.10	Externally provided processes, products and services	The plan should specify the critical characteristics of externally provided processes, products and services that can af...
iso-10005-2018::6.11	Production and service provision	Production and service provision with their monitoring and measurement commonly form the main part of the plan, the proc...
iso-10005-2018::6.12	Identification and traceability	Where identification of outputs is appropriate to meeting the case's requirements the plan should specify the methods; w...
iso-10005-2018::6.13	Property belonging to customers or external providers	The plan should state how products and services provided by customers or external providers (materials, components, tool...
iso-10005-2018::6.14	Preservation of outputs	The plan should state the preservation requirements (identification, handling, contamination control, storage, packaging...
iso-10005-2018::6.15	Control of nonconforming outputs	The plan should define how nonconforming outputs are identified and controlled to prevent unintended use until proper di...
iso-10005-2018::6.16	Monitoring and measurement	Monitoring and measurement processes define how objective evidence of conformity will be obtained; customers sometimes r...
iso-10005-2018::6.17	Audits	The plan should specify the type of audits to be performed for the specific case, their nature and extent, and how the r...
iso-10005-2018::6.9.1	Design and development process	The plan should reference the applicable design and development plans, take account of specifications, codes, industry s...
iso-10005-2018::6.9.2	Control of design and development changes	The plan should state how requests for changes to design and development outputs are controlled, who may initiate a chan...

Clause 7: Operation and control of the quality plan – ISO 10005:2018

4 controls

Controls in the Clause 7: Operation and control of the quality plan – ISO 10005:2018 domain of ISO 10005:2018 — 4 controls
Code	Title	Description
iso-10005-2018::7.1	Review and acceptance of the quality plan	The plan should be reviewed for adequacy and effectiveness and formally approved by an authorized person or a group incl...
iso-10005-2018::7.2	Implementation and monitoring of the quality plan	In implementing and monitoring the plan the organization should consider distribution to all relevant people, distinguis...
iso-10005-2018::7.3	Revision of the quality plan	The organization should revise the plan to reflect changes to its inputs or risks, including the specific case, the prod...
iso-10005-2018::7.4	Feedback and improvement	Where appropriate, experience from applying a quality plan should be reviewed and evaluated, if useful in consultation w...

Scope, terms and introduction – ISO 10005:2018

3 controls

What is ISO 10005:2018 and who does it apply to?

ISO 10005:2018 is a compliance framework from International with 6 domains and 42 controls. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does ISO 10005:2018 actually require?

ISO 10005:2018 has 42 controls organised across 6 domains. The largest domains are Clause 6.1 to 6.8: Content of the quality plan, scope to communication – ISO 10005:2018 (13 controls), Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018 (11 controls), Clause 5: Development of a quality plan – ISO 10005:2018 (8 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of ISO 10005:2018 do I already cover?

ISO 10005:2018 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.

How do I implement ISO 10005:2018?

Start your ISO 10005:2018 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 10005:2018 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 42 controls and track your progress.

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