ISO 10005:2018

Overview

ISO 10005:2018 - Quality management - Guidelines for quality plans provides practical guidance for establishing, reviewing, accepting, applying and revising quality plans. It is a guidance document (not a requirements standard) applicable to any intended output - process, product, service, project or contract - and to organizations of any type or size, whether or not they have an ISO 9001 management system. The standard focuses on the provision of outputs (the “specific case”) and aligns terminology and concepts with ISO 9001:2015 and ISO 9000:2015.

Key topics

ISO 10005:2018 covers the lifecycle and content of quality plans and introduces risk‑based thinking and updated terminology (e.g., documented information, external providers). Major technical topics include:

• Purpose and use of a quality plan: initiation, review, acceptance, implementation and revision
• Context, inputs and scope of the quality plan
• Quality objectives, responsibilities and assignment of actions and resources
• Control of documents and documented information, and control of records
• Provision and monitoring of resources (materials, people, infrastructure, monitoring equipment)
• Requirements, customer and interested‑party communication
• Design and development controls and change management
• Purchasing / externally provided processes, products and services
• Production and service provision, identification, traceability and preservation of outputs
• Control of nonconforming outputs, monitoring & measurement, and audits
• Feedback, improvement and risk‑based planning

Applications and users

ISO 10005:2018 is useful for organizations that need a structured plan to assure quality in:

• Projects, contracts and one‑off deliveries (project managers, contract managers)
• New product or service introductions (design and engineering teams)
• Procurement and supplier management (purchasing and supplier quality functions)
• Small and medium enterprises without a formal QMS who still require documented planning
• Organizations with ISO 9001:2015 systems that want to integrate specific case planning with their QMS

Practical benefits include clearer allocation of responsibilities, improved supplier control, better evidence of conformance during audits, and more consistent achievement of quality objectives.

Related standards

• ISO 9001:2015 - Quality management systems - Requirements
• ISO 9000:2015 - Fundamentals and vocabulary for quality management
• ISO 10006 - Guidelines for quality in projects
• ISO 9004 - Guidance for sustained success of an organization

Keywords: ISO 10005:2018, quality plans, quality management, guidelines, ISO 9001, documented information, risk‑based thinking, supplier quality, project quality.