BS ISO 10005:2018 - TC Tracked Changes. Quality management. Guidelines for quality plans

BS ISO 10005:2018 - TC

Tracked Changes. Quality management. Guidelines for quality plans

Status : Current   Published : January 2020


What is a tracked changes standard?

A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified. This version of the standard includes both a copy of the new standard, along with a track changes version.

What is this standard about?

This is a generic standard giving guidance on how to create plans that will embed quality in a process, product, service, project or contract.

Who is this standard for?

It can be used by any organization, but will be particularly useful to:

  • Users of ISO 9001 and ISO 9004
  • Other quality professionals
  • Construction engineers
  • Users of industry and topic-specific standards such as ISO 10006 on project management

Why should you use this standard?

It supplies guidance on the use, development, content, operation, and control of quality plans which work both with a quality management system and independently.

Quality plans are a way of relating specific requirements to work methods or practices to give greater confidence that requirements will be met and processes are being controlled.

This standard complements industry and topic-specific standards such as ISO 10006 (project management).

NOTE: This standard is not a guide to planning the development of a quality management system

What’s changed since the last update?

This revision reflects changes made to ISO 9001 in 2015.

There are substantial clause and sub-clause changes both in terms of sequence and titles, with extensive extra material
Risk-based thinking has been incorporated
A new clause on using a quality plan has been added
In addition some terminology has changed:

The definition of “specific case” – i.e. what the plan might relate to – now includes service as well as product
“Documented information” replaces words such as “documentation”, “record”, “procedures” and “quality manual”
“Externally provided processes, products and services” replaces “purchased product”
“Supplier” replaces “external provider”

Standard NumberBS ISO 10005:2018 - TC
TitleTracked Changes. Quality management. Guidelines for quality plans
Publication Date31 January 2020
Normative References(Required to achieve compliance to this standard)ISO 9000:2015
Informative References(Provided for Information)ISO/IEC 90003, ISO 31000, ISO/TS 9002, ISO 10007, ISO/TR 10013, ISO 9004, IEC 31010, ISO/IEC/IEEE 24748-5, ISO 19011, ISO 10006, ISO 10015, ISO 10012, BS ISO 10004:2018, ISO 19011:2018, ISO/IEC 27002, BS ISO 10018:2020, ISO 10018:2020, ISO/TR 10017, ISO 9001:2015, ISO/IEC/IEEE 90003:2018, BS ISO/IEC/IEEE 90003:2018, ISO 10004, ISO 10004:2018, BS EN ISO 19011:2018
DescriptorsIdentification methods, Production management, Quality control, Process charts, Planning, Management techniques, Management, Inspection, Records (documents), Plans, Quality, Quality assurance systems
ISBN978 0 539 08251 7
File Size3.757 MB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Access, view and download standards with multiple user access, across multiple sites with BSOL

Develop a PAS

Develop a fast-track standardization document in 9-12 months