Process Improvement

ISO Documentation

ISO documentation refers to the structured collection of policies, procedures, records, and work instructions required to establish, implement, and maintain a quality management system that meets ISO standards.
Read summarized version with

What is ISO Documentation?

ISO documentation is everything your organization writes down to show how it runs and stays compliant with standards like ISO 9001. We're talking about policies, procedures, work instructions, forms, and records that together paint a picture of your operations for auditors and internal teams alike.

Here's something worth knowing: back in 2015, ISO stopped using the terms "documents" and "records" separately. Now it's all called "documented information." Why the change? Flexibility. Organizations can decide how they want to document their processes instead of following some rigid template. The point is that your documentation actually helps you operate well and proves you're meeting requirements.

What you need to document depends on which standard you're following. But the underlying logic stays the same: write down what you do, actually do what you wrote down, and keep records that prove it. Simple in theory, though the execution takes some effort.

Key Characteristics of ISO Documentation

  • Documented Information: Brings together policies, procedures, work instructions, and records into one system that actually supports how you work
  • Controlled Distribution: Proper document control gets the right versions to the right people while keeping outdated docs out of circulation
  • Version Management: Tracks every change with clear revision histories and approval trails
  • Retention Requirements: Spells out how long you need to keep records and how to protect them from getting lost or damaged
  • Format Flexibility: Lets you pick what works for your team, whether that's paper binders, digital files, or visual guides

ISO Documentation Examples

Example 1: Manufacturing Quality System

Consider a precision machining company with an ISO 9001 system. Their documentation includes a quality manual that outlines their QMS scope, procedures covering design control and production, work instructions for each machining operation, calibration records for all their measurement equipment, and nonconformance reports with corrective actions attached. When the annual surveillance audit rolls around, they pull this documentation together to show they're still meeting iso documentation requirements.

Example 2: Service Organization

A software development firm takes a different approach to their ISO 9001 quality documentation. They use process flowcharts for project management, templates for gathering requirements, code review checklists, testing procedures, and records of customer feedback. Their iso quality documentation centers on delivering software that matches client specs and tracking how they find and fix defects.

ISO Documentation vs Quality Manual

These two concepts overlap but serve different roles in a quality management system.

AspectISO DocumentationQuality Manual
ScopeAll documented information in the management systemSingle high-level document describing the QMS
ContentProcedures, instructions, forms, records, and policiesQuality policy, scope, process overview, and references
RequirementRequired for ISO certificationOptional since ISO 9001:2015
Detail LevelRanges from high-level to step-by-step instructionsHigh-level overview only
When to useDaily operations, training, and audit evidenceCommunicating QMS structure to stakeholders

How Glitter AI Helps with ISO Documentation

Keeping ISO documentation up to date takes real effort, particularly when procedures change often. Glitter AI makes this easier by turning screen recordings into visual work instructions automatically. Documenting complex procedures becomes faster, and keeping them current doesn't feel like such a chore.

Version control and approval workflows are built into the platform, which fits naturally with what ISO expects for document control. When a process changes, your team can update the documentation quickly while preserving the revision history that auditors want to see. Less time spent on documentation means more time for the work that actually matters.

Turn any process into a step-by-step guideTeach your co-workers or customers how to get stuff done – in seconds.
Start for Free

Frequently Asked Questions

What is ISO documentation?

ISO documentation is the collection of policies, procedures, work instructions, forms, and records organizations keep to establish and prove compliance with ISO standards like ISO 9001.

What are ISO documentation requirements?

You need to maintain documented information that supports your QMS, control document versions, make sure the right people can access what they need, protect documents from accidental changes, and keep records as evidence that you're doing what you say.

What documents are required for ISO 9001 certification?

ISO 9001 asks for a documented quality policy and objectives, the scope of your QMS, documented information showing how you run your processes, and records proving you're meeting requirements. Most organizations also keep procedures for document control, internal audits, corrective actions, and handling nonconforming products.

Is a quality manual required for ISO 9001?

Not anymore. ISO 9001:2015 dropped the specific requirement for a quality manual. That said, many organizations still create one because it gives auditors and stakeholders a clear overview of the quality management system.

What is the difference between ISO documents and records?

Documents tell you what to do and how to do it, like procedures and instructions. Records show that something actually happened, like filled-out forms or inspection results. Since ISO 9001:2015, both fall under the umbrella term documented information.

How should ISO documentation be controlled?

Good document control means approving documents before release, reviewing and updating them regularly, marking versions clearly, making them accessible to the people who need them, protecting them from unintended edits, and properly retiring old versions.

What is documented information in ISO 9001?

Documented information is the term ISO 9001:2015 uses instead of splitting things into documents and records. It covers both what you need to maintain, like policies and procedures, and what you need to retain as evidence, like records.

How often should ISO documentation be reviewed?

Review your documentation when processes change, after audits flag issues, following nonconformances, and at whatever regular intervals make sense for your organization. Annual reviews are common, though some critical procedures might need a closer look more often.

Can ISO documentation be electronic?

Absolutely. ISO standards don't care whether you use paper or digital systems. Electronic documentation often makes version control, access, and backups easier. Just make sure everything stays readable, identifiable, and protected.

What is the purpose of ISO quality documentation?

ISO quality documentation helps your team execute processes consistently, gives new employees something to learn from, proves compliance when auditors come calling, provides data for spotting improvement opportunities, and captures organizational knowledge so it doesn't walk out the door when people leave.

Turn any process into a step-by-step guideGet Started

Turn any process into a step-by-step guide

Create SOPs and training guides in minutes
Glitter AI captures your screen and voice as you work, then turns it into step-by-step documentation with screenshots. No writing required.
Try Glitter AI Free