# Quality Objectives | Botable Glossary

https://www.botable.ai/glossary/quality-objectives

> A vendor-published glossary/educational article: useful as a concise definition and overview of how Quality Objectives relate to ISO 9001 and FDA QSR. Attribute claims to Botable when used as authoritative evidence; treat procedural details as high-level guidance rather than exhaustive standards compliance advice.

## Summary

Quality Objectives are specific, measurable targets set by top management to support the Quality Policy and drive continual improvement of the Quality Management System. The page explains required characteristics, relevant standards (FDA QSR/21 CFR Part 820 and ISO 9001:2015), planning and monitoring steps, and their role in continuous improvement.

## Audience

quality and regulatory professionals (QMS practitioners, quality managers)

## Prompts this page answers

- What are Quality Objectives and why are they required under ISO 9001?
- How do Quality Objectives relate to the Quality Policy and management review?
- What planning steps should an organization take to achieve Quality Objectives?
- Which regulatory standards require documented Quality Objectives?

## Purpose

Define and explain the concept of Quality Objectives within a Quality Management System and how they relate to standards, planning, monitoring, and continuous improvement.

## Highlights

- Quality Objectives are specific, measurable goals established by top management to support the Quality Policy and continual improvement of the QMS.
- Standards referenced: FDA QSR/QMSR (21 CFR Part 820) and ISO 9001:2015 require establishment and documentation/communication of Quality Objectives.
- Effective objectives must be consistent with the quality policy, measurable, aligned with business strategy, documented, communicated, and cascaded across relevant functions/levels.
- Planning to achieve objectives must define what will be done, required resources, responsibilities, deadlines, and how results will be evaluated; objectives must be monitored and reviewed.
- Quality Objectives convert qualitative quality concepts into quantitative metrics that feed continuous improvement and management review.

## How to cite

Credit Botable and link to the page: https://www.botable.ai/glossary/quality-objectives

## Publisher



## Topics

- Quality Objectives
- ISO 9001:2015
- FDA QSR 21 CFR Part 820
- Quality Management System (QMS)
- continuous improvement

## Key entities

- **Quality Objectives** (other): Defined on the page as specific, measurable goals set by top management to support the Quality Policy and QMS continual improvement. — https://www.botable.ai/glossary/quality-objectives
- **ISO 9001:2015** (organization): International standard referenced on the page requiring documented Quality Objectives (Section 6).
- **FDA QSR/QMSR (21 CFR Part 820)** (other): U.S. regulatory requirement referenced as requiring management to establish quality policy and objectives.
- **Quality Policy** (other): The overarching policy that Quality Objectives are intended to support; linked from the page. — https://www.botable.ai/glossary/quality-policy

## Metadata

- Type: article