ISO 9001:2015 Clause 1 - Scope

ISO 9001:2015 Clause 1: Scope sets out the boundaries and applicability of the standard. It helps organizations understand what ISO 9001 covers and in what situations it can be used.

Purpose of Clause 1

  • Defines what organizations the requirements are applicable to.
  • Identifies the general focus: to consistently provide products and services meeting customer and regulatory requirements.

Key Points

Aspect Description
Universal Applicability ISO 9001:2015 applies to any organization, regardless of size, type, or product/service offered.
Process Approach Focuses on enhancing customer satisfaction through effective process application and continual improvement.
Requirement Compliance Stresses conformity with customer, statutory, and regulatory requirements.
Exclusions Organizations may claim exclusions where certain requirements within clause 8 (Operation) don't apply to them due to their industry or business model.

Official Clause Text (Summary)

"This International Standard specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement and assurance of conformity to customer and applicable statutory and regulatory requirements."

Scope in Practice

Category Examples
Applicable Sectors Manufacturing, services, non-profits, government, etc.
Types of Output Physical products, digital items, services, projects
Geographical Reach Local, national, multinational organizations

How Organizations Use this Clause

  • Define Boundaries: Document which business areas/processes are covered by the QMS.
  • Exclusions Explained: Clearly state and justify any areas of the standard not applicable (primarily clause 8).
  • Certification: When seeking ISO 9001 certification, these boundaries must be declared.

Example Statement for Your QMS

"The QMS at [Organization Name] covers all operations at [site/location], including design, development, production, and delivery of [products/services]. Exclusions: clause 8.3 Design and Development is not applicable as the company only manufactures products based on customer designs."