100%
Dark site-logo
  • Home
  • Industries
    • Food and Drinks Sector
    • Medical Device Sector
    • Pharma/Biopharma Sector
    • Combination Product Sector
    • General Manufacturing Sector
  • Consultancy
    • Operational Transformation
    • Consultancy Services
  • Resources
    • Blog
    • Medical Device Industry eBooks
    • Forging Futures: Women in Manufacturing Network
    • FREE Micro-Learning Videos
    • Glossary
    • Useful Links
  • About Us
  • Contact Us
  • Login
Login
  • Home
  • Industries
  • Consultancy
  • Resources
  • About Us
  • Contact Us
  • Login
  • Food and Drinks Sector
  • Medical Device Sector
  • Pharma/Biopharma Sector
  • Combination Product Sector
  • General Manufacturing Sector
  • Operational Transformation
  • Consultancy Services
  • Blog
  • Medical Device Industry eBooks
  • Forging Futures: Women in Manufacturing Network
  • FREE Micro-Learning Videos
  • Glossary
  • Useful Links

Annex SL

« Back to Glossary Index

Annex SL is the blueprint or “template” that the International Organization for Standardization (ISO) uses to develop all its new and revised management system standards. It’s not a standard itself, but rather a set of rules and a common structure that all these standards must follow.

The goal of Annex SL is to create a consistent, high-level structure and identical core text for all management system standards, such as ISO 9001 (Quality), ISO 14001 (Environment), ISO 45001 (Health & Safety), and many others

The High-Level Structure (HLS)

Annex SL mandates a 10-clause structure, known as the High-Level Structure (HLS), for all management system standards.

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the Organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

Why It’s a Game-Changer

Before Annex SL was introduced around 2012, different management system standards had wildly different structures, terminology, and even core requirements. This made it incredibly difficult for organizations to implement and maintain multiple standards (e.g., a company that wanted to be certified to ISO 9001 and ISO 14001).

Annex SL solved this by:

  • Simplifying Integration: Because all new standards share the same 10-clause structure, it is much easier to combine them into a single, integrated management system. An organization can have one set of procedures for “Leadership” or “Internal Auditing” that satisfies the requirements of all their different certifications.
  • Reducing Duplication: It eliminates the need for redundant documentation, processes, and audits. Instead of having separate quality and environmental manuals, a company can have one integrated manual that references the same common clauses.
  • Enhancing Consistency: It ensures that core concepts like “risk-based thinking,” “leadership commitment,” and “continual improvement” are addressed in the same way across all standards.
« Back to Glossary Index
Recent Posts
  • What is SALSA Certification? A Practical Guide for Food and Drink Manufacturers
  • From Quantity to Quality: What China’s Five-Year Plan Can Teach Us About Manufacturing Excellence
  • FDA QMSR: Why Your Management Review Is No Longer Protected (And What FDA Will Expect)
  • FDA QMSR 101: What Every Medical Device Professional Needs to Know
  • Manufacturing Training Galway | Featured in the Galway Advertiser

Categories

  • Business
  • CAPA
  • Combination Product
  • FDA
  • Food Safety Management
  • GMP
  • HACCP
  • Manufacturing
  • Medical Device
  • News
  • Pharmaceutical cGMP
  • Problem Solving
  • Regulation
  • Root cause analysis

ABOUT US

Quality, Regulatory, and Manufacturing Training Experts.

USEFUL LINKS

  • Contact Us
  • About Us
  • FAQ

CONNECT

  • LinkedIn
  • Twitter
  • Instagram
Copyright 2026 - All Rights Reserved | The Learning Reservoir Ltd. | Privacy Policy | Terms and Conditions

Download 1-Day QMSR Course Syllabus

Enter your email and we will send you the syllabus.

We will use your email to send your requested syllabus and occasional updates about training courses, regulatory news, and events from The Learning Reservoir. You can unsubscribe at any time. View our Privacy Policy.

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.