What It Is

BREEAM (Building Research Establishment Environmental Assessment Method) is a science-led sustainability certification framework for the built environment. Developed by BRE in 1990, it assesses environmental, health, and resilience performance across buildings, infrastructure, and communities using a credit-based, weighted scoring methodology producing ratings from Pass to Outstanding.

Key Components

• Core categories: Management, Health & Wellbeing, Energy, Transport, Water, Materials, Waste, Land Use & Ecology, Pollution, Innovation.
• Credits awarded for issue compliance, weighted by impact, with third-party assurance via licensed assessors and BRE audits.
• Schemes for lifecycles: New Construction, In-Use, Refurbishment, Infrastructure.
• Supported by technical manuals and KBCNs for updates.

Why Organizations Use It

Drives ESG compliance, net-zero alignment, asset value uplift (up to 30%), energy savings (22-33%), and market differentiation. Mitigates regulatory risks, enhances tenant appeal, and builds investor trust through verified performance.

Implementation Overview

Embed early via assessor appointment; multi-stage process (design, construction, post-occupancy). Applies globally to all sizes; requires evidence submission for BRE certification. In-Use valid 3 years.

What It Is

ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for organizations to demonstrate consistent provision of safe medical devices across their lifecycle, from design to post-market surveillance.

Key Components

• Organized into Clauses 4–8 covering QMS, management responsibility, resources, product realization, and measurement/improvement.
• Emphasizes documented processes, validation, traceability, and regulatory integration.
• Built on process approach with exclusions allowed for non-applicable activities like design controls.
• Certification via accredited bodies through staged audits.

Why Organizations Use It

• Enables market access (e.g., EU MDR, FDA QMSR alignment by 2026).
• Mitigates risks of recalls and non-compliance.
• Builds stakeholder trust and supply chain credibility.
• Drives operational efficiency and continual improvement.

Implementation Overview

• Phased approach: gap analysis, documentation, training, validation, audits.
• Applies to manufacturers, suppliers, distributors globally.
• Requires executive commitment and eQMS tools for scalability.