Scope of Management System: Implications for Compliance, and Certification

A management system provides a structured framework for organizations to manage processes and achieve objectives effectively. Whether it’s a Quality Management System (QMS) like ISO 9001:2015, an Environmental Management System (EMS) like ISO 14001:2015, or an Occupational Health and Safety Management System (OHSMS) like ISO 45001:2018, the scope defines the boundaries of the system, including what is covered and what is excluded. This helps ensure compliance and reduces risk while aligning with organizational goals.
The scope of a management system includes the processes, locations, and functions that fall under its framework. It can cover the entire organization or be limited to specific areas. For instance, a manufacturing company might limit its scope to production, while a multinational might include departments like sales, marketing, and procurement across several sites.
The scope must also specify exclusions, which are parts of the organization or processes that are not covered by the management system. These exclusions are typically based on the organization’s business model, regulatory requirements, or strategic objectives. Clear documentation of the scope and exclusions is essential for compliance with standards like ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018.
Management system standards allow certain clauses to be excluded if they are not applicable to the organization. However, exclusions must be justified and documented to ensure the system remains effective and compliant. For example, a service-based organization that does not design products may exclude clauses related to product design but must still comply with other critical clauses like customer satisfaction and regulatory requirements.
Exclusions are acceptable if they do not compromise the ability to meet legal, regulatory, or customer requirements. For example, a software company that doesn’t manufacture physical products may exclude clauses specific to product requirements but must still ensure customer satisfaction and legal compliance.
Certain clauses cannot be excluded, as they are critical to the system’s effectiveness. For example, excluding clauses related to nonconformity management, corrective actions, or customer satisfaction can create risks, including non-compliance, poor product/service quality, and customer dissatisfaction.
Physical Scope and Locations
The physical scope defines which locations are covered by the management system. Organizations with multiple sites—such as manufacturing plants, offices, or warehouses—must determine whether all locations are included in the system or only certain ones. Factors like operational needs, customer requirements, risk, and regulatory obligations guide the decision.
For example, a global organization might include its key manufacturing sites but exclude non-critical offices or smaller warehouses. Once the scope of locations is determined, it is important to ensure consistency across all sites through regular audits and assessments.
When managing a system across multiple sites, audits are essential for ensuring compliance and identifying areas for improvement. Audits should be scheduled based on risk and complexity, with higher-risk sites or those involved in critical processes being audited more frequently. The selection of sites for auditing depends on factors such as customer complaints, operational risks, or strategic importance.
For example, a site producing critical products may require more rigorous and frequent audits compared to a non-manufacturing facility. Regular audits ensure that the management system is applied consistently across all sites, regardless of their size or function.
Organizations with multiple sites can choose between individual certifications for each location or a single certificate covering all locations. Each option has distinct advantages and challenges.
Individual Certification