Understanding the Scope and Exclusions in ISO 9001 and AS9100 Certification
When implementing ISO 9001 Certification, defining the scope of your Quality Management System (QMS) is crucial. This scope outlines the boundaries and applicability of the QMS, ensuring clarity and precision in what is covered by your certification. Let's delve into the key aspects of defining the scope and understanding permissible exclusions.
Defining the Scope of ISO 9001 and AS9100 Certification
The scope of ISO 9001 Certification is detailed in Clause 1, which defines the standard's overall scope. However, Clause 4.3 requires organizations to determine the specific scope of their QMS. This involves identifying the types of products and services provided, the processes involved, and the relevant sites, departments, or divisions.
A well-defined scope should:
Clearly describe the products and services offered.
Specify the boundaries of the QMS, including all relevant processes and locations.
Ensure the scope is not misleading or overly broad.
For example, if an organization is certified for "construction of roads," it should not claim a broader scope like "general construction" unless it covers all aspects of construction.
Challenges in Defining Scope of Certification
Defining the scope of certification can be straightforward for single-location operations but becomes complex with:
Multiple sites
Outsourcing
Logistics
Service centers
On-site services at customer premises
Collaborative products and services
In such cases, the scope must accurately reflect the extent of the QMS, ensuring it is comprehensive and not misleading.
Scope of Certification
The scope of certification should encompass the QMS scope and be clearly defined to avoid confusion. It should detail:
The types of products and services covered.
The main operational processes, such as design, manufacture, packaging, and delivery.
Any non-applicable requirements from ISO 9001, with justifications for their exclusion.
Permissible Non-Applicability (which has replaced exclusions) in ISO 9001 and AS9100 Standards
When implementing ISO 9001 and AS9100 standards, organizations may encounter requirements that are not applicable to their specific operations. These non-applicable requirements can be documented anywhere within the quality management system (QMS) documentation, not necessarily in the scope section of the Quality Manual. Clause 4.3 of ISO 9001:2015 and AS9100 Rev D, allows organizations to determine the applicability of requirements based on factors such as the size and complexity of the organization, the management model, the range of activities, and the nature of risks and opportunities encountered. The key is that any decision regarding non-applicability must not result in a failure to achieve conformity of products and services.
The concept of non-applicability has replaced the term "exclusions" in the context of these standards. It is generally more effective to document non-applicability in the relevant sections of the manual where the specific requirements are addressed, rather than in the scope itself. This approach ensures that the rationale for non-applicability is clearly linked to the specific processes or activities it pertains to, providing better clarity and context. For example, if a particular "shall" statement or clause is not applicable, documenting this directly in the section where the requirement is discussed helps auditors and stakeholders understand the justification without having to cross-reference multiple sections. This method enhances the transparency and coherence of the QMS documentation, making it easier to maintain and audit.
Ensuring Clarity and Transparency
To avoid confusion, the scope of certification should be publicly available and clearly documented. This transparency helps customers and stakeholders understand what is covered by the certification.
Additional Insights from an ISO Consultant
Recent discussions in the ISO community emphasize the importance of a clear and precise scope to maintain the integrity of the certification process. Misleading scopes can undermine trust and lead to compliance issues. Therefore, organizations should work closely with their ISO Consultant to ensure the scope is accurate and reflective of their operations.
Moreover, the ISO 9001:2015 standard has introduced more flexibility in defining the scope, allowing organizations to tailor their QMS to their specific needs while maintaining compliance. This adaptability is particularly beneficial for small and medium-sized enterprises (SMEs) looking to implement ISO 9001 Certification without unnecessary complexity.
AS9100 Certification Considerations
For organizations in the aerospace industry, AS9100 Certification follows similar principles but with additional requirements specific to aerospace. Defining the scope of AS9100 Certification involves the same careful consideration to ensure all relevant processes and locations are included, and permissible exclusions are justified.
