In the context of ISO 9001, permissible exclusions refer to certain requirements within the standard that an organization can choose to exclude from its Quality Management System (QMS) scope (clause 4.3)Â if they do not apply to the nature of its business or operations. It’s important to note that exclusions are allowable only if they do not affect the organization’s ability or responsibility to ensure conformity of products and services and enhance customer satisfaction.
Instead, it tailors the QMS to the organization’s context and scope. This allows for flexibility but requires the organization to consider and justify how it applies each standard requirement within its context or decide what ISO 9001 requirements are not applicable.
Key Points about Permissible Exclusions
The concept of permissible exclusions is more nuanced in the 2015 version of ISO 9001 compared to earlier versions, and you must state that they are not applicable. Here are more key points about permissible exclusions.
Applicability: ISO 9001:2015 allows exclusions only when they are not applicable due to the nature of the organization, its processes, or its products and services. Exclusions should mainly apply to Clause 8 (Operation) requirements, encompassing the QMS’s operational processes.
Justification is Required: Any exclusion must be justified and documented. The organization must demonstrate that the exclusion does not affect its ability to ensure the conformity of its products and services and enhance customer satisfaction. You must clearly state that the requirement cannot be applied in your justification.
Impact on Product/Service Quality: The exclusion must not meet customer or regulatory requirements. Despite the exclusion, the integrity of the QMS must be maintained.
The concept that exclusions in ISO 9001:2015 apply to Clause 8 (Operation) requirements is not explicitly stated in those exact words in the standard. However, this idea is derived from the following key points:
Clause 4.3 – Determining the Scope of the Quality Management System: This clause allows organizations to determine the scope of their Quality Management System (QMS) and consider the applicability of each requirement. The organization must justify any exclusions or non-applicability, and the scope must not affect the organization’s ability to ensure conformity of products and services.
Clause 4.3 also specifies: “The scope shall state the types of products and services covered and justify any requirement of this International Standard that the organization determines does not apply to the scope of its quality management system.” It’s important to note that it allows exclusions only where they do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and enhance customer satisfaction.
Clause 4.3 also specifies: “Conformity to this International Standard may only be claimed if the requirements determined as not being applicable and do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.” The language that must be used in the justification documentation is not applicable or does not apply.
Clause 8 – Operation: In practice, exclusions typically apply to requirements related to Clause 8, mainly when certain operational activities such as design and development (Clause 8.3) or post-delivery activities (Clause 8.5.5) do not apply to an organization’s operations. Clause 8 encompasses the operational processes related to product and service realization, which can vary significantly between different types of organizations.
ISO 9001:2015 Implementation and Guidance Documents: Various implementation guides and training resources for ISO 9001:2015 explain that exclusions are most relevant to Clause 8, which contains specific operational requirements. Exclusions are usually not applicable to other clauses because they address general system management, which applies to all organizations.
The principle that exclusions should mainly apply to Clause 8 (Operation) is based on the standard’s requirement that the scope of the QMS ensures the organization can consistently meet customer and regulatory requirements. Thus, exclusions are typically limited to operational processes that do not affect the overall conformity of products and services. Outsourcing-related exclusions are unacceptable and should cause a nonconformance during the audit.
IATF 16949Â Permissible Exclusions
In the context of IATF 16949, permissible exclusions are explicitly addressed within the standard’s requirements but with more stringent rules than ISO 9001. IATF 16949 allows for limited exclusions, but these are explicitly restricted to certain parts of the standard, particularly in design and development, and not broadly across all of Clause 8 (Operation).
Specific References in IATF 16949
Clause 3.1 of IATF 16949 – Definitions (Permissible Exclusions): IATF 16949 explicitly states that the only permissible exclusions within the standard are related to Clause 8.3 – Design and Development of Products and Services. The standard states: “Permissible exclusions for this Automotive QMS Standard are limited to requirements within ISO 9001, Section 8.3 only. Permissible exclusions do not include manufacturing process design.” This means that the organization can only exclude the requirements related to design and development, and this exclusion is only allowed if the organization does not engage in design activities.
- Scope and Applicability: Suppose an organization does not engage in design and development activities. It can exclude these specific requirements (Clause 8.3). However, it must still comply with all other applicable requirements of the standard, including other parts of Clause 8 related to operations.
- Justification for Exclusion: Any exclusion related to Clause 8.3 must be justified and documented within the organization’s Quality Management System (QMS) scope. The organization must ensure that such exclusions do not affect its ability to meet customer and regulatory requirements.
IATF 16949Â Exclusions
IATF 16949 exclusions are strictly limited to Clause 8.3 (Design and Development) and do not broadly apply to Clause 8 (Operation) as they might in ISO 9001. The standard clarifies that even within Clause 8.3, exclusions are not permitted for manufacturing process design, ensuring that the QMS fully covers the core operational and quality control activities.
Examples of Common Areas for Permissible Exclusions
Under ISO 9001:2015, the approach to permissible exclusions has evolved. While earlier versions of the standard, like ISO 9001:2008, explicitly mentioned permissible exclusions in clauses related to product realization, the 2015 revision does not explicitly define “exclusions.” Note that third-party auditors are often skeptical when companies try to exclude certain ISO 9001:2015 clause eight requirements. Review ISO 9001 Auditing Practices Group Guidance on Service Organizations for more information.
8.1 Operational Planning and Control Exclusion
For organizations that do not produce goods or deliver operational services, clause 8.1, which focuses on operational planning and control for manufacturing and service provision, does not apply to their Quality Management System (QMS). This means that no planning is required for designing, procuring, and delivering the products or services. Everything sold uses commercially off-the-shelf (COTS) components, and there are no unique customer requirements to be designed. This is often unrealistic, but it is possible for extremely simple businesses.
- Example: XYZ Consulting provides strategic business consulting services without producing physical products or delivering operational services. Their work primarily involves advisory activities, analysis, and strategic recommendations, all managed through internal processes.
- Justification: Since XYZ Consulting does not engage in the production of goods or operational service delivery, Clause 8.1, which focuses on operational planning and control for manufacturing and service provision, does not apply to its Quality Management System (QMS). This exclusion is justified because XYZ’s work does not involve operational controls related to product realization, allowing the QMS to concentrate on ensuring the quality and consistency of its consulting services.
8.2 Requirements for Products and Services Exclusion
If an organization does not control the requirements for products and services, it can exclude clause 8.2 Requirements for Products and Services Exclusion from its QMS. This is common in industries such as distribution or maintenance services, where the company is not involved in creating new requirements for products and services but in delivering to existing ones through a contract. However, this is often unrealistic if the company negotiates service contracts.
- Example: LMN Maintenance Services provides routine janitorial services to a single client based entirely on a fixed contract that specifies all requirements. The client provides all necessary materials and equipment, and LMN Maintenance does not engage in any product or service design or customization.
- Justification: Since LMN Maintenance operates under a fixed contract with no variability or need to define additional requirements for products or services, Clause 8.2, which addresses the determination and review of requirements for products and services, does not apply to its Quality Management System (QMS). This exclusion is justified because LMN’s activities are fully predefined by the client, with no need for further requirement analysis, allowing the QMS to focus on maintaining consistent service delivery.
8.3 Design and Development Exclusion
If an organization does not design and develop its products or services, it can exclude clause 8.3 design and development requirements from its QMS. This is common in industries such as distribution or some service sectors, where the company is not involved in creating new products but in delivering existing ones. This is the most common clause found to be inapplicable to contract manufacturers.
- Example: If an organization is a manufacturer that only produces products based on customer-provided designs and does not engage in any design and development activities, it can exclude the requirements of Clause 8.3 from its QMS.
- Justification: The organization does not design its products; therefore, the design and development requirements are not applicable.
8.4 Control of Externally Provided Processes, Products, and Services Exclusion
Organizations that do not control externally provided processes, products, or services (Clause 8.4) can exclude requirements related to servicing external providers. However, this is often unrealistic because most companies utilize outsourced processes, whether maintenance, janitorial, consulting advice, legal, accounting, or other specialized technical knowledge. Therefore, responsibility for controlling outsourced processes still applies.
- Example: ABC Software Solutions develops custom software for clients but does not outsource any part of its development process. ABC’s employees conduct all in-house design, coding, testing, and deployment.
- Justification: Since ABC Software Solutions does not rely on external providers for processes, products, or services related to software development, Clause 8.4 does not apply to its Quality Management System (QMS). This exclusion is justified as no external processes or services impact the quality or delivery of ABC’s software products, allowing the company to focus its QMS on internal controls and procedures.
8.5.1 Control of Production and Service Exclusion
If an organization does not control the production and service (Clause 8.5.1), it can exclude those requirements from the QMS. This is common in industries such as distribution or some service sectors, where the company is not involved in realizing new products but in delivering existing ones.
- Example: A distributor that only stores and ships products without engaging in any manufacturing processes might exclude certain elements related to production control.
- Justification: The distributor’s primary activity is logistics and distribution, not production, so some production-related requirements may not apply.
8.5.5 Post-Delivery Servicing Exclusion
Organizations that do not provide (clause 8.5.5) post-delivery maintenance or servicing of their products can exclude requirements related to servicing activities. For instance, a manufacturer of disposable products might not have any servicing activities associated with their products once they are sold. This is a common clause found to be inapplicable.
- Example: If a company manufactures and delivers a product but does not provide installation, maintenance, or warranty services after delivery, it may exclude post-delivery activities from its QMS.
- Justification: The company does not engage in any activities after the product has been delivered to the customer, so clause 8.5.5 post-delivery maintenance or servicing does not apply.
8.6 Product Release Exclusion
In some specific cases, the responsibility for clause 8.6 product release and final inspection might not lie with the organization but with the customer or an external inspector. If so, these processes can be excluded from the QMS.
- Example: A Warehouse handles the storage and distribution of medical devices for a client. The client’s quality control team conducts all final inspections and authorizes product release before shipping items. The Warehouse does not perform any final inspection or release activities.
- Justification: The client’s quality control team is responsible for the final inspection and product release, so Clause 8.6 is not applicable. This exclusion is justified because the Warehouse has no role in ensuring product conformity before release, which the client entirely manages. Documenting this exclusion allows XYZ to focus its QMS on processes it controls, such as inventory management and distribution logistics.
Guidelines for Permissible Exclusions
It is important to review the organization’s processes to identify any non-applicable requirements within Clause 8. The ISO 9001 guidelines for exclusions include proper justification, documentation, review, and approval, and the exclusion must comply with customer and regulatory requirements.
Justification for Exclusions
Any exclusion regarding the organization’s product, service, or internal context must be justified. The organization must demonstrate that the exclusion does not impact its ability to deliver products or services that meet customers and applicable statutory and regulatory requirements. Then, provide a rationale for each exclusion in the QMS scope (clause 4.3), ensuring that the exclusion does not compromise the ability to meet customer or regulatory requirements.
Exclusion Documentation
Exclusions must be documented in the Quality Manual or other relevant documentation. The organization should clearly describe the rationale for each exclusion, such as the Quality Manual or other relevant documents.
Communicating Exclusions
Communicate the exclusions and ensure all relevant personnel understand them and their implications for the QMS.
Review and Approval of Exclusions
Relevant management should review and approve exclusions to ensure they are appropriate.
Compliance with Customer and Regulatory Requirements
Exclusions must not affect the organization’s obligation to comply with customer and regulatory requirements.
Permissible Exclusions within ISO 9001
Organizations must approach the exclusion of parts of the ISO 9001 standard with caution and thorough justification, ensuring that such exclusions do not compromise the integrity and effectiveness of their Quality Management System. Permissible exclusions in ISO 9001:2015 are limited to specific operational requirements under Clause 8 and must be justified based on the organization’s activities.
Properly identifying, justifying, and documenting exclusions ensures that the QMS remains effective and compliant, without unnecessary requirements that do not apply to the organization’s scope of operations. This flexibility allows organizations to tailor their QMS to their specific needs while maintaining the system’s integrity.
