ISO 9001:2015 Clause 8.4.3 Information for external providers

ISO 9001:2015 Requirements

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
The organization shall communicate to external providers its requirements for:

1. the processes, products and services to be provided;
2. the approval of:
   • products and services;
   • methods, processes and equipment;
   • the release of products and services;
3. competence, including any required qualification of persons;
4. the external providers’ interactions with the organization;
5. control and monitoring of the external providers’ performance to be applied by the organization;
6. verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.

1) The organization shall ensure the adequacy of requirements prior to their communication to the external provider.

Ensuring the adequacy of requirements before communicating them to an external provider is a crucial step to prevent misunderstandings, errors, and non-conformities in the products or services you receive. Here’s how an organization can ensure requirement adequacy:

1. Before communicating requirements to an external provider, ensure that your organization has a well-defined and documented understanding of what is needed. This includes specifications, standards, quality expectations, and any regulatory or legal requirements.
2. Conduct an internal review of the requirements to verify their completeness, clarity, and consistency. Involve relevant departments, such as engineering, quality assurance, and legal, in the review process to ensure all aspects are covered.
3. Collaborate with cross-functional teams, including those responsible for product design, production, and quality assurance, to validate and refine the requirements. Seek input from individuals with expertise in the specific domain or industry to ensure that requirements are technically sound and aligned with best practices.
4. Verify that the requirements comply with all relevant legal and regulatory standards applicable to your industry and product/service. Ensure that any changes in regulations are reflected in your requirements.
5. If the requirements are customer-driven, ensure that they align with customer expectations and are validated with the customer if necessary. Maintain open communication channels with customers to clarify any ambiguities and address their specific needs.
6. Document the requirements in a clear and easily understandable format. Use drawings, specifications, diagrams, or other appropriate documentation methods to convey the information effectively.
7. Conduct a risk assessment to identify potential risks associated with the requirements. Evaluate the impact of these risks on your organization and the product/service.
8. Implement a verification and validation process to confirm that the requirements are accurate and feasible. Verification ensures that the requirements are correctly documented, while validation checks if they meet the intended purpose.
9. Establish a robust change management process to handle any modifications or updates to the requirements. Ensure that all stakeholders are informed and that changes are communicated clearly to the external provider.
10. In cases where complex or innovative requirements are involved, consider pilot testing or prototyping to validate the feasibility and practicality of the requirements before full-scale implementation.
11. Maintain strict documentation control to ensure that the most current and approved requirements are shared with the external provider.
12. Establish a clear and standardized communication protocol for sharing requirements with external providers. Specify the format, channels, and responsible parties for communicating requirements.
13. Provide training to relevant personnel involved in communicating requirements to ensure they understand the importance of clarity, accuracy, and completeness.
14. Establish a feedback mechanism with external providers to encourage them to seek clarification on requirements if they have any doubts or concerns.

By following these steps, your organization can ensure the adequacy of requirements before communicating them to external providers, reducing the risk of errors, misunderstandings, and non-conformities in the products or services you receive from them. This proactive approach enhances communication and collaboration with external providers and contributes to the overall quality and success of your organization’s products or services.

2) The organization shall communicate to external providers its requirements for the processes, products and services to be provided.

Communicating your organization’s requirements effectively to external providers is essential to ensure that they understand and can meet your expectations. Here’s how to communicate your requirements to external providers:

1. Formalize your requirements in written agreements or contracts with external providers. These documents should clearly specify what you expect in terms of processes, products, and services.
2. Provide a detailed scope of work that outlines the specific tasks, responsibilities, and deliverables expected from the external provider. Be precise and avoid vague language.
3. Clearly define quality standards, specifications, and performance expectations for the processes, products, or services. Include details on tolerances, measurements, and acceptable variations.
4. Share technical drawings, diagrams, schematics, or any other relevant documentation that illustrates the design, dimensions, or configuration of products or processes.
5. Specify acceptance criteria that external providers should meet. These criteria serve as benchmarks to evaluate the quality and conformity of their deliverables.
6. Communicate any regulatory, legal, or industry-specific requirements that must be followed. Ensure that external providers are aware of and adhere to these obligations.
7. If your organization has a specific QMS, communicate any relevant QMS requirements that external providers must comply with, such as ISO 9001.
8. If safety or environmental standards are applicable, clearly communicate these requirements to external providers. Specify safety procedures, protective measures, and environmental considerations.
9. Provide a clear delivery schedule or timeline for processes, products, or services. Specify deadlines and milestones to ensure alignment with your organization’s needs.
10. Establish clear communication channels between your organization and external providers. Designate contact persons on both sides to facilitate inquiries and discussions.
11. Outline the process for managing changes to requirements. Clearly specify how changes will be communicated, evaluated, and implemented.
12. Define the performance metrics and KPIs that will be used to assess the external provider’s performance in meeting your requirements.
13. Encourage external providers to provide feedback on the clarity and practicality of the communicated requirements. This helps identify and resolve any ambiguities or challenges.
14. Offer training and support as needed to help external providers understand and meet your requirements effectively.
15. Clearly define procedures for resolving conflicts or disputes related to requirements. Having a dispute resolution process in place can prevent misunderstandings from escalating.
16. Maintain strict document control to ensure that the most current and approved requirements are shared with external providers.
17. Ensure that the communicated requirements comply with all applicable legal and contractual obligations.
18. Establish a culture of continuous communication with external providers. Regularly update them on changes, expectations, and performance feedback.

By following these steps and maintaining clear, open, and effective communication with external providers, your organization can significantly enhance the chances of receiving products, processes, and services that meet your requirements and expectations. Effective communication fosters collaboration and mutual understanding, contributing to the success of your projects and partnerships with external providers.

3) The organization shall communicate to external providers its requirements for the approval of products and services; methods, processes and equipment; the release of products and services;

Communicating your organization’s requirements for the approval of products, services, methods, processes, equipment, and the release of products and services to external providers is essential for ensuring alignment and compliance. Here’s how to effectively communicate these requirements:

1) Requirements for the Approval of Products and Services:

• Clearly document the specifications and criteria that products and services must meet for approval. This includes quality standards, features, performance characteristics, and any other relevant requirements.
• Specify the acceptance criteria that external providers should use to determine whether products and services meet your organization’s requirements. These criteria serve as benchmarks for approval.
• Communicate your organization’s quality control procedures, inspection processes, and testing protocols that external providers must follow to ensure products and services meet approval criteria.
• If applicable, specify the need for samples, their quantity, and how they should be handled, tested, or evaluated for approval.
• Clearly outline the documentation and records that must accompany products and services for approval, including certificates of compliance, test reports, and traceability documentation.
• Ensure that external providers are aware of and comply with any regulatory, legal, or industry-specific requirements related to product and service approval.
• Define the process for communicating changes in approval requirements to external providers and how changes will be evaluated and implemented.

2) Requirements for the Approval of Methods, Processes, and Equipment:

• Provide detailed specifications and requirements for methods, processes, and equipment that external providers must use. This may include technical specifications, design criteria, and performance expectations.
• Communicate any qualifications, certifications, or specific training requirements that personnel operating equipment or conducting processes must possess.
• Specify the testing and validation procedures external providers should follow to ensure the adequacy and effectiveness of methods, processes, and equipment.
• Communicate any safety and environmental standards that must be followed when using specific methods, processes, or equipment.
• Define the documentation and reporting requirements related to the approval of methods, processes, and equipment, including records of validation and qualification.
• Outline the process for managing changes to approved methods, processes, and equipment. Clarify how changes will be communicated, evaluated, and implemented.

3) Requirements for the Release of Products and Services:

• Clearly define the criteria and conditions that must be met for the release of products and services. This includes quality, safety, regulatory, and contractual requirements.
• Communicate the verification and validation processes that external providers must follow to ensure that products and services meet release criteria.
• Specify the documentation and reporting requirements for the release of products and services, including certificates of conformity and release documentation.
• Define traceability and identification requirements to ensure that products and services are properly marked, labeled, and documented for release.
• Outline the process and communication channels for notifying your organization when products and services are ready for release.
• Detail the process for managing changes to release criteria and requirements, including how changes will be communicated, evaluated, and implemented.

By providing clear, detailed, and documented requirements to external providers for product and service approval, methods and equipment, and product and service release, you facilitate effective communication, collaboration, and compliance. This ensures that the products and services you receive meet your organization’s standards and expectations.

4) The organization shall communicate to external providers its requirements for competence, including any required qualification of persons

Communicating your organization’s requirements for competence, including any required qualifications of individuals, to external providers is crucial for ensuring that the personnel working on your projects or providing services meet the necessary standards. Here’s how to effectively communicate these requirements:

• Provide detailed job descriptions or role profiles that specify the competencies, skills, qualifications, and experience required for individuals who will be working on your projects or providing services.
• Clearly define the qualification criteria that individuals must meet, such as educational background, certifications, licenses, or any specific training programs that are mandatory.
• Communicate the level of relevant experience and expertise expected from individuals. Specify the minimum number of years or projects in a similar role, if applicable.
• Clearly state any required certifications or licenses that individuals must hold. Ensure that external providers verify and provide proof of these certifications.
• Communicate any ongoing training and development requirements for personnel working on your projects or providing services. This may include regular updates, continuing education, or specific training programs.
• Ensure that external providers are aware of and comply with any regulatory, legal, or industry-specific requirements related to the competence and qualifications of personnel.
• Specify the verification and validation processes that external providers should follow to ensure that their personnel meet your competence requirements. This may include checks on qualifications, certifications, and licenses.
• Define the documentation and record-keeping requirements for external providers related to the competence and qualifications of their personnel. This includes maintaining records of qualifications, certifications, and training.
• Outline the process for managing changes to competence and qualification requirements. Define how changes will be communicated, evaluated, and implemented.
• Establish clear communication channels between your organization and external providers for discussing and verifying competence and qualification requirements.
• Communicate the possibility of audits or assessments to verify that personnel working on your projects or providing services meet the specified competence and qualification criteria.
• Clearly communicate the performance expectations for personnel in terms of their roles and responsibilities, which should align with the required competence.
• Encourage external providers to provide feedback or updates regarding the competence and qualifications of their personnel. Ensure that they promptly notify you of any changes or concerns.
• Foster a culture of continuous improvement in terms of competence and qualifications. Encourage external providers to seek opportunities for enhancing the skills and knowledge of their personnel.

By following these steps and maintaining clear, open, and effective communication with external providers, your organization can ensure that the competence and qualifications of personnel meet the required standards. This contributes to the overall quality and success of your projects and services.

5) The organization shall communicate to external providers its requirements for the external providers’ interactions with the organization;

Communicating your organization’s requirements for external providers’ interactions with your organization is essential to establish clear expectations, maintain effective relationships, and ensure smooth collaboration. Here’s how to effectively communicate these requirements:

• Clearly define your organization’s specific requirements for how external providers should interact with your organization. This includes expectations for communication, responsiveness, and behavior.
• Formalize interaction requirements in written agreements, such as contracts or SLAs, between your organization and external providers. These documents should outline the terms and conditions governing interactions.
• Specify communication protocols, including the preferred methods of communication (e.g., email, phone, meetings), response times, and points of contact for different types of inquiries or issues.
• Communicate escalation procedures that external providers should follow in case of disputes, issues, or urgent matters. Clearly define who to contact and the process to follow.
• Outline the documentation and reporting requirements related to interactions. This may include records of meetings, communication logs, incident reports, or performance reports.
• Define a clear process for resolving conflicts or disagreements between your organization and external providers. This should include steps for mediation, arbitration, or other dispute resolution mechanisms.
• Communicate your organization’s expectations regarding ethical behavior, integrity, and professional conduct when interacting with your staff, customers, and other stakeholders.
• Clearly communicate your organization’s performance expectations for external providers, including quality, timeliness, and adherence to agreements or contracts.
• Specify data security and confidentiality requirements to protect sensitive information shared during interactions. Ensure that external providers understand and comply with these requirements.
• Establish a process for communicating and managing changes in interaction requirements. Ensure that external providers are informed of any changes and understand how they will be implemented.
• Encourage external providers to provide feedback and suggestions for improving the interaction process. Foster a culture of continuous improvement in collaboration.
• Define the criteria and metrics for evaluating the quality and effectiveness of interactions. Establish a system for monitoring and assessing external providers’ performance in this regard.
• Clearly communicate channels for providing feedback or reporting issues related to interactions. Ensure that external providers can easily reach out to your organization.
• Provide training and onboarding materials that explain your organization’s expectations for interactions. Ensure that external providers’ personnel are familiar with your requirements.
• Ensure that external providers are aware of and comply with all relevant legal, regulatory, and industry-specific requirements related to interactions with your organization.
• Conduct periodic performance reviews with external providers to evaluate their adherence to interaction requirements and identify areas for improvement.
• Maintain strict documentation control to ensure that the most current and approved interaction requirements are shared with external providers.

By effectively communicating these requirements and fostering a culture of mutual respect and cooperation, your organization can establish productive and harmonious relationships with external providers and ensure that interactions are aligned with your organizational goals and values.

6) The organization shall communicate to external providers its requirements for control and monitoring of the external providers’ performance to be applied by the organization

Communicating your organization’s requirements for controlling and monitoring the performance of external providers is crucial to ensuring that they meet your expectations and standards. Here’s how to effectively communicate these requirements:

• Clearly document your organization’s requirements for how external providers should control and monitor their own performance. This documentation should include specific expectations and guidelines.
• Formalize control and monitoring requirements in written agreements, contracts, or SLAs between your organization and external providers. These documents should outline the terms and conditions governing performance evaluation.
• Define the KPIs that your organization will use to assess the performance of external providers. These KPIs should be measurable, specific, and aligned with your organization’s objectives.
• Communicate the performance metrics and targets that external providers are expected to achieve. Clearly define acceptable performance levels and any consequences for non-compliance.
• Specify the reporting requirements for external providers to communicate their performance data to your organization. This may include periodic reports, data formats, and submission deadlines.
• Outline the process for conducting performance reviews and audits of external providers. Describe the frequency, scope, and objectives of these evaluations.
• Ensure that external providers grant your organization access to relevant data and records necessary for performance monitoring. Specify the data-sharing protocols.
• Clearly communicate your organization’s expectations regarding corrective actions. Define the process for addressing performance deficiencies and non-conformities.
• Encourage external providers to actively seek opportunities for improving their performance. Foster a culture of continuous improvement in collaboration.
• Provide channels for external providers to communicate their own performance improvement suggestions and insights. Encourage open and constructive feedback.
• Specify data security and confidentiality requirements for any performance-related data shared between your organization and external providers. Ensure compliance with data protection regulations.
• Define the process for communicating and managing changes in performance monitoring requirements. Ensure that external providers are informed of any changes and understand how they will be implemented.
• Ensure that external providers are aware of and comply with all relevant legal, regulatory, and industry-specific requirements related to performance control and monitoring.
• Maintain strict documentation control to ensure that the most current and approved performance control and monitoring requirements are shared with external providers.
• Recognize and acknowledge external providers for exceptional performance when they consistently meet or exceed performance targets.
• Clearly define procedures for resolving conflicts or disputes related to performance control and monitoring. Ensure that conflicts are addressed in a fair and timely manner.

By effectively communicating these requirements, your organization can establish a clear framework for evaluating and improving the performance of external providers, fostering a partnership that aligns with your organizational goals and values. This transparency and accountability contribute to successful collaborations and enhanced performance outcomes.

7) The organization shall communicate to external providers its requirements for verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.

Communicating your organization’s requirements for verification or validation activities that you or your customer intend to perform at the external providers’ premises is essential for ensuring alignment and coordination. Here’s how to effectively communicate these requirements:

• Begin by clearly documenting the specific verification or validation activities that you or your customer intend to perform at the external providers’ premises. Include details such as the scope, objectives, and acceptance criteria for these activities.
• Formalize these requirements in written agreements, contracts, or SLAs between your organization and external providers. Clearly outline the terms and conditions governing the verification or validation processes.
• Communicate the timelines and scheduling for the verification or validation activities. Specify when these activities will take place and any deadlines for completion.
• Define the scope of access that you or your customer will require at the external providers’ premises. Specify which areas, equipment, or personnel will be involved in the verification or validation processes.
• Specify any qualifications, certifications, or experience requirements for the personnel who will be conducting the verification or validation activities at the external providers’ premises.
• Communicate any specific equipment, tools, or resources that you or your customer will bring or require during the verification or validation processes.
• Outline the reporting and documentation requirements for the verification or validation activities. Specify what records and reports need to be maintained and shared.
• Establish clear communication channels between your organization and external providers to coordinate and schedule verification or validation activities. Designate contact persons for coordination.
• Ensure that the verification or validation activities comply with safety regulations and any other legal or regulatory requirements. Communicate safety protocols and expectations.
• Define the process for communicating and managing changes to the verification or validation requirements. Ensure that external providers are informed of any changes and understand how they will be implemented.
• Specify data security and confidentiality requirements for any information or data shared during the verification or validation activities. Ensure compliance with data protection regulations.
• Ensure that external providers are aware of and comply with all relevant legal, regulatory, and industry-specific requirements related to the verification or validation activities.
• Clearly define procedures for resolving conflicts or disputes related to the verification or validation activities. Ensure that conflicts are addressed in a fair and timely manner.
• Encourage external providers to actively participate in and contribute to the verification or validation processes, seeking opportunities for improvement.
• Establish channels for external providers to provide feedback or report any issues related to the verification or validation activities. Encourage open and constructive communication.

By effectively communicating these requirements, you can ensure that verification or validation activities at external providers’ premises are carried out smoothly, with a clear understanding of roles, responsibilities, and expectations. This fosters collaboration and enhances the quality and reliability of the processes and products involved.

Documented Information required

ISO 9001:2015 Clause 8.4.3, titled “Information for external providers,” outlines the requirements for providing information to external providers (suppliers, contractors, etc.) to ensure that they understand your organization’s needs and expectations. Here are the key documents and records required by this clause:

1. Purchase Orders or Contracts: Purchase orders or contracts serve as formal documents that specify the products, services, quantities, delivery schedules, and other relevant terms and conditions agreed upon with external providers. These are critical for communicating requirements.
2. Specifications and Drawings: Detailed specifications, technical drawings, schematics, and other technical documents that outline the design, dimensions, and configuration requirements for products or services.
3. Quality Requirements: Documentation that communicates your organization’s quality requirements, including quality standards, acceptance criteria, and quality control processes that external providers must adhere to.
4. Delivery Schedules: Information regarding delivery schedules, timelines, and any specific delivery instructions that external providers need to meet.
5. Regulatory and Legal Requirements: Documentation that outlines regulatory, legal, and industry-specific requirements relevant to the products or services being provided by external providers.
6. Performance Metrics and KPIs: Communication of key performance indicators (KPIs) and performance metrics that will be used to assess the performance of external providers. These metrics should align with your organization’s objectives.
7. Communication Protocols: Clear communication protocols that specify how information exchange, inquiries, and issues will be managed between your organization and external providers.
8. Change Notifications: Procedures for notifying external providers of any changes in requirements, specifications, schedules, or other aspects of the contract or purchase order.
9. Documentation Control: Ensuring that all documentation provided to external providers is controlled and that they receive the most current and approved versions.
10. Feedback Mechanisms: Mechanisms for external providers to provide feedback, report issues, and seek clarifications or guidance regarding your organization’s requirements.
11. Performance Monitoring and Reporting: Procedures and forms for monitoring and reporting on the performance of external providers, including evaluations, audits, and assessments.
12. Records of Communication: Documentation of all communications, including emails, meeting minutes, and other correspondence related to the requirements communicated to external providers.
13. Training and Awareness Materials: Materials that help external providers understand your organization’s processes, policies, and expectations, as well as any training materials related to the products or services they provide.
14. Supplier Self-Assessment Forms: Forms or questionnaires that external providers may be required to complete to assess their capability to meet your organization’s requirements.
15. Certificates and Qualifications: Proof of external providers’ qualifications, certifications, and licenses that demonstrate their ability to meet your organization’s requirements.
16. Corrective Action Records: Records of corrective actions taken by external providers in response to non-conformities or issues related to the requirements.
17. Performance Improvement Plans: Documentation of performance improvement plans developed in collaboration with external providers to address performance deficiencies.
18. Supplier Scorecards and Reports: Reports and scorecards summarizing the performance of external providers based on established KPIs and metrics.
19. Audit and Assessment Records: Records of audits and assessments conducted by your organization or third parties to evaluate the performance and compliance of external providers.

These documents and records are critical for ensuring effective communication with external providers, clarifying expectations, monitoring performance, and maintaining compliance with ISO 9001:2015 Clause 8.4.3. They help facilitate a smooth and mutually beneficial relationship with your external providers.