ISO 9001:2015 Clause 8.2.2 Determining the requirements related to products and services

ISO 9001:2015 Requirements

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

  1. the requirements for the products and services are defined, including:
    • any applicable statutory and regulatory requirements;
    • those considered necessary by the organization;
  2. the organization can meet the claims for the products and services it offers.

1) Determining the requirements for the products and services to be offered to customers

Determining the requirements for the products and services to be offered to customers is a critical step in the development and delivery of quality offerings. Here are steps an organization can take to determine these requirements effectively:

  1. Understand Customer Needs and Expectations: Begin by conducting market research and customer surveys to gain insights into the needs, preferences, and expectations of your target audience. Engage with existing customers to understand their pain points and what they value in products or services.
  2. Segment Your Customer Base: Categorize your customers into distinct segments based on factors such as demographics, industry, location, and buying behavior. Different customer segments may have varying requirements.
  3. Analyze Industry Trends and Standards: Stay updated on industry trends, standards, and best practices. Industry associations, publications, and competitor analysis can provide valuable information about evolving customer requirements.
  4. Legal and Regulatory Requirements: Identify and understand any legal or regulatory requirements that apply to your industry or product/service category. Ensure full compliance to avoid legal issues.
  5. Internal Stakeholder Input: Collaborate with internal stakeholders, such as product development teams, engineers, sales, and customer support, to gather their insights and perspectives on customer requirements.
  6. Benchmarking: Study and compare your offerings against competitors or similar organizations to identify gaps and areas for improvement. Benchmarking can highlight industry standards and customer expectations.
  7. Create Customer Personas: Develop detailed customer personas that represent typical customers within each segment. These personas can help you better understand and cater to the unique needs of different customer groups.
  8. Feedback Channels: Establish mechanisms for ongoing customer feedback, such as suggestion boxes, customer support hotlines, or online feedback forms. Actively listen to and analyze customer feedback to identify patterns and trends.
  9. Prototype and Testing: If applicable, create prototypes or minimum viable products (MVPs) and conduct user testing to gather direct feedback from potential users. This iterative process helps refine product/service requirements.
  10. Value Proposition Analysis: Analyze your organization’s unique value proposition. Determine what sets your offerings apart from competitors and how that aligns with customer requirements.
  11. Prioritize Requirements: Prioritize customer requirements based on their impact on customer satisfaction, business goals, and feasibility. Some requirements may be must-haves, while others are nice-to-haves.
  12. Document Requirements: Create a clear and comprehensive document that outlines the identified requirements for your products or services. This document serves as a reference point for all stakeholders.
  13. Cross-Functional Collaboration: Encourage cross-functional collaboration among teams involved in product/service development, marketing, and customer support to ensure alignment with customer requirements.
  14. Regular Review and Update: Customer requirements may evolve over time. Establish a process for regularly reviewing and updating your requirements documentation to stay responsive to changing customer needs.
  15. Validation with Customers: Before finalizing product/service offerings, validate the requirements with key customers or representatives from your target audience to ensure alignment and receive their input.
  16. Continuous Improvement: Maintain a culture of continuous improvement, where feedback and data on customer satisfaction are used to refine and adapt your products or services to changing requirements.

By systematically determining customer requirements and staying attuned to their evolving needs, organizations can develop products and services that are more likely to meet customer expectations, enhance customer satisfaction, and remain competitive in the market.

2) The organization shall ensure that the requirements for the products and services are defined

Ensuring that the requirements for products and services are well-defined is a fundamental aspect of effective quality management and customer satisfaction. ISO 9001:2015, a widely recognized quality management standard, emphasizes the importance of defining requirements for products and services. Here’s how organizations can meet this requirement:

  • Identify and document the specific needs and expectations of customers regarding your products or services. This includes understanding customer specifications, features, performance criteria, and delivery expectations.
  • Determine and document all relevant legal and regulatory requirements that apply to your products or services. Ensure that your offerings comply with these requirements.
  • Research and document any industry-specific standards, guidelines, or best practices that pertain to your products or services. Ensure that your offerings align with or exceed these standards when applicable.
  • Define any internal requirements or specifications that are necessary to meet customer and regulatory requirements. This may include quality standards, safety protocols, and performance metrics.
  • Create clear and comprehensive documented information that outlines the requirements for each product or service. This documentation serves as a reference for all stakeholders involved in the design, development, production, or delivery process.
  • Clearly define the scope and boundaries of your products or services. Document what is included and what is not included to manage customer expectations effectively.
  • If your organization is involved in design activities, ensure that design requirements are thoroughly documented and maintained throughout the design and development process.
  • Establish processes for verifying that your products or services meet the defined requirements during production or service delivery. Additionally, validate that they meet customer needs and expectations.
  • Implement a change control process to manage any changes to product or service requirements. Document the reasons for changes and ensure that they are communicated and approved by relevant parties.
  • Continuously monitor and review the effectiveness of your processes in meeting product or service requirements. Use key performance indicators (KPIs) to track performance.
  • Involve customers in the requirement definition process when applicable. Seek their feedback, preferences, and insights to ensure alignment with their expectations.
  • Encourage collaboration among different departments or teams involved in delivering products or services to ensure that all requirements are addressed holistically.
  • Ensure that employees are aware of and trained in the requirements for the products or services they are responsible for delivering.
  • Implement a robust documentation control system to manage and update the documented requirements effectively.
  • Conduct regular reviews and validations to confirm that products or services meet the defined requirements, and make necessary adjustments as needed.

By clearly defining and documenting product or service requirements, organizations can enhance their ability to consistently meet customer needs, comply with regulations, improve product quality, and ultimately enhance customer satisfaction. This approach also facilitates effective communication and decision-making throughout the organization.

3) Any applicable statutory and regulatory requirements

when determining the requirements for products and services, it is essential to include and comply with applicable statutory and regulatory requirements. These requirements are set by government authorities and industry-specific bodies to ensure that products and services meet specific legal and safety standards. Here’s how an organization can ensure compliance with these requirements:

  • Conduct a thorough assessment to identify all relevant statutory and regulatory requirements that apply to your products and services. This may involve consulting legal experts or industry-specific resources.
  • Create a systematic process for documenting and maintaining records of all applicable statutory and regulatory requirements. This includes laws, regulations, codes, and standards that pertain to your industry and offerings.
  • Stay current with changes in laws and regulations that affect your products or services. Regularly review and update your documentation to ensure ongoing compliance.
  • If necessary, seek legal counsel or expert advice to interpret complex legal requirements accurately and ensure compliance.
  • Integrate identified statutory and regulatory requirements into your product and service requirements documentation. Ensure that all relevant requirements are addressed explicitly.
  • If your organization is involved in design and development, ensure that design processes and specifications align with applicable legal requirements. Document these aspects clearly.
  • Establish quality control processes and verification methods to confirm that products and services meet legal and regulatory standards. This may include inspections, testing, and audits.
  • Maintain detailed records of compliance with statutory and regulatory requirements. This documentation can be critical for audits and inspections.
  • Ensure that employees are aware of the relevant legal and regulatory requirements and are trained to comply with them during the production or service delivery process.
  • Include a risk assessment of non-compliance with statutory and regulatory requirements in your risk management process. Develop mitigation plans to address identified risks.
  • Establish effective communication channels with relevant government authorities or regulatory bodies to ensure that your organization is informed about any changes in requirements or potential compliance issues.
  • Periodically conduct internal audits and assessments to verify compliance with statutory and regulatory requirements. Correct any non-conformities promptly.
  • Maintain records demonstrating conformity with statutory and regulatory requirements. These records may include certificates, reports, and approvals from regulatory bodies.
  • Ensure that suppliers and vendors also adhere to applicable legal and regulatory requirements, especially when their products or services are incorporated into your offerings.
  • Develop emergency response plans that consider potential legal and regulatory compliance issues, ensuring that you can respond effectively in case of non-compliance.

By integrating statutory and regulatory requirements into your product and service requirements, your organization can minimize legal risks, uphold quality standards, and build trust with customers and authorities. Compliance with these requirements is crucial for the safety, integrity, and reputation of your products and services.

4) Those considered necessary by the organization

When determining the requirements for products and services, it’s essential to consider not only external factors such as customer needs, statutory and regulatory requirements but also the internal requirements considered necessary by the organization. These internal requirements are often driven by the organization’s strategic objectives, quality standards, and business processes. Here’s how to incorporate internal requirements into the determination of product and service requirements:

  • Align product and service requirements with the organization’s strategic objectives. Consider how the offerings contribute to achieving the organization’s mission, vision, and goals.
  • Establish and document internal quality standards and specifications that products and services must meet. These standards may go beyond external requirements to reflect the organization’s commitment to excellence.
  • Determine requirements that optimize internal operations, such as production efficiency, cost-effectiveness, and resource utilization. Balance these with customer requirements to achieve operational excellence.
  • Include internal requirements related to safety, environmental sustainability, and ethical considerations. These may involve internal policies and practices that support responsible business conduct.
  • Identify internal requirements related to risk management and risk mitigation. Develop processes and controls to address potential internal risks that may impact product or service quality.
  • Ensure that product and service requirements align with organizational policies, procedures, and guidelines. This includes policies related to ethics, employee conduct, and data security.
  • Define requirements that enhance the efficiency and consistency of internal processes. This may involve standardizing procedures and workflows to improve product or service delivery.
  • Determine resource allocation requirements, including personnel, equipment, technology, and facilities, needed to meet internal quality and performance standards.
  • Incorporate a culture of continuous improvement into product and service requirements. Define requirements related to ongoing monitoring, measurement, and enhancement of offerings.
  • Establish internal requirements for documentation and record-keeping to ensure that processes are well-documented and traceable.
  • Specify internal training and competence requirements for employees involved in delivering products or services. Ensure that they have the skills and knowledge to meet internal quality standards.
  • Set requirements for internal audits, reviews, and assessments to evaluate compliance with internal standards and identify opportunities for improvement.
  • Ensure that product and service requirements align with the organization’s values and culture. Consider aspects such as corporate social responsibility and ethical practices.
  • Establish requirements for gathering feedback from internal stakeholders and using this feedback to drive continuous learning and improvement efforts.
  • Secure commitment from top management to support and prioritize internal requirements that contribute to the organization’s success and long-term sustainability.
  • Encourage collaboration among different departments and teams within the organization to ensure that internal requirements are well-integrated into product and service development and delivery.

By considering internal requirements alongside external factors, organizations can develop products and services that not only meet customer needs but also align with their strategic vision, operational efficiency goals, and quality standards. This comprehensive approach helps drive organizational success and customer satisfaction.

5) The organization must ensure that it can meet the claims for the products and services it offers to the customer.

Ensuring that an organization can meet the claims for the products and services it offers to customers is essential for building and maintaining trust, reputation, and customer satisfaction. Here are key steps an organization can take to meet this requirement:

  • Ensure that all claims made about your products or services are accurate, transparent, and based on factual information. Avoid exaggerations or misleading statements.
  • Conduct thorough testing, validation, and quality assurance processes to ensure that your products or services meet the claims and specifications you make to customers.
  • Clearly document the specifications, features, benefits, and limitations of your products or services. This information should be readily available to customers.
  • Implement quality management processes to monitor and control the quality of products or services throughout their lifecycle. This includes regular inspections and quality checks.
  • Educate customers about the capabilities and limitations of your products or services. Provide clear user manuals, guidelines, and FAQs to help customers make the most of their purchases.
  • Ensure that your marketing and sales teams are transparent when communicating with customers. Avoid making promises or guarantees that cannot be fulfilled.
  • Establish communication channels for customers to seek clarification or report issues related to product or service claims. Provide responsive customer support.
  • Develop a structured process for handling customer complaints and concerns related to product or service claims. Resolve issues promptly and transparently.
  • Continuously monitor customer feedback and performance data to identify areas for improvement. Use this information to enhance your products or services and align them with customer claims.
  • Ensure that your products or services comply with all relevant legal and regulatory requirements. This includes safety, environmental, and quality standards.
  • If your products or services involve components or materials from suppliers or vendors, ensure that they also meet the claims and specifications you make to customers.
  • Conduct internal audits and reviews to assess the organization’s ability to meet product or service claims. Identify any gaps and take corrective actions as needed.
  • Include risk management as part of your strategy to mitigate potential issues that may prevent meeting product or service claims.
  • Ensure that employees involved in product development, service delivery, and customer support are adequately trained and competent to meet customer claims.
  • Maintain documented information that outlines product or service claims, specifications, quality standards, and customer feedback.
  • Periodically review and revise product or service claims to ensure they remain accurate and relevant to evolving customer needs and market conditions.

Meeting product or service claims requires a holistic approach that encompasses marketing, sales, product development, quality management, and customer service. When organizations uphold their claims, they build strong customer relationships, enhance brand reputation, and foster loyalty, leading to long-term success.

Documented Information required

There is no mandatory required for Documented Information in this clause ,here are the typical documents and records that an organization should consider to meet the requirements of Clause 8.2.2:

  1. Product and Service Requirements Document: This document outlines the requirements for each product or service offered by the organization. It includes specifications, features, quality criteria, and any relevant legal or regulatory requirements.
  2. Customer Requirements and Communication Records: Records of customer communications, including emails, contracts, purchase orders, and other forms of written or verbal communication, to capture and confirm customer requirements.
  3. Regulatory Compliance Records: Documentation demonstrating compliance with applicable statutory and regulatory requirements for products or services, such as certificates, permits, or compliance reports.
  4. Quality Control and Assurance Records: Records of quality control and assurance activities conducted to ensure that products or services meet defined requirements. This may include inspection reports, testing data, and quality control checklists.
  5. Change Control Records: Documentation of any changes made to product or service requirements, along with the reasons for the changes, approvals, and implementation plans.
  6. Design and Development Records (if applicable): If the organization is involved in design and development activities, records related to the design and development of products or services. This may include design plans, design reviews, and design verification and validation records.
  7. Product/Service Verification and Validation Records: Records demonstrating that products or services have been verified and validated to ensure they meet customer and organizational requirements.
  8. Internal Audit and Review Records: Records of internal audits and reviews related to the determination of product or service requirements, including findings, corrective actions, and follow-up actions.
  9. Management Review Records: Records from management reviews that assess the adequacy and effectiveness of the organization’s processes for determining product or service requirements.
  10. Supplier and Vendor Documentation: Records of communications and agreements with suppliers and vendors to ensure that external inputs meet product or service requirements.
  11. Customer Feedback and Complaint Records: Records of customer feedback, complaints, and resolutions related to product or service requirements, along with actions taken to address issues.
  12. Training and Competence Records: Records of training and competence assessments for employees involved in determining and meeting product or service requirements.
  13. Documented Information Control Records: Records demonstrating the control and management of documented information related to product or service requirements, including version control and distribution lists.
  14. Records of Continuous Improvement Activities: Records of actions taken to continuously improve the determination and fulfillment of product or service requirements based on customer feedback and performance data.

These documents and records help ensure that an organization effectively determines and manages the requirements related to its products and services, leading to enhanced customer satisfaction and compliance with ISO 9001:2015 requirements. The specific documentation needs may vary depending on the organization’s size, industry, and complexity of products or services.

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