ISO 9001:2015 Clause 8.2

What is ISO 9001:2015 Clause 8.2?

Clause 8.2 of ISO 9001:2015 pertains to Requirements for Products and Services. This clause outlines the criteria that organizations must meet regarding the development of products and services to ensure they fulfill customer requirements and comply with relevant regulations.

Key points outlined in Clause 8.2 include:

Customer requirements:

Organizations must establish and maintain processes for determining and reviewing customer requirements. This includes understanding customer needs, expectations, and any specific criteria related to the products or services.

Product and service development:

Processes need to be established to manage the design and development of products and services. This involves planning, inputs, controls, reviews, verification, validation, and changes to ensure that the resulting products or services meet the specified requirements.

Control of externally provided processes, products, and services:

Organizations are required to determine and apply criteria for the selection, evaluation, and monitoring of external providers (suppliers) that contribute to the organization’s products or services.

Development of goods and services provided by the organization:

This includes processes for designing, purchasing or developing the products and services that are part of the organization’s offerings.

Control of changes:

Procedures must be established to control changes during the development or provision of products and services, ensuring that any modifications do not adversely affect conformity to requirements.

In essence, Clause 8.2 focuses on ensuring that organizations have robust processes in place to meet customer needs, develop products and services that meet specified requirements, and manage external providers to guarantee quality and compliance. Compliance with this clause is crucial for organizations seeking ISO 9001 certification.

How do you comply with Clause 8.2?

Compliance with Clause 8.2 of ISO 9001:2015 involves implementing various processes and practices within an organization.

Here are steps you can take to comply with Clause 8.2:

Understand Customer Requirements:

Engage with customers to thoroughly comprehend their needs, expectations, and specifications for the products or services they require.

Establish Product/Service Development Processes:

Create and document procedures for product or service development. This includes planning, design, implementation, testing, and validation to ensure that the result meets customer requirements and complies with relevant standards.

Control External Providers:

Develop criteria for selecting and evaluating external suppliers and establish processes to monitor their performance. Ensure that external providers meet your organization’s quality standards.

Document Development Processes:

Document all stages of product or service development, including specifications, design reviews, validations, and verifications. This documentation should be readily accessible for audits and continuous improvement.

Implement Change Control Procedures:

Establish protocols for managing changes during product or service development. Ensure that changes are evaluated, approved, and implemented in a controlled manner to prevent adverse effects on quality.

Conduct Reviews and Audits:

Regularly review and audit the product/service development processes to identify areas for improvement and ensure compliance with established procedures.

Training and Competence:

Provide necessary training to employees involved in product/service development to ensure they have the required skills and knowledge to execute their tasks effectively.

Continuous Improvement:

Foster a culture of continuous improvement by analyzing data, feedback, and performance metrics to identify areas where processes can be enhanced for better compliance and customer satisfaction.

Documentation and Records:

Maintain accurate documentation of all processes, procedures, and records related to product/service development and any changes made.

Seek Certification and Compliance Verification:

Consider engaging certification bodies or internal auditors to verify compliance with ISO 9001 standards, including Clause 8.2.

Compliance with Clause 8.2 requires a systematic approach to managing product and service development processes, ensuring customer satisfaction, and maintaining high-quality standards throughout the organization’s operations. Regular monitoring, review, and improvement of these processes are key to achieving and sustaining compliance.

Other ISO 9001:2015 Clauses:

What is the History of Clause 8.2?

Clause 8.2 in ISO 9001:2015 is part of a series of standards developed by the International Organization for Standardization (ISO) to provide guidelines and requirements for implementing a quality management system (QMS) within an organization. The history of this clause is intertwined with the evolution of the ISO 9000 series.

ISO 9000:1987

The ISO 9000 standards originated in the 1980s when the need for standardized quality management practices across industries became apparent. The first version, ISO 9000:1987, focused primarily on quality management concepts and terminology.

Over time, these standards evolved to become more comprehensive and practical in guiding organizations toward effective quality management. Key revisions and milestones in the evolution of Clause 8.2 and its related sections include:

ISO 9001:1994:

This version emphasized the importance of quality management principles and added more specific requirements for processes related to design, purchasing, and production.

ISO 9001:2000:

The structure of the standards was revised to adopt the Plan-Do-Check-Act (PDCA) cycle. This version highlighted the need for continual improvement and introduced the concept of process-based management systems.

ISO 9001:2008:

Minor revisions were made to the 2000 version to enhance clarity and compatibility with other management system standards.

ISO 9001:2015:

The most significant change was made in this version, focusing on a high-level structure called the High-Level Structure (HLS) to align with other management system standards. Clause 8.2 in this version emphasized a more holistic approach to managing product and service realization processes.

Throughout these revisions, Clause 8.2 has consistently focused on ensuring that organizations establish processes for developing products and services that meet customer requirements, manage external providers, control changes, and maintain the quality of goods and services provided.

The evolution of Clause 8.2 reflects a continuous effort to refine and improve quality management practices to adapt to changing business environments and enhance customer satisfaction while maintaining a strong emphasis on meeting specified requirements.

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