The ISO 9001:2015 standard is a globally recognized framework that defines the requirements for a Quality Management System (QMS). This standard helps organizations ensure they consistently meet customer and regulatory requirements while improving customer satisfaction. One of the critical sections of ISO 9001:2015 is Clause 8 – Operation, which outlines the operational processes necessary for delivering products and services that meet customer requirements.
In this blog, we’ll dive deep into the specifics of ISO 9001:2015 Clause 8, break it down, and explain its importance for organizations aiming for ISO 9001 certification. We’ll also explore how Clause 8 fits into the overall structure of ISO 9001 and the practical steps businesses should take to comply with its requirements.
Overview of ISO 9001:2015
Before exploring Clause 8, it’s essential to understand the broader purpose of ISO 9001:2015. The standard provides a risk-based approach to managing quality within an organization. It’s built around a Plan-Do-Check-Act (PDCA) cycle, ensuring that businesses continuously improve their processes.
ISO 9001:2015 consists of 10 clauses, which are:
- Scope
- Normative references
- Terms and definitions
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
Clause 8, titled “Operation,” is where the actual work happens. It focuses on managing the core processes that produce goods or services, addressing everything from planning to delivery.
ISO 9001:2015 Clause 8 Breakdown
Clause 8 is the heart of the standard. It covers the operational planning and control needed to ensure that products and services meet requirements. Here’s a breakdown of the sub-clauses:
Operational Planning and Control
This sub-clause requires organizations to plan, implement, and control the processes required to meet the quality requirements for their products or services. The aim is to ensure that processes are conducted under controlled conditions to prevent non-conformities.
To comply with 8.1, organizations must:
- Determine the processes needed for product/service delivery.
- Define the necessary resources (people, equipment, materials).
- Establish controls for the processes.
- Maintain documented information (such as work instructions and standard operating procedures) to provide evidence that processes are being carried out as planned.
Effective planning ensures that every aspect of production or service delivery is considered before execution, minimizing risks of non-conformance.
Requirements for Products and Services
This section focuses on ensuring that customer needs are clearly understood and translated into the organization’s operations. It involves determining customer requirements, reviewing them, and communicating relevant information within the organization.
Key points include:
- Customer communication: Organizations must have clear channels for interacting with customers, particularly in terms of inquiries, orders, feedback, and complaints.
- Review of requirements: This ensures that all requirements, including statutory and regulatory needs, are identified, understood, and agreed upon with customers before committing to a product or service delivery.
- Changes in requirements: Any changes to product or service requirements must be documented and communicated internally to ensure everyone is aligned with updated expectations.
Design and Development of Products and Services
Clause 8.3 applies if an organization is involved in the design and development of new products or services. Not all companies will need this clause, but for those that do, it’s essential to have a structured approach to designing and developing products/services.
The design and development process must:
- Be planned: Organizations need to determine the stages involved in design and development and assign responsibilities.
- Be controlled: There should be controls at each stage to ensure the design meets requirements.
- Include verification and validation: Verification ensures the product meets design specifications, while validation ensures it meets the intended use or customer needs.
Documentation is crucial here, as it provides a record of the design and development process and decisions.
Control of Externally Provided Processes, Products, and Services
This sub-clause refers to managing suppliers and external partners. Organizations must ensure that any externally sourced processes, products, or services conform to the required standards.
Steps to comply include:
- Evaluation of suppliers: Organizations should have criteria for selecting and evaluating suppliers to ensure they can meet quality standards.
- Monitoring supplier performance: There should be systems in place to monitor how well suppliers are performing, including their ability to deliver consistent quality.
- Controls for external provision: Organizations must ensure that externally provided products and services are controlled to meet their quality requirements.
This is particularly important in complex supply chains, where poor supplier performance can directly impact the end product or service.
Production and Service Provision
This section focuses on ensuring that production or service delivery is carried out under controlled conditions. The aim is to provide confidence that products or services meet the required specifications.
The key aspects include:
- Controlled conditions: Organizations should ensure that processes are carried out in controlled environments, with clear procedures, monitoring, and measurement in place.
- Identification and traceability: Products and services should be identifiable throughout the production process, allowing for traceability in case of issues.
- Preservation: Finished products need to be stored, handled, and transported in a way that preserves their conformity to requirements.
- Post-delivery activities: This involves managing activities that occur after delivery, such as warranties or service agreements.
Release of Products and Services
Before delivering a product or service to a customer, it must be verified to ensure that it meets all specified requirements. Clause 8.6 requires organizations to have a process for inspecting and testing products and services before they are released to the customer.
Steps to ensure compliance:
- Ensure that all requirements have been fulfilled.
- Retain documented information as evidence of conformity.
- Ensure that the release of the product or service is authorized by an appropriate person within the organization.
This helps prevent non-conforming products or services from reaching customers.
Control of Nonconforming Outputs
Finally, Clause 8.7 deals with handling products or services that don’t meet requirements. When non-conformances are identified, organizations must take corrective action to control and correct the issue.
This involves:
- Identifying and segregating nonconforming products or services.
- Determining how to deal with them (e.g., rework, repair, or scrap).
- Recording actions taken and retaining relevant documentation.
The objective is to prevent defective products from being delivered to customers and to fix the root cause of the problem.
Importance of Clause 8 for Businesses
Clause 8 is critical because it covers the entire operational process of an organization. Proper implementation of this clause ensures that businesses can consistently meet customer expectations, maintain high-quality standards, and mitigate risks associated with poor quality or non-conformance.
Failing to comply with Clause 8 could lead to poor product quality, customer dissatisfaction, regulatory penalties, and potential loss of business. On the other hand, businesses that fully implement and comply with Clause 8 are better positioned to enhance customer satisfaction, improve operational efficiency, and foster a culture of continual improvement.
Conclusion
ISO 9001:2015 Clause 8 plays a vital role in the operational aspect of quality management. It covers everything from planning production to managing suppliers and ensuring that products and services meet the requirements before being delivered to customers. For businesses aiming to achieve or maintain ISO 9001 certification, ensuring compliance with Clause 8 is essential to meet regulatory and customer requirements while maintaining a competitive advantage in the marketplace.
