ISO 9001:2015 Clause 8.5

What is ISO 9001:2015 Clause 8.5?

Clause 8.5 of ISO 9001:2015 refers to the requirement for the control of production and service provision. This clause outlines the specific measures that an organization needs to implement to ensure that its products and services meet the intended requirements.

Key points outlined in Clause 8.5 include:

Control of Production and Service Provision:

The organization must plan and carry out production and service provision under controlled conditions. This includes criteria for the processes, equipment, resources, and methods used to ensure conformity of products and services.

Control of Changes:

Any changes that could affect the product or service’s conformity to requirements must be controlled. This involves evaluating the impact of changes and ensuring they are implemented in a controlled manner.

Release of Products and Services:

The organization must ensure that products and services meet their specified requirements before they are released or delivered to customers. This involves verifying that all necessary activities have been completed and that the product/service meets the defined acceptance criteria.

Control of Non-Conforming Outputs:

Procedures must be in place to address any non-conforming products or services. This includes identification, documentation, segregation, and disposition of non-conforming items to prevent unintended use or delivery.

Overall, Clause 8.5 focuses on ensuring that the production and service provision processes are controlled and managed effectively to consistently deliver products and services that meet customer requirements.

How do you comply with Clause 8.5?

Complying with Clause 8.5 of ISO 9001:2015 involves establishing and implementing specific processes and procedures within an organization. Here are steps that can help in achieving compliance:

Establish Clear Procedures:

Develop documented procedures that define how production and service provision will be controlled. This includes outlining criteria for processes, resources, and methods.

Plan and Implement Controls:

Identify and implement controls at every stage of production and service provision to ensure conformity with requirements. This could involve quality checks, inspections, testing, or other measures.

Change Management:

Develop a robust change management process to control and assess any changes that could impact product or service conformity. This involves evaluating potential changes, assessing their impact, and implementing changes in a controlled manner.

Verification before Release:

Ensure that products or services undergo verification processes before release or delivery. This might involve inspections, testing, or validation against specified criteria to confirm they meet customer requirements.

Handling Non-Conformities:

Establish procedures for handling non-conforming outputs. This includes identifying, documenting, segregating, and deciding on the disposition of non-conforming products or services to prevent unintended use or delivery.

Training and Competence:

Ensure that personnel involved in production and service provision are adequately trained and competent to perform their tasks effectively. This includes understanding the procedures and criteria set forth.

Monitoring and Measurement:

Implement systems to monitor and measure the effectiveness of controls in place. This involves collecting data, analyzing performance, and taking corrective actions when necessary.

Continuous Improvement:

Foster a culture of continuous improvement. Regularly review processes, seek opportunities for enhancement and make necessary adjustments to improve the effectiveness of production and service provision.

Documentation and Records:

Maintain comprehensive documentation of all procedures, controls, and records related to production and service provision as evidence of conformity to the requirements.

By following these steps and tailoring them to the specific needs of the organization, it becomes possible to comply with Clause 8.5 of ISO 9001:2015 effectively. Regular audits and reviews help in ensuring ongoing compliance and continuous improvement.

What is the History of Clause 8.5?

Clause 8.5, addressing the control of production and service provision, has its roots in the evolution of quality management standards and practices. While the specific numbering may differ across different iterations of quality standards, the essence of controlling production/service provision has been a fundamental aspect of quality management systems for decades.

Earlier Versions

The International Organization for Standardization (ISO) has been developing quality management standards since the 1980s. The earlier versions, such as ISO 9001:1987 and ISO 9001:1994, emphasized elements of quality control and assurance, including the control of processes related to production and service provision.

ISO 9001:2000

However, the specific structure and numbering of clauses evolved with the release of ISO 9001:2000, which introduced the Plan-Do-Check-Act (PDCA) cycle and a more process-oriented approach. Clause 7 in ISO 9001:2000 addressed product realization, which encompassed processes related to product and service provision.

ISO 9001:2008

Subsequent revisions, like ISO 9001:2008, continued to refine the standards, and the clause related to product realization was further developed. Ultimately, in the ISO 9001:2015 version, the structure was reorganized and expanded to the High-Level Structure (HLS), which placed a greater emphasis on risk-based thinking, the context of the organization, and a process approach.

ISO 9001:2015

Clause 8.5 in ISO 9001:2015 outlines the requirements for controlling production and service provision, emphasizing the need for organizations to ensure that their processes are planned, controlled, and managed effectively to meet customer requirements consistently.

Throughout this evolution, the focus remained on ensuring that organizations establish processes, controls, and measures to deliver products and services that meet quality standards and customer expectations. Clause 8.5 continues to evolve and adapt to the changing landscape of industries and quality management practices.

Helpful Resources:  ISO Audits – What Registrars Look For Part 1

What registrars look for

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