ISO 9001:2015 Clause 8.5.1
What is ISO 9001:2015 Clause 8.5.1?
Clause 8.5.1 pertains to “Control of Production and Service Provision.” This clause outlines the requirements for controlling the production and provision of services to ensure that the organization consistently meets customer requirements.
Key points outlined in Clause 8.5.1 include:
Control of Production and Service Provision:
The organization must plan and carry out production and service provision under controlled conditions to meet customer requirements.
Control of Production Processes:
Establish and maintain criteria for the control of production processes, including the availability of information that describes the characteristics of the products.
Availability of Information:
Ensure that information necessary for the effective planning and control of production processes is made available where and when it is needed.
Documentation and Work Instructions:
Provide appropriate documentation and work instructions that include criteria for conformity of products and services. This documentation ensures that processes are carried out as planned.
Validation of Processes:
Validate processes, as necessary, to ensure that they can achieve planned results. This may include qualifying equipment, personnel, and procedures.
Identification and Traceability:
Ensure the identification and traceability of the outputs when traceability is a requirement. This is particularly important in sectors where traceability of products is critical.
Customer Property:
Exercise care with customer property, including any tools, equipment, or intellectual property provided by the customer. This involves identifying, verifying, protecting, and safeguarding such property.
Preservation of Outputs:
Preserve the conformity of products and services during internal processing and delivery to the intended destination. This includes preventing damage or deterioration.
Post-Delivery Activities:
Consider activities after delivery to the customer, such as actions under warranty provisions, maintenance services, or handling of returned products.
Control of Changes:
Establish criteria for the review and control of changes to the production and service provision processes to ensure that changes do not adversely affect product conformity.
It’s important to note that specific details may vary based on the context, industry, and nature of the organization’s products or services. Organizations should carefully review the requirements of Clause 8.5.1 in the ISO 9001:2015 standard and implement them within their quality management systems.
How does a Company comply with Clause 8.5.1?
Compliance with Clause 8.5.1 of ISO 9001:2015, which addresses the control of production and service provision, involves implementing a systematic approach to planning, executing, and monitoring production processes and service delivery. Here’s a general guide on how a company can comply with this clause:
Develop a Control Plan:
Establish a comprehensive control plan that outlines the steps, criteria, and requirements for controlling production processes and service provision. This plan should cover all relevant aspects, from initial planning to final delivery.
Documented Information:
Provide documented information that describes the characteristics of the products or services, including specifications, work instructions, and relevant quality criteria.
Availability of Information:
Ensure that information necessary for effective planning and control of production processes is available when and where it is needed. This includes providing access to relevant documents and data to personnel involved in production.
Validation of Processes:
Validate critical processes to ensure they can consistently achieve the planned results. This may involve testing equipment, training personnel, and verifying that procedures are followed.
Identification and Traceability:
Implement procedures for the identification and traceability of products throughout the production process. This is particularly important when traceability is a requirement for compliance.
Customer Property:
Establish processes to identify, verify, protect, and safeguard customer property, including any tools, equipment, or intellectual property provided by the customer.
Preservation of Outputs:
Implement measures to preserve the conformity of products and services during internal processing and delivery. This may include appropriate handling, storage, and transportation procedures.
Post-Delivery Activities:
Consider and plan for post-delivery activities, such as warranty provisions, maintenance services, or handling of returned products. Ensure that processes are in place to address any post-delivery requirements.
Control of Changes:
Establish criteria and a process for the review and control of changes to production and service provision processes. Ensure that changes are assessed for their impact on product conformity and are implemented with appropriate controls.
Training and Competence:
Ensure that personnel involved in production and service provision are trained and competent to carry out their responsibilities effectively. This includes training on new processes, equipment, or changes to existing procedures.
Monitoring and Measurement:
Implement monitoring and measurement activities to assess the performance of production processes and service provision. This includes regular checks, inspections, and testing to verify conformity to requirements.
Continuous Improvement:
Regularly review and improve the effectiveness of production and service provision processes. Use feedback mechanisms, corrective actions, and management reviews to drive continuous improvement.
It’s essential to customize these general guidelines based on the specific context, industry, and nature of the organization’s products or services. The goal is to create a tailored system that aligns with the requirements of Clause 8.5.1 in ISO 9001:2015 and ensures consistent conformity to customer requirements.
Helpful Resources: ISO Audits – What Registrars Look For Part 1
In this episode of “The Quality Hub: Chatting with ISO Experts,” host Xavier Francis interviews AJ Puylara, National Sales and Marketing Manager at NQA, a global certification body. AJ shares his experience in the ISO industry and discusses the ISO certification process. He highlights the steps involved, including engaging with a third-party ISO consultant or registrar and conducting a gap assessment. Listen Now
Consulting Support for ISO 9001
Every year, we help hundreds of small businesses achieve ISO 9001 certification. Support for ISO 9001 is available through any of our Consulting Programs As an American business with a story like yours, we know that time is valuable. Our expert consultants are here to take on the difficult, technical aspects of certification so you can focus on your business. They’ll work with you every step of the way until you’re successfully certified. Interested? Get a Free Quote.
In many industries, ISO 9001 has become a supply-chain requirement. When landing a big contract, ISO 9001 certification could make all the difference.
About Core Business Solutions, Inc.
— Scott Dawson, President and Co-Founder
Related Standards
We provide consulting support for various other standards, as well as support for companies seeking multiple certifications through an Integrated Management System.
AS9100
Aerospace Manufacturers
AS9120
Aerospace Distributors
ISO 14001
Environmental Management Systems
ISO 27001
Information Security Management Systems
ISO 20000-1
Service Management Systems
ISO 45001
OH&S Management Systems
ISO 13485
Medical Device Manufacturers
AS9100
AS9120
ISO 14001
ISO
20000-1
ISO 27001
ISO 45001
ISO 13485
Equip Your Business to Meet ISO 9001 With CORE
At Core Business Solutions, we’re here to equip your company for success in meeting ISO 9001 requirements. We’ve helped hundreds of small businesses grow and deliver the best solutions to their clients. We provide ISO training services, consulting help, and compliance software and to help you get certified and stay certified. We focus on optimizing your processes and helping you implement an ISO-compliant QMS. When you partner with us, you’ll get the tools and help you need for success. For more information on the ISO 9001:2015 standard, please visit our articles page. You can also call our consulting office at 866-354-0300 or contact us online.
Do you want to update your existing ISO 9001 QMS System or refresh it?
We provide consulting services to assist you in your ISO 9001 Quality Management System refresh. We listen, conduct a gap analysis, update your Quality Policy and any necessary documentation or procedures, find areas of waste or improvement, simplify and automate. And we do it fast. Core offers firm, fixed pricing. Download our information sheet today to learn more or call us at 866-354-0300 Extension 2.