ISO 9001 Clause 8.5 Production and service provision
- wilkshireconsulting
- Mar 27
- 6 min read
In ISO 9001 8.5 - Production and service provision focuses on how organizations ensure that production and service processes are carried out under controlled conditions to consistently meet product or service requirements. Clause 8.5 ensures that products and services are delivered effectively, efficiently and in full compliance with specifications, customer expectations, and legal requirements.
In this blog post we will be discussing the following:
8.5 consists of 6 sections –
· 8.5.1 Control of production and service provision
· 8.5.2 Identification and traceability
· 8.5.3 Property belonging to customers or external providers
· 8.5.4 Preservations
· 8.5.5 Post-delivery activities
· 8.5.6 Control of changes
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
8.5 Production and service provision
8.5.1 Control of production and service provision
The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2) the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
d) the use of suitable infrastructure and environment for the operation of processes;
e) the appointment of competent persons, including any required qualification;
f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post-delivery activities.
8.5.2 Identification and traceability
The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a
requirement, and shall retain the documented information necessary to enable traceability.
8.5.3 Property belonging to customers or external providers
The organization shall exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
NOTE A customer’s or external provider’s property can include materials, components, tools and equipment, premises, intellectual property and personal data.
8.5.4 Preservation
The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.
8.5.5 Post-delivery activities
The organization shall meet requirements for post-delivery activities associated with the products and services.
In determining the extent of post-delivery activities that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
8.5.6 Control of changes
The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
8.5.1 Control of production and service provision
Organizations must implement controlled conditions to ensure products and services confirm to requirements. These controls should cover:
· Documented procedures and work instructions – Standard operating procedures (SOPs) for production/ service processes.
· Use of appropriate equipment and tools – Ensure machines, software, or tools are properly maintained and calibrated.
· Monitoring and measurement activities – Inspections in-process quality checks, and testing to prevent defects.
· Competency of personnel – Employee preforming tasks should be trained and qualified.
· Defined environmental conditions – Control factors like temperature, humidity, and cleanliness where applicable.
· Validation of processes – Ensure processes that cannot be verified later such as welding, sterilization are validated before execution.
An example of this would be if you are a food processing company you must follow strict hygiene protocols, temperature control, and sanitation procedures during production to ensure food safety.
8.5.2 Identification and traceability
Organizations must identify and track products or services throughout the production or service lifecycle to prevent mix-ups and ensure accountability.
· Identification of materials, components, and products such as serial numbers and barcodes.
· Traceability of products such as tracking raw materials used in a specific batch.
· Maintaining records of unique identification
An example of this would be if you are a pharmaceutical company, you must ensure that each batch of medicine can be traced back to specific raw material suppliers in case of a defect or recall.
8.5.3 Property belonging to customers or external providers
Organizations must take care of any customer-supplied or externally provided property and report any damage or loss.
· Proper handling and storage of customer property.
· Protection from damage, loss, or contamination.
· Recording and reporting nonconformities if damage occurs.
An example of this would be if you are an aircraft maintenance company servicing customer-owned jet engines that must properly store and maintain them to prevent damage before reinstallation.
8.5.4 Preservations
Organizations must ensure that products remain intact and functional throughout the production, storage and delivery process.
· Proper packaging and storage conditions – such as temperature-controlled production, storage and delivery.
· Handling methods to prevent damage – such as fragile items require special transport procedures.
· Protecting products during transit – such as moister-proof packaging for electronics.
· Expiration date monitoring for perishable products.
An example of this would be if you are a chemical manufacturer, you must store materials in temperature-controlled warehouses and follow strict handling guidelines to prevent contamination.
8.5.5 Post-delivery activities
Organizations must consider and define post-delivery support, including:
· Warranty provisions – ensuring defects are addressed after delivery.
· Ongoing maintenance and servicing.
· Disposal or recycling requirements – end-of-life product management.
· Customer support and compliant handling.
An example of this would be if you are a medical device company and you provide after-sales support, including training, software updates, and maintenance services for hospital equipment.
8.5.6 Control of changes
Organizations must identify, review, and control any changes in production or service to prevent unintended negative impacts.
· Evaluating potential risks before implementing changes.
· Reviewing and approving changes before execution.
· Documenting all changes for traceability.
· Communicating changes to affected stakeholders such as production teams, suppliers and customers.
An example of this would be if you are a car manufacturer and your changing a paint formula, you must validate that it meets the durability and aesthetic requirements before full-scale implementation.
In conclusion, implementing Clause 8.5 Production and service provision ensures organizations can deliver high-quality products and services, minimize risk, and enhance customer satisfaction. In the next blog post we will be diving deeper into 8.6 Release of products and services.
Related blog posts –
ISO 9001 8.4 - Control of externally provided processes, products and services
ISO 9001 Clause 8.3 Design and development of products and services
ISO 9001 Clause 8.2 Requirements for Products and Services
ISO 9001 8.1 Operational planning and control
ISO 9001 - 8 Operation Clause 8: 8.1 – 8.7
ISO 9001 – 7 Support Overview Clause 7: 7.1 – 7.5
Contact:
Email: info@wilkshireconsulting.com
Phone: (248) 890-9283
Comments