ISO 9001:2015 requires organizations to meet the requirements for post-delivery activities associated with products and services. Examples of these activities include actions under warranty provisions, contractual obligations such as maintenance services, and other services such as recycling or disposal.
What is the Product and Service Provision?
The Product and Service Provision is a section of the ISO 9001:2015 standard. Six subsections make up this provision. This article will cover sections 8.5.1 to 8.5.3. The first three subsections explain the control of production and service provision, identification and traceability, and property belonging to customers or external providers.
Clause 8.5.1: Control of Production and Service Provision
This clause is about how products and services must be controlled. To fulfill this requirement, an organization can record information that proves they have controlled the environment of the products or services. Proof of control includes documented characteristics of a product or service, documentation of activities to produce a product or service, monitoring resources, suitable environment and infrastructure, competent and trained personnel, validation of achieving results, actions to stop accidental mishandling, product service release delivery and post-delivery activities are implemented. Note that all of these processes do not need to be recorded unless otherwise stated in the ISO 9001:2015 standards.
Clause 8.5.2: Identification and Traceability
This clause can be looked at in two parts: identification and traceability. For the identification section, organizations must identify products used throughout the product or service creation process. During the process note the product’s status as conforming or nonconforming. This is following “monitoring and measurement requirements” outlined in this section and section 8.7 of the ISO 9001:2015 standards. For the traceability section, organizations must be able to track the unique identity of their product. This ensures that any mistakes can be easily traced.
Clause 8.5.3: Property Belonging to Customers or External Providers
Property belonging to customers or external providers needs to be carefully handled. This includes both physical and intellectual property. It is necessary to only use the property for its intended purpose. If an issue arises regarding the property, organizations must have a plan to deal with those problems. Not only should companies be able to deal with arising issues, but they must also record activities to be able to show a customer or external provider.
How can you apply the Product and Service Provision to an organization?
Clause 8.5.1: Control of Production and Service Provision Breakdown
When applying this clause to an organization, please take into consideration the following controlled conditions. These conditions may not apply to all organizations and can be overlooked if so. Controlled conditions include:
- The availability of documented information that defines the characteristics of the products and services. This condition is outlined earlier in section 8.2 of the ISO 9001:2015 standard. Essentially, an organization must prove it has a process to define the requirements for products and services they intend to provide to a customer. This process could include both statutory and regulatory rules. Your organization will need to know the following:
- Customer’s requirements
- Requirements defined by the product’s purpose
- Legal and statutory requirements
- Organizational objectives
- Other appropriate records
- The availability of documented information that defines the activities to be performed and results to be achieved. To achieve this condition, consider creating a control plan. When creating a control plan, feel free to include information that is typically outside of the scope of the plan. Use this plan with a dual purpose by making it a training document. It can be very easy for organizations to get bogged down in creating multiple versions of documentation that state the same thing. While reading over requirements in the standard consider documentation that you might already have.
- Monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met. This condition can be achieved by writing a control plan. Organizations can also create other tools if they do not wish to use a control plan.
- The use, and control of suitable infrastructure and process environment. Some organizations include this condition in their production and service provision. For instance, there could be regular processes that ensure production or provided services are under control. Examples may include machine maintenance or a procedure to turn off equipment.
- The availability and use of suitable monitoring and measuring resources. Again, this condition may be achieved by developing a control plan. However, organizations can choose to use other documentation.
- The competence and, where applicable, required qualification of persons. This condition can be met by including this information in training documentation.
- The validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. Process validation is controlling a process by testing the process to ensure that it can perform the act that it was designed to perform. Organizations must validate and revalidate to ensure that their process results in the desired outcome.
- The implementation of products and services release, delivery, and post-delivery activities. It’s important to ensure that each step in the process is closely documented. Not only must these steps be documented, but they also need to be controlled.
Below is an example of a Control Plan.
Source: https://www.six-sigma-material.com/Control-Plan.html#gallery[pageGallery]/0/
Clause 8.5.2: Identification and Traceability
Corporations need to track their services and products. This clause requires that organizations identify their products and know their status no matter what stage they are in. This will help limit the number of problems caused by loss or damage. Organizations must be able to identify and trace outputs. This displays conformity to monitoring and measurement requirements.
Identification Tools:
- Tags
- Stickers
- Part Numbers
- Bar Codes
- Imprinting Tools
- Laser Engraving
Traceability Tools:
- Part Markings
- Tags
- Labels
- Bar Codes
- Designated Storage Racks
- Signs
- Reference Numbers
- Part Separation
- Job Numbers
- RFID Tag
Companies want to implement this clause to generate benefits. Quality issues due to using multiple parts at once should cease. Incorrect products will not accidentally be shipped. Companies should have detailed records of what was shipped, so they can easily track an error if something happens to go wrong. Overall, the organization will be more organized.
Clause 8.5.3: Property Belonging to Customers or External Providers
This clause has now been extended to cover property belonging to external providers that an organization uses to produce goods or generate services. Organizations must communicate with customers about how they treat their property. Plans must also be made in case issues arise with external providers’ products. To ensure compliance with this clause considers these examples that help provide information to customers.
- Goods returned by the customer
- Warranty Claims
- Credit Notes
- Media Articles
- Consumer Websites
- Communication with Customers
While customers or external property or tools are at an organization’s facility, it is important to treat these things with care. Companies must ensure that borrowed items are not lost, stolen, or damaged. If this happens, it is important to let the customer or external provider know. To ensure that this doesn’t happen, organizations should keep careful records of borrowed tools or property.
It is fairly simple to understand the rules behind governing physical property that an organization doesn’t own, but the intellectual property should also be considered. Data and information is becoming more and more powerful in the modern world, and using customer or external provider data need to be handled with care.
What are common auditing questions?
Is your product identified through each step of the process?
Use the identification tools above to show how your product is being identified through each step of this process.
What traceability measures have been taken?
Organizations must be able to prove that they are able to trace components of their products. Organizations should ensure that products or parts are not mixed up during the creation process. Use the tools above to show how to trace products.
Do you work with customer or external provider property? What is the process to identify and protect customer property?
Again, it must be abundantly clear to all employees when they are working with customer or external provider property. This is to ensure the safekeeping of their products. Consider creating a procedure to handle customer property or labeling customer property in order to prevent damage or misuse.