Mark Hammar Updated according to ISO 9001:2015.
Many people are confused by ISO 9001 section 8.5 on production and service provision. Some of this confusion probably comes from the fact that the international standard is trying to set requirements that are specific enough to be relevant, but general enough to be applicable to any company regardless of what industry they are involved in, or whether they are a product- or service-based business. Due to the vast differences between companies, these requirements are largely denoted as applicable so that each business can apply the overall conditions as specific to the company. There are six sub-sections to these requirements, and below are further explanations and clarifications on applying these to your company.
Control of production and service provision (section 8.5.1). The overall statement from the section is that your company must carry out the activities to provide your product or service under controlled conditions. The standard then includes a listing of common controlled conditions that should be used if they are applicable to your product or service. These include documented information for your products and services, suitable monitoring and measurement resources (including equipment), suitable infrastructure and environment, competent persons, validation of the ability to achieve results, actions to prevent human error, and activities controlling product release, delivery, and post-delivery. As with all other processes, these do not need to be documented procedures unless non-conformances would occur if the procedure was not written down.
For some guidance on what to document, see Checklist of Mandatory Documentation Required by ISO 9001:2015.
Identification and traceability (section 8.5.2). Many industries, such as the food, aerospace, and automotive industries, require the ability to have specific identification of items, and the ability to trace the elemental parts that make up the items. This is normally used when there is a failure of an internal component and you want to know what other items contain components from the same batch of parts. In short, when this is appropriate it needs to be controlled. Additionally, the standard requires that you have a method of telling the status of a product or service through the creation process; for example, is a piece of software tested for functionality, is a product tested and ready for use, or is a service ready to be used.
Property belonging to customers or external providers (section 8.5.3). This requirement is very limited, but also very important if your business involves the use of customer or supplier property. External property can come in many forms: piece parts that will become part of your delivered product, special equipment to perform a specific testing for the customer, or even proprietary information that you need to use to design and deliver the product or service. When a customer or other party has given you any property to use in supplying their needs, you need to control that property from unintended use and have a way of dealing with that property with external party involvement should there be a problem with it. Records of this activity need to be maintained to show accurate records of customer or external property. In fact, with the new General Data Protection Regulation (GDPR), personal data that is provided by you needs protections, which would come under this clause.
Preservation (section 8.5.4). For product or services, there is a need to use proper handling throughout the process to make sure it does not degrade, including through delivery to the customer. These actions will vary widely depending on the product, but could include such things as reducing moisture exposure on metallic parts that could rust, ensuring electronic media storage is maintained so that a software program is not degraded during delivery to the customer, proper cleaning of parts that are affected by contamination, marking and labeling for safety warnings, and using stock in order of receipt (often called first in-first out or FIFO) for stock that can degrade over time.
Post-delivery activities (section 8.5.5). Sometimes there is a need to perform activities on your product or service after it has been delivered to the customer. While the requirements for what needs to be done vary greatly from one product or service to another, this section gives you some main places where these requirements may be found. You need to consider statutory and regulatory requirements, any undesired consequences of your product once in use, the nature and lifetime of your products and services, customer requirements, and customer feedback. Taking these into account will give you an idea of what needs to be done after delivery, such as warranty provisions, maintenance services, or even recycling and final disposal services.
Control of changes (section 8.5.6). If you find it necessary to change your provisions, you want to make these changes in such a way as to protect the continued conformity of the product and service requirements. These changes need to be planned and documented to demonstrate that the change was properly authorized and implemented. While section 8.2.4 gives requirements on changing the products or services, this change management is about the processes you have in place to provide the products and services.
Some final thoughts on production and service provision
It is important to remember that any requirements in the product and service provision section of the standard are able to be excluded from your Quality Management System if they do not apply to your business, with adequate explanation as to why. This allows you to exclude any of these requirements that are not applicable to your organization, even if the statement “as applicable” is not specifically made in the standard requirements. Knowing your product or service and what is required for it is the first step in assuring successful provision activities for creating and delivering the product or service. Product and service provision is at the very core of customer satisfaction, a key principle of the ISO 9001 quality management system, and therefore it needs to function perfectly to ensure your customer’s needs are met. And that is what creates customer loyalty.
Click here to see a free preview of the Procedure for Production and Service Provision template.
