Production and service provision process in ISO 13485

Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The main reason for this is the fact that the standard aims to define requirements applicable to a wide variety of manufacturing and service provision processes in the medical device industry. The requirements had to be general enough to apply to different processes, yet specific enough to be relevant and auditable. Clause 7.5 has 11 sections and below are explanations and clarifications on applying these to your company.

Control of production and service provision

Sub clause 7.5.1 contains general requirements for the production and service provision process. It requires the organization to plan, carry out, monitor and control the production and service provision process in order to ensure a product that conforms to specification.  Control of the production process is a key for manufacturing a product that is compliant with the specification, and this can be achieved through:

  • Documentation of procedures and methods for the production control – Depending on the complexity of the production process, the organization needs to decide on the necessary amount of documentation to ensure the product conformity.
  • Qualification of infrastructure – In cases where the infrastructure used in the production process can affect the conformity of the product, the organization needs to define requirements for infrastructure and ensure the production process is carried out as planned.
  • Implementation of monitoring and measuring process parameters and product characteristics – Depending on the nature of the production process, the organization needs to implement monitoring and measuring activities to ensure the production process is carried out as planned and the product is compliant to the specification.
  • Availability and use of monitoring and measuring equipment – To ensure the credibility of the monitoring and measurement data, the organization needs to provide the monitoring and measuring resources that are fit for the purpose.
  • Implementation of defined operations for labeling and packaging – Depending on the type of product, different requirements for labeling and packaging may apply. The organization needs to identify and apply these requirements during the production process.
  • Implementation of product release, delivery and post-delivery activities – Once the product is manufactured, the organization needs to define and perform activities for product release, delivery and post-delivery, if the nature of the product requires it.

Finally, the clause requires the organization to maintain records for each medical device or lot produced.

Additional requirements for production

Cleanliness of the product. When this requirement is applicable, the organization needs to document requirements for cleanliness and contamination control of the product.

Installation activities. The organization needs to document requirements for installation and acceptance criteria for verification of the installation, if applicable. In cases when the installation activities are outsourced, the organization must provide documented information for the installation and verification of the installation to the outsourcing partner.

Servicing activities. If servicing activities are required by the customer, the organization needs to document the servicing procedures, reference materials, and reference measurements for performing servicing activities and ensuring the product requirements are met.

Particular requirements for sterile medical devices. If applicable, the organization needs to maintain records on sterilization parameters for each sterilization batch.

Validation of process for production and service provision. Process validation is required when you are not able to verify the output of a process afterwards, so that problems only become apparent during product or service use. When this is the case, you validate your process to make sure it achieves the planned results and this is, of course, very specific to the processes in the company.

Particular requirements for validation of processes for sterilization and sterile barrier systems. The sterilization process needs to be validated to ensure it will provide the desired outcome. The organization needs to document the procedure for validation.

Identification and traceability. The organization needs to document the procedure for identification and traceability to identify the product throughout product realization. In the case of implantable medical devices, the traceability should include records of component, materials and conditions for the work environment used, if applicable.

Customer property. When a customer has given you any property to use in supplying their needs, you need to control that property from unintended use. You also must have a way of dealing with that property (with customer involvement) should there be a problem with it. Records of products found unsuitable for use shall be maintained.

Preservation of product. For some products, there is a need to properly handle it throughout the process to make sure it does not degrade. This includes during 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. It can also involve using stock in order of receipt (often called first-in-first-out, or FIFO) for stock that can degrade over time.

Some final thoughts on Production and Service Provision

It is important to remember that any requirements in the product realization section of the standard can be excluded from your quality management system if they do not apply to your business. Knowing your product or service and what it requires 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, and it needs to function perfectly to ensure your customer’s needs are met. That is what creates customer loyalty.

Use this Diagram of ISO 13485:2016 Implementation Process to ensure that the implementation of production and service provision is done in the right sequence.

Advisera Strahinja Stojanovic
Strahinja Stojanovic

Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.