Understanding ISO 9001: Clause 8.4 – Control of Externally Provided Processes, Products, and Services

When establishing or revising a management system under ISO 9001, Clause 8.4 – which focuses on the control of externally provided processes, products, and services – is crucial. Typically, these external entities are referred to interchangeably as vendors, suppliers, or external providers.

Initial Supplier Reviews and Approvals

At the outset of your supplier management process, especially for a new management system, a common method is to apply what is known as the “grandfather clause.” This involves acknowledging long-standing suppliers by drafting a management-signed letter that recognizes them as historic suppliers. To solidify their status in your management system, it is advisable to document their historical significance, such as the frequency of past transactions or the duration of their service.

For businesses dealing with a large roster of suppliers, generating a report from your financial system could help identify how frequently you have engaged with each supplier. This step helps in filtering out non-critical suppliers, such as those providing non-essential services or materials that do not directly impact the quality of your final product or service.

Reevaluation and Continuous Monitoring

Post initial approval, setting up a regular interval for supplier reevaluation is necessary. You can define specific criteria in your procedure, such as the maximum time interval between purchases, to consider a supplier as ongoing. Suppliers not meeting these criteria should be treated as new entries, necessitating a fresh review due to potential changes in their operation quality over time.

For new suppliers beyond the “grandfathering” stage, it’s essential to have a structured assessment process. This might involve a straightforward supplier questionnaire that inquires about their quality management systems, safety protocols, or industry experience depending on what’s most relevant to your business needs. This questionnaire should be tailored to gather essential data without overcomplicating the process, especially for small businesses.

Should a new supplier be considered, they might be initially marked as conditionally approved. Their performance, such as adherence to delivery schedules and quality of service, should be monitored, typically over a 90-day period. Based on their performance, they can either be upgraded to approved status or removed from the list if they fail to meet expected standards.

Supplier Monitoring and Management Review

For ongoing supplier monitoring, leveraging your non-conformance reporting process is highly recommended. This involves documenting any deviations like late deliveries or missing paperwork, which provides valuable data for reviewing supplier performance.

During supplier reevaluation, consider their recent engagement history and any recorded non-conformances. This analysis helps in making informed decisions about continuing with certain suppliers, even if they are critical but have had performance issues. Such cases should be highlighted during management reviews, providing a platform to discuss supplier performance comprehensively and decide on further actions based on documented evidence.

Make it work for you

Managing suppliers under ISO 9001’s Clause 8.4 doesn’t have to be overly complex. By focusing on essential details and maintaining rigorous documentation and review processes, you can effectively manage your suppliers, ensuring they meet the high standards required by your quality management system.

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