ISO 9001:2015 Clause 8.5.1, titled "Control of production and service provision," is a key requirement within the standard that focuses on ensuring the controlled conditions under which the organization's products and services are produced and delivered. This clause is designed to ensure that the production and service provision processes consistently meet customer requirements and conform to the intended quality standards. The detailed aspects of this clause cover several critical areas:
Implementation of Controlled Conditions
The organization is required to carry out production and service provision under controlled conditions. Controlled conditions include, but are not limited to, the following:
-
Availability of documented information that defines the characteristics of the products or services, and the results to be achieved. This ensures clarity and uniformity in understanding the product requirements and service expectations.
-
Availability and use of suitable monitoring and measuring resources where necessary to verify that the specified requirements for the products or services are met. This helps in ensuring that the products and services conform to the organization's quality standards.
-
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. Effective monitoring and measurement ensure that the process is under control and that the final output meets the desired quality levels.
-
Use of suitable infrastructure and environment for the operation of processes. The infrastructure includes the physical workspace, equipment, and facilities, while the environment could refer to conditions like temperature, humidity, and cleanliness that could affect product quality.
-
Competence, including any required qualification of persons. The clause emphasizes that individuals involved in production and service provision must have the necessary competencies, achieved through education, training, or experience, to ensure quality workmanship.
-
Validation, and periodic re-validation, of the ability to achieve planned results of the processes for production and service provision. This involves confirming that the processes are effectively delivering their intended outputs before full-scale production or service execution begins.
-
Implementation of actions to prevent human error. This may involve process design, training, and procedural safeguards to minimize the likelihood of errors during production and service delivery.
-
Release, delivery, and post-delivery activities. Control of these activities ensures that the product or service is not released to the customer until all specified processes have been satisfactorily completed, and that appropriate arrangements are in place for the ongoing satisfaction of customer requirements after delivery.
Documentation
Documentation plays a crucial role in Clause 8.5.1, as it ensures that all processes and specifications are clearly defined, accessible, and consistently applied. This includes work instructions, standard operating procedures, and quality requirements that are documented and maintained.
Adaptability
The clause also implies the need for adaptability and continuous improvement of the production and service provision processes. Organizations are encouraged to regularly review and update their processes in light of performance data, customer feedback, and changing requirements to continually enhance quality.
In essence, Clause 8.5.1 is about ensuring that the organization's products and services are produced and provided consistently, efficiently, and effectively, meeting both customer expectations and regulatory requirements through controlled and well-documented processes.