Any business sustains when its operations run smoothly. Clause 8 of ISO 9001: ‘Operation’ defines requirements for some key processes required to run your business. This is the largest clause of ISO 9001 and most of the requirements of the Quality Management System are addressed within this clause. This single clause includes the process of communicating with the customer, reviewing their requirements, designing the product or service, purchasing of raw material or outsourcing of processes, production or execution of the service and release of the product or service. The entire production process where your organisation convert inputs like labour and raw material into the desired outputs which are the products or services, you deliver is what this clause addresses. For instance, a training institute will have training as its operation where they use teaching professionals and training presentations to provide training to their customers. To provide this service to their customers, they may gather the requirement from customers, design the training program, purchase training equipment like projectors, markers, computers, etc., plan and make arrangements for the training, and finally deliver the training. They may also hire trainers or outsource training to industry experts in the process. The ‘Operations’ clause defines requirements for all these interrelated processes which include all the internal and outsourced processes and defines the controls to effectively manage these processes. This clause requires that an organisation shall plan its operations, implement effective methods and control the processes so that customer requirements are met and quality of product and service is delivered, as expected by the customer.

Operation is what your business does. This is the reason which makes this clause the most important requirement of ISO 9001 that should be implemented. Operations can be optimized and effectively run when all the processes involved are planned, managed and controlled. Each of these processes is dependent on each other and interaction between each process may be very complex. While a large organisation like a manufacturing unit may have various departments handling operations, starting with Sales and Marketing, purchase of raw material, storage of raw material, assembly line, quality control, storage and final delivery of the product to the customer, a smaller organisation may just have 1-2 people handling all the operations. But, this clause should be implemented in full as each of the sub-processes interacts with each other and an issue or a non-conformity in one process may lead to a bad product or a faulty service. Some of the key processes and how these are addressed in ISO 9001 Clause 8 is given below:

Customer Communication and Managing Customer Requirements

Customer Communication is important and shall be done to provide them with information related to the products and services, while handling their inquiries, queries, orders including any changes requested, obtaining feedback from them, handling and controlling customer property, or to understand their specific requirements. Any miscommunication may lead to customer’s expectations not being met.

A customer requirement not understood well or a company accepting the project without evaluating if they have the capability to fulfil the requirement may lead to the project never getting completed or may lead to many customer complaints. It is imperative that an organisation plan processes for determining and reviewing the requirements before accepting any order/project from the customer. Changes to the requirement shall also be addressed in a formal and using a procedural method.

Design and Development

The next key process in Operation is ‘Design and Development.’ Designing and Developing a product/service with the design inputs and producing required designs which will fulfil the customer requirement is what is required in this sub-clause. This process is very critical as a small issue in design may lead to a faulty product which may cause customer dissatisfaction and earn you a bad reputation. That is why controlling the design process with adequate planning, reviews, verification and validation is crucial for any organisation. We will address this in our article on Design and Development.

Managing External Providers

Your organisation may be working with several external providers. These may be your suppliers of raw-materials or you may have outsourced certain operational processes. ISO 9001 requires that you control and manage the external providers with effective processes. Purchasing is another important activity that shall be done correctly. Purchasing the right amount and the right quality of the raw material is critical for any organisation. If the raw material procured is not of the required quality, you cannot deliver high-quality product/service to the customer. So, it becomes important that you have processes for supplier selection, enough reviews and checks to ensure raw material received are on time and of high quality and monitor your supplier performance at defined intervals. More details on this in our article on Managing the External Providers.

Production and Service Provision

Control of Production and Service under controlled conditions is imperative for any organisation to ensure that the product delivered meets the customer requirement. These controlled conditions include the availability of

• documented information on the characteristic of product/ service.
• documented information on the activities to be performed
• suitable monitoring and measuring resources and their use
• suitable infrastructure
• competent personnel to work on production and service provision
• validation of the results of the processes and
• products and services release, delivery, and post-delivery processes

All the above-listed activities are an important part of production and service provision. Imagine what will happen if the personnel required to work on a process is not even aware on what he needs to do or produces more than the amount required and then there is no storage available to properly store the excess produce. What if there is no quality control and the product delivered does not meet the acceptance criteria. Such a company will not operate in an optimized manner and there would be chaos all around. That is why Production and Service Provision is critical to any company’s operations. We will cover more details on this in our article on Production and Service Provision.