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ISO 9001 Blog

Tomislav Stosic

Managing Production and Service Provision using ISO 9001

The need for a comprehensive production and service provision procedure goes beyond the requirements of ISO 9001. It is a necessity for every organization that wants to clearly define its production process and strives towards continuous improvement. A clear, in-depth understanding of the intent and implication of each production step is a must for all employees who participate or influence the production or service provision in any way. By complying with the requirements provided in ISO 9001:2015 (clause 8.5), an organization can easily create a robust and efficient production and service provision.

Flow charts

Every organization has to determine the production and service provision means and all the related processes. This is, however, not limited to its preparation, provision, control, preservation, release, transport and post-delivery activities. These types of procedures have to be established and implemented for every product/service or group of products and services that have identical or fairly similar production processes. It is a good practice for flow charts to be used in order to effectively explain the process flow, but a detailed textual description should never be left out. The flow charts must have the following elements incorporated in order to cover the requirements in section 8.5:

  • All inputs and outputs
  • All processes, sub processes and other activities
  • Intermediate and final control activities (monitoring and measurement)
  • Traceability
  • Property belonging to customers or external providers
  • Preservation
  • Release of products and services
  • Delivery and post-delivery activities

Controlled conditions

In ISO 9001:2015 (clause 8.5), it is stated that the organization shall implement production and service provision under controlled conditions. Analyzing this requirement will provide the organization with the framework of its production and service provision procedure. The procedure has to incorporate, or reference documented information that will define the characteristics of the products to be produced, the services to be provided, the activities to be performed and the results to be achieved. It must also precisely identify and connect every process to the respective documented information that is used in the production flow and the control activities. This will ease the production and service provision and prevent the unintentional use of wrong documented information, thus minimizing the possibility of human errors.

It is of great importance that suitable tools and equipment for the operation of processes are clearly identified in the procedure, but even greater emphasis has to be placed on the people. The organization has to ensure that competent persons with adequate qualification are responsible for every process or activity, especially the validation and verification activities. That being said, the production and service provision procedure has to clearly identify the qualified person, or better yet, mention the job position, responsible for every step in the production process and link these two together. In plain English, the procedure will clearly say what an engineer or an inspector has to do and what can be done by the production floor employees or the drivers.

The organization must establish the manner in which it will exercise care with property belonging to customers or external providers. Regardless of whether it is rental equipment to be used on a project or a client’s intellectual property, a procedure must be implemented in order to protect and safeguard customers’ or external providers’ property. It is of great importance that adequate and traceable documented information is retained. If the property is damaged or lost, it is essential to go back, perform a root-cause analysis and implement appropriate corrective actions.

The release of products and services is something else that has to be covered in the production and service provision procedure. The most efficient way to do so is to establish who within the organization has the authority to release products or services, and to establish the planned arrangements and conditions under which this activity can commence. Documented information must clearly identify the products and services to be released, and those products and services must be in conformance with the acceptance criteria and provide traceability to the person authorizing the release. This can be a product release record, a release checklist, or any kind of documented information that will best suit the organization. Regardless of which option the organization chooses, the person with release authority should always sign this document.

The manner of preservation and the post-delivery activities should be described, in detail, in the production and service provision procedure.  They may also be adequately addressed in a separate procedure. The preservation of products and services will have to provide clear instructions on how the products and services are to be kept or stored until delivered to the client or end user. This applies to each product or group of products or services. The organization should also describe, if applicable, how the products are to be preserved if the production process has been halted by unforeseen events at any given stage.

The post-delivery activities, on the other hand, are pretty straightforward. The organization must determine the extent of the post-delivery services required. This will depend on the nature of the products and services being provided. As a result, information must be included on, and not limited to the following:

  • Warranty provisions
  • Statutory and regulatory requirements
  • Maintenances services
  • Recycling and final disposal services

Don’t forget about it…

Regardless of the industry sector the organization belongs to, the production and service provision procedure is a living document and be constantly be improved and optimized. Don’t wait for the annual management review meeting to do so, every time there is a change or a need for a change in the production or service provision process, analyze it, evaluate it and try to improve it. This is the only way to continually improve the suitability, adequacy and effectiveness of the quality management system.

Use this free Clause-by-clause explanation of ISO 9001:2015 to understand what are the production and service provision requirements.

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