International Organization for Standardization or ISO, are a collection of international standards used to validate quality in the manufacturing, managing, and delivering of goods or services. According to ISO.org, these standards serve as a baseline for establishing quality levels in all areas of business operations, including information security, environmental management, quality management, medical equipment, food service, energy consumption, and more. Adhering to these standards proves a company is committed to providing the highest-quality product / service possible.

Businesses large and small can implement ISO standards to establish universal credibility in the level of parts or services provided to customers. The ISO standards a business holds will vary based on industry and the type of product or service they provide. Below we have outlined some popular standards utilized for injection molding companies.

ISO 9001 and ISO 9000 Series– This family of standards outline the criteria for a quality management system to ensure customers get consistent, high-quality products. Companies that hold this certification adhere to a strong customer focus, utilize a process approach for achieving continuous improvement and are supported by executive level management. The ISO 9000 series of standards are adapted to cover specific industries such as ISO13485 for medical devices.

ISO 13485 – This set of standards outlines the regulatory requirements for quality management systems in the medical device industry. Requirements for medical devices include all steps of the product life cycle, from design to delivery. These standards are non-negotiable for the medical device industry and certifying to the standards is valuable for establishing credibility in the medical field.

ISO 14001 – Sets the guidelines for improving environmental performance. With growing concern for the environment and long-term impacts, ISO14001 sets the guidelines for implementing a continuous environmental improvement cycle. This cycle has four parts – plan, do, check, and act. Commitment to this standard covers year-to year improvement of environmental performance.

ISO 27000 – Information security management is the focus of this popular ISO standard. Implemented to protect information assets, this standard can be utilized in all industries. With more than 12 standards in the 27000 family companies manage maintaining secure employee details, financial information, and intellectual property to the highest degree.

Outlining the processes your company has in place when it comes to producing goods, reducing environmental impacts, or handling sensitive information is made universal with ISO standards. Internationally agreed upon by experts, these ISO standards are created to outline the best way of doing a task. Certifying to these standards establishes a company internationally and speaks to the level of quality and management valued and implemented by the company.

When beginning a new project, it is critical to understand the environment and ISO certifications needed to produce that part. The certifications each supplier holds will vary in turn limiting which injection molders will be a suitable partner. Sussex IM holds several ISO certifications including ISO 9001, ISO 14001, ISO 45001 and ISO 13485 for medical injection molding.

For more information about ISO standards visit: www.iso.org