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Solutions Studies – ISO Certified & Quality Management Systems

The Importance of having an ISO Certified Contract Manufacturing Partner

Say what you do; do what you say.

A simple, yet invaluable statement when it comes to what you need from your contract manufacturing partner. With an organization certified by an independent certification body, top level management can rest assured that the system conforms to required standards as well as having the knowledge that when it comes to quality management; they will say what they do and do what they say.

ISO, the International Organization for Standardization, is an independent organization with no governmental ties that develops and audits quality, safety and efficiency specifications in areas of technology, food safety, agriculture, healthcare and many more. The standard most common in manufacturing is ISO 9000, which is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented in order to maintain an efficient quality management system. Recognition from this body cannot be bought. It is only with hard work and consistent implementation of standards that their requirements can be met.

ISO standards are based on seven quality management principles that senior management can apply for organizational improvement:
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management

While ISO certification is not mandatory, companies searching for business partners to help ensure their success and growth realize there are few things to be prioritized over ISO certification and the reasons are as follows:

• Quality procedures are not going to be a one off, check the box affair. It will be an everyday way of life. There is only one way to ensure consistent high quality services; know it and live it. ISO can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement.

• Official audits take place on an annual basis. However, it is important that the company maintains its own checks and balances to ensure that quality protocols aren’t slipping through the cracks. For example, at SabeRex this is done periodically throughout the day. Each and every time an issue is found by management, an employee or a customer, a Corrective Action Request is created to combat the issue.

• ISO lays out a framework of policies, processes and procedures that help ensure the organization is able to adhere to the standards required to maintain certification. However, it is the responsibility of the company to implement policies regarding the reporting of quality control concerns.

Choosing a contract manufacturing partner can be one of the biggest decisions that you make for your business and it is important to know what to look for. With an ISO certified company you can rest assured knowing that there is nothing coming between your product and an efficient, high quality end result.

For information on how SabeRex, can help with your contract manufacturing needs, check out our Complex System Integration offerings as well as our full-range of service capabilities.

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