Any manufacturer can boast about the level of their quality management system — and many do. But when a company has ISO 9001 certification, they don’t need to boast. This certification means that an accredited third party has audited their entire operation and determined that the manufacturer has developed internal controls and systems in line with internationally recognized best practices, codified in the ISO 9001 standard. Certification ensures that the manufacturer follows through on its documented promises and procedures while working toward continual improvement. Thus, suppliers and consumers are likely to see better systems, higher accountability, and even better products and services when they opt to work with ISO 9001 certified manufacturers.
The ISO 9001: 2008 Certification Standard
First published in 1987, ISO 9000 is a family of standards that addresses various aspects of quality management. ISO 9001 (last updated in 2008 and to be updated again later in 2015) specifically covers quality management systems and is recognized by both customers and suppliers as the definitive, international standard for quality management system excellence. Read the ISO story if you want to learn more about the ISO organization, history, and standards.
Every business is different and is entitled to come up with its own quality management system, but to achieve ISO certification requires the business to:
- Execute on that system
- Prove that its system is both suitable and effective
- Demonstrate continuous improvement and
- Conform to the ISO 9001:2008 written standard
To be certified, the manufacturer must first be vetted by an auditor who, in turn, is audited by a separate oversight body.
Having recently achieved ISO 9001 certification, Replex is proud to be a part of this exclusive group. This case study, which documents Replex’s journey to become certified, provides an example of the comprehensive process and proactive measures a manufacturer must undergo to earn the certification – and the benefits that both the manufacturer and the customer enjoy as a result.
Case Study: Replex’s Journey To Certification
To achieve this coveted status, Replex embarked on a multi-year journey, involving a total overhaul of the processes and systems that had driven the company since its inception.
First, the team dedicated the summer of 2013 to engineering and populating a database which was the start of the construction of an electronic customer and product data system to replace the outmoded paper-based filing system. An accurate and up-to-date record-keeping system — crucial for document revision-level control — is an essential element of ISO 9001. Previously dependent on hard-copy records, Replex’s product profile database is now digital and available to operators on the production floor who can access it with tablet computers via the local area network. This enables the entire team to quickly access information that is guaranteed to be accurate and up-to-date.
Next, the Replex team worked through the long process of documenting the quality management system, which entailed establishing a quality policy, setting objectives for improvement, training employees, and evaluating and recording internal processes within the organization.
The pre-existing quality management system was strong to begin with, but during this process, the team found and fixed gaps that they never even knew existed, which enabled them to improve the system overall. All this work was compiled into The Replex Way Manual, which now serves as a record and a guideline for the entire organization.
Many companies seeking ISO certification, Replex included, find it helpful to engage a consultant who specializes in quality management systems. However, from the beginning, Replex chose to do most of the quality management system development and documentation in-house with existing Replex staff members. This was not a cost-reduction move;,this decision was intended to ensure that the system evolved to be maximally useful to the organization. Doing the work in-house requires more training and takes a lot longer than hiring an outside consultant to do this for you. We believe that by doing this work ourselves under the guidance of an outside expert consultant, we have produced a much better system, and have obtained critical ownership and buy-in of the entire Replex team. What is more, The Replex Way has now become an integral part of the culture of Replex, consistent with our core values of integrity and authenticity. Maintaining The Replex Way going forward should be much easier with all employees fully participating in the system development.
The Auditing Process: How Manufacturers Are Assessed
When the auditors arrived, they reviewed:
- Quality policy
- The overall management system as it pertains to setting quality improvement objectives, and measuring progress towards attainment of the objectives
- Internal audits
- Customer complaints
- Corrective actions
- Continuous improvement initiatives
In these areas, and many other areas, the auditors review the quality management system to ensure that it meets the requirements of the ISO 9001:2008 standard. Furthermore, the auditors seek objective, documented evidence such as meeting minutes, spreadsheets, reports, and audit logs, which can verify without question that the manufacturer actually follows through on its documented protocols as it conducts the day-to-day business of the organization.
The Results: How Working for ISO 9001 Certification Strengthens A Manufacturer
Done well, creating and documenting an ISO 9001 compliant quality management system will help a manufacturer to:
- Improve customer satisfaction
- Improve product consistency
- Reduce scrap and waste
- Shorten lead times
- Enhance the culture of continuous improvement and
- Improve safety.
In addition to the rigorous auditing and high quality, working systems, becoming ISO 9001 certified means a manufacturer familiarizes itself with the common international language used between suppliers and vendors with respect to processes, specifications, revision-level control, nonconformance, and corrective actions. International customers or suppliers may not even speak the same language, but they will be able to communicate clearly through this standard. Suppliers and customers considering working with an international partner should insist on one that is ISO 9001 certified, to ensure that when it comes to these crucial issues, both parties are “on the same page”.
A manufacturer that has invested the significant time, energy, and resources required to achieve ISO 9001:2008 certification has met exhaustive standards for a proven quality-management system and demonstrated to an independent third party that they’re working to improve it every day. The end result is both a better product and a better service to the customers.