Jean publishes a blog called the Enterprise Corner. It features articles on entrepreneurship, local industry trends, manufacturing news and periodic ‘toolbox’ articles showcasing assistance, incentives and other resources for local businesses.
I had the opportunity to visit with Pete Morton recently about quality management. He is the plant and quality manager at Macroplastics in Union Gap. Pete is our community's go to expert on ISO certification and quality management. He is an ISO auditor and has over 30 years of quality management experience under his belt.
JB: What is ISO 9001?
Pete: ISO 9001 is an international standard for quality management systems. It provides a road map to an effective quality management system. It also provides for 3rd party certification of a company’s quality management system. It has specific criteria that must be addressed in a company’s quality management system to be certified.
JB: Why get certified?
Pete: Companies do not need to certify, they choose too. The standard is written to be imposed by a customer on their suppliers. Your suppliers may require that you become ISO 9001 certified. In most cases, a company decides to pursue certification because they see a marketing value in it, or the need to be certified to compete. Effectively implementing the standard will improve the effectiveness of your quality management system. Specifically it will help you ensure you meet customer requirements and improve customer satisfaction.
JB: What’s involved with the certification process?
Pete: First, a company must implement the ISO 9001 guidance. The current 2008 version involves developing a quality manual; implementing work instructions, procedures and other documents to control your processes; implementing continuous improvement programs, an internal quality audit program, customer complaint handling, and corrective and preventive action programs.
Once the elements of ISO 9001 are implemented, and the system is effectively working, the company will contract with a Registrar. This is a company that is certified to provide 3rd party appraisals of the quality management system effectiveness. They audit the quality management system to determine if the criteria of ISO 9001 are implemented and effective. They will then certify that the company quality management system meets the requirements of ISO 9001. Typically a surveillance audit is performed annually, with a complete re-certification required every 3 years.
JB: What are the benefits of being certified
Pete: The primary benefit of being certified is the implementation of an effective quality management system. This will help the company control it’s processes, ensure that customer requirements are met, and provide for customer satisfaction and continuous improvement.
The more practical benefits is having the ISO 9001 certificate as a marketing tool. ISO 9001 certification is used by many customers to establish that a supplier of goods or services has effective control over their processes and can meet customer requirements. In many industries, ISO 9001 is needed to compete even if it is not specified as a contractual requirement. In many cases, ISO 9001 certification is used as a primary basis for approving a supplier.
JB: How long does it take? What costs are involved?
Pete: The time to implement ISO 9001 and become certified varies greatly, depending on the existing control and documentation of a company’s processes, the resources allocated and the scope of the company’s activities. I have obtained ISO 9001 certification for several companies in 6 months or less. Some companies will spend 2 years on the effort. The major initial effort is the documentation of processes (sales communications, order entry and approval, quality planning, manufacturing processes, internal audits, training, material control, storage and shipment requirements, customer feedback, continuous improvement, and document control). You need to have your documents implemented for a period of time to allow internal audits to check their effectiveness. Then you get your Registrar in for the audits. Most registrars require a pre-audit to assess your readiness for certification and to identify areas you need to work on. Then the certification audit. The length of time for this audit depends on the scope of your activities and the number of employees you have working at each facility. The certification audit can be 2 days, for a small single facility company (10 – 30 employees) to much longer. Macro Plastics has 3 manufacturing facilities and about 100 employees. Our certification audit takes a total of 6 days. Annual surveillance audits take 3 days. For a small business, single facility with less than 30 employees, I would expect 6 months (if you have some internal expertise in ISO 9001) to a year would do it. Many small companies will use a consultant to organize the efforts. Typically this would take a little longer and be much more expensive.
Cost also vary greatly. Using a consultant will significantly increase the costs ($10-15K or more). If you do it internally, there is a significant amount of work and labor costs to document your processes, implement internal audits, etc.) You may also need to add resources to meet the requirements. The cost of the registrars audits will vary on the scope of activities, facilities involved, and employment level. The initial audits for a small, single facility company would typically be on the order of $5K, with the annual surveillances about $3K.