Global markets. New business opportunities. Customer satisfaction. These are just some of the reasons a relatively small, but growing independent company, such as the 38-year-old Kokatat, a paddlesports manufacturer, would seek ISO 9001:2008 certification (Click here to read the company’s recent news release about receiving certification.) It is one of many that are seeing the value and improved service.
What is the ISO?
Based in Geneva, Switzerland, the International Organization for Standardization (ISO) is a network of the national standards institutes of 162 countries, one member per country. In the United States, the American National Standards Institute (ANSI) is the country’s representing member organization. According to the ISO’s official website (www.iso.org), it has developed over 17,500 international standards on a variety of subjects and 1,100 new ISO standards are published every year.
According to a February 2009 ISO news release, ISO 9001 certification “specifies the basic requirements for a quality management system that an organization must fulfill to demonstrate its ability to consistently provide products (which include services) that enhance customer satisfaction and meet applicable statutory and regulatory requirements. The standard can be used for certification by organizations seeking independent verification that their quality management system meets the requirements of ISO 9001. ISO 9001 certificates of conformity have been issued to public and private sector organizations of all types in some 170 countries.”
Why an ISO 9001 certification?
For Black Diamond Equipment, which has been ISO 9001 certified since Oct. 27, 1998, ISO certification made sense simply because of the sheer volume of business the company conducts in Europe.
“In order to sell personal protective equipment product into the EU it must meet CE certification standards and part of this involves either being an ISO-certified company or, if not ISO-certified, submitting batch samples from manufacturing to an independent testing agency that is a CE notified body,” Dave Mellon, vice president of product for Black Diamond Equipment, told SNEWS®. “With the volume of products we make and the belief that we had really strong manufacturing and quality systems as well as a world class product design and development process it made sense to become ISO certified.”
To watch a short video that explains how ISO 9001 affects Black Diamond Equipment’s quality control methods, click on the image to the right and then launch the video in the BD website.
Horizon Fitness, one of the Johnson Health Tech North America brands, received its ISO 9001 certification in March 2007.
“There were two main drivers for Horizon Fitness seeking ISO certification. First, ISO 9001 was identified as a solid baseline, providing the frame work to establish key business and quality management system procedures,” said Kyle Schweitzer, director of quality for Johnson Health Tech. “Perhaps even more important for a young company trying to develop a recognizable brand name is demonstrating to our customer base that our organization is committed to upholding strict standards and practices.”
More recently, on Nov. 4, 2009, to be exact, Kokatat received its ISO 9001 certification. In the company press release, Kokatat stated, “Following a nine-month implementation process, the British Standards Institution (BSI) conducted an intensive audit on behalf of ISO. BSI examined all of Kokatat’s quality standards and relevant processes to determine compliance and the intent to make effective improvements in the future.”
ISO 9001 certification is well worth the investment of time and money involved, Michael Duffy, director of marketing for Kokatat, told us. “An ISO audit is very valuable for the intense scrutiny the company endures in terms of manufacturing processes, use of labor, and working conditions. This audit can serve to not only recognize standards but also to improve production, resources and management and in the long-term, help the company become a better social and environmental steward as well.”
Duffy said the ISO certificate will ease the sometimes difficult compliance procedures and measures unique to individual countries. In addition, for companies with products used and sold to the Department of Defense, the Department of Homeland Security and other federal and state agencies, the certification is vital. Regulatory agencies typically require advanced safety standards and products undergo a greater degree of scrutiny, and by default, the consumer product benefits from these elevated standards.
All three companies — Black Diamond, Horizon Fitness and Kokatat — told SNEWS that having an ISO certification ensures the companies stay on their toes with the ultimate beneficiary being the customer – both retailer and end-consumer. Customer satisfaction and continual improvement of well-documented procedures, processes and systems are an integral part of ISO 9001 certification.
“The continuous improvement concept and the framework that the ISO standard requires is oriented on continually evaluating, measuring, and improving areas within the company. So when we do a customer (retailer) survey each year, the results of that survey drive corrective action plans for processes and departments,” Mellon told us. “When we realize we need improved visibility into the warranty returns at a more granular level to better address areas of product weakness or failures that comes out of the ISO audits and requirements.
“Philosophically, the ISO standard requires you to not sit on your accomplishments, but instead focus on what can be better and what can be improved,” added Mellon.
What are the costs to achieve initial certification?
There is no minimum or maximum cost with cost depending on the size of the company and how much work it must do to achieve compliance with the 20 certification elements.
“The direct certification costs will depend on the size and exactly how established the organization is,” Schweitzer said. “Establishing compliance within the organization and then becoming certificated can take anywhere from three months to three years, with the average company taking around 12 months. Generally companies will start by performing a gap analysis to determine the areas of focus. Depending on the level of internal expertise, a company may also choose to bring in an outside consultant for assistance. Obviously these two factors could create variation in the total cost to implement and achieve certification. However, once compliance is achieved, the cost is relatively low for the actual certification process and should cost less than $2,000 depending on the registrar company used and the size of the company being audited. Larger companies could see much higher costs depending on the number of days required to audit the organization and the number of external auditors needed.”
What are the 20 elements on which the certification is built?
Summarized below, from ISO 9001 documentation:
- Management Responsibility/Commitment – A good company will put emphasis on quality and meeting customer expectations from top management all the way down throughout the organization. To ensure this, top management defines the quality policy and key quality objectives while making sure they are communicated, reviewed and constantly improved upon throughout the organization. Top management also ensures that the infrastructure and resource planning is aligned with the quality objectives.
- Quality System – A quality system is established by creating a Quality Manual and related procedures affecting the quality of the product.
- Contract Review – A contract defines the customers’ requirements and expectations.
- Product Realization/Design Control – Product design and development activities are planned and controlled through the product development process.
- Document and Data Control – The creation, revision and approval process for all company documents is defined and controlled by the ISO 9001 standards.
- Purchasing – Purchasing procedures describe supplier requirements and the system for ensuring compliance to these standards.
- Control of Customer Supplied Product – Products supplied by the customer are maintained and kept according to written procedures.
- Product Identification and Traceability – Procedures are established to identify a product and the methods used to allow proper traceability through manufacturing, delivery and installation.
- Monitoring, Measurement and Testing of Product – Product verification and validation to design requirements and customer expectations are carried out throughout the product development and manufacturing processes.
- Process Control – Standard operating procedures and work instructions are documented, verified and audited to ensure that each job function is being carried out.
- Control of Inspection, Measuring and Test Equipment – All gauges and measuring devices used to verify products are controlled and calibrated on a regular basis.
- Inspection and Test Status – Identification of the inspection and/or test status as well as the person or persons performing these activities are recorded and stays with the product as it moves forward through the subsequent stages of the process.
- Control of Nonconforming Product – Materials or products that fail to meet specifications are identified and are required to go through a proper disposition process by authorized personnel to determine if they can be used as is, reworked or returned to the supplier.
- Corrective/Preventative Action (Continuous Improvement) – The corrective action process is meant to identify nonconformance in the product and/or company’s processes. Once identified the company’s systems should focus on identifying the root cause and implementing corrective action. Preventative action is used to identify key processes/product characteristics and implementing solutions to prevent nonconformance.
- Handling, Storage, Packaging, Preservation and Delivery – Processes define the methods to prevent damage during manufacturing, storage and handling of the product.
- Control of Quality Records – Records of key processes are controlled, maintained and used for verification by the auditing teams.
- Internal Quality Audits – Highly trained internal auditing teams are formed to verify that the quality system is effective and being maintained.
- Training – An ISO 9001 certified company requires all employees to be aware of their role and responsibility and how they affect the overall company’s strategic goals. New processes or changes in the company’s processes and procedures require proper training and documentation of such training. Training records are maintained for each employee in the organization.
- Servicing – Establishing methods and procedures for handling customer service.
- Analysis of Data – Appropriate data is determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system. Methods of statistical analysis are used to measure product performance, customer satisfaction and to determine whether key processes are working. Results are used to initiate continuous improvement.
Can a company lose ISO 9001 certification after earning it?
ISO 9001 certification requires surveillance audits after the certification is received. Generally this is done once a year by a third party auditing firm. If a company does not demonstrate the ability to meet the ISO 9001 requirements, the certification can be lost.