9001:2000 can be viewed as a general quality standard that is applicable to virtually any industry. It has been used for companies ranging from semiconductor manufacturers to home construction companies and retail automobile dealerships.
How the Certification Process Works
ISO certification applies to quality systems, not products themselves. In fact, it is prohibited to affix a symbol or claim denoting ISO certification to any product. ISO does not directly certify companies. Actual company certifications are purchased from companies called certification bodies. These certification bodies obtain accreditation from the national ISO member organizations.
Companies achieve certification by demonstrating compliance to the quality system requirements. Evidence for compliance is generated through periodic audits by the certification bodies. The frequency of these audits typically ranges from twice a year to once every three years. The company seeking certification pays fees for the assessments and the ISO certificates.
The Path to Certification
To be ISO compliant requires the creation of numerous documented systems. For an unregulated company, it typically takes 1 to 3 years to put the required systems in place and demonstrate their effective operation to the certification body. Companies that are already in a regulated environment, such as medical device manufacturers and drug manufacturers, have an easier pathway to certification. These companies are required by law to comply with the Good Manufacturing Practices (GMPs) published in the Code of Federal Regulations and enforced by the United States Food and Drug Administration. There is significant content commonality between the GMPs and the ISO standards. As a result, drug and medical device companies can acquire ISO certification in 6 to 18 months.
The Value of Certification
The ISO standards provide the basis of a sound quality system, utilizing the best thinking acquired from several decades of experience. Most companies are not ISO certified, yet many are performing satisfactorily in their marketplaces. Similarly, there are companies that hold ISO certificates yet deliver substandard products and/or services. However, it would be accurate to say that compliance to ISO standards increases the probability of supplying product of acceptable quality, and provides a reasonable degree of assurance to both customers and regulators.
Don’t just take the packaging company’s word regarding its quality standards. The packaging company should be familiar with a customer’s regulations and comply with those to support its customer’s business, ensuring things such as material trace-ability.