We've entered an age when quality has become imperative in the arena of high tech industry. The International Organization for Standardization (ISO) has provided a level playing field for all manufacturers to officially state the quality of their products and business practices.
ISO 9001, ISO 17025, and ISO 17034 are the three most valuable credentials for standard manufacturers. What do these credentials really mean?
- Certifies that a company has official written procedures and training documentation in the areas of customer service, product design, manufacturing, analysis, change management, certification, packaging, shipping, and purchasing. Risks and opportunities are also assessed within these areas.
- This standard is very customer service oriented. Complaints are documented with corrective and preventative measures utilized to ensure continuous improvement.
As long as a company is consistent in its documented actions, it can remain ISO 9001 certified.
- Certifies that quality-oriented tests are performed correctly. These tests establish that the product is indeed a quality product.
- All aspects of quotations and contracts, the Research and Design operation, and Manufacturing and Quality Control activities are examined by this standard. The qualification, education, and training of all associates are scrutinized against their job responsibilities. Even the qualifications of vendors and subcontractors are checked, as well as every Quality Critical specification and purity requirement.
To be ISO 17025 accredited, a company must not only be consistent, but must also be proficient in testing the quality of their products.
- This accreditation deals directly with Certified Reference Material (CRM) manufacturers.
- CRMs can only be manufactured by an ISO 17034 accredited producer.
- All methods that the manufacturer uses to certify their standards must be validated and proven to be accurate.
- Requires that an "uncertainty", which includes all of the sources of error involved in certifying the standard, be reported on the Certificate of Analysis. Furthermore, the Certificate of Analysis must adhere to the requirements established by ISO Guide 31.
ISO 17034 provides the highest level of quality assurance, confidently stating that the manufacturer's standards are produced correctly and competently.