Consistency and reliability: Three steps to streamlining through ISO 9001 certification

13 March, 2015

If you’re manufacturing or selling anything, customer satisfaction matters. A lot. If there are production issues anywhere along the supply chain, the result is often unhappy clients. ISO 9001 certification is a great way for suppliers, manufacturers, and other organizations to manage the quality of their products and services to make sure that customers stay happy with the final product… and that the organization runs smoothly to produce those products!
Usually the most challenging step in pursuing ISO 9001 compliance and certification is the first one — knowing what this accomplishes, where to begin, and why. Companies that have achieved ISO 9001 certification have demonstrated that they have:

  • Established Quality Management Systems (QMS) according to ISO 9001 Standards; this requires knowledge and expertise, and system-wide changes in how the supply and production chain is managed
  • Formalized procedures to ensure the quality of the product at each stage of production; and
  • Established clear lines of communication and formal steps to document activities in each critical area in their organization

Why are these milestones so important, and what should you consider before pursuing ISO 9001 certification? Check out these four steps to establishing this high level of quality in your organization:

1. Meet specific requirements outlined by ISO 9001

  • A Quality Management System, or the collection of processes your business will use to ensure the quality of your product or service, and that the needs of your customers are met
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement analysis and improvement

For example, any verbal processes need to be formalized, in writing, which can be determined during evaluation for ISO 9001 certification.

2. Mind the Big Six

  • Control of documents
  • Control of records
  • Internal Audits
  • Control of nonconforming product/service
  • Corrective action
  • Preventative action

Why do these six points matter? Because communication — and how it is carried out — is all-important. Management must be aligned and constantly in touch with the employees affected by the changes that certification will bring; this ensures stability once all procedures fall into place. To implement these points, training programs must be established to allow existing and new employees to seamlessly pick up the workload in the ISO 9001 environment. This training will need to be comprehensive for those involved in various steps in the operation.

3. Certification

ISO itself does not provide certifications for any Standards that it outlines.Instead, an independent organization such as a CRO must certify that a company has met ISO 9001 standards for that organization’s individual processes.This means that each ISO certification is a highly individualized process, tailored to your organization.
To become certified, an organization is audited and may be presented with a set of observations — also termed nonconformities — of areas where the Standard has not been met.The organization must then submit an improvement plan to the certifying body to address the identified nonconformities in order to achieve ISO 9001 certification.Once certification has been awarded, it is typically in place for up to three years.
Whether you are just starting out, are starting to scale, or have long-standing processes in place, take a look at ISO certification for your company. Long-range goals that include ISO 9001 certification are important milestones for product or service organizations looking to expand their capabilities in the marketplace.