It has often been said that, in order to achieve ISO 9001 registration, an organization must:

• Say what you do
• Do what you say
• Prove it!

To “say what you do,” an organization must formally document its quality system policies and procedures.  To “do what you say,” the organization should carry out its internal processes as laid out in its policies and procedures.  Finally, to “prove it,” the organization must successfully demonstrate that it operates to these policies and procedures to an independent audit team, or “registrar”.

From the time the decision is made to proceed with registration, the organization could be ready for the registrar audit within a timeframe of a few months to two or more years.  Our clients typically achieve registration in less than one year.  (A registrar is an independent organization that has been accredited to perform ISO 9000 quality system audits and issue registration certificates.)

The majority of work in properly preparing for registration involves documenting the quality management system.  Typically, approximately 60-70% of the documentation will relate to existing internal processes.  The balance of the documentation will relate to additional requirements under ISO 9000, such as the process for conducting internal audits, taking corrective and preventative action, and controlling quality system documentation. 

Once the documentation is complete, the organization should conduct internal audits, the results of which must be reviewed by management who should respond by making corrections and improvements to the system.

Approximately six weeks prior to the registrar audit, the registrar’s auditors will perform a “desk audit” of the organization’s quality system documentation, by comparing it to the requirements of the ISO 9001 standard.  Any deficiencies will be noted and must be corrected.

During the registration audit, the registrar's audit team will come on site to interview the organization’s personnel and review records, to determine if the documented quality system is properly implemented.  A successful audit results in the issuance of a registration certificate. 

An experienced consultant can apply years of knowledge to help in the development and implementation of an effective quality system, deriving maximum benefit for the organization.