Applying ISO 9001 to an existing Audit Program

Auditors

Your audit team will need training to meet the ISO 9001 standard. Train them on the new requirements and on the organization of the standard.

Determine how you will Audit

The standard has an impact on how you plan and schedule the audits.

• Will you audit by area of your organization
• Or will you audit by clause of the standard

Auditing By Area

You will need to identify what clauses of the standard apply to the area.

Auditing By Clause

Identify what areas have responsibility for each clause. Many areas have responsibilities for each clause. An audit organized by clause will be moving into different areas of the company.

Auditing after transition to ISO 9001 from another structure.

To comply with ISO 9001,, companies may keep their current document structure and add new requirements. Or, they may choose to restructure their documents to follow the organization of the ISO 9001 standard.

If Current Structure is Maintained

If the system you are auditing will be organized significantly differently than the documented requirements you are auditing against it will be difficult to demonstrate that you have audited against all requirements. Your audit program will be more complex, involving mapping between standards.

If structure is changed

It may be difficult to audit during the transition. Unless all procedure revisions are effective at the same time, you may want your master schedule to include a break from internal audits during revisions. Schedule audits of all areas after procedure revisions are in place.

Develop New Checklists

The standard requires that the organization identify the processes needed for the quality management system. Create an individual checklist for each "sub-clause" of the standard. Tailor it to your organization. Include the new requirements of ISO 9001. Checklists with detail on the new requirements will help your auditors be consistent in their interpretations.