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New Approach Required When Auditing the New ISO 9001:2000 International Standard

Understanding the Requirements :

The new ISO 9001:2000 standard contains significant changes from the 1994 revision. Organizations will need to clearly understand and interpret the new requirements and gain a solid understanding of how the two revisions compare in order to develop an effective method for auditing to the new requirements.

Based on the Eight Quality Management principles and other considerations that depict the Quality Management System as a linked process, the ISO Technical Committee 176 developed a new format for the ISO standard. This format addresses a unified process approach and categorizes the activities into five sections. You will find that most if not all elements of the 1994 standard have been condensed into the appropriate new classifications.

Differing Needs for Documentation :

The new standard has only six specific areas that require documented procedures. Outside of these six, the standard allows the organization to determine which documents are required to ensure effective planning, operation and control of it’s processes. This provides more flexibility and requires the organization to determine their need for documentation based on their size, processes and competence of their employees.

Changes to Auditing Techniques :

The new standard puts more emphasis on top management involvement and commitment. In lieu of documented procedures, auditors will have to audit people by asking for a demonstration of effective control over processes and systems. Management will have to provide evidence of their commitment and involvement. An auditor’s skill in obtaining objective evidence through questioning techniques will be of primary importance. Look for forms, records, charts, meeting minutes etc. to support compliance to the requirements of the standard.

Planning Audits:

The audit schedule will have to be adjusted to match the new format of the standard. Time management will become a consideration due to the many sub clauses that are now condensed into the major elements. Decisions will need to be made on how to logically break down the major elements into more time efficient activities. The inclusion of the phrase “your own work” will provide more flexibility when adjusting the schedule. Checklists will have to be adjusted to reflect the new audit scheme to stay in sync with the new structure. Questions will have to be modified to address the increased need to obtain objective evidence.

Audit Methodology Changes:

The need for audit trails will become more apparent in the lack of documented procedures, particularly in determining objective evidence to support measurable objectives. Look to Management Review Minutes for evidence of measurable objectives. Evaluate the Quality Policy and the Objectives listed in the minutes. Look for charts and graphs that show progress and corrective actions where necessary in areas such as audit results, customer feedback, process performance and product conformity, status of corrective and preventive actions, follow-up actions from previous minutes, planned changes that could affect the quality management system and any recommendations for improvement. Internal Audits done correctly should provide evidence to system effectiveness.

Continual Improvement of the Quality System:

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:

communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
establishing the quality policy,
ensuring that quality objectives are established,
conducting management reviews, and
ensuring the availability of resources.

Auditors should look for evidence that supports the above items. Some of the tools and techniques that would support these items could be pareto analysis, trend charts, management review meeting minutes, training records, team activities, problem solving etc.

Certified lead auditors, internal auditors, quality managers/directors, ISO coordinators, managers and any other individuals assisting their organizations in making the transition from the old to the new standard, should look into the many currently being offered to gather a more thorough understanding of these changes.

Baskar Kotte
Quality Systems Enhancement

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