General Guidelines of Audit Control Standards NBR ISO Series 10000

NBR - ISO 10000

• Part 1 - Audit
• Part 2 - Qualification of Quality System Auditors
• Part 3 - Management of Audit Programs

Here is a brief explanation of guidelines concerning NBR - ISO 10000.

Part 1 - Audit

The series NBR 19000 (ISO 9000) emphasizes the importance of Quality Audit, considering it a management tool to reach goals established within an organization's policy.

Audits must be performed so that elements of a quality system are effective and appropriate to reach quality goals established.

This NBR ISO 10011-1 establishes basic principles and criteria of Audit, and provides guidelines to establishment, planning, performance and documentation of Quality System Audits.

It offers a guide to check the existence of elements of a Quality System, implement them e get to know whether they can reach goals defined. It is a generic guide that can apply or adapt to different types of companies. Companies must create their own specific procedures to implement this guide.

Some of the main purposes of audit are:

• Determine conformance or non-conformance of Quality System elements according to specified requirements.
• Determine efficiency of the Quality System in achieving Quality goals.
• Offer the audited person an opportunity to improve the Quality System.
• Comply with regulation requirements.
• Enable the registration of the Quality System of the audited company in a record.

  
Audits are usually performed due to:

• Evaluate a supplier before establishing a contractual relationship.
• Attest that the Quality System is still reaching goals defined by the company and that is being implemented.
• Attest, within a contractual relationship, that the supplier's Quality System is still complying with requirements specified and is being implemented.
• Evaluate the Quality System of the company according to standards of a Quality Assurance System.

  
These audits can performed as a routine or due to significant changes in the Quality System of the organization concerning quality of process, product or service. They can also follow a corrective action.

Part 2 - Qualification of Quality System Auditors

For Quality System Audits to be carried out efficiently and consistently, some criteria are required for qualification of auditors, as defined in NBR ISO 10011-1.

NBR ISO 10011-2 describes these minimum criteria.

It also provides the method to evaluate compliance of each auditor with criteria and their maintenance.

These are some of recommended criteria to qualify auditors of Quality Systems:

• Education
• Training
• Experience
• Personal Skills
• Management Capacity
• Maintenance of Capabilities
• Language
• Experience acting as a qualified auditor

Part 3 - Management of Audit Programs

Any company that continuously needs to execute Quality Systems Audits must provide training for a global management of all process.

This NBR ISO 10011-3 describes activities that this type of organization must conduct, providing basic principles to manage programs of Quality System Audit.

These principles apply to establishment and management of the Audit program when performing Quality System Audits, according to recommendations of NBR ISO 10011-1.

The Management of Audit Programs is composed of:

• Organization
• Standards
• Team qualification
• Adaptation of team members
• Monitoring and maintenance of auditor's performance
• Operational factors
• Joint audits
• Improvement of audit program
• Code of Ethics