The ISO 9000 and ISO 14000 series of International Standards emphasize the importance of audits as a management tool for monitoring and verifying the effective implementation of an organization's quality and/or environmental policy. Audits are also an essential part of conformity assessment activities such as external certification/registration and of supply chain evaluation and surveillance.
ISO 19011 provides guidance on the principles of auditing, managing audit programmes, conducting quality management system audits and environmental management system audits, as well as guidance on the competence of quality and environmental management system auditors. It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit programme.
The Challenge
Organizations usually need to deal with a large number of compliances, each one with specific requirements and auditing processes. This scenario demands conducting a series of quality, environment, safety and strategic audit programmes at once, challenging auditors to keep audits organized and on schedule. ISO 19011 standard provides all resources needed to organizations to save time, effort and money when conducting audits. Auditors connected to ISO audits and any other auditing process benefit from ISO 19011 by:
- Clear explanations of the principles of management systems auditing
- Guidance on the management of audit programmes.
- Guidance on the conduct of internal or external audits.
- Advice on the competence and evaluation of auditors.
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SoftExpert Excellence Suite ensures compliance with many regulations including the ISO 19011. The solution allows companies to increase efficiency for quality processes, minimize the high costs of compliance, and quickly bring new products to market.
Each SoftExpert module addresses key compliance issues as shown below:
| Module |
ISO 19011 Requirements |
SE Audit
|
- Create audits respecting the size, nature and complexity of the organization to be audited.
- Allow different auditing organizations to cooperate, as part of their audit programmes, to conduct a joint audit.
- Establish objectives an audit programme, to direct the planning and conduct of audits.
- Identify resources for the audit programme, such as financial resources and audit techniques.
- Plan, schedule and conduct audits.
- Appoint audit team leader and audit team.
- Conduct audit follow-up.
- Provide a complete, accurate, concise and clear record of the audit.
|
SE Competence
|
- Assure the competence of auditors and audit team leaders
- Establish and maintain a process for the evaluation of the auditors and their continual professional development.
- Maintain records related to audit personnel covering subjects such as competence and performance evaluation.
- Â Assure auditors have knowledge and skills in leadership, quality management and environmental management systems.
|
SE Document
|
- Safeguard documents involving confidential or proprietary information at all times by the audit team members.
- Review the documentation to determine the conformity of the system, as documented, with audit criteria.
|
SE Performance
|
- Monitor performance and effectiveness of the audit programme.
- Monitor the audit programme at appropriate intervals, reviewing to assess whether its objectives have been met or not.
- Use performance indicators to monitor the ability of the audit teams to implement the audit plan, conformity with audit programmes and schedules, and feedback from audit clients, auditees and auditors.
|
SE Project
|
- Create audit programmes that include all activities necessary for planning and organizing the types and number of audits, and for providing resources to conduct them effectively and efficiently within the specified time frames.
- Establish, implement, monitor, review and improve the audit programme.
|
SE Training
|
- Apply the knowledge and skills gained through the education, work experience and training.
|
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