ISO 9001:2015 Foundation Practice Exam

This practice exam will help you review the ISO 9001:2015 standard – a clause-by-clause review. It covers the following topics

• ISO 9001 Requirements

• PDCA Approach

• Context of organization

• Leadership

• Planning

• Organization Knowledge

• Support Functions

• Operations

• Performance evaluation

• Internal Audit

• Management Review

• Improvement

  ISO 9001 is the international standard for a quality management system (“QMS”). In order to be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.

The new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.[42]

The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.[43]

Some of the key changes include:

• High-Level Structure of 10 clauses is implemented. Now all new standards released by ISO will have this high-level structure

• Greater emphasis on building a management system suited to each organization’s particular needs

• A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy

• Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement

• Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in

• Alignment with other key management system standards through the use of a common structure and core text[44]

• Inclusion of Knowledge Management principles

• Quality Manual & Management representative (MR) are no longer mandatory

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