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ISO 9001:2015, introduced in September 2015, is the most widely adopted standard in the history of quality management. It provides a framework for improving quality and enhancing the understanding of processes within any company or organization. The goal is to consistently deliver goods and services that meet the expectations and needs of customers and other relevant stakeholders in the most efficient manner. A quality management system encompasses all resources, cultural values, processes, and assets that support customer satisfaction and organizational efficiency.

ISO 9001:2015 does not prescribe the specific objectives of a company or how to achieve them. In simple terms, it does not dictate how a company should operate. Instead, it outlines control principles that help create efficiencies by integrating and aligning processes across the organization. It ensures compliance with regulatory requirements and supports organizations in expanding into new markets where customer demand for ISO certification exists.

The primary mission of ISO is to establish common specifications, standards, terms, and units of measurement for organizations worldwide. ISO does not offer certification or conformity assessment; instead, it promotes international trade and innovation by ensuring that every organization across all sectors shares a common language and set of expectations. This applies to diverse industries, including manufacturing, technology, food security, agriculture, and healthcare. ISO’s mission is supported by the following core initiatives for its members:

ISO aims to ensure the efficient operation of organizations while managing finances. It works to increase adherence to Good Standardization Practice (GSP) among standards experts, evaluating all processes to align them with the technical barriers to World Trade Organization (WTO) trade agreements (TBTs). Additionally, ISO strengthens the connection between public policy and standardization by providing thought leadership and promoting awareness of best practices. In terms of risk and sustainability, ISO ensures collaboration and participation from key stakeholders in all standardization projects.

Clause 1: Scope
This section defines the scope of the standard, specifying the requirements for the quality management system (QMS) applicable to any organization.

Clause 2: Normative References
This section outlines the mandatory standard referred to in ISO 9001:2015, which is ISO 9000:2015, covering the fundamentals and terminology used in the QMS.

Clause 3: Terms & Definitions
The terminology used throughout this standard is derived from ISO 9000:2015, which provides the terminology and fundamentals for quality management systems.

Clause 4: Context of the Organization
When implementing a quality management system, it is essential to align business objectives with the QMS. This involves understanding both external and internal issues, the needs and expectations of interested parties, and defining the scope of the QMS and its processes.

Clause 5: Leadership
This section emphasizes the responsibilities of top management. They must demonstrate commitment to the QMS by establishing and communicating a quality policy, ensuring responsibilities and authorities are understood and assigned.

Clause 6: Planning for the QMS
This clause focuses on the planning necessary for the organization to address risks, opportunities, and quality objectives, as well as managing changes within the QMS.

Clause 7: Support
This clause addresses the resources required for the QMS, including ensuring employees are competent, providing necessary resources, and maintaining documented information to support the QMS.

Clause 8: Operation
This section covers the control and planning processes needed to meet customer needs for goods and services, including production, service provision, design and development, and external provider management.

Clause 9: Performance Evaluation
ISO 9001 requires organizations to measure, monitor, analyze, and evaluate the performance of the QMS to ensure its effectiveness.

Clause 10: Improvement
This clause emphasizes the need for continuous improvement. Organizations must identify opportunities for improvement, address nonconformities, take corrective actions as necessary, and continually enhance their QMS.

Scope of QMS
Quality Objectives
Quality policy
Criteria for evaluation and selection of suppliers.

• Procedure for document and record control
• Procedure for competence, training, and awareness
• Procedure for determining the context of the organization and interested parties
• Procedure for production and service provision
• Procedure for management of non-conformities and corrective actions
• Procedure for monitoring customer satisfaction

To certify a company’s QMS, you must first complete the implementation. Once all documentation is in place and processes are established, the company needs to take the following steps to ensure successful certification:

• Internal Audit:
  This step involves checking your QMS processes to verify that records exist confirming compliance with procedures. It helps identify problems and vulnerabilities that may otherwise be overlooked.
• Management Review:
  Management must evaluate the facts about the management system processes to make informed decisions and allocate the necessary resources.
• Corrective Actions:
  After the internal audit and management review, document the root cause of any identified issues and outline how they will be resolved.

Stage 1 (Documentation Review):
The auditors from your chosen certification body will review your documents to ensure they meet the requirements of ISO 9001:2015.

Stage 2 (Main Audit):
At this stage, the certification body auditors will assess whether your activities align with both ISO 9001 and your documentation. This will involve reviewing documents, company practices, and records.

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