ISO 9001

What is ISO 9001?

ISO 9001:2015 is an internationally recognized quality management system (QMS) standard. It defines the requirements that organizations must meet to demonstrate their ability to consistently deliver products and services that meet customer requirements and applicable regulations. Certification to ISO 9001:2015 helps organizations improve product and service quality, increase operational efficiency, reduce costs, and enhance customer satisfaction.

Requirements of ISO 9001

The ISO 9001 standard outlines requirements for a quality management system aimed at improving organizational performance and increasing customer satisfaction. Organizations must understand internal and external factors affecting their operations and take into account the expectations of interested parties. Management commitment is required for the development of the QMS, including the establishment of objectives and communication of the quality policy. The organization should identify risks and opportunities, define quality objectives, and plan actions to achieve them. Key elements include ensuring appropriate resources, employee competence and awareness, and effective communication. Processes must be planned, monitored, and executed in a manner that meets both customer expectations and the standard’s requirements. Organizations are required to regularly monitor, measure, and evaluate the effectiveness of the QMS, conduct internal audits, and perform management reviews. Corrective actions must be taken, and the system must be continually improved to enhance overall effectiveness and efficiency. ISO 9001 is a universal standard that can be tailored to the needs of any organization, regardless of its size or industry sector.

How Does ISO 9001 Certification Work?

The ISO 9001 certification process with GCB involves 6 stages:

1. Initial contact with Global Certification Body. The organization completes an application form for certification and defines the scope of certification. Based on the provided information, GCB prepares an offer. Upon acceptance, a formal agreement is signed, and the certification schedule and scope are confirmed.
2. Two-stage certification audit process.
   1. Stage I – off-site audit. Review of the QMS documentation to determine the organization’s readiness for Stage II. A positive result is required to proceed.
   2. Stage II – on-site audit. Auditors comprehensively evaluate the documentation, including records, for compliance with ISO 9001 requirements.
3. Reporting. Nonconformities and areas for improvement are identified and reported to the client.
4. Corrective Actions. Verification of the corrective action plan submitted by the organization in response to identified nonconformities. Monitoring of the effectiveness of implemented actions.
5. Certification Decision. The decision to issue the certificate is based on the audit findings and the implementation of effective corrective actions (if any nonconformities were found).
6. Certification Maintenance. Regular surveillance audits are conducted to monitor continued compliance with ISO 9001:2015 and support continual improvement of the QMS.

How Long Does the ISO 9001 Certification Process Take?

The ISO 9001 certification process typically takes between 1 and 6 months (or longer), depending on the size and complexity of the organization, the scope of certification, the level of preparation, and the availability of resources.

Can ISO 9001 Help in Obtaining CE Marking?

ISO 9001 can support the CE marking process but is not a direct regulatory requirement. CE marking confirms product compliance with EU directives, while ISO 9001 focuses on the organization’s quality management system. Holding this certificate facilitates legal compliance, enhances process control, and improves the company’s credibility.

Does ISO 9001 Replace Other Certifications?

No, ISO 9001 does not replace other certifications but can complement them. It is a universal quality management standard that can be integrated with sector-specific standards, such as ISO 13485 for medical devices.

Risks Associated with Not Implementing ISO 9001

Risks associated with the absence of ISO 9001 include:

• Loss of competitiveness: Companies without certification may be excluded from tenders or rejected by clients with strict requirements.
• Lower operational efficiency: Lack of process standardization may lead to errors, delays, and resource waste.
• Quality issues: Without a QMS, customer dissatisfaction and damage to reputation become more likely.
• Higher costs: Unidentified process problems may lead to increased costs due to complaints, rework, or customer loss.
• Lack of regulatory compliance: In some industries, certification is mandatory, and lack thereof may hinder market access.