ISO 9001 is a quality management standard that outlines the requirements for a company’s quality management system.
For a novice Quality Engineer or QA-QC Manager, ISO 9001 terms can be extremely difficult. For example:
- What is meant by NCR?
- What is a Certification?
- What is Accreditation?
- What is OFI?
- Is a company is certified or accredited?
In this article I tried to cover important ISO 9001 points for a better clarity and understanding of these ISO 9001 certification terms.
Here are 25 key terms that are important to understand in the context of ISO 9001:
Quality management system (QMS)
Quality management system (QMS) – a set of policies, procedures, and processes used to ensure that a company’s products and services meet customer and regulatory requirements.
Customer – a person or organization that receives a product or service from a company.
Quality – the degree to which a product or service meets the customer’s requirements and expectations.
Quality policy – a statement that outlines a company’s commitment to producing high-quality products and services.
Quality objectives – specific goals that a company sets for improving its quality management system.
Quality manual – a document that outlines a company’s QMS and its policies and procedures.
Procedure – a document that describes how a specific task or process should be carried out.
Work instructions – a document that provides detailed instructions for completing a specific task or process.
Record – a document that provides evidence of the activities that have taken place within a company’s QMS.
Internal audit – a systematic and independent review of a company’s QMS to ensure that it is in compliance with ISO 9001.
Nonconformity – a deviation from the requirements of the ISO 9001 standard.
Corrective action – a process for addressing nonconformities and preventing their recurrence.
Preventive action – a process for identifying and addressing potential issues before they become nonconformities.
Management review – a regular review of a company’s QMS by management to ensure that it is meeting the company’s goals and objectives.
Continual improvement – the ongoing process of reviewing and improving a company’s QMS to enhance customer satisfaction and meet changing requirements.
Certification – the process of verifying that a company’s QMS meets the requirements of the ISO 9001 standard.
Certification body – an organization that conducts audits and grants ISO 9001 certification to companies.
Audit – a systematic and independent examination of a company’s QMS to ensure that it meets the requirements of the ISO 9001 standard.
An audit is a systematic process of collecting and evaluating information about an organization’s management system to determine its level of compliance with the standard by which the audit is carried out.
There are several types of audits, including financial audits, operational audits, and compliance audits. Financial audits are the most common type of audit, and they are typically conducted to assess the accuracy and reliability of an organization’s financial statements.
Operational audits are conducted to evaluate the efficiency and effectiveness of an organization’s operations, while compliance audits are conducted to determine whether an organization is in compliance with laws, regulations, and other standards.
Audits are typically conducted on an annual basis, although they may also be conducted more frequently depending on the size and complexity of the organization. The results of an audit are typically presented in a report, which is provided to the organization or individual being audited, as well as to any relevant regulatory agencies or stakeholders.
Lead auditor – a person who is trained and qualified to conduct audits of a company’s QMS.
Certification audit – an audit conducted by a certification body to determine whether a company’s QMS meets the requirements of the ISO 9001 standard.
Other Important ISO Certification Terms
ISO standard: A document that provides guidelines, requirements, or specifications for a specific product, service, or system. ISO standards are developed and published by the International Organization for Standardization.
ISO certification: A process by which an organization demonstrates that it meets the requirements of a specific ISO standard.
ISO certification is typically granted by an independent certification body, and it is intended to provide assurance to customers and other stakeholders that the organization is operating in a consistent and reliable manner.
ISO management system
ISO management system: A framework that an organization can use to manage its processes and activities in a way that meets the requirements of one or more ISO standards. Examples of ISO management systems include the ISO 9001 quality management system and the ISO 14001 environmental management system.
ISO audit: A process that is used to assess whether an organization is meeting the requirements of an ISO standard. ISO audits are typically conducted by independent auditors who are trained to evaluate the organization’s processes and activities against the relevant ISO standard.
ISO accreditation: A formal recognition that an organization, such as a certification body or testing laboratory, is competent to carry out certain activities in accordance with ISO standards. ISO accreditation is typically granted by an independent accreditation body.
How to apply for ISO 9001 Certification?
To apply for ISO 9001 certification, you will need to follow these steps:
- Determine your organization’s readiness for certification. This includes conducting a gap analysis to identify any areas where your quality management system (QMS) does not meet the requirements of the ISO 9001 standard.
- Develop and implement your QMS. This includes creating and documenting your QMS policies and procedures, and training your employees on how to follow them.
- Conduct internal audits of your QMS. This will help you identify any areas of nonconformity and take corrective action to address them.
- Choose a certification body. There are many organizations that are accredited to conduct ISO 9001 certifications. You will need to select one that is recognized by the relevant national accreditation body.
- Schedule and prepare for the certification audit. The certification body will conduct a thorough audit of your QMS to verify that it meets the requirements of the ISO 9001 standard. You will need to provide evidence of your QMS processes and procedures, as well as records of their implementation.
- Complete the certification process. If the certification body determines that your QMS meets the requirements of the ISO 9001 standard, you will receive your ISO 9001 certification. If there are any nonconformities, you will need to address them before you can receive your certification.
It’s important to note that the process of obtaining ISO 9001 certification can be complex and time-consuming, and it requires a significant commitment from your organization. However, the benefits of certification, including increased customer confidence, improved efficiency, and enhanced competitiveness, can make it well worth the effort.