ISO 9001

What is DIN EN ISO 9001?

ISO 9001 is an international standard for quality management systems (QMS). It defines the criteria for a QMS and is based on the Plan-Do-Check-Act (PDCA) model, which ensures continuous improvement in organisations.

The standard is based on the High Level Structure (HLS) and therefore shares its structure with standards such as ISO 14001 (environmental management), ISO 45001 (occupational health and safety), ISO 50001 (energy management) and ISO 22301 (business continuity management). This facilitates the combination and integration of these standards into a common management system.

Who is it for?

ISO 9001 is intended for organisations of all sizes and in all sectors. It is aimed at companies that want to optimise their quality processes and increase customer satisfaction. Suppliers often use it to fulfil customer requirements. Internationally operating companies use the standard to build trust worldwide. It is also relevant for companies taking part in tenders, as certification is often favoured or required.

How is the ISO 9001 standard structured?

ISO 9001 focuses on the process-orientated approach, whereby the involvement of top management is central. It emphasises the consideration of risks and opportunities and strives for continuous improvement. The standard includes sections such as organisational context, leadership, planning, support and operation to ensure an effective quality management system.

Overview of the standard structure:

• Introduction: Explanation of the background and objectives of the standard.

• Scope: Defines the scope of the standard.

• Normative references: Reference to other relevant standards.

• Terms and definitions: Clarification of key terms.

• Context of the organisation: Understanding the external and internal issues that affect the organisation.

• Leadership: Role of leadership and commitment.

• Planning: Identifying risks, opportunities and environmental aspects.

• Support: resources, competences, awareness and communication.

• Operations: Planning, control and implementation of processes.

• Performance assessment: monitoring, measuring, analysing and evaluating.

• Improvement: non-conformities and corrective actions, continual improvement.

Fundamentals of ISO 9001:

• The standard emphasises the importance of a "process-oriented" approach.

• It requires organisations to consider legal and other requirements.

• It promotes the integration of quality management into the business strategy.

What is QMS certification to ISO 9001?

QMS certification to ISO 9001 confirms that an organisation meets the quality standards of the ISO 9001 standard. It is awarded by an independent certification body and shows that the organisation places value on quality and customer satisfaction. It is an internationally recognised seal of quality.

Here is a brief explanation:

• Confirmation: Fulfilment of ISO 9001 quality standards.

• Independent audit: By an external certification body.

• Quality focus: Emphasis on processes and customer satisfaction.

• Internationally recognised: Global seal of quality.

How does ISO 9001 certification work?

• 1. preparation: The organisation carries out an internal review to ensure that all ISO 9001 requirements are met. This may include training, internal audits and process adjustments.

• 2. selection of a certification body: The organisation selects an accredited certification body to carry out the audit.

• 3. on-site audit: The certification body conducts an on-site audit to verify compliance with the ISO 9001 requirements. This includes interviews, document reviews and possibly observations of work processes.

• 4. report and corrective actions: After the audit, the certification body issues a report. If non-conformities are found, the organisation must take corrective action.

• 5. issuance of certificate: If all requirements are met, the certification body issues an ISO 9001 certificate.

• 6. surveillance audits: In order to maintain the certificate, regular surveillance audits are required to ensure that the organisation continues to meet the requirements.

• 7. recertification: Full recertification is usually required every three years.

This process ensures that organisations not only comply with ISO 9001 requirements at the time of certification, but also continue to do so in the long term.

BFMT's experts have the necessary qualifications and expertise to certify your QMS to ISO 9001.