Methodology followed

▲ Methodology followed for Company Certification.

The approach for the effective development of Management Systems consists of the following key parts:

✔ Initial diagnosis, Mapping, and Evaluation of the Current Situation.

✔ Identification of deviations from the standard's requirements.

✔ Design and Development of the System's procedures.

✔ Preparation of Procedures, Work Instructions, and Other Forms for Implementation.

✔ Training and guidance of personnel for the implementation of procedures.

✔ Consulting support up to the acquisition of the certificate.

✔ System Inspection and Certification for 3 years.

Further analyzing the followed Methodology, it is described in the following individual stages:

1. Definition of processes, procedures, and policies of the Quality Management System

As ISO Quality Management systems such as 9001:2015 do not provide a specific list of procedures, the company determines the most appropriate structure with the help of the Consultant.

• Internal training
• Performance evaluation of Management & Personnel
• Production Process Analysis – logistics
• Outsourcing / Process assignments
• Customer Management
• Supplier Management
• Complaint Management
• Information Management
• Equipment Management
• Risk Identification & Management
• Certification Body Requirements

2. Assignment of roles and responsibilities for each procedure / policy

The appropriate roles are assigned, ensuring proper communication between departments with the aim of:

• Participation of management & employees in the creation of the System
• Training participants in their roles & responsibilities
• Control over the procedures (not the operations)
• Provision of documented information
• Confirmation of the correct operation of procedures

3. Identification of risks and planning of mitigation measures

Risk identification is achieved through monitoring and measuring the performance of procedures. Subsequently, measures are designed for mitigation or prevention.

Preventive action is a critical element for quality assurance and requires the timely identification of all potential risks.

4. Design and Development of Quality Management System

It includes the creation of documentation (Manual, Procedures, Instructions, Forms) in a clear, simple, and practical manner.

• Quality Management Manual
• Instructions, Procedures & Policies
• Updating relevant forms & documents

5. Internal Audit according to ISO requirements

It includes auditing all areas of the Quality Management System:

• Audit of Manual implementation
• Correct operation of procedures & processes
• Recording of deviations & improvement opportunities

6. Support during the Certification process

Full support is provided until the issuance of the certificate by an Accredited Body. It includes corrective actions and resolution of deficiencies.

In case of observations, we undertake all necessary corrections prior to the audit.

7. Continuous support of the Quality Management System

After successful certification, we continue to support the operation of the System:

• Monitoring the correct operation of the System
• Support during Surveillance Audits
• Support during Recertification Audits