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The **ISO 9001:2015** standard is one of the most widely recognized international Quality Standards. It defines the core requirements a business must operate under to ensure its products and services are consistently of high quality and reliable.
The ISO 9001:2015 standard is one of the most widely recognized International Quality Standards. It defines the basic requirements a business must operate under to offer quality services to its clients.
The Quality Management System is based on seven fundamental principles:
Systematic control is exercised over the implementation processes of products or services. It ensures they are continuously offered in the expected manner, while simultaneously meeting customer needs and requirements.
Our company provides comprehensive services regarding Management Systems (ISO), from the design and development of the System to its certification by an accredited Body via ESYD. We undertake:
The Investment Center provides Full Support
at all stages for the successful acquisition of a certification.
By acquiring an ISO 9001 Certification, a significant competitive advantage is created, contributing to benefits such as:
The Investment Center, acting as business consultants for over a decade, provides complete and comprehensive support, from the 1st eligibility check and the assessment of necessary prerequisites to the implementation of an excellent System that will improve processes and secure your Certification from any Body.
The systems we develop are flexible, user-friendly, and above all, automated. They adapt to the specificities of each business individually, helping them optimize their organization and operation, without burdening the staff with time-consuming and bureaucratic procedures.
The ISO 9001 standard is the most widespread quality management standard, which sets the requirements a business must operate under so that the final product or service meets the expectations of stakeholders. It is the only quality management system certification standard that is suitable for all types and kinds of organizations.
The International Organization for Standardization (ISO) started in 1947, while ISO 9000 began in 1987 with strict standards and production procedures for businesses. Its evolution constantly follows an improvement path (Evolution of ISO 9000 standards) as the ISO organization continuously introduces improving changes to the standard's versions.
The introduction of ISO 9001 took place in 1987 due to the American military/defense industry. In businesses, it aimed at total quality management in manufacturing companies (industry - manufacturing), focusing on specific processes.
The first revision (1994) aimed at "proactive" measures instead of "checking" standards. Thus, emphasis was placed on monitoring and controlling all stages of product/service creation and not just the final stage. The result was the introduction of preventive actions to preempt situations. A high bureaucratic cost emerged due to compliance with guidelines combined with forms and manuals.
The second revision (2000) attempted to simplify the acquisition procedures with drastic changes. By involving management in the process, performance and efficiency indicators were added. Requirements for customer satisfaction feedback became clear. Efficiency improved at all levels of an organization, making continuous business improvement achievable.
The third revision (2008) brought clarifications and minor improvements primarily aimed at ensuring compatibility with ISO 14000:2004. No new requirements, conditions, or changes were introduced that would significantly affect the nature of the requirements.
The most recent change to ISO 9001 (2015) aims to create a High-Level Structure for all ISO standards. It was further simplified by reducing bureaucracy and focusing on performance. The goal is continuous evolution over time and globally. The new version introduces Risk, Strategic Planning, and Leadership, adapting the Standard to current and future developments so that it maintains its validity for at least a decade.
The ISO 9001:2015 Standard is the revised version of ISO 9001:2008, designed to be more responsive to the modern market and global trends. New requirements have been incorporated, such as risk assessment and Management, Risk Analysis, and implementation tools are utilized.
The main changes in the new version of the standard include:
New High Level Structure.
Integration into a single structure for all management systems (High Level Structure) as they share certain common core elements. To harmonize the structure and presentation of all relevant standards, a structure with an identical chapter layout, texts, terms, and definitions for all management standards has been developed and applied.
Risk-Based Thinking.
Risk Assessment is particularly important for any type of organization, and therefore the risk-based approach is introduced. Businesses identify threats and opportunities, considering future situations when designing the quality management system, without requiring separate actions for preventive measures.
Improvement of customer satisfaction.
The new version requires the determination and measurement of necessary input and output data for each process related to monitoring, controlling, and measuring processes for Consumer behavior (Key Process Indicators - KPIs).
The Concept of Interested Parties.
The business should not only consider legal requirements and Customer Satisfaction. The variable of Interested parties is also taken into account, concerning relationships with employees, partners, suppliers, and other related parties, as well as financial organizations, the local community, and competitors.
Management responsibilities and the absence of a representative.
The assignment of roles and responsibilities requires a clear recognition of management's responsibility. The role of the quality manager is assumed by one or more members, and management's responsibility extends to Leadership, Strategic Planning, etc.
Flexibility regarding documents.
Each organization can now decide what it wishes to document and to what extent, while documented information is now required instead of documents or evidence (records). This makes document and record management much easier.
Emphasis on Services.
The New Edition focuses more on the needs of businesses and organizations that provide Services, beyond the Products that applied until now. ISO 9001:2015 focuses on the service sector, which aligns with the trends and needs of the global market.
Focus and Emphasis on measurement indicators (KPIs).
Further focus is placed on criteria for defining indicators, evaluating the results of measurements and monitoring, and assessing whether the processes achieve optimal results.
With ISO certification, Businesses and Organizations can document that their products, services, processes, and systems comply with national or international standards and regulations.
ISO 9001 certification demonstrates an organization's ability to consistently meet and exceed customer expectations. At the same time, reducing costs and maintaining competitiveness are critical parameters for business sustainability.
A business achieving ISO 9001 certification is capable of realizing significant improvements in organization, efficiency, and product quality by minimizing defects and increasing productivity.
Many buyers require suppliers to be ISO 9001 certified to minimize the risk of purchasing low-quality products or services.
In brief, the benefits for a business resulting from a documented ISO 9001:2015 Quality Management System are:
The approach for the effective development of Management Systems consists of the following key parts:
Phase A: Mapping of the Current Situation.
Phase B: System Development.
Phase C: System Implementation - Staff Training.
Phase D: Completion - internal audit report.
In summary, the above phases include the following:
A detailed further analysis of the methodology is available here.
The time required for the Development and Certification of a Quality Management System varies for each business. It depends on the size, the involvement of stakeholders (employed personnel), combined with the level of organization/readiness and in relation to the degree of compliance with current legislative requirements.
The average estimated time ranges from 1 - 2 months, provided there is no significant process complexity and the Accredited Body will conduct an Audit within a short timeframe.
Annual Certificate Renewal
Following a successful audit, the business receives the relevant Certificate, proving that the requirements of the Standard are met, and that the Business has the organizational structures, means, and trained personnel to ensure a consistent level of quality in the Products and/or Services it offers.
The validity period is 3 years, during which the respective Accredited Body conducts annual surveillance audits to verify the full and continuous implementation of the certified company's Management System.
This ensures the ongoing compliance of the respective Business with the reference standard and proves that it has established, maintains, and implements a Management System that complies with the requirements.
Obtaining certification under an ISO standard involves the following:
The necessary preparation at the operational level includes all the support for submitting the study for Audit and Inspection by an Accredited Body of the Ministry. The Study consists of documents (electronic or physical forms), which describe how a business covers the requirements of ISO 9001.
Consulting Support includes all necessary services for a business to be certified:
The cost for Consulting Support is annual and recurring (scaled to lower prices from year to year) and depends on the size of the Business, with the main factors being the number of employees and the number of facilities.
The Certification Body, as an independent entity, will conduct the audit to grant the Certification Certificate. The certification body, as an accredited organization, conducts an audit every year, with a fixed annual cost (per annual audit).
It is necessary for the Certification Body to be accredited by the Hellenic Accreditation System ESYD, otherwise, the Certifications are not Approved Standards. The Certification Body must obligatorily be accredited by the Hellenic Accreditation System ESYD, so that each Audit leads to an Approved Certification Standard.
Within the requirements of a standard, unforeseen costs may arise regarding interventions, such as, for example:
To obtain an ISO Standard Certificate, a business will need to be successfully audited to demonstrate full compliance with the respective standard. The audit is conducted by specially authorized certification bodies that have been licensed and correspondingly audited by the state.
Certification bodies are usually private organizations originating domestically or, in some cases, from abroad. Indicatively mentioned as public organizations are ELOT, and the Agricultural Products Certification and Supervision Organization (OPEGEP).
Additionally, there are active private companies representing public organizations as well as foreign organizations such as TUV (Germany), Lloyds (England), SGS (Switzerland), ABS (America). Finally, there are Certification Bodies accredited by respective foreign bodies (UKAS, DGA, COFRAC) which are also recognized in Greece through mutual recognition agreements (MLA - agreements).
In the Greek market, all Accredited Bodies are monitored by the Hellenic Accreditation System (ESYD). A complete list of private and public Certification Bodies accredited by ESYD is available on the website www.esyd.gr. The Certification Body must obligatorily be accredited by the Hellenic Accreditation System ESYD, for the respective Audit to lead to an Approved Certification Standard.
Compliance certificates are accredited by the Hellenic Accreditation System (ESYD) and by Accreditation Bodies of the International Market, making them valid and recognized internationally.
The Investment Center, acting as business consultants for over a decade, provides complete and comprehensive support, from the 1st eligibility check and the assessment of necessary prerequisites to the implementation of an excellent System that will improve processes and secure your Certification from any Body. More information at **2108028330**, **2118505001**, (info@kei.gr).
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