eLearning courses Norme ISO
Our eLearning training and refresher courses for professionals working in companies with a Quality Management System 9001 to the new edition of ISO 9001 2015.
Corsi sulle Norme ISO
What are ISO standards?
With the acronym ISO 9000 we identify a series of regulations and guidelines developed by the International Organization for Standardization (ISO - International Organization for Standardization) which define the requirements for the realization within a system organization. quality management, in order to conduct business processes, improve the effectiveness and efficiency and in the realization of the product and in the provision of the service, obtaining and increasing customer satisfaction.
What is ISO 9001 certification
ISO 9001 is a certificate or, as they say, a "brand" whose possession shows that the activities of the company reflect the minimum requirements of the ISO 9001 standard; in this way the end customer can have full confidence in the fact that the services and products placed on the market correspond to certain specifications and that all the phases relating to their realization are repeatable and verifiable. The adoption of ISO 9001 certification is not mandatory, but its possession is becoming an increasingly indispensable attribute to face the challenges of the market. By now in all public tenders in the state, in tenders and even in the awarding of important supplies, it is required to hold the ISO 9001 Certification.
What is ISO 9001 certification for?
ISO 9001 is in fact a regulation aimed at the continuous and constant improvement of the company, with the aim of optimizing the organizational structure. It is a strategic choice for companies that want to increase their production, reduce costs, become more aggressive on the market and increase customer loyalty. Many urban legends in circulation state that ISO 9001 certification is expensive and unable to offer tangible benefits to businesses. In reality the certification times are mainly linked to the size and complexity of the company that requires it and can vary from 3-4 months to a year. As for the costs, today there are numerous financing possibilities that can reduce the costs of ISO 9001 certification and give a hand in particular to small and new businesses.
What needs to be done to achieve the UNI EN ISO 9001 quality certification?
Here are all the steps necessary to achieve certification:
- investigate the requirements of the ISO 9001 standard or contact a consultancy company
- define a company organization chart specifying who will take on the role of quality system manager and management representative
- analyze all business processes (sales, purchases, production, design, maintenance, calibration of instruments, etc.)
- ensure that the business processes comply with the requirements of the standard
- define the procedures and work instructions that describe the processes related to the above point
- define all the necessary forms
- define the quality manual (it is the summary of all work procedures / instructions)
- carry out internal audits to make sure that the information on the procedure / work instructions corresponds to the company
- choose an accredited certification body (type DNV, IMQ, etc.) and define with the institution when to carry out the certification verification. Following verification by the certification body, if the verification has given a positive outcome, the company is awarded the quality certification; the certification is valid for three years, but annually the certification body will carry out maintenance visits.
What are the costs and timing for obtaining the UNI EN ISO 9001 quality certification?
Usually a medium-sized company to obtain ISO 9001 quality certification should take about 6 months with the help of an external consulting company. The costs to be incurred (apart from the cost of internal personnel that will be involved from time to time) will mainly be related to the use of a consulting company and the certification body.
What is the goal of an ISO 9001 quality system?
The objective of an ISO 9001 quality system is to ensure that the product supplied by the company complies with the specified requirements. The specified requirements are defined by the standard as the explicit and implicit expectations of the Customer.
How long is the ISO 9001 certificate
The ISO 9001 certification lasts three years and can be renewed by repeating the path described above. At the end of the three-year period, companies must activate some procedures to renew the ISO 9001 Certificate. These procedures are normally included in the control and audit works of the quality management system that are implemented every year and culminate in a small verification that is carried out. with the certification body also called "surveillance visit". This annual verification is implemented to prevent companies from putting the "quality" in a drawer and brushing it up after the certificate expires three years ago and to push companies towards "continuous improvement" and a continuous review of the quality management system. / p>
What is the new edition of ISO 9001: 2015?
On September 15, 2015, the new edition of the ISO 9001 standard was published; with news and changes from the previous edition. All companies already in possession of this certification, or who wish to introduce it into their organization, will be required to apply this new standard by adapting their internal organizational processes. Third party audits performed by certification bodies will still be performed according to the 2008 edition standard, up to 3 years from the date of publication of the 2015 edition standard. In fact, a transitional period of three years is expected during which companies they will be able to update their management system, but in order to plan and plan the resources and energies necessary to obtain the new certification in the appropriate time and manner, it is advisable to learn more about ISO 9001: 2015 immediately.
What are the main innovations of the ISO 9001 2015 revision compared to the previous 2008 edition?
- Restructuring of the standard according to the HLS (High Level Structure)
The ISO 9001-2015 standard has been restructured: the titles of the chapters, the sub-chapters, as well as the presentation of the clauses and paragraphs have been completely revised. Overall, this restructuring does not change either the foundation or the requirements of the standard. Nevertheless, if you look at it in detail, the shape has evolved to respect this new breakdown and the concatenation of the themes. With this new and common structure, the objective of ISO is to facilitate the integration of all or part of the various management systems for companies and organizations and to obtain a unified management system. It thus becomes easier for a company to include in its management system the elements of other standards that it considers relevant: elements of the ISO14001-2015 environmental standard and elements of the future ISO45001 standard on health and safety at work management.
- Risk management becomes a cornerstone of the standard
Risk management with a risk-based approach becomes a fundamental element of the revised standard: identifying risks, their qualification, their management. Quality is a result of proper risk management, which goes beyond the scope of the product or service offered: there can be no quality if you are not able to offer the customer, in the long term, a product or service compliant.
The risk has its opposite corollary: the opportunity. The ISO9001: 2015 standard also includes this concept of positive uncertainty. Obviously the concept of risk is an additional concept that does not replace the previous concepts at all. Instead, it integrates with them and completes them.
The commitment to quality through responsible and visible leadership is reinforced:
- the concept of "Management Representative" disappears altogether;
- the quality policy and the defined objectives must be aligned with the strategic guidelines;
- A decidedly open norm for the service industry
The restructuring of the standard has taken into consideration the evolution of the economy and companies. Initially structured for manufacturing and industrial activities, the ISO9001 standard was the victim of its success and many organizations from other fields of activity have taken it over.
The ISO9001-2015 revision accounts for this evolution and its updating , in the choice of vocabulary but also in the level of abstraction, simplifies the implementation for all sectors, including services.
- The quality manual is destined to disappear?
It is possible, but certainly not immediately, since the concept of a quality manual is very much rooted in the culture of quality. In fact, the revision no longer requires the certified organization to keep a quality manual up to date. But beware: despite everything, the need for documentation remains. It is always necessary to document, maintain and retain relevant information. A quality manual remains an element of possible response to this need, even if it is not the only one.
The objective of the standard is to take into consideration technological and ethical-social developments. The information is no longer structured, organized, managed, stored, diffused and accessible as 20 years ago when paper support reigned supreme.
This evolution also allows greater flexibility in the organization of companies. Now it will be possible to be in compliance with the standard also through flexible management, as long as this management is adequate to the requirements of the standard.
- The importance of the context of the certified organization and the beneficiaries
The standard contains two new points (4.1 and 4.2) that require a better consideration of the context of the organization: context analysis, identification of internal and external stakeholders to the organization and understanding of their expectations.
- Knowledge is a resource like any other
Once again, the ISO9001: 2015 standard adapts to the times. Knowledge has become a key element for the success of numerous projects and for commercial development. For a system to work, the subjects involved must be fully aware of their role, the new standard therefore requires:
- identify the knowledge necessary to carry out the activity correctly and achieve the objectives set;
- to ensure that knowledge is maintained, protected, made available when necessary in order to anticipate the needs of knowledge evolution and manage the risk of not acquiring it in due time.