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ISO9001-2015 : How regulations have changed and why it matters for businesses

On 15th September 2005, the new edition of ISO9001 certification regulations was published. We shall take a look at the main news and changes.

ISO9001-2015 certification: what has changed for businesses?

All companies which already have this certification, or would like to introduce it in their organisations, will be obliged to apply this new

Azienda-certificata-Iso-9001

 standard, adapting their internal organisation processes. Third-party audits carried out by certification authorities will still be done following the regulations laid down in the 2008 edition, until three years from the date of the 2015 edition’s publication.

There will be a three-year transition period for companies to update their management systems. However it is advisable to start gaining knowledge of the new ISO9001-2015 certification as soon as possible in order to schedule and plan the resources and energies necessary to obtain certification within established time frames and methodology.

What are the main innovations of ISO9001-2015 compared to the previous 2008 edition?

1- Restructured standard according to HLS (High Level Structure)

The ISO9001 standard has been revised: the chapter titles, sub-chapters and presentation of the clauses and paragraphs have been completely reviewed. Ultimately the revision does not modify the foundation or the requirements of the regulation. However its form has evolved to respect the new organisation of information and the way the topics are linked. With this new structure, ISO intends to help companies and organisations integrate different management systems, bringing together their complementary aspects. It is now easier for a company to include elements of other regulations which they consider pertinent within their management system: from environmental regulation ISO14001-2005 to elements of the future ISO45001 regulation on occupational health and safety management.

2- Risk management becomes one of the standard’s cornerstones

Risk management with a risk-based approach, by which we mean risk identification, qualification and management,  is an essential element of the revised standard. Quality is the result of a correct risk management, and it goes beyond the boundary set by the product or service a company provides. Without long-term compliance of products and services, there can be no quality.

Risk is analysed like its opposite element, “opportunity”. The ISO9001-2015 standard also includes this concept of positive uncertainty. The concept of risk is obviously an additional concept which does not replace previous concepts, but on the contrary integrates and completes them.

3- Leadership

We can see a reinforced commitment to achieve quality through  responsible and visible leadership:03-ISO-9001-standard-presentation

  • the concept of “direction representative” has completely disappeared
  • quality policies and defined objectives must be in line with strategic orientation

 

 

4- This standard is clearly open to the service industry

The review has taken into account the evolution of the economy and of businesses. Initially geared towards manufacturing and industrial activities, ISO9001 was a victim of its own success, and a large number of organisations from other sectors took over.

This reviewed ISO9001-2015 accounts for this evolution and its update, both in terms of wording and of abstraction levels, and simplifies its implementation for all sectors including services.

5- Quality manual

The revised version no longer requires the certified organisation to keep an updated quality manual. However it is still necessary to keep some kind of documentation to maintain and preserve any pertinent information. The quality manual unequivocally remains the guide element.

The regulation’s aim is to consider technological and ethical and social evolutions. Information is no longer structured, organised, managed, preserved, shared and accessible in the same way it was 20 years ago, when hard copy files prevailed.

This evolution allows companies to have a greater flexibility for their organisation. From now on it will be easier for companies to comply to the standard through a flexible management, as long as it respects the standard’s requirements.

6- The importance of a certified organisation’s background and its recipients

The reviewed standard contains two new points (4.1 and 4.2) which require a better knowledge of an organisation’s background: background analysis, identification of the organisation’s internal and external interested parties, and an understanding of their expectations.

7- Knowledge is a resource like any other

Once more ISO9001-2015 adapts to changing times. Knowledge has become a key element for the success of projects and for commercial development. For a system to work, the interested parties need to be fully aware of their roles, so the new standard prescribes to:

  • identify the knowledge needed to carry out the activity correctly and achieve fixed goals;
  • make sure that knowledge is maintained and made available whenever necessary, to be able to anticipate the management requirements especially in terms of risk.

 

ISO9001-2015 Certification: Interviews with Inveco Group’s main figures involved

Andrea Girelli, MEng.

Deputy Quality Manager since 2014

I took over this important role to guarantee continuity for the work being accomplished for over ten years. The reviewed standard really needs to be regarded as a general opportunity and an overall stimulus to improve the company’s organisation. Although today the quality manual is no longer required by the standard, we will continue to use it because we always have done, and we think it is a dynamic document which can be useful for the life and organisation of our company.

Filippo Barbetti, MA

Quality Manager from 2006 to 2010, currently CEO of Inveco Group

Creating organisational procedures, editing the manual, and programming the stages of the project seemed to be an academic exercise to start with instead of a practical and useful activity for the company, and now these activities have turned out to be an actual managerial model. In line with the prescriptive changes, I firmly believe that drawing attention to any internal issues in a business should become an opportunity to make overall improvements in what the company offers.

Andrea Bonifazi

Consultant with Qualitas Srl, ISO9001 advisor for the Inveco Group

Back in 2006, the first year of Inveco’s certification, I discovered a company that was able to make the most of the opportunities that ISO9001 management system brought forward, both on a formal and an organisational level. Many of the original professional profiles are still included in Inveco’s organisation chart today, which is proof of their aptitude to change and their perseverance to reach goals established year after year.

 

 

 

 

Ilenia Pappafava


Quality Manager from 2010 to 2014, currently employed elsewhere

During the years I was responsible for Inveco Group’s quality, we doubled the standard procedures laid down by regulations with the aim of improving our business management in every respect.

 

 

 

 

Simona Dottorini

Head of Administrative Office, Supervisor and Controller of the Group since 2007

Thanks to our perseverance with applying ISO9001, the company has grown a lot; of course, working with formal and concrete procedures makes our job more difficult, however these difficulties should be seen not as a handicap but rather as an elevation of our professional level.

 

 

 

Vannia Cecchetti

Administration Manager of the Group since 2001

The administrative area of an international and multi-sectoral Group like Inveco cannot afford not to have a quality management system in line with the ISO9001 standards. The company’s whole administration, both of our clients and of our suppliers, follows established and consolidated rules and procedures.

 

 

 

 

Conclusions

In conclusion, the ISO9001 revision tends to identify the main element of adding value to the company and the services offered in a Quality Management System that reduces business risks.

INVECO HOLDING SPA, ISO9001 certified since 2006, has successfully applied the relative regulations in all the services we have been  providing for our structured and multinational clients who work in the industrial sector. Right from the start we have considered the quality management system a “guideline” for our general organisation system, going well beyond legal obligations and even implementing business procedures in areas where it is not required by the standard, for example in real estate management.