• English
  • German
  • Company
    • Profile
    • Consulting approach
    • Satisfied customers
  • Consulting
    • Explosion protection
    • Ex Installations
    • Quality Management
  • Ressources
    • Downloads and links
  • Contact
  • Alle Kennzeichnungen
  • Menu Menu
  • Xing
  • LinkedIn
  • DeutschDeutschGermande
  • EnglishEnglishEnglishen
Tel.: +49 (0)511 94 02 507   Mail: info@germersdorf-beratung.de

Quality Management

Quality management systems affect several processes, products and services worldwide.

Depending on the risk potential of the products, the requirement for “surveillance” (Audits) of the manufacturer often arises. This is then performed by a notified body (NoBo).

The ISO 9001 standard makes an important contribution to the CE conformity of products and services. For ATEX / IECEx manufacturers it can be understood as a starting point and is supplemented by the requirements of ISO 80079-34. Annex X of the Machinery Directive 2006/42 / EC also states that an effective Quality management System is justified.

In terms of product liability and associated risk minimization, an effective QMS is often indispensable.

Important items
  • Contribution of the QMS to CE conformity
  • Implementation of ISO 9001: 2015
  • Implementation of ISO 80079-34
  • Audit Program, Internal Audits, External Audits
  • QMS and the safe production of products
  • Appoint, empower and coach ex- authorities
  • Make documented information meaningful

Topics around quality management systems

ISO 9001:2015

This International Standard is based on the principles of quality management described in ISO 9000. The descriptions include a statement on each principle, a rationale for why the principle is important to the organization, some examples of policy benefits and examples of typical measures to enhance the organization’s performance in applying the principles.

The principles of quality management are as follows:

  • customer focus
  • leadership
  • inclusion of persons
  • process-oriented approach
  • improvement
  • evidence-based decision-making
  • relationship management

The current revision of ISO 9001 is the ISO 9001: 2015. A certificate is valid for 3 years.

ISO 80079-34 for ATEX/IECEx

This standard specifies requirements for a quality management system that can be used by an organization for the manufacture of ex-products and for ex-service. It may also be used by third parties, including certification bodies, to assess the organization’s ability to meet the system requirements conformity assessment and / or regulatory requirements.
The application of this standard is intended for both electrical and non-electrical equipment, protective systems, safety devices, ex- components and their combinations.
Quality requirements are an integral part of most certification systems and therefore this standard has been adopted against the background of IECEx system requirements (QAR), it is also intended to support the requirements of ATEX (QAN) and may be used in other national or regional certification schemes designed for the manufacture of ex-products and ex-service.

Documented information acc. ISO9001:2015

The following list should give you an overview of the 21 “Documented Information” required in ISO9001: 2015.

The standard sections can be found in the brackets:

  1. Scope of QMS (4.3)
  2. Process documentation (4.4)
  3. QMS-Policy (5.2.2)
  4. Information about quality targets (6.2.1)
  5. The suitability of resources for monitoring and measurement (7.1.5)
  6. The basis for calibration or verification (7.1.5)
  7. Proof of competence(7.2)
  8. Proof that the processes are carried out as planned (8.1)
  9. Results of the review of customer requirements.
  10. Confirmation that the development requirements and any development changes have been fulfilled (8.3.2, 8.3.6)
  11. Results of assessments, performance and re-assessment of external providers (8.4.1)
  12. Characteristics of the products and services provided (8.5.1a)
  13. Activities to be carried out and results to be achieved (8.5.1b)
  14. Information needed to maintain traceability where appropriate (8.5.2)
  15. Review of changes in production or service provision (8.5.6)
  16. Authorization of the release of products and services to the customer (8.6)
  17. Implemented measures regarding non-compliant process results, products and services (8.7)
  18. Proof of the results of the monitoring and control activities (9.1)
  19. Internal audit programs and audit results (9.2)
  20. Results of Management Review(9.3)
  21. Non-conformities and results of corrective actions (10.2)

Ex-Authority acc. ISO 80079-34

An Ex- authority acc. ISO 80079-34 with stated and documented responsibilities shall be appointed to ensure that the following requirements are met:

a) the effective coordination of activities with regard to ex-products

(b) cooperation with the notified /certification body responsible for issuing the Ex certificate (if not issued by the manufacturer) with regard to any intended changes to the design specified in the Ex certificate and the related technical file

c) cooperation with the person responsible for the quality management system assessment

d) the authorization of releases and changes to production drawings, if appropriate

e) the authorization of special releases (see 8.7 f)

f) the accuracy of the ex-product information given to the customer in sales information and installation instructions (which must include the specific conditions of use and restrictions)

g) the effective coordination of manufacturing processes of Ex products, including the externally provided products, services and processes listed in 8.4; For manufacturers with multiple manufacturing sites, an ex-authority with the appropriate responsibilities per site must be appointed.

Risk management

Meeting the requirements requires the organization to plan and implement actions that address risks and opportunities. The treatment of both risks and opportunities forms the basis for increasing the effectiveness of the quality management system, for achieving improved results and for avoiding negative effects.

Process-oriented approach

ISO 9001: 2015 requires a process-oriented approach of the organization.

In principle, it is possible to work according to the IPO model (input, processing, output). It makes sense to describe the main processes and divide them into support, core, and management processes. Recommendation: Process owners should now be determined.

Processes of ISO 9001

Context of the organization

The organization must identify external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended outcomes of its quality management system.

With regard to the ISO 80079-34 standard, the context of the organization must ensure that all Ex products comply with their certificate and technical documentation.

Interested parties

Due to their impact or potential impact on the organization’s ability to consistently deliver products and services that meet customer requirements and applicable regulatory and regulatory requirements, the organization shall identify the interested parties relevant to their quality management system and the requirements of those interested parties relevant to their quality management system. quality management system.

Get in contact!

I look forward to hearing from you.

Get in contact!

Contact

Tel.: +49 (0)511 94 02 507
Mail: info@germersdorf-beratung.de

Networks

Memberships

VDI Logo

Consulting areas

  • Explosion protection
  • Ex Installations
  • Quality Management
© Copyright - GERMERSDORF CONSULTING
  • Xing
  • LinkedIn
  • Privacy Policy
  • Imprint
Explosion protection
Scroll to top

This site uses cookies. By using our services, you agree that we set cookies.

OKMore

Cookie and Privacy Settings



How we use cookies

We may request cookies to be set on your device. We use cookies to let us know when you visit our websites, how you interact with us, to enrich your user experience, and to customize your relationship with our website.

Click on the different category headings to find out more. You can also change some of your preferences. Note that blocking some types of cookies may impact your experience on our websites and the services we are able to offer.

Essential Website Cookies

These cookies are strictly necessary to provide you with services available through our website and to use some of its features.

Because these cookies are strictly necessary to deliver the website, refusing them will have impact how our site functions. You always can block or delete cookies by changing your browser settings and force blocking all cookies on this website. But this will always prompt you to accept/refuse cookies when revisiting our site.

We fully respect if you want to refuse cookies but to avoid asking you again and again kindly allow us to store a cookie for that. You are free to opt out any time or opt in for other cookies to get a better experience. If you refuse cookies we will remove all set cookies in our domain.

We provide you with a list of stored cookies on your computer in our domain so you can check what we stored. Due to security reasons we are not able to show or modify cookies from other domains. You can check these in your browser security settings.

Google Analytics Cookies

These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.

If you do not want that we track your visit to our site you can disable tracking in your browser here:

Other external services

We also use different external services like Google Webfonts, Google Maps, and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.

Google Webfont Settings:

Google Map Settings:

Google reCaptcha Settings:

Vimeo and Youtube video embeds:

Other cookies

The following cookies are also needed - You can choose if you want to allow them:

Privacy Policy

You can read about our cookies and privacy settings in detail on our Privacy Policy Page.

Datenschutzerklärung
Accept settingsHide notification only