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You have already heard that a change of standard is imminent, but you do not yet know when this will have to take place? On this page you will find an overview of the current transition periods. You have not yet changed over or still have open questions? We will be happy to get in touch with you. Please send us an e-mail to: info.tncert@tuev-nord.de 

Management Systems

Further information on the changeover:

From ISO 9001:2008 to ISO 9001:2015

Organisations which were certified to ISO 9001:2008 before had a three-year transition period up to 14 September 2018 in order to change their certificates to the current version of the standard.

Important changes in the revised standard:

• Introduction of the High Level Structure

• Considering the strategic focus of the organisation (context of the organisation, stakeholder analysis)

• More process orientation

• Extension of the responsibility of the top management with regard to commitment and involvement

• "Risk-based approach" (analysis of risks and opportunities)

• Control of outsourced processes, products and services

• Systematic knowledge management

Further information on the transition can be found on the dedicated page for ISO 9001.

From ISO 14001:2004 to ISO 14001:2015

  

The period for transition to ISO 14001:2015 ended on 14 September 2018. Organisations which were certified to ISO 14001:2004 before had time until this date to change their certificates to the current version.

Important changes to the revised standard:

• Introduction of the High Level Structure

• Considering the strategic focus of the organisation (context of the organisation, stakeholder analysis)

• Extension of the responsibility of the top management with regard to commitment and active involvement

• "Risk-based approach" (analysis of risks and opportunities)

• Consideration of the whole life cycle when determining significant environmental aspects

• Compliance obligations

• Systematic knowledge management

• Measuring environmental performance using indicators (KPIs)

• Continual improvement of the environmental Performance

Further information on the transition can be found on the dedicated page for ISO 14001.

From ISO/TS16949 to IATF 16949

For many years ISO/TS 16949 acted as the internationally-recognised quality management standard in the automotive industry. Now it has been replaced by the new standard IATF 16949. Certificates according ISO/TS 16949 which were not changed over by 14 September became invalid on 15 September 2018.

As IATF 16949 is adapted to quality management standard ISO 9001, it has the High Level Structure which guarantees greater consistency between the various management system standards.

Further important changes:

• Requirements for responsibility of the organisation

• Safety-relevant parts and processes

• Traceability of products

• Products with integrated software

• Warranty management processes (including No Trouble Found - NTF)

• Supplier management and development

Further information on IATF 16949 can be found here

From IRIS to ISO 22163

After ten years in use, worldwide acceptance of the respected non-governmental Railway Industry Standard (IRIS) has now been officially confirmed. In May 2017 the new international standard for quality management systems in the railway industry, ISO/TS 22163:2017, was published. Organisations which were previously certified to IRIS Rev. 02 had to change their certificates to the new standard by the end of the transition period on 14 September 2018.

Important changes to the standard:

• Introduction of the High Level Structure

• Greater emphasis on process approach

• More consideration of interested parties

• Customer satisfaction, awareness and feedback

• The requirement for “Documented information”

Further information on ISO/TS 22163 can be found here.

 

 

From ISO EN/AS 9100:2010 to ISO EN/AS 9100:2016

Organisations which were certified to ISO EN/AS 9100:2010 had time until 14 September 2018 to change their certificates to the 2016 version.

Important changes to the standard:

• Introduction of a High Level Structure

• Greater flexibility of documentation

• Stronger focus on product safety and safeguarding against counterfeit parts

• More intensive consideration of risks

• Introduction of knowledge management

Further information on ISO EN/AS 9100 can be found here.

From systemQM to systemQM2.0

Following the revision of ISO 9001:2015 the systemQM versions were also modified. The transition period ended on 14.09.2018.

The new versions are based on the terminology and structure of the revised ISO standard. This means that there is no problem with combination with the BAR requirements, like before. The clauses of systemQM 2.0 follow those of ISO 9001:2015 but place more emphasis on rehabilitation.

Further information on certification can be found here.

KRITIS (Critical Infrastructures): End of implementation period for Sector Basket 2

According to the Act on the Federal Office for Information Security (BSI Act), operators of critical infrastructures must in future guarantee a minimum level of IT security. This can be achieved by means of an inspection according to §8a BSI Act or if appropriate by certification based on ISO 27001 which, depending on the sector in question, has to be completed by means of sector-specific additions.

After organisations from the 1st basket of sectors had to demonstrate a minimum level of protection by May 2018, the implementation period for the 2nd basket will end on 30.06.2019. By this date corresponding evidence in the area of IT Security has to be provided by the transport, health and finance and insurance sectors.

MAAS/BGW and ISO 9001:2015

Based on revised standard ISO 9001:2015, the management requirements of the BGW (German Professional Association for Health Services and Welfare) regarding occupational health and safety were modified. The change to the standard is followed by a one-year transition phase up to 14 September 2019. By that time, certificates issued after 04/2013 have to be changed over to the new version.

The new MAAS-BGW follows its own system and aims at review and evaluation of the core requirements in the area of occupational health and safety. In the same way, MAAS-BGW 06/2017 contains detailed explanations and notes on the documentation and also a glossary with the most important concepts in the area of occupational health and safety.

From BS OHSAS 18001 to ISO 45001

For many years, British Standard BS OHSAS 18001 was the basis for certification of an internationally recognised occupational health and safety management system. This standard will now be replaced by the new International Standard ISO 45001. Existing certificates according to OHSAS 18001 will become invalid on 11 March 2021 following a three-year transitional period. This period offers organisations sufficient time within the framework of a recertification or surveillance audit to transition to the new Standard ISO 45001 and to successfully implement the changed requirements.

Major changes in the new standard relate to:

• Introduction of the High-Level-Structure

• Context of the organisation

• Leadership and commitment

• Consultation with and participation of employees

• Opportunities resulting from occupational health and safety

We recommend that you get to know the new requirements and start the transition as soon as possible. Further information on ISO 45001 can be found here.

From ISO 50001:2011 to ISO 50001:2018

The new version of ISO 50001 appeared on 21 August 2018.

Already 18 months after publication of the new version – in other words as from 21.02.2020 -certification bodies are not allowed to perform audits according to the old standard ISO 50001:2011!

This applies to certification audits and also surveillance and recertification audits.

Certificates according to the “old” standard ISO 50001:2011 will expire at the latest on 21.08.2021 or will be withdrawn!

Important changes in the revised standard:

• Introduction of the High Level Structure

• Strategic focus of the organisation (Context of the organisation, stakeholder analysis)

• Extension of the responsibility of the top management with regard to commitment and active contribution

• “Risk-based approach” (Analysis of risks and opportunities)

• Determination and analysis of energy data

• Continual improvment of energy performance

More detailed information on the revised version of ISO 50001 can be found here.

Further information on certification to ISO 50001 can be found here.

Food

Further information on the changeover:

GMP+ rearranges unannounced audits

The unannounced audits in the form of a supplementary audit opened up the possibility for manufacturers to obtain parallel recognition for other animal feed safety systems. GMP+ will offer this option only until 15 November 2019. Thereafter, additional audits will no longer be possible. If you want to have other animal feed safety systems recognised, you will have to switch to the unannounced audit programme.

This change will allow you to keep the recognition to be able to deliver into other animal feed safety systems. However, the consequence of the unannounced audit programme is that the surveillance audit is replaced by an unannounced surveillance audit. Please inform us in good time if such an unannounced surveillance audit is to be carried out in your current certification cycle. You also have the option of specifying 15 days in each calendar year on which the audit shall not be performed.

Basically, GMP+ International will introduce the unannounced audits for companies with manufacturing application areas (GMP+ B1 and GMP+ B2) for Germany and the rest of Europe. The target date for the implementation of unannounced audits in Germany is 31 December 2019. For the rest of Europe, the deadline is extended to 31 December 2020.

Update FSSC 22000 Version 5

The FSSC 22000 version 4.1 will be changed to the new FSSC 22000 version 5 in order to meet the requirements of the also newly published ISO 22000:2018 standard, the GFSI and the decisions of the FSSC stakeholders. According to information provided by the FSSC, the new version 5 will be published on the FSSC website from May 2019 onwards.

Audits after version 4.1 may only be carried out until 31 December 2019.The transfer to FSSC 22000 Version 5 has to take place between 1 January 2020 and 31 December 2020.

After 29 June 2021, all certificates issued according to the old version lose their validity.

For the changeover, one of the planned surveillance and recertification audits will be carried out as an upgrade audit. This will usually be an announced audit. If you wish, the upgrade can also be carried out as an unannounced audit. If you would like to make use of this option, please contact us at foodcert@tuev-nord.de.

For the upgrade audit no additional audit time will be calculated. Please be so kind as to inform all locations within your FSSC 22000 scheme.

More information can be found on the homepage of the standardowner under: http://www.fssc22000.com/documents/news-items/requirements-for-the-fssc-22000-v5-upgrade-process.xml?lang=en We will be happy to answer any questions you may have.

Upgrade on ISO 22000:2018

The new version of ISO 22000:2018 has been in publication since 19 June 2018. By 18 June 2021, all ISO 22000 certificates must have been converted to the new version. Companies that are certified according to ISO 22000:2005 have three years time to upgrade their certificates.

Many requirements remain the same within ISO 22000:2018 but some new requirements are added. The High-Level-Structure is implemented and a stronger focus on the context of the company. In order to ensure full consideration of risk-based thinking in the food industry, the old ISO 22000:2005 has been extended by two new clauses to a total of 10. The new requirements are given in clauses 4 to 10. The implementation of these clauses is mandatory, while the provisions of clauses 1 to 3 are not examined and are not part of the requirements. The new definitions, such as e.g. for action criteria, validation and verification, provide for a clearer formulation of the standard. Greater emphasis is also placed on prevention.

Final Version 6 of FAMI-QS published

The final Version 6 of FAMI-QS was published on 12 October 2018, and is now switching over to the high level structure of the ISO standard. Risk-based thinking and a dedicated process approach are now becoming the focus of the standard. A corresponding article on risk-based thinking can be found in our latest newsletter.

The transitional phase spans 3 years, and has begun with the date of first publication of Version 6, which took place on 2 October 2017. The transitional phase thus ends on 1 October 2020. The validity of FAMI-QS certificates following Version 5.1 will then expire. 

With the new version, unannounced audits are now additionally implemented in the standard – both for manufacturers and for dealers. Under these rules, one unannounced audit must be included in each certification cycle of 3 years. Version 6 can be accessed on the homepage of FAMI-QS (www.fami-qs.org). Here you can learn about the details of the changes.  

Starting on 1 March 2019, companies that have already been certified must request a new approval letter from the FAMI-QS administration. The changeover to Version 6 must take place within the framework of a recertification, at the latest by 1 October 2020. Based on current planning, we will be able to issue certificates under FAMI-QS Version 6 starting in April 2019. 

Medical Products

Further information on the changeover:

From ISO 13485:2003 to ISO 13485:2016

Companies that have been certified according to ISO 13485:2003 have a transition period until March 1, 2019 to convert their certificates to the current version. Otherwise they will lose their validity from 01.03.2019. 

Significant changes to the revision concern:

  • Scope
  • quality management system
  • Management responsibility resource management product realization
  • Design and development
  • Procurement
  • Production and service provision
  • Control of recording and measuring equipment
  • Measurement, analysis and improvement

Further information about MDSAP can be found here.

From ISO 13485:2012 to ISO 13485:2016

Companies that are currently certified according to EN ISO 13485:2012 have a transitional period until 31 March 2019 to convert their certificates to the current version. Otherwise they will lose their validity from 31.03.2019. 

Significant changes to the revision concern:

  • Scope of application
  • quality management system
  • Management responsibility
  • resource management
  • product realisation
  • Design and development
  • procurement
  • Production and service provision
  • Control of recording and measuring equipment
  • Measurement, analysis and improvement

Further information about MDSAP can be found here.

From ISO 13485:2003 MDSAP to ISO 13485:2016

Companies that are certified according to ISO 13485:2003 - MDSAP have a transition period until March 1, 2019 to convert their certificates to the current version. Otherwise they will lose their validity from 01.03.2019. 

Significant changes of the revision concern:

  • Scope of application
  • quality management system
  • Management responsibility
  • resource management
  • product realisation
  • Design and development
  • procurement
  • Production and service provision
  • Control of recording and measuring equipment
  • Measurement, analysis and improvement

Further information about MDSAP can be found here. https://www.tuev-nord.de/index.php?id=23701

From ISO 13485:2003 under CMDCAS to ISO 13485:2016

Companies that have been certified according to ISO 13485:2003 under CMDCAS have a transitional period until December 31, 2018 to convert their certificates to the current version. Otherwise they will lose their validity from 01.03.2019. 

Material changes in the audit concern:

  • Scope of application
  • quality management system
  • Management responsibility
  • resource management
  • product realisation
  • Design and development
  • procurement
  • Production and service provision
  • Control of recording and measuring equipment
  • Measurement, analysis and improvement

Further information about MDSAP can be found here.

From ISO 13485:2016 under CMDCAS to ISO 13485:2016

Companies that have been certified according to ISO 13485:2016 under CMDCAS have a transitional period until December 31, 2019 to convert their certificates to the current version. Otherwise they will lose their validity from 01.03.2019. 

Significant changes of the revision concern:

  • Scope of application
  • quality management system
  • Management responsibility
  • resource management
  • product realisation
  • Design and development
  • procurement
  • Production and service provision
  • Control of recording and measuring equipment
  • Measurement, analysis and improvement

Further information about MDSAP can be found here.

We are looking forward to your inquiry

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