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ISO 9001:2015 Quality Management System

 

ISO 9001:2015 has been published on 15 September 2015.
 
The new version will be much easier to incorporate to more business management, and the documentation requirements are much less prescritive and left more to the organisation to judge their own operation needs.
 
in general, the standard is written to benefit the organisation, and the auditors are likey to be more challenging to understand and recognise the extend and the type of evidence that will be acceptable to ensure compliance to the new ISO 9001:2015 requirements.

SS590:2013, Singapore Standard for HACCP-Based Food Safety Management Systems – Requirements for any Organisation in the Food Chain.

 

This new Singapore Standard will replace the Singapore Accreditation Council (SAC) HACCP Document No. 2, which is the existing document for companies to attain HACCP certification in Singapore.  SAC will require all accredited Certification bodies to migrate the existing certifications of HACCP Doc. 2 to SS 590 by 10 Jan 2016.

Building Construction Authority – Specific registration requirements for

  • Construction Work-heads (CW)

  • Construction related Work-heads (CR)

  • Mechanical & Electrical Work-heads (ME)

  • Maintenance Work-heads (MW)

  • Trade Heads (TR)

  • Supply leads (SY)

  • Regulatory Work-heads (RW)

  • Transfer of Work-heads (TW)

ISO 14001:2015 Environmental Management System

 

ISO 14001:2015 has been published on 15 September 2015. 

 

Other key improvements in the new version include:

  • A greater commitment from leadership

  • An increased alignment with strategic direction

  • Greater protection for the environment, with a focus on proactive initiatives

  • More effective communication, driven through a communications strategy

  • Life-cycle thinking, considering each stage of a product or service, from development to end-of-life

 

The current standard (ISO 14001:2005) will be recognized and can be audited within the 3 year transition period. All certified Organisations need to transit to 2015 version before 15 September 2018.

 

ISO 45001:2018 – New occupational health and safety management standard

 

ISO recently announced that ISO Committee ISO/PC 283. Occupational Health & Safety Management Systems, has been formed with an objective to develop and publish an international standard for Occupational Health and Safety (OH&S) based on OHSAS 18001. The new standard will be known as ISO 45001. The publication expected on 12 March 2018, and all transition to be done by 11 March 2021.

SS 524:2014 and SS 600:2014 – Enhancement

 

The revised editions of the SS 524 and SS 600 been launched on the 15 October 2014 during the MPA event “Port of Singapore prepares for bunkering of the future”

 

The revised SS524 inline with the new developments of the international quality management systems and practices.

 

The revised SS600 emphasis better platform to provide greater transparency in the bunkering transactions which will enhance the customers’ confidence level within our Singapore’s bunkering industry.

SS 620:2016 Good Distribution Practice for medical devices - Requirement

 

This new Singapore Standard will replace the HSA TS-01 Version 2.1, it was approved by the Biomedical Standards Committee on behalf of the Singapore Standard Council on 13 Oct 2016, and First Published in 2017.

Transition Period

The relevant agencies (SAC & HSA) have stipulated the effective implementation of SS 620:2016 –
Good Distribution Practice for Medical Devices – Requirements from 9 November 2017 until 8 November 2020.

Therefore, companies certified to GDPMDS – TS-01 Rev 2.1 are given three years to transit to SS 620:2016.

 

Health Science Authority GN-33 (published in Oct 2017) - Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices

 

  • 0 - Introduction​

  • 1 - Scope

  • 2 - Normative references

  • 3 - Terms and definitions

  • 4 - Quality Management System

  • 5 - Management responsibility

  • 6 - Resource Management

  • 7 - Premises and facilities

  • 8 - Secondary assembly

  • 9 - Traceability

  • 10 - Counterfeit, adulterated, unwholesome or tampered medical devices

  • 11 - Complaint Handling

  • 12 - Field safety corrective action (FSCA)

  • 13 - Internal audit

  • 14 - Outsourced activities

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