The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality management system.
This ISO 9001:2015 version follows the new high-level structure and comprises ten sections:
Scope
Normative references
Terms and definitions
Context of the organisation
Leadership
Planning (including Risk Analysis)
Support
Operation
Performance evaluation
Improvement
How can you prepare?
Organisations that have established management systems should familiarise themselves with the changes and subsequently upgrade their management systems accordingly in 2015.
There will be a three-year transition period during which both the old and the new standard will apply in parallel. However, within the scope of certification, organisations should not leave the upgrade until the very end of the transition period. It is recommended that organisations upgrade their systems to the new standard at an early stage within the scope of a regular re-certification audit.
About CMS:
Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:
Australian ARTG registration/sponsorship/consultancy (medical devices/medicinal products)
Implementation and maintenance of Management Systems (TGA/MDD/ISO 13485/Sterilization/ISO 9001)
Management Systems audits – (TGA/MDD/ISO 13485/Sterilization/ISO 9001)
3rd Party Notified Body Certification Audits (MDD/ISO 13485/ISO 9001/ISO 22716)
Quotations for ISO Certificate Transfer (can be transferred at surveillance audit)
Risk Management
Continuous improvement including Corrective/Preventive Action
Validation including (Process/Equipment Qualification/Sterilization)
Machinery/Equipment commissioning/installation and troubleshooting
Complaint handling
Process Improvement using Lean Six Sigma methodologies