Are you ready for ISO 9001:2015?

With the scheduled release of ISO 9001:2015 three months away it is time to start thinking about the changes your QMS requires (if any) to comply.

The key areas of change in the new Standard are as follows:

  • Understanding the Organisations Operating and Stakeholder Context – this is a new requirement.
  • Understanding the Needs and Expectations of Interested Parties/Stakeholders – this is a new requirement.
  • Leadership – this is a new requirement.
  • Quality Risk Management – this is a new requirement.
  • Planning to Achieve the Quality Objectives and Planning of Changes – this is a new requirement.
  • Competence – now must relate to ‘Quality’ objectives.
  • Awareness – now includes contacted workers, volunteers.
  • Communication – now includes external communication.
  • Documented Information – new emphasis on learning organisation and knowledge management.
  • Production and Service Provision – this is an expansion on ISO 9001:2008 requirements (eg, documented information to specify intended results, and to determine the nature and extent of any post-delivery/after-sales activities [eg, including warranty (where applicable).
  • Monitoring, Measurement, Analysis and Evaluation – there is a new requirement to obtain information relating to customer views and opinions of the organisation.
  • Internal Audit – there is a new requirement for the Internal Audit Schedule to take customer feedback into account. Also, Internal Audit schedule will need reflect the risk to the business and audit higher risk areas more frequently than annually.
  • Management Review – there is an expanded requirements for management review of inputs or agenda
  • Nonconformity and Corrective Action – Specific reference to ‘preventive action’ has been removed.
  • ISO 9001:2015 now includes an additional requirement to record the nature of nonconformities. On discovering a nonconformity, an explicit requirement is introduced for organisations to determine whether other similar nonconformities actually exist, or could potentially exist.

 

If you would like to discuss the upcoming changes then don’t hesitate to contact us.