Thamer James Blog

Governance, Risk & Compliance

Quality Consultant – Customer focus

The customer focus section within ISO9001: 2015 5.1.2 aims to address the needs of the customer of consumer purchasing goods or services. In the older versions of 9001 this important area was sadly missing, and the Standard was inherently...

Quality Consultant – Competence

The Standard section 7.2 relating to competence is relatively straightforward. In simple terms the organisation should determine the skills and knowledge for staff that have a bearing on the key activities of the organisation. The Standard is not...

Quality Consultant – Changes

Section 6.3 of ISO9001: 2015 requires the organisation to consider changes in a broader sense. In previous iterations of the 9001 series, changes would traditionally have been thought of as document and version control. In this clause the...

Quality Consultant – Understanding the organisation & context

Understanding the organisation and its context arises from the Annex SL model to simplify the use of management standards.  Previous versions of the Standard were not easily relatable to most organisations and did not assist with integration with other management...

Quality Consultant – The QA system & its processes

Quality Consultant This is an important clause 4.4 of ISO9001: 2015 as its intention is for the organisation to plan its quality system and processes and to define the interaction of those processes with other key support functions. This would include audit...

Quality Consultant – Risk & opportunities

Quality Consultant Risk and opportunity assessment are a welcome addition in the author’s view as it makes 9001: 2015 more business focussed. It helps address the issues facing the organisation. In the previous Standard preventive action used to...