Thamer James Blog

Governance, Risk & Compliance

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...

Quality Consultant – Organisational roles & responsibilities

Quality Consultant Section 5.3 of ISO9001: 2015 requires that an organisation seeking to implement the Standard should establish clear roles and responsibilities, in relation to the quality system and its scope. The author would advocate examination of the...

Quality Consultant – Organisational knowledge

This clause of ISO9001: 2015 section 7.1.6 examines a new specific area to the Standard, that of organisational knowledge. The definition of competence has often included the application of skills and knowledge, but this clause now requires greater focus. Many...