Maintain Documented Information in ISO 9001:2015

Alex Woods offers a guide to the documented information requirements in ISO 9001:2015. One of the more eagerly discussed differences between ISO 9001:2015 and its predecessor is the absence of the terms “documents” and “records”. The six mandatory documented procedures are gone, so too has the requirement for a documented quality manual. Instead, throughout the…

Brief Information about Changes in ISO/DIS 45001

Colin MacNee analyses the latest developments on ISO/DIS 45001 and finds some significant changes have been introduced. The Draft International Standard, ISO/DIS 45001 occupational health and safety management systems – Requirements with guidance for use, has been published for ballot and comment. There are significant changes from the second committee draft (CD 2). Annex SL High…

Role and Responsibility of Top Management in Quality Management System

Top Management in QMS In our latest dilemma, Chris Achillea, UK Head of Compliance at Integral, UK, explains how the quality managers can encourage senior teams to take the ownership and more responsibility for their management system(s).  Dilemma The QMS manager for a national service delivery organisation has scheduled a formal quarterly management review meeting…

Adopting Strategic Audit To Improve Audit Quality

Strategic To Improve Audit Quality Hadi El Cheikh, Quality Health and Safety Executive at Veolia Water Technologies, Middle East, explains how a strategic approach can lead to a more successful audit on the assessment day. Most of us will still remember the times when the third-party auditor(s) came and met the quality management representative to…

ISO 9001 Approach – Prioritize Actions Taken To Address Risks And Opportunities

David Finney, CQP MCQI, founder of The Energy of Conversation and trainer in coaching and auditing, shares his top tips for problem solving, while meeting the requirements for ISO 9001:2015. I’ve been training professionals in coaching and auditing skills for many years. When I discuss internal issues arising in business I constantly come across the…

Understanding The Requirement, Challenges And Benefits of ISO 9001:2015 Transition

Challenges And Benefits of ISO 9001 Antonis Louloudis, CQP MCQI, head of SWISS APPROVAL/TUV Rheinland-North Hellas Branch, Greece, tells Andrew Holt that effective ISO 9001:2015 transition is about embracing the standard’s philosophy. Antonis Louloudis, CQP MCQI, is head of SWISS APPROVAL TECHNISCHE BEWERTUNG SA/TUV Rheinland representative office at the North Hellas Branch in Thessaloniki, Greece,…

Why is Transition ISO 9001:2015 Required

Transition ISO 9001:2015 CQI interim head of membership services Richard Green explains why ISO 9001:2015 transition is important for quality professionals. ISO standards are the result of international, expert consensus and the CQI contributes towards the revision process in a detailed way. As a result, the standards offer the benefit of global management experience and good practice. These…

Context of The Organization in ISO 9001 And ISO 14001

Context of Organization in ISO 9001 And ISO 14001 John Hartill looks at how quality professionals should address the organisational context requirements of ISO 9001 and ISO 14001. Understanding the organisation and its context is a new requirement within Annex SL-based revisions to ISO 9001:2015 and ISO 14001:2015. This is a ‘shall determine’ requirement, indicating…

Understanding Quality Policy for Effective Auditing in ISO 9001:2015

Quality Policy for Effective Auditing in ISO 9001:2015 Andrew Holt examines how ISO 9001:2015 sets out the development and communication of the quality policy and what this means for auditors. It is in sub-clause 5.2.1 of ISO 9001:2015 that sets out the requirements of top management in respect of the organisation’s quality policy. Top management…

Managing An Audit According to ISO 19011 Guidelines

Managing Audit According to ISO 19011 Guidelines Richard Green explains the fundamental changes to ISO 19011:2011 ISO 19011:2011 provides guidance on auditing management systems. It identifies the principles of auditing and provides advice as to how to manage an audit programme and conduct management system audits. It additionally advises on the evaluation of the competence…