ISO 9001:2015 QMS Implementation – Consultancy Programme

ISO 9001:2015

Since the introduction of the first edition of ISO 9001 standard in 1987, minor and major revisions to the standard have alternatively happened every 7-8 years. The standard tries to adapt based on changes in the business world as the requirements change. As the world has become smaller, the supply demand requirements are seeing a lot of transformation. Keeping pace with the requirements, the latest 2015 edition focuses more on performance than documentation.

Some of the salient features introduced in this edition includes a higher level of emphasis on the involvement from the leadership with ownership and change being accounted at every level of the organisation for an effective management system to be followed. The strategy driven approach of an organisation has been integrated into the QMS thereby driving an alignment towards a common goal with the end customer in mind. Risks and opportunities towards attainment of the common strategy are now part of the QMS by adopting an approach that has constant evaluation, using a PDCA methodology. This is encouraged using a risk-based thinking technique for operational and audit requirements.

This edition also brings in a greater level of harmonisation between the safety and environment management systems in terms of the structure to the clauses thereby creating more opportunities towards having an integrated management system using a framework that is easy to navigate, apply and derive benefits.

Hierarchy of Quality Management System Documentation

  • Level 1- Quality Manual: The QM is not a mandatory document; however, it helps encapsulate the QMS flow in an organization thereby providing any stakeholder an opportunity to understand the structure of the organization, the business process and how the different processes interact within each other including references to procedures.
  • Level 2- Procedures: The different procedures that describe how each activity is performed within the organization and also ensuring the procedures satisfy the requirements of the ISO 9001:2015 standard based on the applicable clauses. This is a key document that establishes the relationship of who, why, what, when and where in an organization by including key elements for references.
  • Level 3- Work Instructions: These are referenced to procedures and provide in depth information on how an activity is done. This document provides details of what needs to be realized and covers step by step information, the use of tools, the expected output and the acceptance criteria.

Phases for ISO 9001:2015 Quality Management Standard

Phases Type Objective
Phase 1 Plan To plan for a proper understanding of what is required from ISO 9001:2015 and the existing systems in place to set up a foundation
Phase 2 Design and Structure To put in place a strong and simple QMS foundation that is easy to use and simple to follow
Phase 3 Develop To develop day to day use documents based on RACI chart for activities that impact the effectiveness of the business management system and customer satisfaction
Phase 4 Implement To put to action all captured requirements of business processes that effectively convert systems into practices using a closed loop of employee participation
Phase 5 Audit To ensure company is prepared prior to certification audit through pre-assessment audits (emphasis on ISO 9001 clauses)
Phase 6 Sustain To find out extent to which current system complies with the new documented QMS