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ISO 9001:2015 – Module – II : Auditable Clauses in ISO 9001:2015
This module breaks down the core requirements of the ISO 9001:2015 standard, explaining each clause in detail.
Learning Outcomes: This module aims to familiarize learners with the structure and content of the ISO 9001:2015 standard, enabling them to understand the specific requirements for a QMS.
Clauses on Planning of the Quality Management System (Clauses 4-6):
Clause 4: Context of the organization:
As discussed in Module 1, this requires understanding internal and external issues. It also includes determining the interested parties (e.g., customers, suppliers, employees) and their requirements.
Clause 5: Leadership:
Top management must demonstrate commitment to the QMS by defining the quality policy, setting quality objectives, and ensuring resources are available. They are also responsible for assigning roles and responsibilities and promoting a culture of quality.
Clause 6: Planning:
This involves addressing risks and opportunities, setting quality objectives, and planning changes to the QMS. Objectives should be measurable, achievable, relevant, and time-bound (SMART).
Clauses on the Operation of the Quality Management System (Clauses 7-8):
Clause 7: Support:
This covers the resources needed to support the QMS, including people, infrastructure, environment, monitoring and measurement resources, organizational knowledge, competence, awareness, communication, and documented information.
Clause 8: Operation:
This deals with the actual implementation of the QMS processes. It covers operational planning and control, design and development, production and service provision, control of externally provided processes, and release of products and services.
Clauses on the Check & Act of the Quality Management System (Clauses 9-10):
Clause 9: Performance evaluation:
This involves monitoring and measuring the performance of the QMS, analyzing data, conducting internal audits, and holding management reviews.
Clause 10: Improvement:
This covers addressing nonconformities and taking corrective actions, as well as driving continual improvement of the QMS.
Lesson Summary: This section summarizes the key requirements of each clause and how they relate to each other, providing a holistic view of the ISO 9001:2015 standard.
