What is ISO 9001 Requirements?
Meaning of ISO 9001
ISO 9001 requirements consist of a set of standard elements that will guide you in the implementation of a
Quality Management System (QMS).It has ten sections (also called ISO 9001 clauses) with supporting subsections (clauses). Sections 0 to 3 serve as the basic introduction and allow readers to have an insight into what Quality Management System QMS) entails. The requirements to be applied to your quality management system (QMS) are covered in sections 4 to 10 and you must fulfill the requirements in order to successfully implement ISO 9001. So ISO 9001 is seen as an essential part of food safety which could affect your brand’s recognition.
The objective of the ISO 9001 requirements are designed according to a certain standards and is applicable to any company in every industry encompassing both production and service line. Different industry will require different methods of application and hence the requirements in ISO 9001 only tells what elements are mandatory in a QMS, but it’s up to each industry and business to decide how to implement these necessary elements.
Breaking down briefly on Sections of ISO 9001
Section 0: Introduction
This section introduces the purpose, principles and key concepts of the standard including risk-based thinking and process approach.
Section 1: Scope
This section outlines the scope of the standard including specifying requirements for a QMS of any organization.
Section 2: Normative References
This section covers the terminology and fundamentals for complete and smooth standard application.
Section 3: Terms and Definitions
This section shows the terminology extracted from ISO 9000:2015, Quality management systems – Fundamentals and vocabulary.
Section 4: Context of the organization
This section delves into the identification of external and internal issues, the needs and expectations of interested parties, quality management system scope and its processes.
Section 5: Leadership
This section emphasizes the role of top management to demonstrate leadership and commitment, establish and communicate a quality policy, and ensure responsibilities and authorities are assigned, communicated and understood.
Section 6: Planning
This section explains the Organizational Quality Management System Planning to address organizational risks, opportunities, changes and quality objectives.
Section 7: Support
This section deals with providing resource needs, ensure competency of employees and their awareness, and include documented information to support your quality management system.
Section 8: Operation
This section pinpoints the structured plan and control processes needed to meet the requirements for products and services (Design and development, external providers, production and service provision, release of products and services, nonconforming outputs)
Section 9: Performance Evaluation
This section stipulated the process of monitoring, measuring, analyzing, and evaluating your quality management system.
Section 10: Improvement
This section guides users on seeking opportunities for improvement, take essential actions against nonconformities, implement corrective actions when necessary, and continually improve your quality management system
That said, implementing the standard requirements to ensure the collection of policies, procedures, processes and records meet the needs of the company and their customers while allowing for improvement of the system is not an easy process but an important one. Let Magcolm Solutions help you and your business to implement QMS together as it benefits the company in the long run.
