ISO 9001 Requirements
ISO 9001 Clauses
There are 10 clauses that ISO 9001 standard requires your organization to follow. The clauses are set to help in achieving continuous improvement in your Quality Management System (QMS). These are:
Introduction, Scope, References, Terms and Definitions
Planning
Performance Evaluation
Context of the organization
Support
Improvement
Leadership
Operation
These ISO 9001 certification requirements supported by Quality management principles helps in the successful implementation of an efficient quality management system in your company.
Clause (0 to 3) Introduction, Scope, References, Terms and Definitions
ISO 9001:2015 standard clause 0 to 3 provides foundational elements whose good understanding can help your organization to use the standard properly. They are not necessary for implementation but set up a solid basis for the standard. That’s why knowing them would be very beneficial.
Introduction: This clause gives you information regarding the standard, its purpose and benefits of implementing a Quality management standard.
Reference: Any normative references—external texts to which ISO 9001 refers for further information—are listed in this section.
Scope: This clause tells you what the standard covers and what it doesn't.
Terms and Definitions: The key terminologies used in the standard are defined in this section for clear understanding.
Clause 4 – Context of The Organization
ISO 9001:2015 Standard clause 4 specifies the objective and strategic direction of your organization in terms of quality. It addresses the following points:
Identifying the internal and external factors that influence your company's service quality.
Understanding your clients' demands.
Identifying stakeholders in your firm, such as employees, suppliers, and other interested parties.
Clause 5 – Leadership
The ISO 9001 standard emphasizes the senior management key role in an effective Quality management system. Therefore clause 5 of the standard requires the leadership to take responsibility for:
Development of Quality management system.
Discuss these policies and goals with the team responsible for quality management of the products and services.
Setting up the quality policies and goals.
The management of Annual reviews.
Clause 6 – Planning
Clause 6 focuses on proper planning with risk-based thinking as the best course of action for an effective quality management system. It should have proper measures for both risks and opportunities alike. According to ISO 9001 standard clause 6 a company must:
Document all the potential risks with their level of severity and chance of occurrence.
Incorporate strategies to maximize desired outcomes.
Make plans to avoid or lessen negative outcomes.
Clause 7 – Support
ISO 9001:2015 standard clause 7 states about the provision of adequate resources to operate an effective Quality management system. This includes offering resources for the following:
Robust infrastructure
Appropriate working conditions
Effective HR Management
Clause 8 – Operation
This section of ISO 9001:2015 defines the work that your organization must do to produce and supply items or services to its customers.
Your ISO 9001 processes will specify:
The specifications and quality objectives of your products or services
The monitoring, inspection or testing your company needs to ensure the quality of your products or services
The procedure manuals, paperwork, and tools your workforce will require to properly deliver products or services.
The rules for creating and storing your records.
Clause 9 – Performance Evaluation
Clause 9 of ISO 9001:2015 requires an organization to monitor its performance and record it to make sure:
It complies with ISO 9001 standard requirements
It is applied to all parts of the Quality management system
Continuous improvement is made in quality management of the organization
Clause 10 – Improvement
The final clause of the standard stresses on the culture of continuous improvement within an organization. According to Clause 10, actions shall be taken to:
Improve products and services for the benefit of the company.
Find instances where processes aren't meeting their objectives and make the necessary updates.
Boost customer happiness by meeting their demands successfully.
Frequently Asked Question
The 2008 revised version of ISO 9001 standard requires your organizations to address 5 key areas:
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis and Improvement
Not anymore. ISO 9001:2015 no longer demands a formal quality manual; nonetheless, maintaining documentation is still vital and can assist your organization.
You don’t need to worry about that. The gap analysis we conduct is for finding out which areas of your organization meet ISO 9001 requirements, and which needs improvement.
Continual improvement is an essential aspect of ISO 9001. It is a constant effort to identify and implement changes that will improve the effectiveness of your Quality Management System (QMS).
Planning to elevate your business with ISO certification