ISO 9001 2015 Certification
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Overview of ISO 9001:2015
ISO 9001:2015 is a globally recognized standard for developing, maintaining, and implementing a Quality Management System (QMS). Introduced in September 2015, it provides a framework for organizations to consistently deliver products and services that meet customer and regulatory expectations, fostering efficiency and satisfaction. A QMS under ISO 9001:2015 encompasses resources, culture, processes, and assets that support customer satisfaction and business effectiveness. The standard offers guiding principles for optimizing processes, meeting compliance requirements, and expanding into ISO-demanding markets.
Fundamental Mission of ISO
The core mission of ISO is to offer universal standards, specifications, and units of measurement to businesses worldwide. ISO promotes trade and innovation by ensuring all sectors operate under a unified framework. Key initiatives include enhancing organizational efficiency, promoting Good Standardization Practices (GSP), aligning with WTO TBT Agreement, connecting public policy with standardization, focusing on risk management and sustainability, and involving all relevant stakeholders in standard development.
Importance of ISO 9001 Certification
ISO 9001 Certification assures customers that your QMS is built on ISO’s 7 core management principles. It is widely used as a base for other sector-specific standards, such as ISO 13485 (medical devices) or AS9100 (aerospace). ISO 9001 certification remains stable worldwide, even during global recessions, and helps organizations gain in-depth knowledge and credibility.
What Is a Quality Management System (QMS)?
A QMS is a structured system of policies, objectives, and processes aimed at achieving quality goals. ISO 9001:2015 provides a flexible, risk-based framework to build, monitor, and improve your quality system. It is compatible with other ISO standards due to its high-level structure.
Enhancements in ISO 9001:2015
ISO 9001:2015 introduces enhancements such as an emphasis on process-based approaches and risk management, a focus on the needs of interested parties, and context analysis for quality assurance.
ISO 9001:2015 Certification Procedure
Step 1: Internal Audit
• Evaluate your QMS processes to ensure compliance.
Step 2: Management Review
• Leadership reviews system data to make informed decisions.
Step 3: Corrective Actions
• Address issues found during audits and document resolutions.
Certification Stages:
• Documentation Review – Certification body reviews compliance documents.
• Main Audit – On-site audit checks conformity of business operations and documents.
Do Startup Support for ISO 9001:2015:
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Listicles
Mandatory Documents for ISO 9001:2015 Certification
- QMS Scope
- Quality Policy
- Quality Objectives
- Supplier evaluation criteria
Mandatory Records for ISO 9001:2015 Certification
- Employee training, skills, and qualifications
- Non-conformance logs
- Product/service review records
- Internal audit program results
- Management review findings
- Customer property records
- Acceptance criteria documentation
Conditional Records (Clause-Dependent)
- Calibration logs
- Design & development records
- Equipment maintenance reports
Non-Mandatory Documents for ISO 9001:2015 Implementation
- Risk & opportunity management procedures
- Sales and warehousing procedures
- Internal audit and document control processes
- Competency & training guidelines
- Context assessment documentation
- Service provision and customer feedback processes
Clauses
Clause 1: Scope
The clause defines the scope of the ISO 9001:2015 standard and the scope of this standard comprises specifying requirements for a Quality Management System of any organisation.
Clause 2: Normative References
The supporting standard referenced in this standard is indispensable for its application is ISO 9001:2015, which covers fundamentals & terminology.
Clause 3: Terms & Definitions
Terminology used throughout this standard comes directly from ISO 9000:2015, QMS – Vocabulary & Fundamentals.
Clause 4: Context of the Organisation
When you are implementing a Quality Manual System, the 1st step is to align your business objectives & intent with the QMS. Know the external & internal issues, needs & expectations of interested parties, QMS scope & its processes.
Clause 5: Leadership
This clause covers leadership responsibility. Top management must demonstrate leadership & commitment, establish & communicate a quality policy and ensure effective implementation.