An Overview of ISO 9001:2015

ISO 9001:2015 is an international standard for establishing, maintaining, and implementing a Quality Management System (QMS). Introduced in September 2015, it is one of the most widely adopted standards. It provides a structured framework for enhancing quality and ensuring that goods and services consistently meet customer expectations and regulatory requirements.

A Quality Management System (QMS) includes all resources, processes, values, and assets that drive customer satisfaction and operational efficiency.

ISO 9001:2015 does not dictate an organization's objectives or methods but provides principles for improving efficiency, streamlining processes, and meeting regulatory requirements. It also helps organizations expand into new markets where ISO certification is a prerequisite.

---

What is the Fundamental Mission of ISO?

The core mission of ISO is to establish common specifications, standards, terminology, and units of measurement for organizations worldwide.

ISO does not provide certification or conformity assessment. Instead, it facilitates international trade and innovation, ensuring a common language and expectations across industries such as manufacturing, technology, food safety, agriculture, and healthcare.

ISO’s mission is built on the following key initiatives:

• Ensuring efficient operations and financial management within organizations.
• Increasing adherence to Good Standardization Practices (GSP) and evaluating process alignment with the World Trade Organization (WTO) Technical Barriers to Trade Agreement (TBT).
• Strengthening public policy and standardization by promoting best practices and thought leadership.
• Addressing risk management and sustainability in standardization projects.
• Encouraging collaboration with key stakeholders in all standardization efforts.

Why is ISO 9001 Certification Essential?

This certification provides your customers reassurance that you have set up a QMS based on the 7 management principles of ISO 9001. In fact, ISO 9001 is such a vital and significant standard that it is used as the foundation when industry groups desire to create their own industry standards; this includes ISO 13485 for the medical devices industry, and AS 9100 for the Aerospace Industry and so on.

A survey of this certification in 2017 tells that in spite of the global recession, the number of companies or entities that have implemented the ISO 9001 QMS still remains stable globally. ISO 9001 Certification for individuals is not a requirement of the standard, but this certification is the best method to get knowledge and competence regarding this standard.

What is QMS?

QMS or Quality Management System is defined as a set of interrelated or interacting elements to create policies, objectives & processes to achieve those objectives regarding quality. Quality Management System is part of the overall management system based on a business risk approach to operate, monitor, establish, review, implement, maintain & improve quality.

ISO 9001 2015 specifies requirements to implement, monitor, maintain, establish, plan, operate and continually improve a Documented management system used to manage quality. The requirements under ISO 9001 2015 are flexible, standard, and useful to all types of organisations. Hence, this standard aligned & united with other Management Systems such as Business Continuity Management, Energy Management and other management systems due to their identical structure.

The standardisation of Quality Management evolves with ISO 9001 2015 by adding:

• Greater importance on process approach, monitoring performance & metrics, and risk management
• Focus on interested parties
• Analysis of the context of the organisation required for ensuring quality improvement

Key Clauses of ISO 9001:2015

Below are the key clauses of ISO 9001:2015:

Clause 1: Scope
Defines the scope of ISO 9001:2015, outlining requirements for a Quality Management System (QMS) applicable to any organization.

Clause 2: Normative References
Refers to ISO 9000:2015, which provides fundamentals and terminology essential for applying this standard.

Clause 3: Terms & Definitions
Defines terminology used throughout the standard, sourced from ISO 9000:2015 (QMS – Vocabulary & Fundamentals).

Clause 4: Context of the Organisation
Organizations must align their business objectives with the QMS, identifying internal and external issues, interested parties, QMS scope, and processes.

Clause 5: Leadership
Top management must demonstrate leadership and commitment, establish and communicate a quality policy, and ensure that roles and responsibilities are assigned and understood.

Clause 6: Planning for the QMS
Covers QMS planning to address organizational risks, changes, opportunities, and quality objectives.

Clause 7: Support
Focuses on the resources required for the QMS, including competence, awareness, documented information, and infrastructure.

Clause 8: Operation
Covers the control and planning of processes needed to meet product and service requirements (e.g., design, development, production, service provision, external providers, and product release).

Clause 9: Performance Evaluation
Requires organizations to measure, monitor, analyze, and evaluate the QMS for continuous performance improvement.

Clause 10: Improvement
Focuses on continuous improvement, including identifying opportunities, corrective actions, and addressing non-conformities to enhance the QMS.

List of Vital Documents and Records Required by ISO 9001:2005

Following are some vital documents required for ISO 9001:2005 compliance:

• Scope of the QMS
• Quality objectives
• Quality Policy
• Criteria for evaluation & selection of suppliers

Mandatory Records

• Records of skills, experience, qualifications, and training
• Record of non-conforming outputs
• Product or service requirements review records
• Characteristics of product to be produced and services to be provided
• Records about customer property
• Internal audit program
• Results of the management review
• Results of corrective actions
• Monitoring and measurement review
• Record of conformity of product/service with acceptance criteria
• Production or service provision change control records

Other Mandatory Records (only when the relevant clause is not excluded):

• Monitoring and measuring equipment calibration records
• Records of design and development outputs
• Records of design and development inputs
• Records of design and development controls
• Records of design and development outputs review
• Design and development changes records
  
  

Non-Mandatory Documents for the Implementation of ISO 9001

These documents are not mandatory but are commonly used in the implementation of ISO 9001:

• Procedure for addressing risks and opportunities
• Sales procedure
• Procedure for internal audit
• Procedure for design and development
• Procedure for measuring equipment and equipment maintenance
• Warehousing procedure
• Procedure for document and record control
• Procedure for competence, training, and awareness
• Procedure for determining the context of the organisation and interested parties
• Procedure for production and service provision
• Procedure for management review
• Procedure for management of non-conformities and corrective actions
• Procedure for monitoring customer satisfaction

Procedure for a Company to Get ISO 9001:2015 Certified

For the company’s QMS to be certified, the implementation must first be completed. After finalizing the paperwork and implementing the processes, your company must perform the following steps to ensure a successful certification:

1. Internal Audit
   Conduct an internal audit to assess your QMS processes. The objective is to confirm that records are in place to demonstrate compliance with processes, and to identify problems and weaknesses that could otherwise remain hidden.

2. Management Review
   A management review is conducted to evaluate the facts regarding the management system processes in order to make appropriate decisions and allocate resources effectively.

3. Corrective Actions
   After the internal audit and management review, the root cause of any identified problems should be corrected, and documentation should be provided to show how the issues were resolved.

The certification process is further divided into two stages:

• Documentation Review: Auditors from the certification body will review your documents to ensure they meet ISO 9001:2015 requirements.
• Main Audit: During this stage, the certification body auditors will assess whether your activities align with both ISO 9001 and your documented processes, by reviewing documents, company practices, and records.

Fastzeal Support for ISO 9001 2015

• Purchase a Plan for Expert Assistance
• Add Queries Regarding ISO 9001 2015
• Provide required Documents to Fastzeal Expert
• Complete all Procedural Actions
• Get your work done