ISO 9001:2015 Mandatory Documentation Requirements

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ISO 9001 2015 documentation: In ISO 9000 family, ISO 9001 is the only standard that requires a certificate. It is an internationally accepted, tried, and tested ISO standard that has provided a concrete Quality Management System (QMS).

We hope that you have already upgraded your quality management system to ISO 9001:2015 as the due date to transition to the updated version was September 15, 2018. If you haven’t upgraded yet feel free to Contact us for help.

ISO 9001 2015 Documentation: Busting the Myths

The term “ISO 9000 Certified” is an incorrect term sometimes being used in the corporate world. Another term is also being wrongly used such as “ISO Certified” because it does not indicate which ISO standard one is certified.

Only the term “ISO 9001 Certified ” means that an organization has fulfilled all the mandatory and non-mandatory requirements indicated in ISO 9001, which has been built on the foundation of ISO 9000 Quality Management System.

Benefits of ISO 9001 2015 Documentation

Let us take you to the ride to blockbuster benefits of ISO 9001:2015.

Risk identification and Opportunity Management

Identification of risks and minimizing it is one of an essential requirement of ISO 9001:2015. Seeking opportunities for improvement is another new way to improve one’s business through any means be it cost reduction, new products, or other innovative methodologies to manufacture the same or better product.

Continuous Improvement Cycle

The revised version of ISO 9001:2015 documentation will ensure that quality management has to be fully aligned and integrated with your business strategies related to your organization. Being continuous improvement cycle embedded in your organization’s management system has only aimed to make your organization a better workplace in every aspect be it machine safety, human safety, cost reduction, high productivity, waste control or employee engagement.

Emphasis on Leadership and Better Employee Engagement

ISO 9001:2015 has put particular stress for enhanced leadership involvement so that your team consisting of peers and your juniors, can feel more motivated and better employee engagement resulting in high productivity with more positive outcomes.

Basic Principles of ISO 9001:2015

Enlisted below are the principles of ISO 9001:2015:

1. Focus on Customer

The main emphasis of most businesses is to fulfill customers’ requirements and mostly aims for exceeding customers’ expectations. ISO 9001:2015 helps to integrate an organization’s goals and objectives to the latest market trends and customer demands to keep your business ahead of time.

2. Process-Based Approach

A process-based approach has been designed for those organizations who choose to work systematically, which means their documentation processes, methodologies, and compliance would fall under ISO 9001:2015 by fulfilling the standard’s requirements.

In a process-based approach, one must define quality objectives as most relevant and significant function with integrating quality management and its requirements. All organizations must comply with the processes and guidelines to perform tasks related to managing the quality of products and services.

3. Better Relationship Management with Third Parties

By the term “Third Party,” it is usually meant as suppliers/vendors and other business partners to enable better quality and more successful outcomes for both. One can make their relationships better with third parties with the help of healthy networking and by sharing goals and objectives, knowledge, and some business values that your business and their business share with each other. The success formula lies here is to pick and choose the right supplier for your business that can help your business flourish by executing improvement activities and setting benchmarks for other business partners as well.

4. Better Risk Management Methodology

Another highlighted focus point of ISO 9001:2015 documentation is to manage risks effectively. Seamless and safe business processes are what every business should aim for. Risk-based thinking is the segment of the preventive action approach. It can save you from many hazards that can lead to an asset or financial loss.

The methodology to manage risks as defined in ISO 9001:2015 determines the actual impact of risk and making its category, planning to address the risks involved, establishing and maintaining the processes to make operations risk free and enabling continuous improvement chain to address risks and identifying opportunities for improvement.

Mandatory ISO 9001 2015 Documentation

  • Scope of the QMS (clause 4.3)
  • Quality policy (clause 5.2)
  • Quality objectives (clause 6.2)
  • Criteria for evaluation and selection of suppliers (clause 8.4.1)
  • And, here are the mandatory records (note that records marked with * are only compulsory in cases when the relevant clause is not excluded):
  • Monitoring and measuring equipment calibration records* (clause
  • Records of training, skills, experience, and qualifications (clause 7.2)
  • Product/service requirements review records (clause
  • Record about design and development outputs review* (clause 8.3.2)
  • Records about design and development inputs* (clause 8.3.3)
  • Records of design and development control* (clause 8.3.4)
  • Records of design and development outputs *(clause 8.3.5)
  • Design and development changes record* (clause 8.3.6)
  • Characteristics of the product to be produced and service to be provided (clause 8.5.1)
  • Records about customer property (clause 8.5.3)
  • Production/service provision change control records (clause 8.5.6)
  • Record of conformity of product/service with acceptance criteria (clause 8.6)
  • Record of nonconforming outputs (clause 8.7.2)
  • Monitoring and measurement results (clause 9.1.1)
  • Internal audit program (clause 9.2)
  • Results of internal audits (clause 9.2)
  • Results of the management review (clause 9.3)
  • Results of corrective actions (clause 10.1)

Non-Mandatory ISO 9001 2015 Documentation

  • Procedure for determining the context of the organization and interested parties (clauses 4.1 and 4.2)
  • Process for addressing risks and opportunities (clause 6.1)
  • Procedure for competence, training, and awareness (clauses 7.1.2, 7.2 and 7.3)
  • Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
  • Procedure for document and record control (clause 7.5)
  • Sales procedure (clause 8.2)
  • Procedure for design and development (clause 8.3)
  • Procedure for production and service provision (clause 8.5)
  • Warehousing procedure (clause 8.5.4)
  • Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
  • Procedure for monitoring customer satisfaction (clause 9.1.2)
  • Procedure for internal audit (clause 9.2)
  • Procedure for management review (clause 9.3)

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