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What is ISO 9001 Certification?

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When your business is “ISO 9001 Certified,” it means that your business has met the requirements of ISO 9001, which defines in the ISO 9001 Quality Management System.

ISO 9001 Certification evaluates whether your Quality Management System is appropriate and effective while ensuring that you identify and implement improvements.

What is ISO 9001:2015?

 Looking to find the latest ISO 9001 requirements? Well, they have changed considerably since the last version of ISO 9001. Creating, implementing, and maintaining your Quality Management Systems (QMS) is an important documentary requirement for any company. It formalizes the procedures and policies that promote the quality of products and services that a company provides.

One way to do this is to follow the ISO standard and gain ISO 9001:2015 certification.

The international standard that is known as ISO 9001:2015 gives a list of requirements for a system that determines that a company is able to provide international quality products and services consistently.

It also aims to improve the internal system of a company so that it is able to produce quality services and products while promoting a culture that is aimed toward growth and continuous improvement.

What is a Quality Management System (QMS)?

A quality management system (QMS) is a set of policies, processes, and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System.

What are the ISO 9001 Requirements?

The requirements of ISO 9001 are provided in QMS Standard in clause no 4 to Clause no 10. The key objective of ISO 9001 requirements is

  • Enhancement of Customer Satisfaction by the consistent supply of products and services which meets the customer requirement and applicable legal /regulatory requirement (if any).
  • Continual Improvement
  • Enhancement of Process and products performance
  • Adopting the Risk-Based Thinning
  • Apply the QMS Principles  

Mandatory requirements need to be complied with, while non-mandatory requirements may be submitted for documentation purposes. To be certified compliant with ISO 9001:2015, the following documents must be submitted.

ISO 9001 Mandatory Requirements — as such mandatory document’s requirement wording is not used in ISO 9001:2015 Standards.

The Classification of Mandatory or Non- Mandatory documents of ISO 9001:2015   can depend on the activities of the organization and it applicability.

But as a general business organization, the some of documents given below are the minimum requirements for QMS are given below as reference.

  1. Quality Policy and Objective
  2. Procedures of different processes/functions/ SOP
  3. Details of Process, Functions, interactions of Process
  4. Product Process Characteristic
  5. Monitoring and Measurement Criteria of product / Process
  6. Risk Analysis Record
  7. Monitoring measurement results
  8. Internal audit program
  9. Results of internal audits
  10. Results of the management review
  11. Results of corrective actions

Non-Mandatory Requirements — But Often Included

  1. Procedure for Determining the context of the organization and interested parties
  2. Procedure for addressing risks and Opportunities
  3. Procedure for competence, Training, and Awareness
  4. The procedure of equipment maintenance and measuring equipment
  5. Procedure for document and record control
  6. Sales Procedure
  7. Procedure for Design and Development
  8. Procedure for production and service provision
  9. Warehousing Procedure
  10. Procedure for management of non-conformities and corrective actions
  11. Procedure for monitoring customer satisfaction
  12. Procedure for internal audit
  13. Procedure for management review
  14. Monitoring and measuring equipment calibration records
  15. Records of training, skills, experience, and Qualifications
  16. Product/service requirements review records
  17. Record about design and development outputs review
  18. Record Design and development inputs
  19. Records of design and development controls
  20. Records of design and development outputs
  21. Design and development changes records
  22. Characteristics of product to be produced and service to be provided
  23. Records about customer property
  24. Production/service provision change control records
  25. Record of conformity of product/service with acceptance criteria
  26. Record of nonconforming outputs

To conclude, ISO 9001 outlines a set of quality standards that must be actively followed and maintained by any certified organization in order to ensure that everything coming in and out of the business is in tip-top shape for distribution.

While becoming certified with ISO 9001 Certification is not a legal requirement in order to run a company, it is highly recommended for the best possible business practices and results.

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