ISO 9001 Quality Management System


ISO 9001 is an internationally recognized standard, which can be applied / implemented to any production or services industries. This standard can be uniformly applied to organizations of any size or description.It was drawn up by the International Organization for Standardization (ISO), with an intent to set international requirements for Quality Management System.

The focus of the standard is to streamline the business processes for the better performance and sustainability of the business. This standard is utilized to standardize the processes in all the industries by organizations to exhibit their capacity to consistently provide products and services that meet client and regulatory prerequisites and to show continuous improvement, it does not characterize an item’s quality.

The 2015 version is a 10 clause structure and has adopted P-D-C-A cycle, risk-based thinking and requirement to determine context of the organization. Besides this, the new version of the standard excludes requirements for preventive actions, quality manual, management representative.

ISO 9001 is a procedure based standard that one can use to control the processes, rather than the finished products meeting the desired results. There are different other standards such as ISO 15378, IATF 16949, AS 9100 etc. which also cover ISO 9001 requirements in addition to sector specific requirements.

Evolution of ISO 9001 and Revision History

Year 1987 – Publication of ISO 9000 series if standards
Year 1994 – 1st Revision of the standard (20 clauses and 20 required procedures)
Year 2000 – 2nd Revision of the standard (8 clauses and Process approach introduced)
Year 2008 – 3rd Revision of the standard (Minor revision for clarification of words)
Year 2015 – 4th Revision of the standard (10 Clauses and Risk assessment included)

Applicability (Which organizations can avail ISO 9001 certification)

  • Manufacturing units
  • Service sector including Educational institutes, Hospitals and other service providing units
  • Trading units
  • Any other business units irrespective of nature of business, size and location.

Focus Points – ISO 9001:2015 Implementation

  • Streamlining and Standardizing the business processes
  • Formulating Quality Policy and Objectives
  • Setting up system for documentation and records.
  • Management information system
  • Risk management for the business
  • Business performance and sustainability

Benefits of ISO 9001:2015 implementation

  • Business process streamlining and efficiency improvement
  • Satisfaction and Retention of Valuable Customers
  • Responsibility and Accountability across the organization
  • Elimination of non-value-added activities from the system
  • Good Marketing Tool and Credibility in Overseas Business.
  • Better sustainability prospects

ISO 9001:2015 Implementation Process by PQSmitra

PQSmitra adopts a result oriented approach for the effective system implementation at the organization. The simple and practical method of system implementation help organizations to enhance the business performance and sustainability. PQSmitra offers 100% documentation support to achieve successful certification in addition to enhanced business performance. The implementation process is described below:

  • Initial visits and review of the existing system
  • Gap analysis and planning for the documentation (Records and Procedures)
  • Training and Hand holding/ support for implementation
  • Internal audit for verification of implemented system
  • Management review
  • Certification audit – Stage 1
  • Certification audit – Stage 2
  • Closure of non-conformities
  • Rewarding the certificate to the organization

ISO 9001:2015 Reference Standards

  • ISO 9000:2015 – Quality management – customer satisfaction – Guidelines for complaint handling in organizations
  • ISO 9004:2018 – Quality management – Quality of an organization — Guidance to achieve sustained success
  • ISO 10002:2018 – Quality management – customer satisfaction – Guidelines for complaint handling in organizations
  • ISO 19011 – guidelines for auditing management systems

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