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ISO9001:2015 Quality Management System Certification


About ISO

ISO stands for International Organisation for Standardisation.

It is an international body based in Geneva, Switzerland and was formed in the year 1947. The organisation consists of representatives from over 160 countries. Each country is represented by its national standards body. For example, India is represented by the Bureau of Indian Standards.

ISO comprises more than 180 technical committees, covering many industrial sectors and products. These technical committees, as far as possible, try to address the requirements of the member countries while formulating their standards. It aims at harmonization of standards at the international level with a view to minimise trade and technical barriers. ISO publishes both product and system standards.

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ISO9000 Standards

ISO9000 is a series of standards for Quality Management System. While ISO9001 is meant for certification purpose, ISO9000 and ISO9004 provide vocabulary and guidelines respectively. The latest revision of the standard has taken place in September 2015. This latest edition (ISO9001:2015) replaces the ISO9001:2008 standard.

ISO9001:2015 is based on the new seven principles of quality management, and is modelled on 'process approach' and 'risk-based thinking'. It advocates the P-D-C-A (Plan-Do-Check-Act) cycle for continual improvement and customer satisfaction. The new standard also stresses on taking the organizational context into account while developing an organization's quality management system. Please note that ISO9001:2015 certification is for quality management system, and NOT a product certification scheme.

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Who can apply ?

Any legal entity having manufacturing / service operations can apply for ISO9001 certification. Manufacturers, Service Organizations, Trading Houses, Banks, Hospitals, Educational Institutions, Government Agencies, NGOs, etc. are eligible.

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Benefits of ISO9001 certificate

For Small and Medium Scale companies, which normally do not enjoy much of  brand image,  ISO9001 certification helps to build confidence in the minds of customer organisations. This is particularly true in case of  tenders and other contractual situations involving institutional buyers.

In India, where the Government is a prominent buyer, most of the public sector organisations have already started insisting on ISO9001 registration for vendor enlistment. In private sector also, the situation is not much different.

Other benefits of ISO9001 registration are:

  • Clarity in definition of authorities and responsibilities
  • Enhanced corporate image and market positioning
  • Better records and documentation in case of litigation
  • Use of recognized mark (of certifying agency) on stationary and advertisement
  • Reduction in the need for multiple second party assessments
  • Better traceability to root causes of quality problems
  • Rectification of errors at the earliest stage
  • No repetition of  errors

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Steps involved in ISO9001 certification

The steps involved in any ISO9001 certification project are the following:

  • Gap Analysis:  Assessment of  existing quality management practices vis-a-vis ISO9001 requirements.
  • Orientation Training:  Top/Senior Management orientation on ISO9001 requirements and action plans.
  • System Documentation: Preparation of quality manuals and design of quality record formats.
  • System Implementation: Implementation of quality system as per the quality manuals.
  • Company-wide Training: Training on ISO9001 clauses, Statistical Quality Control Techniques, Housekeeping (Japanese 5-S), and Quality Audit.
  • Internal Quality Audits: Periodic assessment of quality system implementation and corrective actions.
  • Pre assessment:  Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification.

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Major cost elements

There are three major cost elements  in any ISO9001 project. They are:

1. Cost of purchase/calibration of measuring instruments (if required)
2. Cost of training resources and fee to be paid to external consultants, and
3. Fee to be paid to the certifying agency.

The above costs depend on the size and complexity of  operations of the applicant company. In India,  for a small company having a manpower of around 20, with factory and office located in one place, the total cost falls in the range of  Indian Rupees 40,000 to 60,000 only. Yes, it doesn't cost so much as one might think.

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Choosing a consultant

Before deciding on your on-site / off-site ISO9001 consultant, please consider the following:

Formal Qualifications: 

As in the case of  medical / financial services, look for formal qualifications. At its minimum level, a graduate in science/engineering with additional degree/diploma in Quality Assurance and Management may be acceptable. (Today, there are many reputed institutions in India that conduct degree/diploma courses in Quality Management). Apart from knowledge of ISO9001, your consultant should have adequate knowledge of quality improvement techniques (SQC, SPC, Six Sigma, Design of Experiments, etc.).

Relevant Experience:

Your ISO9001 consultant should have at least three years experience of handling two to three ISO9001 projects independently or as the principal consultant. Avoid those with long experience in other fields and little exposure to ISO9001.

Professional Ethics:

Do not sign-up those ISO9001 consultants who claim to represent a particular certifying agency and/or offer package deals. Also, do not go with those document forgery experts who assure you the ISO9001 certification within ridiculously short time span (say, fifteen days). When you expose your personnel to such unethical people during project implementation, it would cause irrepairable damage to your organizational culture.

Please keep in mind that any organisation (big or small) with genuine commitment to quality and customer satisfaction can achieve ISO9001 certification without much difficulty.

Willingness to help in documentation:

Your ISO9000 consultant should prepare the first draft of at least the Quality Manual, Quality System Procedures, and Standard Forms for QMS record keeping. This would help in quick implementation of the system. (99.99% cases of  project dragging is due to incomplete documentation !)

Support till certification:

Get firm commitment from your consultant that he shall provide support till your company gets certified.

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Choosing a Certifying Agency

This job is also very important. Usually, your ISO9001 consultant suggests some reputed names. But, do not forget to ask your friends in the industry and verify the credibility of the certifying agency. As ISO9001 is more relevant in contractual situations, your customer can be well aware of the standard of certifying agencies. Although there are over 700 ISO9001 certifying agencies worldwide, only a few have good reputation !

Also, you must insist on signing the service agreement between the Certifying Agency and the Organization applying for certification and pay the audit fees directly to the Certifying Agency. Reputed certifying agencies do not sign-up or bill via a third party like a consulting / accounting / manpower placement agency.

Another point is regarding recognition of certification. In case your buyers are from a different country, it is better to select an auditing agency well recognized in the buyers' country.

Cost is yet another factor. Due to stiff competition, certification fee has come down a lot. However, there can be hidden costs like cost of flying down an auditor from a remote location. In that case, hidden cost can be more than certification fees. So, always go for a credible agency with sufficient number of auditors stationed locally.

BV, DNV, SGS, TUV, and UL are some of the reputed ISO9001 certifying bodies operating globally.

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Useful ISO9001 resources

The following products and services could be helpful in understanding the requirements, developing the system documents, implementing the system, and getting the coveted ISO9001:2015 certification:

  1. ISO9001:2015 Awareness Training Kit (Product Codes: M0003A / M0003B)
  2. ISO9001:2015 Implementation Kit (Product Codes: M0051A / M0051B or M0052A / M0052B or M0053A / M0053B)
  3. Management System Audit Training Kit (Product Codes: M0005A / M0005B)
  4. FBM Tools: Calibration Management module - a computer software for calibration tracking of measuring instruments & gauges and Measurement System Analysis (Product Codes: S0006A / S0006B)
  5. Project eConsulting Service for ISO9001:2015 Certification (Service Codes: C0021 / C0022)

Please visit our eShop to know more about these resources and to purchase them right away.

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