How to get ISO Certification in India- A step by step approach to get ISO certification.

ISO is the family of standards for Quality Management System. A standard is a benchmark that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are often treated as strategic tools that reduce costs by minimizing waste and errors, and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.

ISO has over 19,500 standards touching almost all aspects of daily life; therefore
consumers can have confidence that they are safe, reliable and of good quality.

There are various benefits of grabbing an ISO certificate some of which include:

i. Cost savings – International Standards help optimise operations and therefore improve the bottom line

ii. Enhanced customer satisfaction – International Standards help improve quality, enhance customer satisfaction and increase sales

iii. Access to new markets – International Standards help prevent trade barriers and open up global markets

iv. Increased market share – International Standards help increase productivity and competitive advantage

v. Environmental benefits – International Standards help reduce negative impacts on the environment

The Certification process shall consist of the following key stages:

a. Deciding upon the need of ISO:

First of all an entity need to establish an actual requirement of ISO certification. ISO
has over 19,500 standards out of which relevant one need to be selected.

The organization need to prepare documents or Standard Operating Procedures which meet the requirements of the ISO quality standard. The quality documentation says what you do, how you do it, and provides proof that you do it. It is necessary to demonstrate that quality is improving significantly.

Staff should be suitably trained to ensure they are capable of carrying out their job
function. The records of past experience, education and training must be kept to
identify their capabilities. Future training requirements can then be implemented
together with any new skills that may be needed as the business evolves.

b. Certification body:

A certification body, also known as a Registrar, is a third-party organization
contracted to evaluate the conformance of your organization’s management system to the requirements of the appropriate standards and issue a certificate of conformance when warranted.

Make sure your registrar is well-established and its name is known and recognized in the marketplace. The cost of the Certification body’s services will depend on the size and complexity of the organization; the scope of Quality Systems Update (QSM) registration and the number of locations to be included.

c. Fee of Certification body:

The cost of the CB’s services will depend on the size and complexity of your
organization; the scope of QMS registration and the number of locations to be included.

It is better to ask CB’s to provide details of application fees; administration fees;
accreditation mark fee; fees for documentation review, pre-assessment audit,
certification audit; all surveillance audits during the three-year cycle and any travel
and related expenses. Clarify what are essential and optional services.

Check below link for Authorised Certifying Boday in India:

d. Certification Audit:

The number of auditors needed, and the time involved to conduct a registration audit
will vary according to the size and complexity of organization. During an ISO audit, the auditor examine records and talk with staffs. So, properly trained and orderly staffs are very important.

There are two stages of audit in ISO Certification- Stage 1 and Stage 2.

Stage 1 audit which is conducted before the Certification audit at client’s option to
provide a macro level assessment of the status of implementation and identification of any major deficiencies in the compliance of the documented quality system with the requirements of the certification standards, for corrective actions to be taken in
advance of the certification audit. It provides valuable inputs to give confidence to
the clients and saves time for taking necessary corrective action, later. Stage 1 audit
is done in all cases and it is also ensured that the auditor signs the conflict of
interest before every visit.

Stage 2 audit covers Information and evidence about conformity to all requirements of the applicable management system standard. Performance monitoring, measuring, reporting and reviewing against key performance objectives and targets are goals of Stage 2 audit.

Stage 2 audit also covers the client’s management system and performance as regards legal compliance.

e. Certification Decision:

A finding can be of either of the following:

Major non-conformity- A Major Nonconformity would be the total breakdown of the quality management system or one of its processes, or the failure to address a key requirement. It would be a nonconformity that in the auditor’s judgment and experience would likely result in the system failure or materially reduce its ability to assure controlled processes and products.

It would also be a major nonconformity if the failure would result in the probable shipment of nonconforming or uninspected product, or materially reduce the usability of the product for its intended purpose. Minor non-conformities against the same.

Examples of major non-conformities would be the absence of a required documented procedure, critical purchases made from unapproved suppliers, document changes routinely made in an unauthorized way, or product being shipped without completion of required tests.

Minor non-conformity- A Minor Nonconformity would be the failure to conform to a requirement that in the auditor’s judgment and experience is not likely to result in a failure of the quality management system. It may be a single observed lapse or isolated incident where there is minimal risk of nonconforming product being released to the customer.

Examples of minor nonconformities would be a document with an unauthorized change, a missing training record, a purchase order released without approval, or an instrument past its calibration date.

Observation- An observation is a finding without a clear reference to a standard requirement, or a finding without clear evidence.

Opportunity for improvement- An opportunity for improvement will be issued if the process meets the minimum requirements, but the process can be improved. An opportunity for improvement in most times is system or process related and is based on the experience and knowledge of the auditor. Or it is best practice within the sector or organization that has been audited.

Noteworthy effort- A noteworthy effort will be reported as a positive finding. A noteworthy effort can be an improvement compared to the previous audit, or processes that perform better than expected, e.g. best practice.

f. Renewal Audit:

The process of recertification would include a reassessment of the organization’s documented quality management system including a review of the Management System, where necessary, to be conducted before the expiry of three years term of validity. The recertification audits planned and conducted to evaluate the continued fulfillment of all of the requirements of the relevant management system standard or other normative document. The Renewal audit plan is verified to ensure that the majority of the audit time is given to verify the effective implementation of the management system

[For Further Information or Professional Advice, contact Rahul Vats at vatsrahul.ca@gmail.com]