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ISO Certification

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If you are running a business then you must know the crucial importance of ISO Certification for maintaining the standards of your organization. International Organization for Standardization (ISO) certification is a globally recognized seal of approval granted by an independent, third-party body, ensuring that a company meets the stringent international standard established by the ISO. It is a mark of excellence, achieving ISO certification not only enhances the credibility of business and trust among customers but also improves operational performance and gains a competitive edge in the global market.

What IS ISO Certification?

The International Organization for Standardization (ISO) is an independent international organization that develops standards for a wide range of industries internationally. ISO is a group of national regulatory bodies of 167 countries with a single regulatory body representing each member country. It is governed by the members of an organization.

ISO Certification is mandatory for your company as it ensures the quality, safety and efficiency of both product and services. it helps in maintaining the standards of your brand and generates various ways for innovation and development of trade

What Are The Benefits of ISO Certification?

ISO registration issued by the International Organization for Standardization provides various advantages to the company including being obedient to laws and regulations and ensuring the safety of employees and its customers. The various benefits ISO certification is as follows:

ISO-registered companies gain brand reputation and credibility faster than Non-ISO registered companies.

Enhance customer trust and satisfaction

By improving the quality and safety of both product services.

Global Recognition

ISO certification is valued worldwide, This enhances your business’s reputation and market value.

Attracts More Clients

Adherence to quality standards draws more customers, keeping you competitive.

Consistency in Quality and Efficiency

Defined processes, swiftly resolved issues, and upheld high standards.

Cost Effective

Identifying waste and inefficiencies reduces scrap and overtime, lowering overall costs.

Bring more Business Opportunities

Enhanced quality and efficiency create avenues for the existing and new markets.

Improved Management Insight

Data-driven decision-making leads to more effective management practices.

Minimized Disruptions

Problems are easily identified and resolved, reducing interruptions in operations.

Valuable External Audits

Third-party audits offer fresh perspectives, helping to refine processes and address challenges.

What Are The Types of ISO Registration?

There are around 21700 types of ISO registration certificates available in different domains across the world. Below are some ISO registration certificates relevant to the pharmaceutical industry:

  • ISO 9001:2015 – This ISO registration certificate is basically for the quality management system. This standard of QMS helps to ensure the company is continuously making products that meet the regulatory standard in terms of safety and quality.
  • ISO 13485:2016- This standard is followed by the pharmaceutical companies that deal with the production and installation of medical devices. It demonstrates that the medical device is consistently producing quality products as per the regulatory requirements.
  • ISO 22716:2007- This standard specifies guidelines and regulations for the quality management of cosmetic products, ensuring the products are consistently being manufactured as per the regulatory standard and specifications comply with the regulatory requirement.
  • ISO 22000- This standard specifies the guidelines for the food and safety management department.
  • ISO 45001- This standard is responsible for occupational health and safety management system.
  • ISO 14001- Environment management system.

However, the most common ISO registration types are ISO 14001 and ISO 9001.

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Documents Required for ISO Registration

The following documents required for ISO registration are:

Name and address of the applicant

Company details

Company Letterhead

Bill copy for purchase and sale order

Copy of PAN card

GST certificate

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Prerequisites to ISO Certification in India

  • Identity and select the relevant ISO standard: There are various ISO standards, each depending on different industry needs, you need to select the appropriate ISO standard as per your requirement.
  • Analyze your current situation: Identify the gaps that require improvement as per the chosen ISO standard.
  • Develop an improvement plan: Create a plan to address the identified gaps.
  • Implement the outlined plan: Execute the plan by making required changes to the process of documents.
  • Perform internal audits: An internal audit shall be conducted to check and verify whether the implemented changes are effective and whether the company is in compliance with the ISO standard or not.
  • Choose a certification body and undergo audit: Certification body will perform the audit to assess whether your company is in compliance with the ISO standard.
  • Receive certificate: If your company is found to be in compliance with the ISO standard, you will be granted ISO certificate.

What is the ISO Certification Process?

The process of obtaining ISO certificate is described below:

Submit application

Apply by submitting the application to ISO registrar, outlined by the responsibilities between your company and certification body.

Documents review

ISO will review your documents manual and process to ensure its alignment with ISO standard.

Pre-assessment

Initial review will analyze any gaps in your quality management system (QMS).

Action plan

Based on feedback create a plan to address the identified problems.

Onsite audits

The ISO registrar conduct the onsite audit to check compliance with the ISO standard.

Final audit

After resolving the major and minor problems the final audit is conducted.

Obtain ISO certificate

After all the requirements are meet as per ISO standard, the registrar issues ISO certificate.

Submit application

Apply by submitting the application to ISO registrar, outlined by the responsibilities between your company and certification body.

Documents review

ISO will review your documents manual and process to ensure its alignment with ISO standard.

Pre-assessment

Initial review will analyze any gaps in your quality management system (QMS).

Action plan

Based on feedback create a plan to address the identified problems.

Onsite audits

The ISO registrar conduct the onsite audit to check compliance with the ISO standard.

Final audit

After resolving the major and minor problems the final audit is conducted.

Obtain ISO certificate

After all the requirements are meet as per ISO standard, the registrar issues ISO certificate.

Why ISO Registration Is Important?

ISO registration is crucial for a company, that is quality-conscious and wants to build its brand reputation. ISO registration is important for all companies who want to market their products. Company must work as per the rules and regulations govern that the company products are of quality standard. ISO registration provides companies with a certification for being obedient to laws and regulatory requirements. Therefore, enhancing the credibility and efficiency of products.

Types of Audits Conducted Under ISO Certification

Below are the types of audits conducted under ISO certification:

Internal audit:

Conducted by training staff, to ensure compliance within the organization.

Supplier audit

Conducted by the lead auditor to check the suppliers are functioning correctly, ensuring consistency in high-quality supply of products to the organization.

Certification audit

Conducted by the certification body to ensure the process meets the ISO standard.

What Is The Timeline Of ISO Certificate Registration?

The timeline of obtaining an ISO certificate differs from Organization to organization depending on the expertise of the company and how it handles complexity. Also, the ISO certification body plays an important role in determining the time for each application.

Validity of ISO Registration

The validity of the ISO certificate is three years from the date of issue.

Renewal Process Of ISO Certification In India

The renewal process of an ISO certificate is a complex process that involves the organization’s consistency in adhering to ISO standards. ISO certificate is valid for a limited time period, quite sometimes it is three years. For renewal of the ISO certificate, the organization must go through the renewal process involving the recertification audit conducted by the certification body to renew the certificate.

The performed audit checks the ongoing compliance of the organization and meets ISO standards. Once it is verified, the renewal ISO certificate is issued from the certification body demonstrating the organization’s commitment in maintaining quality standards and reinforcing customer trust.

How ELT Corporate Can Assist You with Ease ISO Registration?

At ELT corporate, we leverage our expertise in the regulatory and legal departments to simplify the process of obtaining ISO registration certificates for our clients.

FAQ

It depends on company which consultancy they choose. We at ELT corporate are quite efficient with the timely completion of the registration process.

It depends on the company or consultancy through which you are registering your organization. We ELT corporate provide service at a reasonable cost.

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