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ISO 9001:2015 Certification – Ensure Business Quality & Operational Excellence

  • ISO 9001:2015 Certification provides the assurance that your processes are compliant with internationally accepted quality standards, something that can benefit businesses in any sector.
  • It establishes a robust Quality Management System (QMS), enabling an appreciation for your processes, removing risk and improving customer satisfaction.
  • Diligence Certifications facilitates expert-led end-to-end assistance for ISO 9001:2015 Certification starting with a gap analysis (audit), then training and audit preparation, and ending with the certification stage.
  • Moreover, it encourages risk-based thinking, leadership commitment to quality and provides a foundation of continual improvement. 

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An Overview of ISO 9001 2015

The ISO 9001 2015 is an internationally accepted standard for planning and maintaining a Quality Management System (QMS). It was conceived by the International Organization of Standardization (ISO) to provide a strong framework for organizations to enhance customer satisfaction, meet regulatory requirements, and continually evolve performance.

Introduced in September 2015, ISO 9001 2015 is also the most widely implemented management standard in the world. It places emphasis on adopting a process-based approach, on risk-based thinking, and being oriented toward the wider context of the organization.

At Diligence Certifications, our expert ISO 9001 2015 Certification Consultants help businesses across India to get ISO 9001 2015 certification with ease and precision.

ISO 9001 2015 Certification

What is the ISO 9001 2015 Certification?

As an international standard, ISO 9001 2015 provides requirements for Quality Management Systems. Developed by the International Organization of Standardization (ISO), it assures an organization that it will maintain a level of quality to meet the requirements of those it serves and also comply with applicable statutory and regulatory requirements. It proposes a process approach to working, risk-based thinking, and continual improvement of all operations of the business. A company getting certified to ISO 9001 2015 shows its commitment toward quality, customer satisfaction, and operational excellence, thereby enhancing its reputation and ability to compete with others both domestically and internationally.

The ISO 9001:2015 framework is built on seven principles:

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management

Why ISO 9001 Certification is Essential?

ISO 9001 2015 Certification is a guarantee given to customers stating that an organization has created a QMS based on 7 management principles. It forms the basis for standards in other specific areas, such as ISO 13485 (medical devices) and AS 9100 (aerospace). However, despite the economic slowdown, the trend of implementing ISO 9001 2015 Certification is on the rise worldwide. Although an individual can remain uncertified, certification is the best way to acquire and demonstrate competency regarding this standard.

Key Enhancements of ISO 9001 2015 Are:

  • Strengthening the importance of the process approach to performance measurement and risk management.
  • Greater focus on requirements and expectations of interested parties.
  • Analyzing the context of the organization thoroughly as a basis to enhance quality.

Why Should You Get ISO 9001:2015 Certification?

With the high stakes present in today’s business world, the certificate can provide a competitive advantage beyond mere compliance. In India, the ISO 9001 provides third-party credibility from a global perspective, helps build customer trust, adds discipline to internal procedure, and promotes smooth functioning within the company.

ISO 9001 formalizes the process enhancement related to quality; thus organizations are shifted from informal or merely acting philosophies to serious, methodical, and data-driven approach in assuring quality. Whether an organization is in competition for international contracts, addressing customer complaints, or simply seeking operational improvements, ISO 9001:2015 uses a truly disciplined and formalized approach that can help steer an organization through the process.

What is QMS (Quality Management System)?

QMS full form is Quality Management System. Quality Management System is a set of interrelated or interacting elements aimed at establishing policies and objectives, and processes to achieve those objectives on quality targets. It acts within an organization, interfacing with the bigger management system on the basis of risk-based thinking to produce, monitor, review, and continuously improve quality.

ISO 9001 2015 outlines generic requirements for an organization to use in setting up and maintaining a documented QMS suitable for any type of organization. It aligns itself with other management systems, such as Business Continuity and Energy Management, because they share a common structure.

The QMS is concerned with the following:

  • Designing and reviewing quality objectives
  • Monitoring performance and risks
  • Customer satisfaction
  • Regulatory compliance

The ISO 9001 2015 standard defines requirements for the implementation, maintenance, and continual improvement of a QMS and can be adapted to any organization.

Core Clauses of ISO 9001 2015

  1. Clause 1 – Scope: Defines the applicability of the standard. 
  2. Clause 2 – Normative References: Key referenced standards
  3. Clause 3 – Terms and Definitions: Terms form ISO 9000:2015. 
  4. Clause 4 – Context of the Organization: Internal/external issues, stakeholders. 
  5. Clause 5 – Leadership: Commitment by top management, quality policy. 
  6. Clause 6 – Planning: Risks, opportunities and quality objectives. 
  7. Clause 7 – Support: Resources, awareness, communication. 
  8. Clause 8 – Operation: Product/service planning, control and delivery. 
  9. Clause 9 – Performance Evaluation: Monitoring, analysis and evaluation. 
  10. Clause 10 –Improvement: Improvement continuingly and corrective actions.

Mandatory Documents for ISO 9001 2015 Compliance

Following are some crucial documents you need to produce if you want to be compliant with ISO 9001 2015

  • Scope of the QMS
  • Quality Policy and Objectives
  • Supplier evaluation criteria

Following are some mandatory records

  • Training and qualification records
  • Records of non-conformities
  • Audit results and management reviews
  • Product/service conformity reports
  • Customer property and change control records

Following are some Conditional Records (Based on Applicability)

  • Equipment calibration records
  • Design & development lifecycle documentation

Following are some non mandatory documents

  • Risk management procedure
  • Internal audit procedure
  • Training & awareness procedure
  • Document control procedure
  • Sales, warehousing, and customer satisfaction procedures

Key Benefits of ISO 9001 Certification:

Increased Customer Satisfaction — you will have systematically managed to exceed customer expectations through consistency in quality.

Fewer Operational Inefficiencies — streamline your internal processes flow and remove delays and redundancies.

Fewer Defects and Rework — associated costs of correction reduces to zero before errors occur

Legal and Regulatory Compliance — reduced risk of legal ramifications or issues with non-compliance

Less ambiguity and an understanding of interdependence across departments — improved communication, coordination and accountability

Globalized recognition of quality — eligibility of tenders, global markets and prestigious partnerships

Involvement and engagement of employees (defined functions, roles, and KPIs) in using data for quality and motivation of intent – performance involvement

Registration Process for ISO 9001 2015 Certification

The road to ISO 9001 2015 Certification is a structured one, ensuring that your organization’s Quality Management System (QMS) meets international standards. Here is a stepwise conceptualization of the road to certification:

Step 1: Internal Audit

Start with conducting an internal audit for your current Quality Management System to check how well your processes are aligning with the requirements of ISO 9001 2015. This will help you find the gaps, non-conformities, and areas for improvement before the process retests the QMS externally.

Step 2: Management Review

Following the internal audit, top management must review the audit’s findings and the overall QMS performance. This step locks management involvement and commitment. Management may decide that resources need to be reallocated to improvements that are aligned with strategic goals and ISO standards. 

Step 3: Corrective Actions

Take corrective actions against the causes of non-conformities defined during the internal audit and document every corrective action taken with verification of its effectiveness in order to ensure that your processes are stable, capable of repeatability, and in line with ISO 9001’s principle of continuous improvement. 

Step 4: Stage 1 Audit- Documentation Review

The certification body’s auditors will carry out the Stage 1 audit with a focus on documentation and will assess whether your QMS documents meet the requirements of the standards. This review includes your quality policy, procedures, manuals, and records.

Step 5: The Stage 2 audit, known as the Certification Audit

Stage 2 is an on-site audit during which auditors evaluate the implementation and efficacy of your QMS under actual conditions. There will be interviews with employees, reviewing of records of operations, and observation of activities under contract to ensure that ISO principles are adhered to in practice. 

Certificate Issue

When the certification body is satisfied that complete conformance with ISO 9001 2015 requirements has been achieved, the organization is awarded the ISO 9001 2015 Certificate. This certificate is internationally recognized and provides credibility, customer confidence, and new market opportunities.

How Diligence Certifications Can Help You Achieve ISO 9001 2015 Certification

Diligence Certifications provides ISO 9001 2015 certification with utmost precision, efficiency, and transparency to all businesses. Our aim, as a reputed ISO 9001 Consultant for India, is to make the ISO 9001 2015 certification process very easy for you while maintaining full compliance with the ISO 9001 2015 standards. This is how we support your organization every step of the way:

Gap Analysis & Strategic Planning

We conduct a detailed Gap Analysis for ISO 9001 2015 to check the quality management practices presently adopted. Subsequently, it becomes important to prepare a roadmap customized to the size, nature, and structure of the organization so that the final certification journey appears smooth and without a hitch.

Complete Documentation Support

Documentation is a very important factor in ISO 9001 2015 compliance, and our consultants help you prepare your Quality Manual, Policy Statements, SOPs, Work Instructions, and Process Flowcharts in line with ISO 9001 2015 clauses so that you are always audit-ready.

Internal Audit and Training of Employees

Through internal audits, we identify areas of non-conformance and improvement, while employee training programs develop awareness and competence within your team to empower everyone to comprehend their roles within the QMS.

Certification Audit Coordination

Directly dealing with certification bodies for scheduling the audit and providing full guidance for Stage 1 and Stage 2 audits.

Our consultants are close to you right from the start so you can discuss whatever comes up in the process until the final audit is achieved.

End-to-End Compliance & Beyond

Our support doesn’t stop at the certification. Post-certification maintenance services are meant to support you in maintaining ISO standards through continuous improvements and ready you for surveillance audits.

Coming to the Diligence Certifications, it does not merely qualify you for a certificate—there is a culture of quality that promotes operational efficiency in areas of customer satisfaction and market credibility.

ISO’s Global Mission

The mission of ISO Certification is to facilitate international standardization and trade internationally through the following ways:

  • Increasing operational efficiency
  • Ensuring good standardization practices (GSP)
  • Linking public policy and standards
  • Working on sustainability and risk management
  • Pulling stakeholders in for standard development

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Frequently Asked Questions

 It’s an international standard of Quality Management Systems in industries conducting activities to consistently ensure quality products and service.

 To enhance customer satisfaction, operational efficiencies, and to enter into new markets.

 Any kind of organization, big or small, from any industry, can apply.

 Usually 3 to 6 months, depending on the readiness of your company.

Better quality, better processes, trustworthiness on the part of the customers, and compliance with regulations.

 It is voluntary, but ISO is often required by clients or for market access.

Charges vary due to company size and scope; we give full consultancy that fits your budget.

 Quality policy, objectives, training records for labor, audit reports, and corrective actions.

 It is about management of risk, leadership, and the alignment of QMS with business context.

Yes. We give guidance through every step of the process to make a hassle-free journey.

Every 3 years with a surveillance audit carried out annually.

 No, ISO 9001 2015 is about the quality. For environment or safety, other standards will be applicable.

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