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ISO 9001 (QMS)

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ISO 9001 : 2015 (QMS) overview

ISO 9001:2015 is a well-known and adopted standard internationally for Quality Management Systems (QMS). ISO 9001 establishes a framework and principles for your organization’s management to ensure that customers and other stakeholders are continuously satisfied. In addition, ISO 9001 certification demonstrates the foundation for successful processes and effective people to deliver effective products or services consistently.

Whether an organization is B2B or B2C, setting and managing the right processes is paramount. The right methods need to be functioning at their optimal level. Increased cost and decreased efficiency can lower the profits on the company’s balance sheet. However, companies can turn the tables around by standardizing the processes by implementing ISO 9001.

The ISO 9001:2015 certification does not certify the company’s products but focuses on the working methods that compel a company to build a quality management system.

CUNIX is a leading ISO 9001 Consulting organization in India. We help our customers align their processes and people with business goals through ISO 9001 consulting and certification. We are not restricted by geography and offer our service to customers across the globe. We have an excellent team of experienced and certified consultants with knowledge and understanding of various industries and processes. This enables us to integrate internal processes and apply diverse industry knowledge to add value to the pre-existing system.

Certification Process

Once the organization has implemented ISO 9001:2015 standard, it can plan for the certification audit by approaching and contracting with CUNIX Infotech.

A. Introductory information

The client’s wants and expectations are the starting point for the process. It’s important to know about the client’s company, management system, size, and types of operations. Both parties will work together to determine the assessment and/or certification objectives, as well as any related standards and specifications.

A contract should be established between the applicant and the registrar.

This contract primarily spells out both parties’ rights and obligations, and concerns like liability, confidentiality, and accessibility.

C. Checklist of action plan

After the CUNIX ISO auditor conveys the existing gaps in your organization, the Client has to prepare an action plan to dispose of these gaps. CUNIX will help in preparing list of the required tasks to be performed to bring adequate changes in your organization. CUNIX will conduct required training for client organisation’s employees to work effectively while adapting to the new processes. Create awareness for all the employees about ISO standards in terms of work efficiency and quality standards.

B. Quality Documents Review

CUNIX ISO auditor will examine all of your quality manuals and papers pertaining to the organization’s various policies and processes.

Examining previous work will assist the ISO auditor in identifying any potential gaps in comparison to the ISO standards’ criteria.

The certification audits are carried out in 2 phases

The Phase 1 audit focuses on the availability and compliance of the documents. This phase is generally conducted off-site.

The Phase 2 audit focuses on checking the evidence on-site. This involves interaction of auditors with the senior management, process owners and other key SPOCs in the organization.

Upon successful completion of both phases, the auditor submits the report to the certification body and gives the recommendation letter to the organization. The certificate is released by the certification body upon acceptance of report submitted by the auditor.

Benefits of Quality Management Systems (ISO 9001:2015)

It develops an ability in the organization to consistently deliver product and service which meets the customers as well as other stakeholders’ requirements.
It provides an opportunity to have sustained customer satisfaction.
It addresses risks and opportunities with respect to the context of the organization and its objectives.
Audits by 3^rd party reputed certification bodies gives an opportunity to the organizations to showcase their capability in implementation and adherence to ISO 9001:2015 standard requirements.
It provides clarity to employees in the organization with well-defined processes, tasks, responsibilities, and structure which leads to employee satisfaction and engagement.
It helps in building a long-term sustainable brand image.
It gives an opportunity to meet the qualification criteria in bids/tenders and hence provides a competitive advantage.

Our Offering

Trainings:

ISO 9001:2015 Awareness Training – This training focuses on decoding ISO 9001:2015 clauses and their requirement to the client implementation team.
ISO 9001:2015 Internal Auditor Training – The objective of this training is to create competence for internal audits of ISO 9001:2015 internally.

Consulting:

AS-IS Gap Analysis:

The objective of this offering is to identify the gaps in the documents and implementation before the start of the implementation of ISO 9001:2015. This gives clear idea about the time this initiative would take for its success.

QMS Gap Analysis:

Gap Analysis of QMS documents prepared by implementation team after going through the awareness trainings. The gaps identified here will give the further direction.

Implementation Gap Analysis:

This gives clarity on the level of implementation of QMS in the organization and provides the clarity on the actions needs to be taken for getting the cycles.

Guidance during documents creation:

Our consultants work deeply with the implementation team of the client in phase of creation of documents. This has various review and guidance cycles before the compliance with respect to ISO 9001:2015 is achieved.

Guidance during implementation:

Our consultants work intensely with the implementation team of the client during implementation phase. It requires quick cycles of audit and gap closure guidance before the compliance in implementation is achieved.

Internal Audit:

This activity is done keeping in mind the requirement of internal audit report as one of the documents during the final audit. Also, after various round of gap analysis, this audit ensures that no non-compliance remains, and the client is fully prepared for the final audit.

Support during Certification Audit:

We also provide support during certification audit phase as required by the client.

Please Note: The Gap Analysis activities mentioned above can have more than one cycle depending upon the client requirement.

Why CUNIX?

CUNIX projects are lead by consultants with an average industry experience of 25+ years, of performing in various roles and providing consultancy in the field of QMS Quality Management System.
CUNIX has done consulting projects in 20+countries and hence can boast of having multi-cultural, multi-lingual experience and successes.
650+ projects, including 120+ projects on various ISO standards, SOC, GDPR, HIPAA etc. completed till March 2023.
CUNIX has provided ISO consulting services to diverse industries like Manufacturing to Banking, I.T. to Health-Care, Engineering Services to Automation and many more.
CUNIX has consulted organization of all sizes, from small to medium to large sizes, in terms of people, towards success in their quality initiatives.
CUNIX has deep tie-ups with all types of certification bodies and can provide end-to-end experience to the clients, as per their requirement.
CUNIX is one of India's leading Consultants, for ISO consulting services, ISO training and ISO audit or assessments globally.

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