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Quality Consultation

Our range of services include iso 9001:2015, iso 17025:2005, iso 15189:2012, as 9100:2016 and iso 17020:2012.

ISO 9001:2015

ISO 9001:2015
  • ISO 9001:2015
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Service Details:

Duration15 Years
Type Of IndustryAll industries
Mode Of ReportOnline, hard copy and offline
Document Verification ModeOnline,hard copy and offline
Location/CityPan India
Type of CertificationNew Certification
Type Of Service ProviderConsulting Firm
Suitable ForQuality managment

What is ISO 9001 quality management system (QMS)?

ISO 9001 refers to a group of standards for quality management systems. It is maintained by the International Organization for Standardization and is administered by different accreditation and certification bodies.

ISO 9001 Overview

The ISO 9001:2015 standards are based on seven quality management principles that senior management can apply to promote organizational improvement:

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

We believe that focus on the above seven quality management system principles can bring about the improvement of the organization as well as its employees with the help of our ISO consulting services.

We provide benefits in the form of helping our clients organize an ISO 9001 quality management system (QMS) while helping them in creating satisfied customers, management, and employees, continually improve their processes and saving costs across the board.

We deliver our product on the basis of three principles:

  • Organize processes
  • Continually improve
  • Improve the efficiency of processes
ISO 9001 Certification Requirements
  • A quality management system in place, including documented information, planning and determining process interactions.
  • Management of resources, including human resources and an organization’s work environment.
  • Periodic analysis, measurement and improvement of the QMS through activities like internal audits and corrective and preventive action.
  • Properly outlined responsibilities of management.
  • Predefined steps for product realization, like the steps from design to delivery.
How to get an ISO certification - ISO 9001 Training

We provide a training program focused on “How to get an ISO certification?”.

Our training courses provide individuals in organizations with an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment. 

These individuals are then responsible for the development, implementation, auditing and managing on ISO quality management systems in their organizations.

ISO 9001 Certification Services

At Samarth Consultants, we provide assistance in ISO 9001 certifications which are of global quality standards. We also help clients in clearing the ISO audit and receiving the subsequent ISO certification services effectively and efficiently.

In ISO 9001 certification consulting services, we acknowledge you about our training sessions and implementation process. We provide specialized training to the management and employees to properly execute the strategies that are needed to get a successful registrar’s audit confirming the certification.

An ISO 9001 Certification shows that an organization has done the following:

  • It follows the guidelines of an ISO 9001 standard like the ISO 9001 accreditation UK.
  • It fulfils its own requirements.
  • It meets customer requirements and statutory and regulatory requirements.
  • It maintains proper documentation.

ISO 9001 Standard Certification can enhance an organization’s credibility by highlighting that its products and services meet the expectations of the customers.

To know more about the ISO 9001:2015 certification services, request us to call back you. We are offering our ISO 9001 certification Consultant services in India, UK, and Europe or across the world. We are also providing consulting services for other quality management certifications. You can also checkout that as well.

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ISO 17025:2005

ISO 17025:2005
  • ISO 17025:2005
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Service Details:

Location/CityPan India
Type of CertificationNew Certification
Type Of IndustryAny Industry
Type Of Service ProviderConsulting Firm
Mode Of ReportOffline,online and hard copy
Document Verification ModeOffline,online and hard copy
Location PreferencesAnywhere in India

What is ISO 17025:2005?

ISO 17025 refers to the quality standard for testing and calibrating laboratories. Its accreditation is done by an accreditation body. The current release was published in 2005.

The two main clauses in ISO 17025 certification are:

  • Management Requirements
  • Technical Requirements.
ISO 17025:2005 certification - Overview

The ISO 17025:2005 standard is useful for laboratories in the process of developing their management system for quality, administrative and technical operations. It is also used by laboratory customers, regulatory authorities and accreditation bodies for confirming or recognizing the competence of laboratories according to the ISO 17025 checklist.

ISO 17025:2005 certification Requirements

Management requirement dictates the operation and effectiveness of the quality management system QMS in a laboratory, its requirements are similar to ISO 9001 certification.

The technical requirement relates to the competence of the staff, methodologies used for testing, quality of the equipment and reporting of test & calibration results.

  • A laboratory management system in place, including documented information, planning and determining process interactions.
  • Properly outlined responsibilities of management.
  • Management of resources, including human resources and an organization’s work environment.
  • Predefined steps like the ISO 17025 procedures that are to be followed.
  • Periodic analysis, measurement and improvement of the laboratory management system and the state of equipment in the laboratory.
How to get ISO 17025 certification – Training

We are always focus on how to get ISO 17025 certification in the best way with proper training, implementation and auditions. In our training sessions, we provide train on maintenance of the equipment, increasing the efficiency of the processes based upon the standard set by the ISO for the ISO IEC 17025 requirements for testing laboratories.

Like the ISO 9001:2015 product process we deliver our product on the basis of the following steps: 

  • Organize processes
  • Continually improve
  • Improve the efficiency of processes
ISO 17025:2005 Certification Services

ISO 17025:2005 accreditation is built for all of the organizations that perform tests and/or ISO calibration, as it can be called, this also includes the first-, second- and third-party laboratories and laboratories where testing and/or calibration forms part of inspection and product certification.

At Samarth Consultants we aim to deliver the training and information that is required to successfully get accredited for the ISO 17025:2005 standard. We are available to give you complete ISO 17025:2005 certification consulting services. We provide periodically training sessions and most effective implementation process. We are offering our ISO 17025:2005 certification Consultant services in India, UK, Germany, Europe and across the world.

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ISO 15189:2012

ISO 15189:2012
  • ISO 15189:2012
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Service Details:

Duration15 years
Type Of Industrymedical laboratories, Diagnostic centres, X Ray labs
Mode Of ReportOnline, hard copy and offline
Document Verification ModeOnline,hard copy and offline
Location/CityPan India
Type of CertificationNew Certification
Type Of Service ProviderConsulting Firm
Is It CustomisedCustomisation

ISO 15189:2012 dictates the requirements for quality, competence and abilities in medical laboratories.

It governs the quality management systems in these medical laboratories. Laboratory customers, regulating authorities and accreditation bodies also use this certification to determine, confirm or recognize the competence of medical laboratories.

Overview

A country could have specific regulations and requirements that apply to some or all of the professional personnel and their activities in the medical laboratories.

We provide the following benefits with the ISO 15189:2012 certifications:

  • Improvement in the national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • A predefined basis for all the major quality systems, related to the laboratories, such as Good Laboratory Practices.
  • Mutual Recognition Agreement (MRA) in several different countries where test report is acceptable without repetition of analysis.
  • Customer satisfaction is achieved through the introduction of a Quality Management System which is a part of ISO 15189.
Requirements for Medical Laboratories

Technical requirements and management requirements.

The Medical Laboratories Management Requirements are:

  • Organization and Management
  • Document Control
  • Examination by Referral Laboratories
  • Advisory Services
  • Identification and Control of Nonconformities
  • Preventive Action
  • Quality and Technical Records
  • Management Review
  • Quality Management System
  • Review of Contracts
  • External Services and Supplies
  • Resolution of Complaints
  • Corrective Action
  • Continual Improvement
  • Internal Audits

Technical Requirements in Medical Laboratories are:

  • Personnel
  • Lab equipment
  • Examination procedures
  • Post-examination procedures
  • Accommodation and environmental conditions
  • Pre-examination procedures
  • Assuring quality of examination procedures
  • Reporting of results

We work as an ISO certification consultants who specialize in ISO medical laboratories standards to ensure a proper outlining of the requirements during medical laboratories training.

Training

Samarth Consultants provides the inspection parameters which include matters of quantity, quality, safety, fitness for purpose, and continued safety compliance of installations or systems in operation.

We offer training to individuals within organizations with the training after which they can properly execute the ISO 15189:2012 audit checklist and provide ISO Certification consulting services.

Our ISO 15189:2012 Certification training covers the following:
Through the whole process, we provide awareness training, gap analysis of existing systems, process mapping and process definition, documentation including manuals, procedures, work instructions, test instructions, checklists, formats etc.
During ISO 15189:2012 Certification training we provide:

  • Awareness training to the laboratory personnel.
  • A gap analysis of the existing systems of the laboratory.
  • Process mapping and process definition.
  • Documentation including manuals, procedures, work instructions, test instructions, checklists, formats etc.
  • Step by step assistance in proficiency testing, inter-laboratory comparison and measurement of uncertainty.
  • Assistance in documentation implementation.
  • Internal auditor training and conduct of internal audit.
  • Pre-assessment audit and pre-certification audit.
  • Assistance during the entire phase of accreditation audit.
  • Post-certification assistance in system maintenance.
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AS 9100:2016

AS 9100:2016
  • AS 9100:2016
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Service Details:

Type Of IndustryAviation
Mode Of Reporthard copy, online and offline
Document Verification ModeOnsite
Location/CityPan India
Type of CertificationNew Certification
Type Of Service ProviderConsulting Firm
Suitable ForAviation Industry

"Aerospace Basic Quality System Standard".
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ISO 17020:2012

ISO 17020:2012
  • ISO 17020:2012
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ISO 17020:2012 specifies the requirements for the abilities of entities performing inspection of the impartiality and consistency of their inspection activities.ISO 17020:2012 Certification OverviewPrivate clients, parent organizations, or authorities are assisted by Inspection bodies or entities to carry out assessments on their behalf, with the objective of providing information about the conformity of the inspected items with regulations, standards, specifications, inspection schemes or contracts.
The types of Inspection Bodies are as follows :
Type A: The Type A inspection body provides "third party" inspection services. The inspection body and its staff don’t engage in any activities that could conflict with their independence of judgement and integrity towards their inspection activities.Type B: The Type B inspection body forms a separate and identifiable part of an Organization and is established to supply inspection services to its parent organization.Type C: The Type C inspection body is an identifiable part of an organization and is established to supply inspection services to its parent organization as well as other external organizations.ISO 17020:2012 Certification RequirementsISO 17020:2012 certification requires for the inspection services or ISO certification consultants to follow a list of procedures before they can provide inspection services.
The list is as follows:
A procedure to ensure that individuals or organizations separate from the inspection body cannot influence the results of inspections by the ISO 17020-accredited organization.Properly outlined responsibilities of management.A plan for corrective action.An outlined procedure for the care and maintenance of equipment.A procedure for selecting qualified suppliers.An outlined procedure for purchasing.Documentation for the inspection of materials received by the organization.Procedure for appropriate storage facilitiesA system for protecting the integrity of data produced by the organization.A method for ensuring the security of data produced by the organization.A method for dealing with defective equipment.Procedure(s) in place for performing inspections.Predefined procedure(s) in place for performing non-standard inspections.Predefined procedure(s) in place for avoiding deterioration or damage to inspection items.A procedure for dealing with complaints.A plan for dealing with appeals against the results of inspections.How to get ISO 17020:2012 certification - TrainingSamarth Consultants provides the inspection services parameters which include matters of quantity, quality, safety, fitness for purpose, and continued safety compliance of installations or systems in operation.
We offer inspection services training to individuals within organizations with the training they can properly execute the ISO 17020 audit checklist and also provide ISO consultancy services to get ISO 17020 certification.
The training covers the following:
Understand the ISO/IEC 17020:2012 requirementsLearning about how to coordinate a quality management system audit under ISO/IEC 17020:2012.Develop an understanding of the technical systems and issues of the accredited inspection body.Training that explains how to collect audit evidence and document observations, including techniques for effective questioning and listening.Learning how to report the findings and conclusions.ISO 17020:2012 Certification Services:An accreditation body issues the ISO/IEC 17020:2012 Accreditation Certificate, which is then authorized by the IAF MRA to provide accreditation under the ISO/IEC 17020:2012. After the completion of pre-assessment and registration (final) assessment, the ISO 17020 certificate is issued for a two years period. The surveillance audits are conducted by the Accreditation body after one year. Upon completion of two-year cycle, at every two years interval a renewal audit is conducted without any periodic surveillance assessment.
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