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Punyam.com has Started New Service – ISO 15378 Certification Consultancy

Punyam.com, one of the largest ISO Consultancy Company in India has new service for ISO 15378 Certification Consultancy. ISO 15378:2015 is a standard developed by ISO for primary packaging material for medicinal products manufacturers based on GMP requirements. ISO 15378 certification represents the requirements of quality management system for manufacturers of pharmaceutical and medical device primary packaging materials.

Punyam is offering ISO 15378 certification with system implementation, system awareness training, GMP training, auditor training and as well as ISO 15378 documentation. Punyam has a team experienced ISO consultants who deliver this ISO 15378 certification consultancy services for medical packaging material manufacturers and it will helpful for medical packaging manufacturer in developing their management systems and maintaining their own competence.

Punyam.com has aim to provide effective system implementation with ISO 15378 certification and GMP requirements in India and rest of the world. By join hands with Global Manager Group, Punyam has designed and sell ready-to-use ISO 15378 documentation kit to implement fast and effective documentation of quality as well as specific GMP requirements of ISO 15378 international standard, which will guide organizations management team as well as ISO consultants to offer services in ISO 15378 certification.

Steps Followed by Punyam for Achieving ISO 15378:2015 Certification

Punyam.com, leading ISO 15378 Consultancy in India, is having vast industrial experience in the implementation of ISO 15378:2015 for all types of Pharmaceutical and medical device manufacturer. Punyam implements the ISO 15378 system for its customers in the following manners;

  1. Micro-level survey for each and every medicinal products of the pharmaceutical and medical device and preparation of detail Gap analysis report,
  2. Preparation of applicable documents required by ISO 15378:2015 based on detail study of all activities of the medical device, such as;
    • ISO 15378 Quality Manual,
    • Quality Procedures for ISO 15378:2015 Certification (Mandatory procedures required by the standard),
    • Standard Operating Procedures (SOPs) for inspection of various activities as well as operation and calibration of identified equipments used in the inspection,
    • Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter.
  3. Preparation of Quality assurance plan for maintaining and assuring quality of inspection services provided to its customer.
  4. ISO 15378 training to all levels of employees within the medical device.
  5. Helps in effective implementation of system by periodic visit till accreditation.
  6. Conduct internal audit for ISO 15378 system to check readiness for the accreditation.
  7. Conduct management review meeting in presence of Top Management to guide the Inspection bodies for effective implementation on all the issues related to management requirements and technical requirements.
 

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Anupam Rasayan Awarded with ISO 9001:2015 & ISO 14001:2015 from UKAS

Anupam Rasayan India Limited manufacturer of Specialty Chemicals has been awarded with ISO 9001:2015 and ISO 14001:2015 Certification for implemented Quality Management System and Environment Management System by ISOQAR, UKAS Accreditation for Jhagadia Gujarat based Unit-4. The ISO 9001 and ISO 14001 consultancy project has been done by Punyam.com as per the requirements of the ISO 9001:2015 & ISO 14001:2015 standards.

Punyam.com – India, as India’s leading ISO Consultant has helped Jhagadia based Unit-4 of Anupam Rasayan in QMS and EMS implementation that satisfy all the requirements of ISO 9001:2015 and ISO 14001:2015. Punyam.com helped their client to understand system requirements via system awareness and auditor training. In this project, Panyam’s key focus is on preparing standard ISO documents for both the upgraded systems. The key documents like ISO 9001:2015 manual, ISO 14001:2015 manual, procedures, quality policy, risk assessment policy, audit checklist, SOPs, work instruction, etc., are prepared as per ISO 9001:2015 and ISO 14001:2015 documented information requirements.

The team of experienced ISO Consultants has successfully completed this project as certification audit taken by ISOQAR team on 8th July 2017 and recommended Anupam Rasayan Unit-4 for EQMS certification. During this project, Punyam.com has helped Anupam Rasayan to learn ISO 9001:2015 that specifies requirements for a quality management system and ISO 14001:2015 that specifies requirements for environment management system and provided internal auditor training after implementation of integrated EQMS system, which helped them in achieving certification in first attempt.

About Anupam Rasayan India Limited

Anupam Rasayan India Limited, one of leading manufacturer of Specialty Chemicals, with products catering to a plethora of market segments such as Agrochemicals, Anti-Bacterial, Polymers, Pharmaceuticals and Material Sciences. Anupam Rasayan India Limited started its journey on 6th March 1977. Over a period of time Anupam Rasayan has grown gradually and established itself as a company that manufactures products with world class quality. Research & Development is a passion for Anupam Rasayan and due to which they have introduced numerous products for the first time in India, they have developed new eco-friendly routes for many products and most of this products have been introduced on an exclusive basis for our customers.

 

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Bodal Chemicals Limited Achieved ISO 14001:2015 Certification

ISO 14001:2015 Certification Consultancy Ahmedabad

Bodal Chemicals Limited, world’s largest manufacturer and exporter of Dyes Intermediate, Dyestuff and Sulphuric Acid has been awarded with ISO 14001:2015 certification for implemented Environment Management System by UKAS accreditation. The ISO 14001 Consultancy project has been taken by Punyam.com and has been successfully completed as per the requirements of ISO 14001:2015 standard.

Punyam’s team of ISO consultants has successfully completed ISO 14001:2015 consultancy for Bodal chemicals Limited in given time frame. Punyam.com has helped during EMS implementation that satisfies all the requirements of ISO 14001:2015. During ISO 14001 consultancy, the consulting team has helped to their client to understand system requirements by providing awareness and auditors training.

With this ISO 14001:2015 certification, the aim of Bodal Chemicals to implement internationally acknowledged ISO 14001 Environmental Management System and get listed in recognized companies that have adopted environmentally responsible practices in their business processes. Punyam has helped them in all the process like providing implementation guidance, training, documentation preparation, internal and external audit, which results in achieving this goal through UKAS accreditation.

The project of ISO 14001:2015 certification audit for Bodal Chemicals Limited has been completed on 4th May, 2017. The chemical giant has recommended for ISO 14001:2015 that specifies requirements for Environment Management System which can be used for internal application by organizations, or for certification, or for contractual purposes.

About Bodal Chemicals Limited

Bodal Chemicals Limited, world’s largest manufacturer and exporter of Dyes Intermediate, Dyestuff and Sulphuric Acid, with vertically and horizontally integrated who provides product solutions and service solution on fastest possible route to their customers. Bodal Chemicals Limited is an Integrated and Innovative company, offering end-to-end solution to our customers globally. BCL has its presence not only in India but across the Globe and serving to 50+ countries with its Innovative products and services. It is coupled with technical know-how, & expertise in manufacturing of Dyes Intermediate & other Specialty Chemicals, our growth is propelled with the support of team members and management professionals, who work diligently to take the organization to newer heights year-on-year.

 

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Punyam.com Achieved NABL Accreditation for Keytech Material Testing Laboratory

NABL Accreditation Consultancy in India

Keytech Material Testing Laboratory, one of leading laboratory to test the engineering materials as per norms laid down by Indian Standard / International Standard has successfully completed NABL accreditation under guidance of Punyam.com’s team. The NABL consultancy team of Punyam has provide all necessary helps as part of consultancy to complete this NABL accreditation project in given time frame.

Punyam has successfully implemented NABL, ISO/IEC 17025 based quality system in the Keytech Material Testing Laboratory, by providing technical and management training to all the level of employees. Punyam has provided many testing and calibration laboratory to achieve NABL accreditation and Keytech is added to the list of such valuable clients.

During system implementation, Punyam has help in preparation of NABL documentation, system awareness training, internal auditing as well as providing necessary help with active participation to all employee of Keytech Material Testing Laboratory till the accreditation. The documents prepared as per ISO/IEC 17025 requirements includes Quality manual, Quality procedure, Standard Operating Procedures, Work sheet, Test report template, audit checklists etc.

Punyam.com has been completed this project of NABL accreditation for Keytech on 17th April, 2017 in given time limit as final audit taken by NABL auditors and recommended Keytech for NABL accreditation without any NCR.

About Keytech Material Testing Laboratory

Keytech Material Testing Laboratory, one of one of leading laboratory to test the engineering materials as per norms laid down by Indian Standard / International Standard. Keytech is established in the 2016 and now it is a unique professional organization in the Ahmedabad. The laboratory is the sister concern of Keystone Consultancy division. The Laboratory is managed by Mr. Nimitt Shah – CEO engaged in the testing of the soil, civil engineering materials. Keytech has state of art technology equipments for the testing of soil and materials used in the infrastructure development and having well structured infrastructure for the testing of materials as per the user defined need. Keytech is operated by well experienced technical persons Engineers in the civil disciplines.

 

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Binaykia Impex Private Ltd Entrusts Punyam Management for ISO 9001:2015 Certification

ISO 9001:2015 Certification Consultancy in India

Ahmedabad, India 23-Dec 2015, Binaykia Impex Pvt. Ltd. Has entrusted Punyam Management Services and given consultancy for implementation of quality management system that helped them to get ISO 9001:2015 certification from UK based accreditation body ISO QAR and UKAS. Punyam has helped the organization in development of best quality management system for getting continuous improvements, which is aim to motive Binaykia Impex.

ISO 9001:2015 certificate

ISO 9001:2015 Certification by UKAS – ISO QAR with help of PUNYAM MANAGEMENT SERVICES PVT LTD

Binaykia Impex Pvt. Ltd. has got all necessary support with ISO 9001:2015 consultancy services by team of Punyam Management, in preparation of QMS documents, providing training as well as system implementation. The documentation that ISO consulting team has prepared for ISO 9001:2015 certification were ISO 9001:2015 manual, quality policy, process flow charts, SOP, work instruction, exhibits, registration forms, risk assessment sheet etc documented information as per requirements to accelerate process. Also provide quality audit checklist as per revised clause wise and department wise requirements, which helped management and other employees of the company in internal as well as registration audit, taken by lead auditors from ISO QAR and UKAS certifying body. With the help of consultancy provided by Punyam management services, implemented many measures to reduce the quality cost and implemented controls for quality management system.

As per employees and management heads reported that the Punyam Management Services Pvt. Ltd. is the preferred choice of organizations across the world for implementation of ISO standards. It takes ISO 9001:2015 consultancy into account the various factors such as the extent to which quality should occur, the political and cultural situation within the company, the levels of competence necessary, clear objectives for the QMS project as well as all Legal and other regulatory requirements before implementing the ISO 9001:2015 system.

About Binaykia Impex Pvt. Ltd.

Binaykia Impex Pvt. Ltd. is one of India’s reputed manufacturers and exporters of all type of work wear. With an experience of more than 25 years and a customer base all over the world, Binaykia Impex Pvt. Ltd. specializes in production of Work wear and Aluminum Foils. The company would benefit to their customers because of its rich experience in the industry with quality meet and trained workforce to satisfy requirements from their customers.

 
 

Sintex Infra Projects Limited Achieves Certification to ISO 9001:2008 with Our Assistance

ISO 9001 Certification Consultancy in India

Kalol, Gujarat – Sintex Infra Projects Limited, pre-fabricated infra products designing and supplying company; has reached its goal of ISO 9001:2008 certification with the assistance of quality service management consultant Punyam Management Services pvt ltd.

ISO 9001:2008 certification allows Sintex Infra to implement a quality management system that will improve communication between employees, management and customers. All technical and management employees in the company are trained and acknowledged by Punyam with quality policies, ISO 9001 manual and procedures that work to ensure uniformity and efficiency when it comes to serving the needs of each customer.

PUNYAM Management specifically focuses on providing manufacturing and service providing companies with the tools needed to streamline their quality control and communications to serve clients of all sizes. The Quality Management System – ISO 9001 consulting services from Punyam have helped Sintex Infra Projects ltd a high level of customer satisfaction. “The approach towards QMS was greatly appreciated as it allowed Sintex Infra to remain focused on our core mission while the necessary work of creating a new quality mission was put into place,” said Sintex Infra Projects resources, about the company’s experience with Punyam Management.

The QMS representative from Punyam was involved in preparing quality documents, writing of new procedures to improve business practices, creation of a manual designed with ISO 9001:2008 standards in mind and working with the ISOQAR registrar auditor on behalf of Sintex Infra Projects limited. Punyam has also provided system awareness training, auditor training as well as helpful during the certification process. The consultant provided with services including internal auditing of employees to ensure understanding and compliance with the quality management system. The certification audit for ISO 9001:2008 is done on 20-July 2015 by registrar auditors from ISOQAR, UK based certifying body and after successfully auditing the implemented quality system, they have recommended Sintex Infra Project limited for ISO 9001:2008 certification.

About Sintex Infra Projects Ltd.

Sintex Infra Projects Ltd., was founded in 2009 and is based in Kalol, Gujarat and a wholly owned subsidiary of Sintex Industries Ltd. It is a Construction and Infrastructure Company engaged in designing, supplying & installation of pre-fabricated & pre-engineered houses, offices, schools, health centres, sanitation facilities including factory building, ware house, prefab used for government and privet infrastructure etc,. The company designs and serves as per customer requirements as well as readymade predesigned products in plastocrete, PVC, sandwich panel, monolithic form, PVC furniture.

 

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ISO 15189 Certification – Medical Laboratory Accreditation

The ISO 15189 standard is closely based on the accreditation of laboratories ISO 17025 system, but incorporates essential components for medical laboratories. This standard focuses on the needs of patients and is focused on the clinical roles staff, responsibilities and needs. It addresses issues specific to medical laboratory that include the provision of advisory services to clinicians , collection of patient samples, providing tests in a medical emergency and the contribution of medical laboratory services to patient care . The standard is applicable to private laboratories and laboratories from both public and private hospitals.

ISO 15189 system provides an effective quality management and technical competence framework that enables medical laboratories to meet international standards of patient care and laboratory responsibility. The ISO 15189 Certification, when carefully planned to meet the laboratory requirements, can also improve laboratory services, products and business processes.

Medical laboratories can also benefit from the automation of business processes and controls that achieve or maintain permanently ISO 15189 certification. Automation also helps with standard inspections.

For medical laboratory, ISO 15189 audit is taken by combination of technical experts and medically qualified assessors from the accreditation bodies that have significant experience in medical laboratory accreditation. The concept of laboratory accreditation is defined by the ISO / IEC standard that formal recognition that the testing laboratory is competent to perform specific tests or specific types of tests. The test is defined as a technical operation of determining one or more characteristics of a product, process, or service according to a specified procedure.

Benefits of Medical Laboratory Accreditation:

Medical Laboratory Accreditation – ISO 15189 demonstrates the competence of a laboratory to manage and perform activities defined by the scope of its specific accreditation program. With accreditation of medical laboratories, laboratories are able to obtain an independent third party, the results credible trials for them and for their customers.

ISO 15189 accreditation of medical laboratories helps laboratories deliver services with confidence and attract new customers. A major benefit of accreditation to ISO 15189 is that it is recognized worldwide. Medical laboratories also experience many benefits in becoming accredited.

In addition to reducing the risks Accreditation encourages sharing of best practices and stimulates innovation. Undergoing accreditation process can also have a positive effect on laboratory results because it is accurate and standardized clinical trials directly contributes to the control of all health care costs . This cost control is mainly achieved by targeting accurately all treatment modalities once an accurate diagnosis is reached.

 

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