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Category Archives: ISO 15378

Started Consultancy Service for Upgrading ISO 15378:2017 Certification

Punyam.com is one of the largest ISO consultancy company in India that offers system certification, system auditor training and ISO system implementation services. Punyam.com has announced to offer ISO 15378:2017 consultancy services to help primary packaging material for medicinal product manufacturer to update their existing Quality Management System as per revised ISO 15378:2017 standard or want to gain new ISO 15378:2017 certification.

ISO 15378 Certification

ISO 15378 Standard has been revised in 2017. There are several new changes presented in the new ISO 15378:2017 standard. Punyam.com offers ISO 15378 Certification Consultancy service with aim to provide better system up-gradation for organization as per standard guidelines.

ISO 15378 Consultant of Punyam.com will help organization understand the structure of the newly revised standard by providing system awareness and auditor training. Along with effective system up-gradation, the company has committed to provide proper documentation during this consultancy service.

By join hands with Global Manager Group, Punyam has designed and sell ready-to-use ISO 15378:2017 documentation kit to implement fast and effective documentation of quality management system.

Steps Followed by Punyam for Achieving ISO 15378:2017 Certification

  1. Micro-level survey for each and every activity of the organisation and preparation of a detailed gap analysis report,
  2. Preparation of applicable documents as required by ISO 15378:2017 based on the detailed study of all activities of the organisation.
  3. Provide ISO 15378 awareness training to all levels of employees within the organisation.
  4. Conduct internal audit to check readiness for the ISO 15378 certification.
  5. Take corrective actions for non-conformities.
  6. Apply for ISO 15378:2017 Certification.
  7. Avail pre-certification audit of certifying body.
  8. Take actions on suggestions given by them.
  9. Final audit by certifying body.
  10. Take corrective actions on the non-conformities to the satisfaction of the certifying body.
  11. Get certified for ISO 15378:2017

 

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Posted by on February 7, 2019 in ISO 15378

 

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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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