ISO 15378 Manual, Procedures, Audit Checklist
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ISO 15378 Certification Documents - Manual, Procedures, Audit Checklist

We are offering ISO 15378 certification consultancy for primary packaging material for medical products manufacturing industries. So far company is having many clients who have successfully developed ISO management system with readymade ISO 15378 documentation kit. Our 15378 documentation kit helps them in step by step implementation of quality system and accelerate proper documentation as well as internal audit, which helped organizations to achieve quick certification. The ISO 15378 Certification Documents are created by team of experienced ISO consultants.
D141 - ISO 15378:2015 Documentation Kit for Primary Medicinal Packaging - $ 899
This ISO 15378 certification document can help user in making certification process easier and effective. The 4tire documentation written in plain English is designed by team of highly experienced ISO consultants. It includes ISO 15378 manual, mandatory and standard operating procedures, exhibits, sample formats, process approach, internal audit checklist etc., in editable formats. Any organization can easily modify this ready-to-use templates as per their company requirement and within 5 days their entire documents for ISO 15378 certification with all necessary controls will be ready.

Content of Readymade Templates of ISO 15378 Documentation Kit

ISO 15378 Documents Manual
  • ISO 15378 Manual - Sample manual in English (8 chapters and 5 Annexure).
  • ISO 15378 Procedures (19 mandatory procedures)
  • SOPs (61 standard operating procedures).
  • Sample formats for records keeping (43 blank forms).
  • Exhibits (04 smaple exhibits)
  • Process Approach with flow charts (12 process approaches)
  • Department wise and requirements wise audit checklists (more than 500 audit questions).
During implementation of ISO 15378 documentation, including ISO 15378 manual, procedures, policies, sop and forms are used by many medical packaging products manufacturers to establish good quality management system as per ISO 15378:2015 requirements and GMP guidelines. This ISO 15378 document kit includes mandatory procedures templates covering all the details like purpose and scope for system implementation, responsibility, how procedure is followed as well as list of exhibits, reference documents and formats. The sample formats are given to frame the information and records for all departments. Total more than 500 audit questions are given as internal audit checklist for all departments and clauses.
Benefits of Using Our Documents in ISO 15378:2015 Certification:
  • By using this time saving iso 15378 documents, you can save a lot of your precious time while preparing documentation.
  • Complete set of documentation requirements - Take care for all the section and sub sections of Packaging Products Quality Management System requirements that help you in establishing effective system.
  • User Friendly Documents and templates enables you to change the contents and print as many copies as you need.
  • Ready to Use Formats editable templates and sample documents can reduce cost of manpower in document preparation.
  • You will get better control in your implemented system due to our proven formats and templates developed under the guidance of our experts and globally proven consultants having rich experience of more than 20 years in system certification consultancy.
  • Many companies have achieved ISO15378 certification and getting benefits of GMP based implemented system in day to day life.
  • It is been verified and evaluated at various levels of Good Manufacturing Practices in system implementation by our team and more than 2000 hours are spent in preparation of this document set.

Method of Online Delivery of Our Documents

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