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ISO 15378:2017 Certification Documents - Manual, Procedures, Audit Checklist

We offer ISO 15378 certification consultancy  for primary packaging materials for medical products manufacturing industries. We are having many clients who have successfully developed ISO management system with readymade ISO 15378:2017 documentation kit. Our 15378:2017 documentation kit helps organzations in step-by-step implementation of quality system and accelerates documentation process as well as internal audit, to achieve quick certification. The ISO 15378:2017 Certification Documents are created by team of experienced ISO consultants.






This ISO 15378:2017 certification documentation kit can help users in making certification process easier and effective. The Entire documentation is written in plain English and designed by a team of highly experienced ISO consultants. It includes ISO 15378:2017 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's requirement and within five days their entire documents for ISO 15378:2017 certification with all necessary controls will be ready.

Contents of Readymade Templates of ISO 15378:2017 Documentation Kit


 ISO 15378 Manual - sample manual in English (8 Chapters and 5 Annexures).

 ISO 15378 Procedures (19 mandatory procedures)

 SOPs (61 standard operating procedures).

 Sample formats for record-keeping (43 blank forms).

 Exhibits (4 sample 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 15378:2017 documentation, ISO 15378 manual, procedures, policies, SOPs and forms are used by medical packaging products manufacturers to establish good quality management system as per ISO 15378:2017 requirements and GMP guidelines. This ISO 15378:2017 documentation kit includes mandatory procedures templates covering all the details such as purpose and scope for system implementation, responsibility, how procedure is followed 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.



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