CERTIFICATION OF QUALITY MANAGEMENT SYSTEM OF LLC «CENTER OF PHARMACEUTICAL ANALYTICS» ACCORDING TO THE REQUIREMENTS OF ISO 9001:2015 (GOST R ISO 9001-2015) (REVIEW)
Bibliographic record
Abstract
Introduction. In 2018 «Center of Pharmaceutical Analytics» LLC successfully passed the certification of quality management system for compliance with the requirements of ISO 9001: 2015 and GOST R ISO 9001-2015 «Quality Management System. Requirements». Text. Certification was conducted by the Certification Association «Russian Register» – a Russian company, which is an accredited body for certification of management systems of organizations. This article describes the program of certification audit of the «Russian Register», which includes: certification, consisting of two stages, inspection checks during the first and second year and re-certification audit during the third year before the expiration of the certificate. The structure of works on confirmation of the certificate of conformity of «Russian Register» includes field audits designed to assess the degree of compliance of the organization with the established requirements of the standard for compliance with which certification was carried out [1]. The objectives of the certification audit were: verification of compliance of the management system with the requirements of ISO 9001: 2015 (GOST R ISO 9001-2015), verification of established processes and documentation of the management system of the organization; assessment of the ability of the management system to ensure compliance with applicable legislative, regulatory and contractual requirements; assessment of the effectiveness of the management system to ensure that the goals can be achieved; identification of areas for possible improvement of the management system. The audit was conducted over two days on processes and units related to the activities of the organization. The audit confirmed the scope of certification in respect of: research work, bioanalytical studies, pharmacokinetic studies, STCR (comparative text of dissolution kinetics). The scope of the audit included verification of adequacy, compliance of activities and elements of the management system, including: production, management and support processes; policies; goals; organizational structure of management; documentation of management system, analysis of measures taken by the organization to eliminate the problem areas identified at the 1st stage of certification [2]. Conclusion. In September 2018, the analytical center was issued certificates of compliance with the requirements of GOST R ISO 9001:2015 in the certification Association «Russian Register» with the accreditation of the Federal service for accreditation of the Russian Federation (Rosaccreditation); international standard ISO 9001: 2015 in the Certification system of the Russian Register, a member of the international forum on accreditation IAF; certificate of conformity.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.005 | 0.004 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".