English to Russian Medical Other

Компания производит медицинские инструменты

New Supplier:
A review of the implemented QMS - Quality Management System.
A-1
MANAGEMENT RESPONSIBILITY
(Ref ISO 5.6)
a.
b.
c.
d.
CAPA
e.
f.
RESOURCE MANAGEMENT
PRODUCT REALIZATION
(Ref ISO 8.2.2)
An audit schedule is established and maintained.
OTHER PROCESS CRITERIA
(Other Criteria)
Observation (Critical, Major or Minor)
Evidence Reviewed
(Ref ISO 14001, 4.1)
(Ref ISO 14001, 4.5.2)
(Ref ISO 14001, 4.3.1a)
Manufacturing processes
(Other criteria)
Calibration standards are traceable to a recognized standard such as NIST.
Process operation excursions, scrap, rejects, safety issues, validations results, customer complaints, and CAPA are monitored, analyzed, and trended (if appropriate).
There is routine analysis of conformance against material specifications.
Supplier has direct access to Metallurgical personnel whose qualifications are known and adequate.
LABORATORY CONTROL
Sufficient inspection equipment/capabilities exist.
There are NDT capabilities using CERTIFIED Sources (e.g., X-ray, magnetic particle, fluorescent penetrant inspection (FPI), etc.).
(NOTE: Use NDT checklist if deeper investigation is required.)
CLEANING METHODS AND CONTROL
Cleaning methods are established and controlled.
There is dedicated abrasive blast equipment for implantable metal grades.
If chemical cleaning, chemicals are controlled.
(NOTE: Use Critical Process Evaluation and Process Validation checklists to evaluate.)
Process requirements / operations are defined in a **shop router**.
IDENTIFICATION & TRACEABILITY
Identification is traceable to a heat run.
FINAL INSPECTION
Visual inspection is defined and a part of final release.
There are established and controlled visual standards.
The results of the performance analyses are inputs into the facilities management review process.
3
NDT PROCESSES
g.
PLATING PROCESSES
CHANGE CONTROL
h.
i.
BOVINE SPONGIFORM ENCEPHALOPATHY (BSE)
Inspection, process, or test equipment is controlled under a formal calibration program.
Specification review is performed on new customer orders.
An up-to-date system is maintained on customer specifications.
Personnel who perform testing are trained and certified.