Services

Productivity improvements    Environmental and food safety management

  • Auditing & Training – – ISO9001, ISO17025, ISO22000, cGMP, ISO13485, GLP and GMP in packaging, toiletries, pharmaceuticals, nutriceuticals, textiles, packing, manufacturing and the food industry
  • Continuous Improvements Strategies – process mapping, risk assessment (SHEQ) and operations realignment – Kaizen, APQP, 5S and Six Sigma
  • Systems development and improvements: Pharmaceutical GMP ISO13485 medical device , Environmental ISO14000, food safety management HACCP ISO22000 & Safety management for OSHAct compliance system development and implementation
  • Productivity improvements by means of improvement identification and translation of the physical business process, using a systemized approach, to provide clear process direction and management control through the use of process mapping to develop and implementing improvement interventions.
  • Quality Assurance through ISO9001, PIC cGPM & HACCP development and Implementation with GMP (Good Manufacturing Practice) installation with validation and verification activities.
  • APQP: Advanced Product Quality Planning (Verification and validation of process & product)
  • Kaizen: Process Improvement through IOP analysis and solution achievement with waste elimination and value added process design realising cost improvements and continuous improvement
  • Regulatory: GMP compliance for pharmaceuticals and medical devices. Medical aid re-imbursement motivations and submissions
  • Quality Control: Appropriate and effective process quality inspection and GLP (Good Laboratory Practice) installation
  • Systems evaluations and alignment:
    • People – organizational structures and development strategies
    • Equipment – Total planned maintenance, calibration and validation
    • Premises – Factory layout, construction (clean room and controlled environments)
    • Infrastructure – Good manufacturing practices, ISO9001, ISO22000 (PRPs), ISO13485
    • (Risk assessment ISO14971), ISO14000 (Environment) & ISO18000 (Safety)/ OSH Act,
    • Measurement – Sampling and statistical techniques and testing methodology
    • Product – New product design and development, medicine registration and regulatory affairs
    • Methods – 5S housekeeping, 6 Sigma value stream analysis and improvement, Process mapping

Contact Simone on

082 871 5740
simone@isohealthsa.co.za


Removing RISK by linking business to ISO standards, legal compliance and GBP(Good Business Practice)

Contact Rudolph-Shortt Consultancy



Joint venture for project management GMP renovations and new facilities

Compliance Projects


R-SC Training

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