Risk Management - Buffalo Rochester NY
Risk Management - Buffalo Rochester NY
Risk Management - Buffalo Rochester NY
Risk Management - Buffalo Rochester NY

ISO 9001 – Quality Management System

ISO 9001 Consulting Services


ISO 9001:2015 is the most recent update to the International Organization for Standards’ requirements for a Quality Management System. It is part of the ISO 9000 set of standards and is designed to help organizations become more efficient and improve customer satisfaction with an emphasis on continual improvement. The ISO 9001 is intended for use by all sizes of companies to document and follow a standardized system for Quality Management. This standard puts the customer first, which can result in increased customer satisfaction as well as new clients resulting in growth for the business. It will also help to meet statutory and regulatory requirements, identify and address risks, and expand into new markets.

Freed Maxick can help clients implement ISO 9001 and assess you level of compliance with the standards.

ISO 9001 compliance benefits include:

  • Requires assessment of the company’s customers’ needs and expectations
  • Allows for a clear statement of objectives
  • Places customers first
  • Meet statutory and regulatory requirements
  • Many customers require ISO 9001 certification before business can be done
  • Identify and deal with risks facing the company

ISO 9001 Checklist

ISO 9001:2015 compliance requires the following components for an effective quality management system (QMS):

  1. Responsibility of management
    • Management must create a system and clearly document it, implement it and explain it.
    • The roles of those within the system must be clearly defined and trained.
    • Resources must be allocated properly to those within the QMS
    • Management must oversee implementation and maintenance of the QMS
  2. Quality system
    • Procedures must be clear and concise
    • Procedures must be put in place and explained comprehensibly
  3. Contract review
    • Contracts must clearly define requirements, agree with bid, and be achievable
  4. Design control
    • Design project must be planned
    • Parameters must be defined
    • Output must be documented and verified
    • Any changes to design must be controlled
  5. Document control
    • Generation, distribution, and changing of documents is to be properly overseen
  6. Purchasing
    • Sub-contractors/suppliers must be evaluated to ensure their capabilities meet standards
    • Requirements for sub-contractors/suppliers will be clearly defined
    • Sub-contractor quality assurance systems must be assessed
  7. Customer-supplied material
    • Any material supplied by a customer is to be kept safe and unharmed
  8. Product Identification and traceability
    • Products must be identifiable and traceable through all steps of production
  9. Process control
    • Production must be defined and planned
    • Production must occur under controlled circumstances
  10. Inspection and testing
    • Incoming materials must be inspected and tested before use
    • Inspection must occur during production as well as at the end
    • Records of inspection and testing must be kept
  11. Inspection/Measuring/Test equipment
    • Instruments used for testing must always be inspected for calibration
    • Measurement and conformance tests of products must be defined and documented
  12. Inspection and test status
    • Inspections and tests of product must occur throughout production
    • Statuses of product after each inspection/test must be documented
    • Records must show whether product met conformance standards at each step
  13. Control of nonconforming product
    • Control of nonconforming product must occur to prevent installation or use
    • Nonconforming product must be formally reviewed
  14. Corrective action
    • Causes of non-conformity must be identified and corrected
    • Corrective actions must be assessed for effectiveness
  15. Handling, storage, packaging and delivery
    • Procedures for safe and effective handling, storage, packaging, and delivery must be defined
    • Procedures must prevent damage and assess product for damage at each step
    • Final inspection before product delivery must occur and be documented
  16. Quality records
    • Quality records must be created, stored, and effectively organized
  17. Internal quality audits
    • Audits must be planned and performed, whether by internal entities or third-party groups
    • Audit results must be communicated to management
    • Deficiencies found in audits must be corrected
  18. Training
    • Training needs must be identified, planned, and provided when necessary
    • Records of training will be kept
  19. Servicing
    • Servicing activities must follow company standards
  20. Statistical techniques
    • Statistical techniques must be created and used to analyze processes and product quality

ISO 9001 Consulting

To learn more about our ISO 9001 consulting services, please contact one of our ISO 9001 certification consultants at 716-847-2651 or use the contact form at the bottom of this page and one of our team members will be in touch soon.