Tuesday, April 28, 2015

Documents and record required by ISO 9001:2008 and OHSAS 18001


Q. Discuss the mandatory records to be maintained under ISO 9001:2008 .


Documents required by ISO 9001:2008 are
  • Documented statements of a quality policy and quality objectives; 
  •  A quality manual
  • Documented procedures required by this International Standard specifically for the following six activities :
  1. Control of documents 
  2. Control of records
  3. Internal audit
  4. Control of nonconforming product 
  5. Corrective action
  6. Preventive action
 Documents needed by the organization to ensure the effective planning, operation and control of its  processes, and Records required by this International Standard

Records required by ISO 9001:2008 are 
    1.  Management reviews
    2.  Education, training, skills and experience
    3.  Evidence that the realization processes and resulting product fulfill requirements
    4. The results of the review of requirements related to the product and actions. 
    5. Design and development inputs relating to product requirements
    6.  Results of design and development reviews and any necessary action
    7. Results of design and development verification and any necessary actions 
    8. Results of design and development validation and any necessary actions
    9. Results of the review of design and development changes and any necessary actions
    10. Results of supplier evaluations and any necessary actions arising from the evaluations
    11. As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.
    12. .The unique identification of the product, where traceability is a requirement. 
    13. Customer property that is lost, damaged or otherwise found to be unsuitable for use.
    14. Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist.
    15. The validity of the previous measuring results when the measuring equipment is found not to conform to  the requirements.
    16. Results of calibration and verification of measuring equipment. 
    17. Internal audit results and follow-up actions.
    18. Indication of the person(s) authorizing release of product.
    19. Nature of the product non-conformities and any subsequent actions taken, including concessions obtained
    20. Results of corrective action 
    21. Results of preventive action 


    The Health and Safety & OHSAS Guide 

                OHSAS 18001 is a standard used for an occupational health and safety management system, which enables an organisation to control its risks and improve its performance in this area.  The standard provides a systematic approach to identifying hazards, and then either eliminates or reducing the risks of the hazards.

    Benefits

    1. Reduce risks - it can contribute to a healthier working environment and help reduce accidents, employee illness and lost time.
    2. Improved staff morale - it can help support improved staff morale and offers potential reductions in liability claims and lower insurance premiums.
    3. Credibility - your organisation can benefit from increased credibility by having an OHS management system independently assessed.
    4. Supplier of choice -   it lets you work with companies where certification to OHSAS 18001 is a contractual requirement.