James J. King


 

ZERO TO 9000


 

     

Home Up Zero to 9000 Zero to 14/18001

 

This program has been established to provide your organization with an accelerated program of development, which includes creating and installing an ISO 9000 Quality Management System (QMS). This can be accomplished within a six-month [1] time frame.  The Zero to 9000 QMS has six phases for implementation.  All times are approximations and will depend upon the continuing availability of the client’s staff.

  • Phase 1:

  1. The orientation of top management to the requirements of ISO 9000.

  2. The organization’s level of commitment (barrier analysis) will be evaluated and recommendations made.  This element evaluates management’s understanding and commitment for successfully implementing ISO 9000. This is an organization wide evaluation.

  3. A “State-of-Practice,” or “Gap-Analysis” is performed to evaluate the existing quality management efforts against the requirements of ISO 9000. A clearly defined list of recommendations will be made to fill in the “Gaps” so that the standard is satisfied.

  4. Time line to ISO 9000 QMS completion.  Establishes a fast-track approach to registration.

  5. Five days on-site.

  • Phase 2: 

The creation of a QMS Manual is not a mandatory requirement of the current standard but is essential to a well-organized QMS.  The Manual is a road map for the QMS.  Based on the findings of the “Needs Analysis” the identification of procedures and work instructions is performed here.  This Manual should only be 15-30 pages in length and is only a preliminary draft. The Manual will be finalized during Phase 6.

  •  Phase 3:

Procedures, work instructions and record development are identified here and documentation outlines and interviews are performed during this initial yet critical stage of procedure development.  This documentation can be adapted from existing procedures or developed from zero.

  • Phase 4:

Training:  Those persons performing work, which could effect product quality, have a training requirement mandated by the standard.  The training provided at this time would include Internal Auditor training and an initial internal audit.

  •  Phase 5:

Internal audits are now performed.  It is the Registrar's expectations that 100% of the QMS be audited before the certification audit.  Procedures will be edited after finding shortcomings in the written procedures.

  • Phase 6:

Registrar selection process.  A thorough due-diligence will be performed to ensure the right chemistry exists between Auditee and Registrar.  The organization is entering into a long-term business relationship and this should be treated as one of the most important aspects of Certification.  Choosing the wrong Registrar can be overly costly and can adversely effect the veracity of the QMS. Last minute changes to the QMS are made during this week.

  • Optional Services:

Quality/Environmental cost accounting systems development: This will be integrated into your existing management accounting system.  Two to four additional weeks.

 Health and Safety Manual: Based on OHSAS 18001:1999, the manual is an overview document, similar to the QMS Manual.

On-going Surveillance Auditing and Consulting: Once a year an evaluation of the organizations “state of practice” and preparation for the Registrars surveillance audits.  One week.

Note: Times quoted above are subject to change depending on the availability of the organizations personnel; the greater the availability the faster the process.


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