The DO's and DON'Ts of ISO AS or TS implementation:

Do!

  • Document your way of doing business and align the implementation of ISO 9001:2000, ISO 13485, AS9100, or TS 16949 with your business objectives and business practices.
  • Keep the documentation simple.
  • Document the flexibility you need in your procedures.
  • Use the ISO implementation as a stepping stone to get better efficiency in your operation.
  • Choose a Management Representative that is part of the management team and well liked and respected within the organization.
  • Conduct your implementation on a faster-track approach, slow implementations are more disruptive and difficult in the long run.
  • Choose an ISO/Management representative who sees the big picture and understand ISO at a higher level.
  • Provide ISO training to the management level individuals even if you are going to use an external consultant. (see Online training).
  • Provide Internal Auditor training to the Management Representative and some other key members of the organization. (see Online training).
  • Select a consultant firm on the basis of how well their style will fit your company culture, as well as their success rate in helping companies achieve certification. An inappropriate consultant can do a lot of damage. Check the references!
  • Make sure you use consultants with practical business experience in your field. Check their references and recent certification success stories.
  • Check credit history of consulting firms... there are a lot of reputable and yet unreliable entities out there...
  • Beware of consultants that quote you a fixed cost without conducting a thorough audit of your operation. They are low-balling to get the job. Once they get it and they do get a feel of the amount of work, they will either start cutting corners to save time, which will put you at risk, or find a way to abort the implementation process in midstream after having pocketed a chunk of money.
  • Ask for detailed quotes from registrars that cover a 3-year period, which include the yearly Surveillance Audits.
  • Lock in a registration audit date right away, so that all your organization has a clear target and stays focused.
  • Choose and treat your Registrar like a long-term partner.
  • Use a Registrar's Preliminary Assessment as an improvement tool, as well as to maintain momentum for the implementation.
  • If you feel confident that you are ready without having to go through a preliminary assessment, call for a certification audit.
  • Parallel process the ISO/EN certification with the preparation of your technical file for CE certification of medical products.

Do Not!

  • Start implementation before an experienced person or a professional conducts a gap assessment to determine exactly what needs to be done. You may go off-track and waste precious time and resources implementing unnecessary items, and missing some crucial tasks.
  • Select a consulting or training firm based on cost. The cheap ones will cut corners. You will end up paying for the incomplete implementation or training during AND after the registration audit. (Use State Funds instead to have an adequate training budget).
  • Create more work for yourself and your colleagues just to comply with ISO. That may mean that you are not aligning the implementation with your business practices and worst of all that the maintenance of the quality management system is going to be cumbersome and burdensome for your organization.
  • Use canned documentation or wonder software: they just plainly don't work if you want to comply with ISO and be certified by a reputable registrar.
  • Conduct ISO implementation just to get a certificate.
  • Over-document procedures: the more you say the more you commit to.
  • Sacrifice the operational flexibility you need for your business to please the auditors.
  • Use a consultant that you will have to depend on to maintain your quality management system after certification. It will just cost you more and imply that the implementation was incomplete.
  • Use an expensive consulting firm as a guarantee of better results: they usually have large corporation background, and may impose inapplicable requirements to your businesses, or may send their trainees to work on your account.
  • Document artificial or hypothetical ways of doing business to please a Registrar.
  • Leave the Registration audit date TBD until you assess implementation progress.
  • Think a Registrar is here to fail you.
  • Use an obscure Registrars who may almost give you a certificate for the right price… Their ISO certificates are worthless in the eyes of the business community.
  • Think that a good auditor is necessarily good at implementation.
  • Have a Preliminary Assessment conducted by a Registrar, if you do not have a well-implemented quality management system.
  • Implement SPC if it does not make sense for your process.

Check out The Bookstore for more sources of information on ISO certification.

For Training on ISO 9000 and internal auditing see Online training.




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