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Quality Management System implementation:
Got a customer that will give you more orders if you get AS9100? Is ISO 9001 certification required to bid on a government contract? Are you trying to break into the medical device industry and see ISO 13485 in the supplier requirements? Do you want to formalize your processes and make your business more robust and survive potential turnover? Implementing a quality management system and getting certified to a QMS standard may be for you.
A typical implementation project consists of:
1. Talking to process owners and determining what you currently do
2. Identify gaps that need to be addressed to meet a particular standard
3. Draft procedures and identify process changes needed to meet the standard. Your current process and work flow will be prioritized and changes presented only when necessary
4. Review draft procedures with process owners. Ensure your current process and work flow is accurately documented and ensure any changes are understood and agreed upon by key personnel
5. Start implementing needed process changes
6. Conduct internal audits
7. Perform corrective action, update processes and procedures to address issues found during the audits
8. Stage I audit – audit performed by certification body – primarily a documentation review – have you determined what you need to do to meet the requirements of the standard?
9. Address stage I findings
10. Stage II audit – audit of people and processes. Are you actually doing what is required to meet the standard
11. Address any stage II findings
12. Get certificate
13. Promote to current and potential customers.
Internal audits - ISO 9001, AS9100, ISO 13485 and ISO 14001:
Large companies may have a full-time internal auditor. Smaller companies either train internal staff to perform the audits or outsource them to a quality management professional.
Having your internal audits done by a certified and experienced auditor is often more effective and economical than using your own staff. Being a good internal auditor takes more than training. It takes experience and talent and the time away from employees’ normal work to do it properly. A company might train eight internal auditors. However, after a while, it turns out that two lacked the aptitude or interest, two left the company, two had promotions or other job duties added and no longer have time, leaving only two internal auditors remaining. This occurs frequently at small and mid-sized companies and commonly leads to getting behind in your audits and threatening your registration status.
Outsourcing your internal audits leaves your staff free to perform their normal jobs and provides experience and expertise, as well as additional perspective, you would not normally get. The cost of training alone may be as much as a full year cycle of audits by a professional. When you add that to the cost of your employees' time spent training and auditing, it can easily be less expensive to use an external resource. The smaller the organization and higher the turnover, the more likely this is to be the case.
Internal audit training - ISO 9001 and AS9100:
Your employees are often in the best position to know your requirements and your customers' and notice mistakes and room for improvement. If the internal resources are available and turnover is low, this may be the best option.
Training is provided onsite and typically lasts two days, plus additional time for audit coaching, depending on the group size.
Audit coaching - having the trainer accompany and assist new internal auditors - is including in the training program. New auditors will conduct their first audit with the trainer to get 'on-the-job' experience. If you do not have experienced internal auditors on staff, it is often beneficial to have audit coaching for the few audits people perform.
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