THE CERTIFICATION PROCESS

K&S Quality Associates, LLC can assist with the implementation and certification process for organizations seeking to have a Quality Management System in place.

1. The process begins with K&S performing a two day on-site writing session to create the quality manual and required procedures. During the two days of writing, key personnel will be interviewed by our consultants to get a better understanding of your core processes and to customize the quality documents to match your company. The quality manual will outline the organization’s goals and processes for compliance. The processes outlined in the quality manual and procedures will then have to be implemented within the organization. Additional, assistance can be provided by K&S for the implementation. Companies requiring this additional guidance will have one of our consultants visit the organization one or two days per week for approx. 60-90 days until the system is in place and enough objective evidence has been obtained.

2. Prior to certification a complete internal audit of the system must be performed. K&S Quality Associates can perform the internal audit (based on daily fee) or K&S can provide auditor training to select individuals (fee based on number of personnel trained). An initial management review meeting must be performed prior to the certification assessment, this is another area that K&S can provide expertise to ensure that all areas of the management review topics are addressed and correct content is being discussed.

3. The organization must then seek out a certification body that they feel comfortable with to certify their quality system. K&S can assist you with the selection of a registrar. The registrar must be accredited by an accrediting body to include a scope of the certification that you desire to be certified to (i.e. ISO13485, AS9100, and ISO14001).

4. The selected registrar will begin the process by performing an off-site document review followed by a pre-assessment (optional) and then assessment. After certification, your organization will be subject to on-going surveillance by your certification body. These are usually conducted annually or semi-annually. The assessment length is contingent on an organization’s scope—facility size, number of employees, complexity of products/services.

5. In addition to the service listed above, K&S Quality Associates, LLC has also provided ongoing maintenance of the QMS for companies that do not have enough resources to hire a full time Quality Manager or Management Representative to maintain the Quality Management System. This ongoing weekly consultation includes the annual internal audits, periodic management review meetings, monitoring and measurement of customer satisfaction, the review of discrepancies, root cause analysis, corrective/preventive actions, and continuous improvement.

For more information or to speak with a member of the Quality Associates team, click on the contact link.