A Quality System Registration Service

Registration Process

Back

Registration Process Steps

The Registration Process at International Quality Registrars (IQR) Corporation involves the following steps:

A – DOCUMENT REVIEW

B – PRE-ASSESSMENT (OPTIONAL)

C – REGISTRATION AUDIT

D – SURVEILLANCE AUDITS

E - VALIDITY OF REGISTRATION CERTIFICATES

 

A - DOCUMENT REVIEW

Purpose

The document review addresses the recorded description of the methods selected by the company for meeting the quality system requirements (such as the quality manual). It provides a basis for the company and the lead auditor to determine that the system, as described, is complete and that the audit objectives for registration are achievable.

 

Process

Prior to the pre-assessment and/or registration audit, the quality manual and applicable procedures are submitted to International Quality Registrars (IQR) Corporation for review*. The revision status is verified and the contents are compared with the requirements of the selected standard. Any requirements that are not or do not appear to be covered will be identified and a request will be made for either clarification or for action to expand the system description. A summary of these items is sent to the company and the process is continued until it is determined that the system description is complete.

* - The document review can also be initiated at the time of the pre-assessment if so desired. Determination of the timing of the document review is completely at the discretion of the company as long as it is completed prior to the registration audit.

 

Results

Upon completion of the document review, plans are finalized for the registration audit. Any revisions made to the reviewed documentation by the company are communicated to International Quality Registrars (IQR) Corporation to ensure continuing validity of that plan.

 

B – PRE-ASSESSMENT (OPTIONAL)

Purpose

The pre-assessment is conducted to assist the company in determining the status of its implementation of the quality system. It will allow the company to determine the timeframe for full implementation and schedule its registration assessment.

 

Time

The size and complexity of the operation defined by the quality system documentation will determine the amount of time needed to perform the pre-assessment. Typically, one to two days is sufficient to assess those activities that significantly impact the overall effectiveness of the system. Additional time can be scheduled depending on the extent of the pre-assessment up to and including a full system evaluation.

 

Process

The company representative and International Quality Registrars (IQR) Corporation will establish a lead auditor, determine the amount of time needed to perform the pre-assessment and decide the elements/activities to be addressed. The company representative will then notify the personnel who operate the quality system of the agreed upon schedule.

The pre-assessment begins with an opening meeting where the audit and registration guidelines are presented, the plan for elements/activities to be covered is updated and a decision on the reporting method is made based on the needs of the company. An audit format is followed which includes documentation review, observation of activities, interviews with personnel and quality record review. This will continue throughout the duration of the pre-assessment. Any changes made to the areas that are covered will be submitted to the company representative for approval.

 

Outcome

The lead auditor presents the results of the pre-assessment at the closing meeting. These results are for the company use only and are not used during the registration assessment.

 

C - REGISTRATION AUDIT

Registration Audit Team

The audit team is introduced, in writing to the client. The client shall review the audit team and, if any concerns exist, contact International Quality Registrars (IQR) Corporation The client can request a replacement for another team without giving a reason.

 

Registration Audit Schedule

The client has 2 days prior to the initial scheduled audit to change the date. A registration audit schedule and checklist are sent to the client within two (2) days prior to the registration audit.

 

Registration Audit Progress Reports

Daily meetings are held by the audit team with the client to discuss audit progress as well as any non-conformities discovered or concerns that have arisen.

 

Registration Audit Completion

Upon completion of the audit, a closing meeting will be held to discuss any non-conformances discovered. During this meeting, the client will have the opportunity to propose corrective action to the audit team for approval. The client must confirm, in writing, the implementation of any corrective actions taken. The effectiveness of corrective actions taken is verified during the subsequent surveillance audit.

 

D - SURVEILLANCE AUDIT

General

International Quality Registrars (IQR) Corporation will propose surveillance audit dates at least four to six weeks prior to the audit. The client is requested to confirm these dates or propose alternative dates.

A surveillance audit schedule including the elements to be audited will be sent to the client so that all personnel/departments can make arrangements for the audit.

Upon completion of the surveillance audit, a meeting is held with the client to discuss any non-conformances found. The client has the opportunity to propose corrective actions and establish a timeframe for implementation of these actions.

 

E - VALIDITY OF REGISTRATION CERTIFICATES

The client has two types of certificates to choose from:

Three Year Validity Registration Certificate - this certificate is valid for three years. Annual surveillance visits are carried during the validity period.

One Year Certificate of Compliance - this certificate is issued with a 1 year validity period. Optionally, Surveillance visits maybe conducted every six months. It is mandatory that all elements of the appropriate standard(s) are audited within a one year period.