1. Purpose and Scope

The purpose of this procedure is to establish a system and assign responsibilities for scheduling, conducting, and recording management reviews of our quality system.

This procedure applies to all IsoQual functions and operations and encompasses all Quality Management System (QMS) processes as defined in our Quality Manual, Standard Operating Procedures (SOP) and associated Deployment Flow Charts (DFC) and Process Assessment Worksheets (PAWs).

2. Reference Documents. The following internal documents are referenced in this procedure to define their interaction with the document control process. Hereafter, these are only referred to by their document number. The latest edition of the document referred to applies. SOP 4.2.3 contains procedures governing the control of these and other QMS documents. (list all documents actually referenced in this procedure).

QM - Quality Manual

DFC 4.1 - Sequence and Interaction of Key QMS Processes

SOP 4.2.3 - Control of Documents

SOP 4.2.4 - Control of Records

SOP 6.2.2 - Competence, Awareness and Training

SOP 7.3 - Design and Development

SOP 7.4.1 - Supplier Evaluation

SOP 8.2.1 - Customer Satisfaction

SOP 8.2.2 - Internal Audit

SOP 8.2.4 - Monitoring and Measurement of Product

SOP 8.5 - Continual Improvement

3. Terms and Definitions.

Our QMS uses the same internationally recognized terms, vocabulary and definitions given in ISO 9000:2000. Acronyms, terms, vocabulary and definitions unique to our QMS and management review process include (list all unique terms and definitions contained in this procedure):

Top Management: At IsoQual, Inc., members of top management include: (?) the Chief Executive Officer (CEO), the Chief Operations Officer (COO), the Chief Financial Officer (CFO) and the Human Resources Officer (HRO).

Key Performance Measures: Members of top management establish performance measures and related improvement objectives and monitor progress towards their achievement.

4. Control and Maintenance. By delegated authority from the CEO, the ISO Management Representative (?) has overall responsibility for administering the management review process, including the issuance and maintenance of this procedure. All proposed changes and other suggestions for improvement should be submitted to the ISO Management Representative (?) in accordance with SOP 4.2.3. The ISO Management Representative (?) reviews all proposed changes as they are submitted and otherwise reviews this document annually for compliance with ISO 9001:2000 requirements and consistency with established policy, objectives and other QMS processes/systems. The Information Systems Manager (?) maintains a master copy of this document and controls its electronic and hard copy distribution as well as any IsoQual Forms and/or record formats required by the provisions of this SOP and any associated DFCs.

5. Management Review Process.

NOTE: DFC 5.6 can be used in lieu of or in conjunction with this procedure to document and manage the Management Review Process. PAW 5.6, can be used by the CEO, as process “owner”, to manage the process and can be used by internal auditors to assess its overall effectiveness per paragraph 6.5 following.

5.1 Objective. The primary objective of the management review process is to review our quality policy, objectives and QMS for continuing suitability and to identify any actions and related resources needed for its improvement.

5.2 Process Summary. Top management conducts a management review meeting at least once annually. Each attendee has designated responsibilities for presenting specific review meeting inputs and for providing related recommendations for review and action. DFC 4.1 which is contained in our quality manual, depicts how the key outputs of all our key QMS processes serve as key inputs to our management review process. The ISO Management Representative (?) documents management review minutes. Approved actions are entered into the corrective and preventive action system to ensure follow up and effective implementation in accordance with provisions contained in SOP 8.5. The ISO Management Representative (?) assesses the effectiveness and efficiency of the management review process through self assessment and/or as a result of internal audits conducted per SOP 8.2.2, initiates appropriate corrective/preventive actions per SOP 8.5, and provides trend data and related recommendations to top management for review and action per SOP 5.6 and/or DFC 5.6.

6. Management Review Procedures and Responsibilities

6.1 Attendance. The ISO Management Representative and members of top management attend management review meetings; others may attend as requested by any member of top management. Members of top management unable to attend must send an informed and duly authorized representative capable of presenting review inputs and related recommendations.

6.2 Scheduling. The ISO Management Representative (?) schedules a management review meeting at least once annually during the last quarter of the calendar year, usually during December. Additional review meetings may be scheduled through the ISO Management Representative (?) by any member of top management who feels that changes or events may adversely impact the continuing suitability of the QMS. The agenda for the annual meeting will consist of a review of the inputs discussed in the following section; the agenda for other management review meetings will be published by the ISO Management Representative (?).

6.3 Review Inputs. The annual Management Review Meeting includes a review of current performance and opportunities for improvement in an open discussion format to foster idea generation. The agenda for the annual Management Review Meeting is prepared by the Management Representative and distributed to the participants at least one week prior to the meeting. At a minimum, the agenda will include a review of the following inputs:

MANAGEMENT REVIEW INPUT ITEMS	Responsible Manager
Follow-up Actions from Previous Management Reviews	ISO Management Rep (?)
Strategic or Operational Changes that could affect the QMS	ALL
Review of Quality Policy	ALL
Progress towards meeting specific improvement objectives established in accordance with section 5.4.1 of the Quality Manual	ALL
Establishment of New or Changed Objectives	ALL
Recommendations for Improvement and Required Resources	ALL

6.4 Review Output. Outputs from management review meetings will be documented in the meeting minutes prepared and issued by the ISO Management Representative (?); output will include any corrective, preventive or other actions required for improvement of the QMS and its processes, improvement of product related to customer requirements, and provision of resource needs. System changes, issues requiring further investigation, or recommendations for improvements will also be documented on a Corrective/Preventive Action Request (CPAR) in accordance with provisions contained in SOP 8.5 to ensure implementation and follow-up.

Minutes of the meeting are documented and distributed to members of top management and any other attendees. The minutes, together with other internal documents pertaining to the meeting, are “for official use only” records and shall not be made available to anyone outside the organization without specific authorization from the ISO Management Representative (?).

6.5 Records. Management reviews meeting minutes are documented in any format deemed appropriate by the ISO Management Representative, however, must include “Management Review” as part of the title, and must be dated and signed by the ISO Management Representative (?) and the CEO (?), and retained in accordance with provisions contained in SOP 4.2.4.

6.5 Analysis of Results. The ISO Management Representative (?) periodically reviews internal/external audit results conducted per SOP 8.2.2 and other relevant data to determine the effectiveness/efficiency of the management review process and initiates corrective/preventive action per SOP 8.5 as required; and identifies and reports trends and related recommendations to top management for review and action during management reviews. PAW 5.6, can be used by the ISO Management Representative and/or internal auditors to assess the effectiveness/efficiency of the management review process and identify opportunities for improvement.

Document: SOP 5.6 - Management Review

Revision: 1-1-03

Page: 2 of 1

IsoQual, Inc. (insert your logo here)	Document: SOP 5.6 - Management Review
		Revision: 1-1-03	Page: 1 of 1
		Reviewed by ISO Management Representative Signature/Date:	Approved by ISO Management Representative Signature/Date:

Distribution:
	CEO		COO		CFO
	ISO Management Rep.		HRO

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