Sl. No. |
Activity |
Responsibility |
01 |
Information to top management of the main requirements of the relevant management systems standard, and the roles of the organization and the consultant in the management system design and development. |
Consultant |
02 |
Analysis of the needs and the expectations of the organization’s customers and other interested parties.
Note: The results of the initial evaluation shall be generally used to
- To establish the organization’s strength and weakness opportunities and threats,
- To understand and help to define its policy and objectives,
- As a basis for planning the management system,
- To asses the availability of the resources needed to implement the management system,
- As a basis for initial auditing, and
- For the establishment of measurable objectives.
|
Organization’s top management (consultant provides assistance) |
03 |
Appointment of a management representative and the establishment of definitions of policy, objectives and commitments of the established management systems. Reference of such objectives to appropriate levels and functions within the organization. |
Organization’s top management (consultant provides assistance) |
04 |
In-depth analysis of organizational structure, processes channels of communication and existing interfaces.
Identification of the processes and responsibilities needed to achieve the desired objectives.
Definitions of sequences and interactions among such processes. |
Management representative and consultant, with the cooperation of the persons in charge of the various functions within the Organization. |
05 |
Set up a plan for defining the management system architecture and for identifying and developing the procedures needed for the management system. To asses the progress and quality of the implemented actions, appropriate milestones should be defined within the plan. The assessment may refer to Consistency between what has been prepared and developed and the contractual activities objectives,
- Work progress, and
- Satisfaction of the organization
|
Management representative and consultant |
06 |
Review of the results of the analysis carried out and of the plan prepared in advance. |
Organization’s top management and consultant |
07 |
Identification of internal resources needed to achieve the organization’s objectives. |
Organization (Consultant provides assistance) |
08 |
Training of the persons responsible for the developing activities for the management system realization, and of the organization’s other personnel (“facilitators”) involved. |
Management representative and consultant |
09 |
Identification and definition of processes, interrelation of processes and preparation of the necessary procedures, including procedures for record maintenance. |
Management representative (consultant provides assistance) |
10 |
Alignment of interrelated processes relevant procedures to avoid any inconsistencies, gaps and overlaps. |
Management representative and consultant. |
11 |
Elaboration of the final version of the manual, Mandatory Procedures, SOP, Work Instructions/ Process Qualification Records/ Necessary documents as per the requirement of the standards. |
Management representative (consultant provides assistance) |
12 |
Training of all core personnel involved with the quality management system. |
Consultant and management representative |
13 |
Implementation of the management system |
Organization (consultant provides assistance) |
14 |
Training of internal auditors, emphasizing auditing concepts, audit question development and audit report development and audit report preparation and other required training |
Consultant |
15 |
Development of a programme for internal audits. |
Management representative and consultant |
16 |
Participation in an initial series of internal audits, together with internal auditors, to provide them the additional training(including writing audit report and reports of nonconformities) and assistance in the formalization of detected nonconformities and their causes |
Consultant along with Management Representative |
17 |
Assisting top management in conducting effective management review meetings |
Consultant along with Management Representative |
18 |
Assisting with any implementation difficulties, focusing on corrective action and preventive action. |
Consultant along with Management Representative |
19 |
Continual improvement of the implementation process |
Organization’s top management(consultant provides assistance) |
20 |
Information about certification issues |
Consultant |