S.

NO DOCUMENTED INFORMATION MAINTAIN / RETAIN

1 Quality Management System & its processes Maintain
2 Information to have confidence that the processes are being carried out. Retain
3 Focus on enhancing customer satisfaction. Maintain
4 Quality Policy Maintain / Retain
5 Quality Objective Maintain / Retain
6 Infrastructure Maintain
7 Environment for the operation of process Maintain
8 Evidence of fitness for the purpose of the monitoring & measuring resources Retain
9 The basics used for calibration or verification Retain
10 The organizational knowledge Maintain
11 Appropriate evidence of competence Retain
12 Evidence of conformity Retain
13 Results of the review on any new requirements for the product & service Retain
14 Design & development inputs Retain
15 Design & development controls Retain
16 Design & development outputs Retain
17 Design & development changes Retain
18 Results of the review on design & development changes Retain
19 Any necessary actions arising from the evaluations Retain
20 The property of a customer lost, damaged or otherwise found to be unsuitable for use Retain
21 The results of the review of changes, the person authorizing the change and any actions Retain
arising from the review
22 On the release of products and services Retain
23 The non conformity, action taken, concessions obtained and the authority deciding the action. Retain
24 Evidence of the results of the performance and the effectiveness of the quality management Retain
system
25 Audit program including the frequency, methods, responsibilities, planning requirements and Maintain
reporting
 26 Audit program & the audit results Retain
27 Results of management reviews Retain
28 Nature of the non conformities and any subsequent actions taken Retain
29 Results of any corrective action Retain
30

CLAUSE TOP MANAGEMENT

5.LEADERSHIP
5.1. Leadership & Commitment
5.1.1. General Shall demonstrate leadership and commitment with
respect to the quality management system
5.1.2. Customer Focus Shall demonstrate leadership and commitment with
respect to customer focus
5.2. Policy
5.2.1. Establishing the Shall establish, implement and maintain a quality
quality policy policy
5.3. Organizational roles, Shall ensure that the responsibilities and authorities
responsibilities and authorities for relevant roles are assigned, communicated and
understood within the organization.