ISO: 9001:2008 QMS AUDIT CHECKLISTS: MANAGEMENT REPRESENTATIVE (HEAD OFFICE)

MANAGEMENT REPRESENTATIVE

Sl ISO - 9001:2008 Clause Check Conformity

CHECKLISTS
No No. Yes No N/A

1 Quality Manual /Quality Policy / Quality Objectives

1.1 Is Quality Manual available in the department. 4.2.2

Is Quality System Procedure (QSP) and Standard Operating Procedures (SOP)

1.2 4.2.2
available in the department.

1.3 Is department aware of Quality Policy and communicated and display in office . 4.2.1

Status of achievement of quality objectives – Defining measurable annual targets for

1.4 4.2.1
different departments / functions; action plans and quality objective tracker.

1.5 Are quality objectives established and being reviewed regularly? 5.4.1

2 Document and Data Control

Site Organization Chart and definition of responsibilities and authorities of personnel -
2.1 5.5.1
work distribution.

2.2 Master list of records maintained in the department / function and their retrievability 4.2.3 a

2.3 Availability of QMS audit report, Records, compliance reports? 4.2.1d

2.4 Are all formats / records available in the department matching with master list? 4.2.3f

2.5 Are all obsolete document identified as "S/S" or scrapped. 4.2.3g

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 ISO: 9001:2008 QMS AUDIT CHECKLISTS: MANAGEMENT REPRESENTATIVE (HEAD OFFICE)

MANAGEMENT REPRESENTATIVE

Sl ISO - 9001:2008 Clause Check Conformity

CHECKLISTS
No No. Yes No N/A

3 Management Review

3.1 Determining quality objectives and monitoring their achievement.

All HODs report the status of achievement of the quality objectives at quarterly
3.2
intervals.

Quality Objectives Trackers submitted by all HODs are consolidated and reported for
3.3
review during the Management Review Meetings (MRM).

The management review of the QMS is conducted by MRC at least once in six
3.4
months.

The decisions taken by MRC based on the review of the performance of QMS are
3.5
recorded and circulated to all concerned for taking necessary actions.

Customer Feedback:Consolidated report of customer complaints received, settled and

3.6
age analysis of pending complaints

3.7 Changes to the Quality Management Systems

3.8 Improvement Plans

3.9 actions for improvement and effectiveness of the systems

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 ISO: 9001:2008 QMS AUDIT CHECKLISTS: MANAGEMENT REPRESENTATIVE (HEAD OFFICE)

MANAGEMENT REPRESENTATIVE

Sl ISO - 9001:2008 Clause Check Conformity

CHECKLISTS
No No. Yes No N/A

To plan internal quality audits and ensure that internal quality audits are effective and
3.1
timely corrective actions have been implemented based on the audit findings.

To identify the areas for improvement of QMS and for reporting on the performance of
3.11
the QMS at the management reviews.

To coordinate effective conduct of the management review meetings, record the

3.12
decisions taken and monitor their implementation and effectiveness

To ensure internal communication of the effectiveness of QMS and promote the

3.13
awareness of the customer and regulatory requirements throughout the organization

4 Control of non conformities

4.1 Is Product nonconformity and disposition records updated? 8.5.3d

4.2 Is Corrective & Preventive Action records (CPAC) maintained? 8.5.3d

Analysis of non conformities in order to establish the required corrective and

4.3 8.4
preventive actions?

4.4 Are there any Control defined for handling customer Complaints? 4.2.4

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 ISO: 9001:2008 QMS AUDIT CHECKLISTS: MANAGEMENT REPRESENTATIVE (HEAD OFFICE)

MANAGEMENT REPRESENTATIVE

Sl ISO - 9001:2008 Clause Check Conformity

CHECKLISTS
No No. Yes No N/A

4.5 Whether the procedure for handling customer correspondences is established? 4.2.4

4.6 Establishment of procedure to control the customer documents? 4.2.4

5 Corrective and Preventive Action

5.1 Is all corrective action taken and verified since last External and Internal QMS audit. 8.5.2

Auditor Auditee
Name: Name:
Designation Designation
Sign Sign
Date: Date:

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AD OFFICE)

Remarks

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AD OFFICE)

Remarks

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AD OFFICE)

Remarks

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AD OFFICE)

Remarks

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 ISO: 9001 QMS AUDIT CHECKLISTS
Check Confirmity
S.No. Checklist (Clause No.) Remarks
Yes No N/A
Does your quality policy include the framework for setting and
1
reviewing the quality objectives? (Clause 5.3c)
Are your organisation’s quality objectives
2 actually measureable? And do you measure them? (Clause
5.4.1)
Are your quality objectives cascaded through the organisation
3
and do they align from top to bottom? (Clause 5.4.1)
Have you identified and described your organisation’s
4 own business processes and how they interact with each
other? (Clause 4.1 a&b)
Has the criteria been set for what is an acceptable product or
5
service? (Clause 7.1c)
Have you established effective processes for communicating
6 with your workforce, and for them to communicate with you?
(Clause 5.5.3)
Do you review the performance of your organisation at
7
planned intervals? (Clause 5.6.1)
Does this review address all of the following information; the
results of audits, customer feedback, process performance,
8 your product and service conformity, the status of corrective
actions, the status of preventive actions, changes, and
improvement opportunities? (Clause 5.6.2)
Do actions arise from the reviews that you undertake? (Clause
9
5.6.3)
Have you determined the necessary competence levels for
10 your entire workforce that can affect your product or service?
(Clause 6.2.2a)
Do you analyse data in order to identify any trends or
11 characteristics that may lead to a non conformance? (Clause
8.4C)
Can you demonstrate how your organisation is actually
12
improving? (Clause 8.5.1)
Auditor Auditee
Name: Name:
Designation Designation
Sign Sign
Date: Date: