Section 4 Auditing & Certification of QMS

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QSM Associates, QualityManagement Series, Rev. 3.0, All

Auditing & Certification of Auditing & Certification of

Quality Management SystemQuality Management System



QSM Associates, Quality ManagementSeries, Rev. 3.0, All Rights Reserved

Contents

Review of Existing System

ISO 9001 Team Building

Development of System According to ISO 9001:2008

Considerations for Inspection, Maintenance & Refinery

Operations

Implementation of New System

Auditing

Certification




Review of Existing System

Identify All Processes

Determine Interaction and overall flow

Determine Input & Output of Processeseach process

Map Detail Flow of Each Activity

Analyze Gap Between Existing System &

Requirements

Develop Checklist

based on ISO 9001

Standard




ISO 9001:2008 Team Building

Determine Organization Chart

Identify Unit Head

Form Steering Committee

Steering Committee Lead by

Senior Management

Identify Clause Related to Each Unit

Identify Assistants

Regular Meetings &

Decision Making

Appoint ManagementRepresentative




ISO 9001:2008 Team Building

Tips for Team Building

Have a mission statement

Odd number of members

Determine norms and behavior

Requirement for contribution from each member

Make it a point to meet all deadlines

Trust all members

Empowerment to all members




Develop System According to ISO 9001:2008

Development,

Gap Analysis

Training

Concepts

Training

Auditors

Internal

Audit

Second

Audit

Manual

Procedures

Instructions

Correction

Correction

Management

Review

CERTIFICATION

Yes

No

Re-do

Yes No

Re-do




Considerations for Inspection, Maintenance &

Refinery Operations

Quality Management System

Determine inputs and outputs

Determine interaction and flow process

Identified relevant industrial standards, codes, regulations, work

instructions, inspection methods, legal and regulatory requirementsetc.





Refinery Operations

Management Responsibility

Determine objectives including those for each relevant functions

Identify who are the customers and how to determine their perception

and needs

Determine what are the key criteria for success like timeliness, good

reports

Determine method for communications like memo, tool box briefing

to promote requirements, results of performance, problems etc.





Refinery Operations

Resource Management

Determine based on industrial problems, new findings, requirements

what type of equipment and new system needs to be in place.

Training in terms of knowledge, skills and attributes of each

individual positions and job functions.

How to verify competence of staff.





Refinery Operations

Product Realization

Planning for operations, inspection and maintenance

Methods of operations and work requirements

Method of inspection, frequency and meaningful recording

Recording and review of variations in inspection results and data.

Verification of subcontractors personnel, skills and knowledge.

Verification of subcontractors products.

Data, precautions, warning signs, hazards and risk in operations,inspection and maintenance.





Refinery Operations

Measurement, Analysis & Improvement

Data to collect, particularly in reporting of incidents, accidents,

breakdown, damages, changing of parts, etc.

Data on all key functions efficiency

Proper and adequate recording of results

Speed and effectiveness of detection and actions taken for non-

compliance.




Implementation of New System

The following steps should be considered:

Briefing to all staff on the importance of ISO 9001 and its success

Memorandum by Top Management on the importance of ISO 9001

and its success

Checking and reporting on implementation progress by unit head

Review of progress by Top Management every month

Implementation to take place by part and not as whole, and

immediately after each system activity is approved

Feedback system to be created and opinions sought for all

recommended system activities.




Auditing

Quality Audit

² A systematic and independent examination to determine

whether quality activities and related results comply with

planned arrangements and whether these arrangements are

implemented effectively and are suitable to achieve objectives.

² Audits can be done by trained personnel in an organization, or by

hired or professional auditors

Observation

² A statement of fact made during an audit and substantiated by

objective evidence




Auditing

Objective Evidence

² Qualitative or quantitative information, records or statements of

fact pertaining to quality of an item or service or to the existing

quality system element, which is based on observation,

measurement or test which can be verified .

Nonconformity

² The non-fulfillment of specified requirements




Auditing

Two Basic Audits to be Conducted:

The Ad eq uacy Audit

Also known as syst e m or manage me nt audit and is a d e sktop

e xe rcise

De t e rmine s t he e xt e nt of conformance of t he docume nt e d

q uality syst e m to its applicabl e standard.

Me t h od includ e :

R e vi e w t he standard clause by clause and d e t e rmine if t he y are

addre sse d in t he q uality syst e m docume ntation

R e vi e w t he docume ntation and find t he applicabl e clause in t he

standard




Auditing

A Compliance Audit

To asse ss the e xt en t of impl emen tation & m ai n t en a nce of the

doc u men t e d quality syst em

Basi c s of this audit :

Checking on all defined records

Checking on implementation and understanding

Checking on effectiveness of system




Auditing

An quality audit consist of the following steps :

Initiating An Audit

Informa tion and performance review

Review of manual and procedures (Adequacy)

Preparing & P lanning the Audit

Prepare audit plan and schedule

Determine resource requirements

Execution of the Audit (Compliance)

Auditing and preparing reports

Concluding the audit

F ollow-up on Corrective Actions

Ensure all nonconformities found are corrected




Auditing

Non-Conformities found during audit are divided into two

categories :

´Ma jorµNon Conformities

O ther possible terms are ´Hold Pointsµ, ́ Serious Non-

Complianceµ, ́ Category 1µ

A complete break down or absence of a required element

MinorNon-Conformities

Can also be known as ´Category 2µ

An isolated f ailure to comply w ith requirement

A number of minor related non-conformities, may be jud ged b y theLead Assessor to constitute a ma jor non-conformity .




Certification Process

Initial

Assessment

Bi-Annual

Surveillance

Reassessment

Award of Certificate

Application

Submit

Manual

Preliminary

Assessment

Documents

Section 4 Auditing & Certification of QMS