ISO 9001: 2008 Gap Analysis

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ISO 9001:2008 FORMAT

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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

General Requirements

1.2

Organization has identified all exclusions that apply to the QMS

4.1

Organization shall control all processes that are outsourced (7.4)

Documentation

4.2.1

Documentation includes:
a) statement of quality policy and quality objectives
b) quality manual
c) documented procedures and records
d) those determined necessary to ensure planning, operation and
control of its processes

4.2.2

Quality Manual includes:

a) scope of QMS and exclusions (with justifications)
b) documented procedures or reference to them
c) description of interaction between the processes of the QMS

4.2.3

Documented Procedure established and maintained for control of

documents
a) Approve documents for adequacy prior to issue
b) Review and update as necessary and re-approve documents
c) Changes to current revisions are identified
d) Relevant revisions of documents available at points of use
e) Ensure documents remain legible and readily identifiable
f) Ensure documents of external origin are identified and distribution
controlled
g) Prevent unintended use of obsolete documents

4.2.4

Documented Procedure for the identification, storage, protection,

retrieval, retention and disposition of records
Management Responsibility

5.1
5.2
5.3

Top Management commitment to develop and implement QMS and

continually improve effectiveness
Focus on the customer - requirements are determined and met with aim
of enhancing customer satisfaction
Quality Policy:
(b) includes commitment to comply and continually improve
QMS
(c) provides a framework for establishing quality
objectives
(d) is communicated and understood within the
organization
(e) is reviewed periodically (MR)

5.4.1

Top Management establishes quality objectives that are measurable and

consistent with quality policy

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5.4.2

Planning of QMS carried out to meet requirements of quality objectives

5.5.1

Responsibilities and authorities are defined

5.5.2

Management representative:
a/ b) is identified and has authority to ensure that quality
system is implemented and maintained
c) Promotes awareness of customer requirements
throughout organization

5.5.3

Top Management commits to establishing communication within the

organization (internal communications)

5.6.1

Management Review of QMS conducted

Records of management reviews are maintained

5.6.2

Management review includes:

a) results of internal audits
b) customer feedback
c) process performance (to include product nonconformity)
d) status of corrective and preventive actions
e) follow-up actions from last management reviews
f) changes that could affect the QMS (to include oil/gas
industry standards)
g) recommendations for improvement

5.6.2

Management review output includes:

a)Improvement of effectiveness of QMS
b) improvement of product to meet customer needs
c) resource needs

Resource Management
6.2.1

Human Resources: Personnel shall be competent on the basis of education, training, skills and
experience

6.2.2

Human Resources:
a) Determine necessary competence (requirements) for
personnel performing work affecting conformity

b) Provide training
c) Evaluate effectiveness of actions taken
d) Ensure personnel are aware of importance of their work
with respect to QMS

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e) Maintain records of education, training, skills and
experience
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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

6.3

Provide and maintain the infrastructure (equipment, buildings, etc.)

needed to achieve conformity to product requirements

6.4

Determine and manage work environment needed to achieve conformity

to product requirements
Customer Related Processes- Contract Review

7.1a

The organization shall determine the quality objectives and requirements

for the product

7.1b

The need to establish processes and documents, and to provide resources

specific to the product

7.1c

The organization shall determine verification, validation, monitoring,

measurement, inspection and test activities

7.1d

Records needed to provide evidence that the realization processes and

resulting product meet requirements (4.2.4)

7.2.1

Customer Related Processes: Determination of Requirements Related to

the Product

7.2.2

Contract review ensure that:

a) product requirements are defined
b) requirements differing from those previously expressed are
resolved
c) organization has ability to meet defined requirements
Records of the results of reviews shall be maintained
Organization shall ensure amendments are made and transferred to
proper function

7.2.3

Determine and implement arrangements for communication with

customers

Design and Development

7.3.1

Organization shall manage the interfaces between different groups

involved in design and development
Design output updated as the design and development progresses

7.3.2

Input includes:
a) functional and performance requirements
b) applicable statutory and regulatory requirements

7.3.3

Output shall:
a) meet the input requirements

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b) provide information for purchasing, production and service
c) contain or reference product acceptance criteria
d) specify the characteristics of the product that are essential
for the safe and proper use
7.3.4

Review shall occur at suitable stages to evaluate design as it meets

requirements
Participants of review shall include representatives of functions concerned
with design and development
Records of review shall be maintained

7.3.5

Verification shall be performed

7.3.5

Verification results shall be recorded

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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

7.3.6

Validation shall be performed

Validation results shall be recorded

7.3.7

Changes shall be identified, reviewed, verified, validated and records

maintained
Evaluation of design changes on constituent parts and delivered product

Purchasing
7.4.1

Organization establish the criteria for evaluation/selection of a supplier

ability to supply product in accord with requirements
Receiving Inspection performed on all incoming materials
Quality records of acceptable suppliers maintained

7.4.2

Purchasing documents includes:

a) products, procedures, processes, equipment, personnel and
QMS requirements
Organization shall ensure adequacy of specified purchase requirements
prior to communication to the supplier

7.4.3

Organization established & implemented controls to ensure purchased

product meets specified purchasing requirements
Organization has implemented controls for verification of product at
suppliers premises (by itself or its customers)

Control of Production and Service Provision

7.5.1

Controlled conditions include:

a) information that describes the characteristics of the
product
b)

availability of work instructions

c) use of suitable equipment

d) Availability and use of monitoring and measuring equipment
e) Implementation of monitoring and measurement

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f)

Implementation of product release, delivery and postdelivery activities

Validation of Processes for Production and Service Provision

7.5.2

The Organization shall demonstrate ability of these processes to achieve planned

results:
a) Define criteria for review and approval of processes where
resulting output cannot be verified
b) Approval of equipment and qualification of personnel

c) Use of specified methods and procedures

d) Requirements for records
e) Revalidation

Identification and Traceability

7.5.3

Organization shall identify product by suitable means throughout product realization

Where traceability is requirement, organization shall control and maintain records
Organization shall identify the product status with respect to monitoring and measurement requirements

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ISO 9001:2008 FORMAT

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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Customer Property

7.5.4

Control of customer property while under organizations control

Preservation of Product
7.5.5

Preservation of product during handling

Preservation of product during packaging
Preservation of product during storage

Control of Monitoring and Measuring Devices

7.6

Determine the monitoring and measurements required and obtain the required equipment
Equipment shall be:
a)

calibrated against standards traceable to international or national standards

b) adjusted or re-adjusted as necessary

c) identified to determine calibration status
d) safeguarded from adjustments that would invalidate the measurement results

e)

protected from damage and deterioration during handling, maintenance and storage

Assess and record the validity of previous measuring results when the equipment is found not to conform
to requirements

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Action taken on monitoring and measurement equipment when found to be out of calibration
Calibration records of equipment maintained

Measurement, Analysis and Improvement

8.1

8.2.1

Plan and implement the monitoring, measurement, analysis, and improvement processes needed to:
a)

demonstrate conformity to the product requirements

b)

ensure conformity of the QMS

c)

continually improve the effectiveness of the QMS

Customer Satisfaction - monitor info relating to customer perception whether organization met customer
requirements

8.2.2

Procedure includes responsibilities for planning and conducting audits, establishing records and reporting
results
Internal audits (RECORD):
Consider the results of previous audits

Auditors shall not audit their own work

Audit criteria, scope, frequency and methods shall be defined
Management responsible shall ensure that any actions are taken to
eliminate nonconformities
Follow up includes verification of action taken and reporting results
8.2.3

Apply suitable methods of monitoring and measurement of QMS

conformity

SECT

ISO 9001:2008 FORMAT

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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

8.2.4

Monitor characteristics of product to verify it meets requirements

Monitoring carried out at appropriate stages of product realization process
Evidence of product conformity maintained
Records indicate the person(s) authorizing release of product for delivery
Product release and delivery to customer shall not proceed until planned
arrangements have been completed

Control of Nonconforming Product

8.3

Documented procedure established for dealing with nonconforming product

Nonconforming product controlled by taking action to eliminate nonconformity;
acceptance under concession; or by taking action to preclude its intended use or
application
Organization shall take appropriate action when nonconformity is detected after
delivery or use
Responsibility for review and disposition defined

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Records of nonconformities and any subsequent actions maintained
When nonconformity is corrected, it shall be re-verified to demonstrate conformity
to requirements

Analysis of Data
8.4

Determine, collect & analyze data to demonstrate the suitability & effectiveness of
QMS & evaluate continual improvement
Data provided relating to customer satisfaction, product conformity,
process/product trends, supplier information

Improvement
8.5.1

Continually improve the effectiveness of the QMS

Corrective Action

8.5.2

Documented procedure required to take action to eliminate the causes of nonconformities to prevent
recurrence
Corrective action established and include:
a)

reviewing nonconformities (including customer complaints)

b)

determining the cause of nonconformities

c)

evaluating the need for action to ensure that nonconformities do not re-occur

d)

determining and implementing action to eliminate nonconformity

e)

records of results taken

f)

reviewing the effectiveness of corrective action taken

Preventive Action
8.5.3

Documented procedure required to take action to eliminate the cause of potential nonconformities to
prevent occurrence
Preventive action established:
a) to determine potential nonconformities and their causes
b) evaluating the need for action to prevent nonconformities
c) determining and implementing action needed
d)

records of results taken

e) reviewing the effectiveness of preventive action taken

Date:

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