ISO 9001-2008 Gap Assessment

Gap Analysis Report Summary
This reference is a quick clause-by-clause summary of the ISO 9001:2008 requirements.

Note: See the actual standard along with the Gap Analysis Checklist for a complete description of the requirements.
ISO 9001:2008
Summary of Requirements
4. Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communications
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Training, and Awareness
6.3 Infrastructure
6.4 Work Environment
7. Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Product Requirements
7.2.2 Review of Product Requirements
7.2.3 Customer Communication
7.3 Design and Development
Implement quality system and continually improve it

Include the required documents and records
Establish and maintain a quality manual
Ensure documents are at right status in right places
Identify records and keep as evidence of conformity
Show evidence of top management commitment
Meet the requirements and satisfy your customers
Have top management express quality intentions
Set measurable targets for products and processes
Carry out plans for quality system and its processes
Make sure everyone knows their duties and roles
Appoint a manager as focal point for quality system
Keep everyone informed of system effectiveness
Review the quality system at planned intervals
Ensure the required agenda topics are covered
Record the decisions and actions from reviews
Provide necessary resources to meet requirements
Ensure everyone working in system is competent
Train personnel and recognize their contributions
Provide facilities, equipment, and support services
Manage combination of human and physical factors
Plan and develop processes for product realization
Define customer, regulatory, and own requirements
Review requirements before committing to customer
Talk to customers about products and complaints

ISO 9001:2008
Summary of Requirements
7.3.1 Design and Development Planning

7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Production & Service Processes
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Equipment
8. Measurement, Analysis, and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
Plan design stages, activities, and responsibilities

Identify and review input requirements for design
Prepare design outputs and approve before release
Review ability of design results to meet requirements
Verify the design outputs meet input requirements
Validate the product is okay for application or use
Review, verify, and validate any design changes
Evaluate, select, monitor, and control your suppliers
Create purchase orders describing supplier products
Check purchases to ensure they meet requirements
Plan and control production and service activities
Examine the process if you cant check the product
Identify the product and its inspection and test status
Exercise care with any customer property
Handle, store, package, and protect the product
Calibrate measuring equipment for valid results
Plan, measure, analyze, and improve processes
Ask customers what they think about your products
Evaluate conformity and effectiveness of system
See if processes are achieving planned results
Verify products meet acceptance criteria
Prevent use or delivery of nonconforming product
Analyze effectiveness and identify improvements
Continually improve effectiveness of quality system
Fix detected problems and prevent recurrence
Avoid potential problems by preventing occurrence

Result/Observations

Result/Observations
ISO/TS 16949:2009 Gap Analysis Checklist

ISO 9001:2008
SECTION
REQUIREMENTS
CURRENTLY IN PLACE
(List documents or evidence)
4 QUALITY MANAGEMENT SYSTEM

4.1
General Requirements
4.1
This clause asks you to identify how management applies the

process approach to achieve the effective and efficient control
of processes, resulting in performance improvement.
Specifically this section is looking for an overall process
evaluation of all quality related processes and their
interrelationships. Look to see that your organizational
processes are defined and that consideration is given to the
items described below.
4.1
Is there a Quality Management System in place that has been

established and documented to meet the requirements of the
ISO/TS 16949:2009 Technical Specification?
4.1
Look for documentation of the processes included in the QMS
4.1
Look for information on the relationship and sequence of the

QMS processes.
4.1
Ask Management if operation and control of processes is

effective. How do they know if it is effective?
4.1
Ask how they are able to know if resources and information

needed to support processes have been provided.
4.1
Is there any information on the effectiveness of processes?
4.1
How are improvements made to processes?

GAP ANALYSIS PAGE 5 OF 115

ISO 9001:2008
SECTION
4.1
4.1
REQUIREMENTS
Is there implementation of process measure, monitoring and
analysis?
What processes does your organization outsource?
How are the process controlled?
4.2
Documentation Requirements
4.2
This section addresses how you use documents and records

to support effective and efficient operation of your
organization. A review of your processes, procedures, work
instructions, and records will determine if the standard
requirements are met.
4.2.1
General
4.2.1
Does your quality system documentation include the

documentation required by the technical specification ISO/TS
16949?
4.2.1
Is the documentation sufficient to ensure adequate operation

of the QMS?
4.2.1
Is the documentation sufficient to ensure adequacy for the

size and type or organization, complexity and interaction of
processes and competency of personnel?
4.2.1
4.2.1
CURRENTLY IN PLACE
Does the quality management system documentation include

the following:
Documented statements of a quality policy and quality
objectives?
4.2.1
A quality manual?
4.2.1
Documented procedures required by ISO/TS 16949:2009?

(there are seven)

ISO 9001:2008
SECTION
REQUIREMENTS
4.2.1
Documents needed by the organization to ensure the

effective planning, operation and control of its processes?
4.2.1
Records required by ISO/TS 16949:2009?
4.2.1
Is there a list or other means of identifying other

documentation required by your QMS?
Are the required documents available?
4.2.1
Does the QMS documentation include Quality Records?
4.2.2
Quality Manual
4.2.2
Review the Quality Manual if available:
4.2.2
What is the scope of your QMS?
4.2.2
What processes have been excluded? Is this appropriate?
4.2.2
Is a description or illustration of the interrelation of the

processes included?
4.2.2
Does the Quality Manual include a scope?
4.2.2
Does the Quality Manual adequately describe the QMS?
4.2.2
Does the Quality Manual document or reference the required

documented procedures?
4.2.3
Control of Documents
4.2.3
A documented procedure is required.
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
4.2.3
Do you have a formal procedure regarding the control of

documents for your organization?
4.2.3
Are documents approved prior to release?
4.2.3
Are documents updated and re-approved prior to release?
4.2.3
How are changes identified?
4.2.3
Are documents available to those that need to use them?

How is the most current version kept in the correct locations?
4.2.3
Can users easily identify documents? Can users easily read

the documents? Are the documents easy and accessible for
the employees use?
4.2.3
If documents such as reference books, users manuals and

other outside documents are used, how are they controlled?
4.2.3
How are old documents handled? Are they removed from

use?
Are they labeled?
Is a copy maintained for reference?
Is there any chance that an old document could be used by
accident?
4.2.3
Does the organization adequately document (revision level,

date, etc.) the revision level, date, etc.?
4.2.4
Control of Quality Records
4.2.4
A documented procedure is required by this clause of the

standard.
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
4.2.4
Is there a documented procedure in place for records control?
4.2.4
Where are records kept?

Is this identified somewhere so users can easily find records?
Can users identify the records? Are the records legible?
4.2.4
4.2.4
CURRENTLY IN PLACE
How are the retention times, storage requirements, and their

disposition identified?
Are they stored in areas and locations are suitable to prevent
loss, damage or deterioration?
4.2.4
Can they be retrieved?
4.2.4
How long does it take?
4.2.4
Are records disposed of according to the retention times?
4.2.4
If the documents and or records are in the network or

Internet, can they be changed?
4.2.4
Are records available on demand? Is there evidence that

records are easily retrievable for the organization?
5 MANAGEMENT RESPONSIBILITY
5.1
Management Commitment

ISO 9001:2008
SECTION
REQUIREMENTS
5.1
This section asks you to identify how your top management

demonstrates its leadership, commitment and involvement. Is
management communicating the importance of meeting
customer requirements? Verify how this is being done,
interview personnel to see if this is actually being done. Is the
quality policy signed off by top management, do they know it?
Review management review meeting minutes. Ask how
resources are determined. Remember resources are not
limited to people.
5.1
Have employees heard about the importance of meeting

customer requirements?
What role did Top Management play in communicating this to
employees?
5.1
What role did Top Management play in establishing the

Quality Policy?
What evidence is there of their role?
5.1
How were the Quality Objective established? (Have they been

established?)
What evidence is there of Top Management involvement?
Is there a strong linkage between the quality objectives and
the quality policy?
5.1
5.1
CURRENTLY IN PLACE
Can you see evidence of Top Management involvement in

Management review?
What process is used for Top Management to identify and
provide resources necessary for the QMS?

ISO 9001:2008
SECTION
REQUIREMENTS
5.1
Is the organization headed in the right direction, do the

management review minutes show positive trends for key
measurables such as customer satisfaction, customer
returns, delivery, and other key customer expectations
identified in 5.2 Customer Focus?
5.1
Does management show involvement and take action when

things are not going in the right direction?
5.2
Customer Focus
5.2
This is a requirement that may be defined in a document

describing how your organization addresses this clause. If no
document is available interview top management for
compliance. Top management and other personnel should be
involved in this section.
5.2
Is there a process in place to identify your customer

requirements?
How is Top Management involved?
5.2
How does Top Management know if customer requirements

are being met?
5.2
Is your organization aimed at achieving customer

satisfaction?
How?
5.2
Are all types of customers: consumer, client, end user,

retailer, and beneficiary identified?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
5.2
Does the organization gather the type of information that

could be translated into physical (dimensional), sensory
(smell, touch, taste), behavioral (courtesy, honesty), temporal
(punctuality, reliability), ergonomic (linguistic, physiological,
human safety), and functional terms?
5.2
Do you include the following expectations:

satisfaction/dissatisfaction, customer complaints/rejects,
product requirements including regulatory and legal and
product failure information?
5.2
How do expectations translate into requirements?
5.2
How is the organization distinguishing between product and

business requirements?
5.2
How are customer requirements prioritized?
5.2
Are customer expectations gathered at least once a year with

the business planning cycle?
5.2
Is the information gathered suitable for converting into

requirements, setting objectives, identifying processes, and
for improvement?
5.2
Does the process provide confidence that fulfilling the

requirements will achieve customer satisfaction?
5.2
Is the process conducted from a narrow compliance viewpoint

or is it conducted with the idea that customer satisfaction is
the goal?
5.3
Quality Policy
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
5.3
Review the quality policy, management, personnel,

management review meeting minutes and other documents
that might apply to this clause for compliance. Evaluate how
the quality policy leads to improvements.
5.3
Is the quality policy appropriate for the organization and

aligned with customer expectations, business environment,
and management goals?
5.3
Does the quality policy include a commitment to meeting

requirements and to continual improvement?
5.3
5.3
CURRENTLY IN PLACE
How does the quality policy provide a framework for

establishing and reviewing quality objectives?
What is the relationship between the quality policy and the
objectives that are set?
5.3
How is it communicated and deployed to be understood at

appropriate levels of the organization?
5.3
Is the quality policy reviewed at a minimum once a year and

do the management reviews evaluate the need for change to
the quality policy reference?
5.3
Does the quality policy inspire and lead organization forward?
5.4
Planning
5.4.1
Quality Objectives

ISO 9001:2008
SECTION
REQUIREMENTS
5.4.1
Review your defined quality objectives. Do your quality

objectives translate your quality policy into measurable goals?
Are they documented so all personnel knows what they are
and how the objectives apply to their processes? Are the
quality objectives being reviewed? Are they measurable? Do
the objectives contain commitment to the continual
improvement of the QMS?
5.4.1
Review Quality Objectives:
5.4.1
Where are objectives defined for meeting product

requirements?
5.4.1
At what levels have quality objectives been established?

Department? Process?
5.4.1
How are objectives measured?

How do they contribute to meeting the quality policy?
5.4.1
How are the objectives deployed?
5.4.1
Do the quality objectives show continual improvement?

If not, why not?
5.4.1
Do the organizations objectives target the areas that are

important to the customer (refer to 5.2 Customer Focus)?
5.4.2
Quality Management System Planning
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
5.4.2
Review the documents or evidence in the QMS complying

with this clause. Verify planning includes requirements for
continual improvement specified in clause 8.1. Verify quality
planning includes resources and takes into account the needs
of your organization as changes occur.
5.4.2
What quality planning process is in place?
5.4.2
a) How does the planning process address quality objectives

for new processes or products?
5.4.2
b) How are business and external changes evaluated and

approved?
c) Does this take into account how changes will affect the
QMS?
5.4.2
Is there evidence of planning for customer-oriented

processes and support processes?
5.4.2
Is there Analysis for each process?
5.4.2
5.4.2
5.4.2
5.4.2
5.4.2
CURRENTLY IN PLACE
Is there evidence that top management is involved in quality

planning?
Do the QMS planning records show a continual improvement
plan for the objectives and the QMS?
Is the QMS planning driven and linked to the Management
Review process?
Is there a process for controlling changes from QMS
planning?
Does the planning include all the appropriate processes?
(such as: Customer Oriented Processes-COPS, Management
Oriented Processes-MOPS, Support Oriented ProcessesSOPS)

ISO 9001:2008
SECTION
REQUIREMENTS
5.4.2
Are the improvement targets appropriate to achieve customer

satisfaction?
5.4.2
Will the plan accomplish the task of meeting the customers

needs and expectations expressed in 5.2 Customer Focus?
5.5
Responsibility, Authority and Communication
5.5.1
Responsibility and Authority
5.5.1
Verify how top management has defined responsibilities and

authorities. This information could be in the form of an
organizational chart.
5.5.1
Review documentation on responsibility and authority.

Is it defined?
5.5.1
Do employees clearly understand their roles and the

organizational lines of authority?
5.5.2
Management Representative
5.5.2
Verify the appointment of the management representative.

The management representative is now responsible for
implementing and establishing the QMS. Verify how
customer requirements are communicated throughout the
organization. If more than one management representative is
appointed, how are the responsibilities and authorities
handled?
5.5.2
Is the management representative a direct report to the

CEO / President / General Manager and a part of top
management?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
5.5.2
5.5.2
5.5.2
REQUIREMENTS
Is the management representative actively involved in the
implementation and maintenance of the QMS?
Does he/she ensure that the processes of the QMS are
established and maintained?
Is the Management Representative knowledgeable of the
QMS?
5.5.2
Does he/she report to top management on the performance

of the QMS and the need for improvement?
5.5.2
Does he/she promote awareness of customer requirements

throughout the organization?
Are there meeting minutes, meeting notices, bulletins, and /
or newsletters?
5.5.2
Is he/she promoting the correct/important customer

requirements?
5.5.3
Internal Communication
5.5.3
Verify the internal communication processes of your

organization. It could be in the form of internal memos,
bulletin boards, or meetings. Assess the communication for
information on the QMS, effectiveness of the processes, and
changes to the system. Verify this information is
communicated to all levels within the organization.
5.5.3
Has the organization established communication processes?
5.5.3
5.5.3
CURRENTLY IN PLACE
Do the communications include the effectiveness of the

QMS?
What tools does the organization use for internal
communication?

ISO 9001:2008
SECTION
REQUIREMENTS
5.5.3
Does the communication communicate both process

information and its effectiveness?
5.5.3
What processes are they communicating?
5.5.3
How are they communicating effectiveness of processes? Is it

appropriate?
5.5.3
Do employees understand the status and effectiveness of the

QMS, where the organization is headed, and their role and
contribution?
5.6
Management Review
5.6.1
General
5.6.1
Review your management review records for conformance.

The requirements for management review input could be
presented in an agenda or written in a document. Verify the
input requirements are discussed and recorded in your
management review record. Review the management review
record for compliance to the requirements. If there is a
document defining the management review process then this
will need to be assessed for conformance. Also management
is required to identify customer needs. If new customer needs
are identified does management review identify the
improvements made to meet these new customer needs?
5.6.1
Is there a schedule for management review?
5.6.1
Does the review frequency ensure the QMSs suitability,

adequacy, and effectiveness?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
5.6.1
Are there records or management reviews?
5.6.1
Do the organizations management reviews include assessing

opportunities for improvement and the need for changes to
the quality management system, including the quality policy
and quality objectives?
5.6.1
Are the organizations records from management reviews

maintained?
5.6.2
Review Input
5.6.2
Does the Management Review Process address all the

required Inputs?
5.6.2
a) Results of audits
5.6.2
b) Customer feedback
5.6.2
c) Process performance and product conformity
5.6.2
d) Status of preventative and corrective actions
5.6.2
e) Follow-up actions from previous management reviews
5.6.2
f) Changes that could affect the quality management system
5.6.2
g) Recommendations for improvements
5.6.3
Review Output
5.6.3
Does the output of management review include actions

related to improvement of the QMS?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
5.6.3
Does the output of management review include processes,

improvement of product related to customer requirements,
and resource needs?
5.6.3
Is there evidence that resources are allocated to meet

customer satisfaction and QMS objectives?
5.6.3
How are resources allocated?
5.6.3
Are management review inputs presented in such a fashion

that management can easily identify the current performance
and improvement opportunities of each of the items
presented?
5.6.3
If the current performance is inadequate, are actions

identified in the output to address improvements needed?
CURRENTLY IN PLACE
6 RESOURCE MANAGEMENT
6.1
Provision of Resources
6.1
Verify that resources are available for the QMS. Assess

resources for addressing customer satisfaction, implementing
and improving the QMS processes. Are resources available in
a timely manner? Resources can be people, information,
supplies, equipment, facility, work environment, or financial
resources.
6.1
Is there evidence to show that resources are being provided

as needed to develop, maintain and improve the QMS?
6.1
Are resources sufficient to meet customer requirements?

ISO 9001:2008
SECTION
REQUIREMENTS
6.1
Does the resource allocation process provide resources in a

timely manner to implement and improve the processes and
to address customer satisfaction?
6.1
Has management provided adequate resources to meet the

continual improvements targeted?
6.2
Human Resources
6.2.1
General
6.2.1
Verify the training records of personnel, especially as related

to sections 4.0, 5.0, 6.0, 7.0, & 8.0 of the standard. If you
have a training document, assess the document for
compliance to the standard.
6.2.1
Evaluate the competence of personnel:
6.2.1
Do the records indicate that the employees are competent to

perform the job based upon education, training, skills and
experience?
6.2.2
Competence, Training and Awareness
6.2.2
If there is a training document, verify conformance to the

requirements below. If there is no document, determine how
personnel know their activities. The standard places great
emphasis on competency. Assess how your organization
evaluates the effectiveness of training and how personnel
know the importance of their activities. This clause applies to
all personnel at all levels.
6.2.2
How is the necessary competence of personnel determined

and defined?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
6.2.2
Has the determined training been provided?
6.2.2
Is there on-going continual education training?

And is this training documented in the employees training
records?
6.2.2
Is the effectiveness of the training evaluated?

How?
Is there sufficient evidence?
6.2.2
Are personnel aware of the relevance and importance of their

activities and how they contribute to the achievement of the
quality objectives?
6.2.2
Are appropriate records maintained describing employees

education, training, skills and experience?
6.2.2
Are there competency requirements defined for all types of

jobs?
Make sure all types of employees are sampled
6.2.2
6.2.2
CURRENTLY IN PLACE
Have the competency needs of employees affecting quality

been identified?
Is there a training plan to satisfy these needs?
Is it followed?
6.2.2
Is there new employee orientation and training?
6.2.2
Does it cover relevance and importance of employee

activities, and how they relate to the quality objectives?
6.2.2
Are there records for all employees indicating their training,

skills education and experience?

ISO 9001:2008
SECTION
REQUIREMENTS
6.2.2
Are competent personnel effectively carrying out activities

and providing results for the organization through
improvement? Are there weaknesses?
6.3
Infrastructure
6.3
This clause addresses how your organization ensures that

the infrastructure is appropriate for the achievement of your
objectives. Verify the facilities are maintained to achieve the
conformity of the product. Safety, maintenance, management
review, and meeting minutes are some of the records to
review. Different processes within the organization may have
different requirements.
6.3
What is your infrastructure?
6.3
6.3
6.3
CURRENTLY IN PLACE
Does product or service meet requirements when produced

or delivered using this infrastructure?
Is there adequate space for nonconforming materials or
returned product from customer?
Are there adequate facilities (lab) for returned product
analysis?
6.3
Review the maintenance and prevention maintenance

process that is used to maintain the facilities. Is it adequate?
6.4
Work Environment

ISO 9001:2008
SECTION
REQUIREMENTS
6.4
Examples to look at for compliance would be work methods,

safety, ergonomics, and temperature and humidity controls.
Elements that may also be included in work environment are
information, suppliers and partnerships, natural and financial
resources.
6.4
What work environment is needed to meet product or service

requirements?
6.4
Has this work environment been provided?
6.4
Has the organization identified the human and physical

factors of their work environment?
Physical factors include heat, noise, light, hygiene, humidity,
cleanliness, vibration, pollution, and airflow.
6.4
6.4
6.4
CURRENTLY IN PLACE
Has the organization identified work rules for people

involvement, safety rules, and ergonomics?
What process do they use to manage the human and physical
factors?
Do records show work environment as a root cause for nonconformances?
6.4
While walking through the facility, monitor the level of

housekeeping. Is there oil on the floor, chips & dirt, cigarette
butts, etc?
6.4
What is the general work environment as it relates to noise,

air quality, etc?
7 PRODUCT REALIZATION
7.1
Planning or Product Realization

ISO 9001:2008
SECTION
REQUIREMENTS
7.1
This section may be addressed in a documented procedure

or in the quality manual. Does your organization understand
the processes needed to meet product requirements? The
planning activity for the processes related to product
realization must address the requirements in section 4.1.
7.1
For each product/project or contract sampled study the

planning of the realization process:
7.1
Is there a quality plan for the process?
7.1
Does the plan include appropriate quality objectives?
7.1
Do the objectives relate to customer requirements and the

business goals established in 5.4 Planning?
7.1
Was the need to establish new processes and/or change

existing product realization process, documentation,
resources, and facilities for product identified?
7.1
Does the plan specify verification and validation and criteria of

acceptability of the product as it goes through each process?
7.1
Does the plan identify the records necessary for process and
product conformance?
7.1
Is the plan output appropriate to the operation?
7.2
Customer-Related Processes
7.2.1
Determination of Requirements Related to the

Product
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
7.2.1
If customer requirements are not understood there is the

possibility of not meeting the customer needs. A review of
customer complaints, surveys, and reports will denote any
problems. Also look at any contract, logs, or orders to see if
any amendments have been made. If so, is the reason for
the amendment documented? This requirement also includes
recycling, environmental impact and characteristics identified
as a result of the organizations knowledge of the product and
manufacturing processes.
7.2.1
How are customer requirements determined?
7.2.1
Are product requirements (physical, functional, ergonomic,

etc.) identified from the customer including delivery and postdelivery activities determined?
7.2.1
Does the organization add requirements that they identified

that were not specified by the customer, but necessary for
intended or specified use?
Is there a process for this to happen?
7.2.1
Are obligations related to the product, including regulatory

and legal, identified?
7.2.1
Are additional requirements determined by the organization?
7.2.1
Are these requirements input into 5.2 Customer Focus?
7.2.1
Are product requirements gathered only during contract

stages?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
7.2.1
Does the organization try to analyze / summarize product

requirements gathered between customers, by product family,
etc as to input the planning process?
7.2.2
Review of Requirements Related to the Product
7.2.2
When looking at the documents (records, procedure, and

work instructions) consider required delivery dates, applicable
standards, and any organizational requirements. Is the same
process being followed for verbal orders?
7.2.2
How does your organization review customer requirements?
7.2.2
What information is reviewed?
7.2.2
What records are maintained?
7.2.2
How are customer requirements confirmed on a verbal order?
7.2.2
How is your ability to meet order requirements confirmed?
7.2.2
How are changes to orders handled?
7.2.2
7.2.2
7.2.2
CURRENTLY IN PLACE
Does the organization review product requirements for the

products sampled from 7.2.1?
Are the product requirements from 7.2.1 reviewed before the
commitment to produce is made?
Are differing requirements resolved?

ISO 9001:2008
SECTION
REQUIREMENTS
7.2.2
Does the review make sure that they have the ability to meet
all requirements before commitment to supply?
7.2.2
Is the review and subsequent actions documented?
7.2.2
When customer requirements or product requirements are

changed, are relevant personnel made aware of the change?
7.2.2
Is each order reviewed, documented and approved prior to

commitment to the customer?
7.2.2
When the customer provides little to no documented

requirements, does the organization review the requirements
from 7.2.1 with the customer?
7.2.3
Customer Communication
7.2.3
If there is no document available regarding customer

communication then the questions below should be asked to
determine compliance to this clause. Customer requirements
are important and usually involve different levels in the
organization. Ask different levels to see if the answers are
consistent and do they agree with the organizations policy
and objectives.
7.2.3
How do you communicate product information to customers?
7.2.3
7.2.3
CURRENTLY IN PLACE
What process is used for customer enquiries, contracts or

order handling, including amendments?
What mechanism is in place to collect customer feedback,
including complaints?

ISO 9001:2008
SECTION
REQUIREMENTS
7.2.3
Is the language specified by the customer used for

communications?
7.3
Design and Development
7.3
Does product and manufacturing process design focus on

error prevention rather than detection?
7.3
If your organization does not have a PRODUCT DESIGN

and DEVELOPMENT function, the elements associated
with PRODUCT DESIGN will not be applicable and
exclusion should be noted. However, all
MANUFACTURING PROCESS DESIGN cannot be
excluded.
7.3.1
Design and Development Planning
7.3.1
This section for planning is done to the level necessary to

achieve the design/development objectives. Planning could
be in the form of a flow chart (GANTT chart, PERT chart) to
give the information. A review of projects and records will
determine how this is being done and if consistent with the
clause. Advanced Product Quality Planning (APQP) is one
acceptable method to develop products and/or manufacturing
processes.
7.3.1
How does your organization plan and control the design and
development of product?
7.3.1
Sample various products.

For each product that was designed or developed check the
following:
7.3.1
Was there a plan for the design and development of the

product?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
7.3.1
7.3.1
7.3.1
REQUIREMENTS
Were the stages of design and or development determined?

Were reviews, verification, and validation activities conducted
for each stage?
Were the responsibilities and authorities for these activities
identified?
7.3.1
How was the interface between the different groups managed

for effective communication and clarity of responsibilities?
7.3.1
Was the output of the plan updated as the design or

development progresses?
7.3.2
Design and Development Inputs
7.3.2
Although the standard does not specifically require it,

consider preparing a document to address the input
requirements in order to avoid any misunderstandings.
Review any document or paperwork that addresses this
clause.
7.3.2
7.3.2
7.3.2
7.3.2
7.3.2
7.3.2
CURRENTLY IN PLACE
Continue the same product samples from

7.3.1 Design and/or Development Planning:
Were inputs relating to product requirements defined and
documented?
Did they include functional and performance requirements?
Did they include applicable regulatory and legal
requirements?
Did they include applicable information derived from previous
similar designs?
Did they include other requirements essential for design
and /or development?

ISO 9001:2008
SECTION
7.3.2
7.3.2
REQUIREMENTS
Is there evidence that the inputs were reviewed for
adequacy?
Is there evidence that incomplete, ambiguous, or conflicting
requirements were resolved?
7.3.3
Design and Development Outputs
7.3.3
Verify the outputs of the design/development satisfy the

design/development inputs. Assess the documents that apply
to this clause for compliance. This clause does not require a
quality record, but to demonstrate compliance some form of
quality records should exist.
7.3.3
7.3.3
CURRENTLY IN PLACE
Continue the same samples from 7.3.1 Design and/or

Development Planning:
Were the design outputs documented in a manner that
enables verification against the inputs?
7.3.3
Was the output reviewed prior to release?
7.3.3
Did the outputs meet the input requirements?
7.3.3
Did the output provide appropriate information for production

and service operations (read as process control, i.e. ongoing
functional testing, product characteristics etc.)?
7.3.3
Did it contain or reference product acceptance criteria?
7.3.3
Did it define characteristics of the product essential for safe

and proper use?
7.3.4
Design and Development Review

ISO 9001:2008
SECTION
REQUIREMENTS
7.3.4
Verify the design review record to confirm compliance.

Confirm the reviews are taking place, done according to the
plan, appropriate attendance at the reviews, and follow up
action has taken place. The standard does not require the
number of design reviews that should be conducted. The
review is intended to confirm internal and external needs
have been taken into consideration or addressed.
7.3.4
How do project managers identify the stages of design where

design review is required?
7.3.4
What is covered in design review?
7.3.4
Continue to follow the same product samples from 7.3.1

Design and/or Development Planning:
7.3.4
Were design reviews conducted at suitable frequencies?
7.3.4
Were they conducted as per the planned schedule?
7.3.4
Did the review evaluate the ability to meet the requirements

needed at the stage, and identify problems and proposed
follow up actions?
7.3.4
Are they accomplishing what is required at the stage?
7.3.4
Did they identify problems and propose action?
7.3.4
Did the review include representatives of the functions

involved in that stage of the design?
7.3.4
Was the review well documented including follow-up actions?
7.3.5
Design and Development Verification
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
7.3.5
Verification considers the product after it is finished.

Verification makes the determination that the product meets
the stated requirements. This can be done by review of test
data, calculations, or additional testing. For verification the
capability of the product must meet the specified
requirements and there must be objective evidence available
to demonstrate it. Assess the records for compliance.
7.3.5
How is verification planned?
7.3.5
What does verification include?
7.3.5
7.3.5
7.3.5
7.3.5
CURRENTLY IN PLACE

Was the output of the design or development verified to
ensure that it met the inputs?
Did it ensure that the output meets the input without any
ambiguity?
Were results of the validation and any subsequent follow-up
actions recorded?
7.3.6
Design and Development Validation
7.3.6
Validation assures that the design/development output

conforms to defined user needs and is capable of meeting the
requirements for the intended use. Validation is usually
performed after verification. Verify that the requirements of
this clause are met by reviewing the validation records.
7.3.6


ISO 9001:2008
SECTION
REQUIREMENTS
7.3.6
How is validation planned?

What is included in validation?
7.3.6
Was the output of design or development validated to test

whether the product is capable of meeting the requirements
for the specified or intended use or application?
7.3.6
Note: the validation should be testing the product as close to

real use as possible. It should be testing the product under
the various conditions or worst conditions that it will be put to
use by the customer.
7.3.6
Was the validation completed before delivery or

implementation of the product whenever practicable?
7.3.6
If full validation was impractical prior to delivery or

implementation, was partial validation performed to the extent
applicable?
7.3.6
7.3.6
7.3.6
7.3.7
CURRENTLY IN PLACE
Were the results of the validation and any subsequent followup actions recorded?
Does the validation process include an analysis of field
reports for similar products?
Does verification and validation evident for both product and
manufacturing processes?
Control of Design and Development Changes

ISO 9001:2008
SECTION
REQUIREMENTS
7.3.7
Some of changes that may take place are omissions, errors

or inconsistencies in the design or requirements, changes in
statutory or regulatory requirements, or issues raised during
reviews. It is important that changes be documented and
actions taken to prevent any possible effect on the product.
Assess the design/development records for compliance and
verify that changes have been communicated to all parties.
7.3.7
How are changes to the design recorded and implemented?
7.3.7
7.3.7
7.3.7
7.3.7
CURRENTLY IN PLACE
Are the changes verified, validated and approved prior to

implementation?
Are the changes evaluated for the effect on constituent parts
and delivered products?
Are the results of the review of changes and any necessary
actions recorded?
Do design and development changes include all changes
during the product program life?
7.4
Purchasing
7.4.1
Purchasing process
7.4.1
This clause asks your organization to base the type and

extent of control of suppliers on the effect of the purchased
material on both the product realization processes and
products produced. Assess the records of supplier
evaluations and follow up actions.
7.4.1
Is there a process in place to ensure that purchased product

conforms to requirements?

ISO 9001:2008
SECTION
REQUIREMENTS
7.4.1
Is the control appropriate to effect the purchased product has

on the subsequent or final product?
7.4.1
Is there a method of controlling the suppliers?
7.4.1
How are suppliers selected?
7.4.1
What criteria are there for evaluating suppliers?
7.4.1
Are evaluation and any necessary actions being recorded?
7.4.1
Is there a list of approved suppliers?
7.4.1
Does the list include all the appropriate types of suppliers?
7.4.1
Were the suppliers evaluated and selected based upon their

ability to supply product in accordance with requirements?
7.4.1
Was there a criteria for their selection?
7.4.1
Were the suppliers periodically evaluated?
7.4.1
Were their criteria for their periodic evaluation?
7.4.1
Did they base their purchasing commitments on supplier

evaluation?
7.4.1
Are there records of supplier selection and evaluation?
7.4.1
Does the organizations purchasing process include all

products and services that affect customer requirements such
as sub-assembly, sequencing, sorting, rework and calibration
services?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
7.4.1
When there are mergers, acquisitions or affiliations

associated with suppliers, the organization should verify the
continuity of the suppliers quality management system and
its effectiveness.
7.4.2
Purchasing Information
7.4.2
Assess how the organization describes the products,

materials or services that are purchased.
7.4.2
What does purchasing information include?
7.4.2
How do your purchasing personnel confirm that the purchase

requirements are complete and correct before the order is
placed?
7.4.2
Does the organization use purchase orders?

Do the purchase orders include information describing the
product?
7.4.2
Do the P.O.s include requirements for approval or

qualifications (as appropriate) for approval of products,
procedures, equipment and personnel?
7.4.2
Do the P.O.s include quality management system

requirements?
7.4.2
Does the purchasing process include an evaluation to ensure

the adequacy of specified requirements prior to release?
7.4.3
Verification of Purchased Product
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
7.4.3
Assess how the organization has defined the inspection

process for compliance and verify evidence of product
acceptance. Verification of purchased product performed at
the suppliers premises is seldom used. If being done assess
the process for compliance.
7.4.3
Is inspection used to verify that purchased product meets

requirements?
What other methods are used in addition to inspection?
7.4.3
Are the activities for verification of purchased product

identified and implemented?
7.4.3
If the customer performs verification activities on the

suppliers premises, are the methods of verification and
release specified?
7.4.3
Is there evidence that purchased product quality, delivery, or

cost is affecting in- process, delivered product, and /or
customer satisfaction/customer dissatisfaction?
7.5
Production and Service Provision
7.5.1
Control of Production and Service Provision
7.5.1
The requirements noted below cover process control,

inspection and testing, inspection and test status, and
servicing and requirements for the release, delivery, and postdelivery of the product.
7.5.1
How are production and service provision controlled?
7.5.1
Where are the product characteristics documented?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
7.5.1
7.5.1
REQUIREMENTS
How do personnel know what equipment to use for a
process?
Does documentation identify what monitoring and measuring
equipment should be used, and when?
7.5.1
Select a representative sample of the processes of the

organization.
Is there a quality plan or other document that identifies the
characteristics controlled in each step of the process?
7.5.1
Is enough information available to specify the characteristics

of the product?
7.5.1
Are work instructions available for each process step or are

operators able to explain how to perform that step of the
process?
7.5.1
Is the equipment suitable for the work
7.5.1
7.5.1
CURRENTLY IN PLACE
performed and do records show that maintenance is planned

and being carried out?
Do they have the necessary gauge and/or monitoring
equipment for process and product monitoring?
7.5.1
Do records indicate that the monitoring activities are properly

implemented and that all persons operating the process are
following it?
7.5.1
Do they have defined processes for release, delivery and

post-delivery activities?
7.5.1
Does the organization control the provision of product and

service so that it is meeting or exceeding customer
expectations?

ISO 9001:2008
SECTION
REQUIREMENTS
7.5.1
Does monitoring and measurement data show that the

organization is meeting objectives set for the product?
7.5.2
Validation of Processes for Production and Service

Provision
7.5.2
If special processes are part of your organizations scope the

above requirements will be assessed for compliance. Define
conditions and the criteria for revalidation. If you have no
special processes, identify that in the quality manual.
7.5.2
Does your organization have any processes for production

and service where the output cannot be verified by monitoring
or measurement?
Do you validate these processes?
7.5.2
How is validation performed?
7.5.2
7.5.2
7.5.2
7.5.2
7.5.2
7.5.2
7.5.2
CURRENTLY IN PLACE
If the process being audited is a special process, how is

validation performed?
Does validation demonstrate the ability to achieve planned
results?
Does the validation process include defined criteria for review
and approval of the process?
Does the validation process include validation of processes?
Does the validation process include validation of equipment
and personnel?
Does the validation process include use of defined
methodologies and procedures?
Does the validation process include requirements for
records?

ISO 9001:2008
SECTION
REQUIREMENTS
7.5.2
Does the validation process include Re-validation?
7.5.2
Does the organization validate all of its processes for all its
production and service provision where the resulting output
cannot be verified by subsequent monitoring or
measurement?
7.5.3
Identification and Traceability
7.5.3
Product need to be identified in such a way as to know its

status, that is, is good, bad, or dont know?
7.5.3
How is product identified?
7.5.3
How is measuring and monitoring status identified?
7.5.3
Does your organization control and record the unique

identification of the product, where traceability is required?
7.5.3
7.5.3
7.5.3
7.5.3
CURRENTLY IN PLACE
Is the product identified throughout the process until it is

shipped?
Is the identification clear and legible? Is each form or tag to
be filled out completely?
Is the status of the product in relationship to measurement
and monitoring clearly discernible?
How does the operator know what has and has not been
checked?
7.5.3
To what level is traceability required?
7.5.3
How do they track the product to the traceability level

required?
7.5.4
Customer Property

ISO 9001:2008
SECTION
REQUIREMENTS
7.5.4
Property provided by the customer can include intellectual

property, as well as tooling, information, software, containers,
or materials. Remember to include all these items in the
review of customer property.
7.5.4
Is there any customer property used in the process?
7.5.4
How is the customer property identified, verified, protected

and maintained?
7.5.4
Do they have a process of recording and reporting to the

customer any lost, damaged, or otherwise unsuitable
product?
7.5.4
Is there evidence that this is happening?
7.5.5
Preservation of Product
7.5.5
7.5.5
7.5.5
7.5.5
7.5.5
7.5.5
7.5.5
CURRENTLY IN PLACE
Products need to be protected in order to preserve conformity

to requirements
How do you make sure that product quality is maintained
during processing and delivery?
Is any product on the floor, misplaced, mishandled?
Are packaging specs defined and understood?
Are they being followed?
Are there customer complaints related to improper
packaging?
Are there customer complaints for damage products during
transport?
Are there opportunities where something may go wrong?

ISO 9001:2008
SECTION
REQUIREMENTS
7.6
Control of Monitoring and Measuring Equipment
7.6
. Review procedures, work instructions and records for

compliance.
7.6
Has your organization established a mechanism to ensure

monitoring and measuring is performed consistent with
requirements?
7.6
7.6
CURRENTLY IN PLACE
What action is taken if equipment is found to be out of

calibration?
Does your organization take appropriate action on the
equipment and any product affected above?
7.6
7.6
How is software used for measuring and monitoring verified

prior to use and reconfirmed as necessary?
7.6
Has the organization identified measurements to be made

and the measurement and monitoring equipment required for
conformity of product?
Audit the gages: (check quality, manufacturing prototype lab
and maintenance department gages)
Accuracy, precision? How chosen?
Identification?

ISO 9001:2008
SECTION
REQUIREMENTS
7.6
Acceptance criteria?
Handling, storage and preservation of inspection, measuring
and test equipment?
Environmental conditions? Location?
Corrective actions? Frequency of checks?
Audit the calibration program.
NOTE: Monitoring and measuring equipment should be
trailed from processes audited in Production and Service
Provision (7.5)
7.6
Sample several pieces of equipment used in the organization

for the following:
7.6
Are they calibrated to International or National Standards?
7.6
Are results recorded?
7.6
7.6
Daily/weekly mastering of gages before use (usually during

plant audit)?
Where no International Standard exists, is the basis of the
calibration recorded?
7.6
Are they adjusted periodically or before use?
7.6
Is calibration status identified?
7.6
7.6
7.6
CURRENTLY IN PLACE
Are they safeguarded from adjustment that would invalidate

the calibration?
Are they protected from damage and deterioration during
handling, maintenance, and storage?
Does the organization have a process to re-assess previous
results if equipment is found to be out of calibration and have
corrective action taken?

ISO 9001:2008
SECTION
REQUIREMENTS
7.6
What action is taken when equipment is found to be out of

calibration?
7.6
Audit backtracking of product when gage is found to be bad?
7.6
Have they recorded the results of calibration?
CURRENTLY IN PLACE
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1
General
8.1
Verify that your organization is monitoring, measuring, and

improving the processes. How this is being done is defined by
your organization. This may be written in procedures,
although there is no requirement for this clause to have a
procedure. Assess if your organization has determined the
need for, and use of statistics.
8.1
How is product conformance demonstrated?

Is there a measuring and monitoring process in place?
8.1
How is the conformity of the QMS ensured?

Is there a measuring and monitoring process in place?
8.1
Does measuring and monitoring allow continual improvement

of the effectiveness of the QMS?
8.1
Does the process include identification of methods, including

statistical techniques for the measuring and monitoring?
8.1
Have measurement and monitoring activities been defined?

What do they involve?

ISO 9001:2008
SECTION
REQUIREMENTS
8.1
Have measurement and monitoring activities been planned?

How?
8.1
Have measurement activities been implemented?
8.1
Do they employ applicable methodologies?
8.2
Monitoring and Measurement
8.2.1
Customer Satisfaction
8.2.1
This clause does not define how your organization is to

monitor information on customer perceptions. For compliance
to this clause, verify how your organization monitors the
customer information, follow through on the methods being
used. Are the methods being used consistent with the quality
policy and quality objectives?
8.2.1
What methods does your organization use to monitor

information on customer perception regarding fulfilling
customer requirements?
8.2.1
Is there a defined process with documented methodologies

for obtaining customer satisfaction and dissatisfaction?
8.2.1
Are all the types of customers surveyed / interviewed?
8.2.1
Is the number of customers surveyed/interviewed enough to

provide good information, i.e. statistically valid?
8.2.1
Are they surveying/interviewing different departments within

the customer who affect the buying decision?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
8.2.1
How is this information used when determining customer

expectations?
8.2.1
What is the quality of the information gathered? Is the

information gathered useful in improving the organization?
8.2.1
Can they provide evidence of using this information for

continual improvement?
8.2.1
Does the customer satisfaction process provide a true picture

of the perception (opinion) of the organizations customers? Is
the information gathered useful in improving the organization?
8.2.1
Are the performance indicators headed in the right direction?

Does it show correlation to customer satisfaction?
8.2.1
Is the information gathered being used to improve customer

satisfaction?
8.2.1
Is there an evaluation of the realization process indicators, in

order to better understand the correlation between customer
satisfaction and the product realization performance
indicators?
8.2.1
Is the manufacturing process performance monitored?

Do trends show conformity with customer requirements?
8.2.2
Internal Audit
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
8.2.2
A documented procedure is required for this clause. Assess

the internal audit procedure for conformance to the
requirements below. Verify the auditors have determined the
QMS has been effectively implemented. It is managements
responsibility to make sure actions are taken in a timely
manner.
8.2.2
Is an internal audit system in place?
8.2.2
Are they being performed on time?
8.2.2
Are they effective?

Do they identify good improvements and eliminate nonconformances?
8.2.2
How is the audit schedule prepared?
8.2.2
What measures are in place to ensure the audits and auditors

are objective and impartial in the audit process?
8.2.2
Is there a documented procedure and does the procedure

define the responsibilities and requirements for planning and
conducting audits, including audit reports and maintaining
records?
8.2.2
How does the management responsible for the area audited

take timely action to eliminate nonconformities and their
causes?
8.2.2
Do follow up activities include verification of the corrective

action and the reporting of those results?
8.2.2
Is there an audit schedule that takes into account the status,

importance of areas and activities, and the results of the
previous audit?
Does the audit frequency change?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
8.2.2
Do the records show that the schedule is being followed?
8.2.2
Does the internal audit cover the full scope of the standard as
well as any customer specific requirements?
8.2.2
Do the audit schedule and the audit process indicate that the
current auditing process audits effective implementation and
maintenance of the system?
8.2.2
Have audits, scope and frequency, and methodologies been

defined?
8.2.2
Are the auditors independent of the area audited?
8.2.2
Are audit questions comprehensive?

Are they focused on the performance of the process meeting
planned objectives?
8.2.2
Is the objective evidence recorded for each question?

There should be objective evidence for both conformance and
non- conformances.
8.2.2
Do the questions and the evidence indicate that the audit is

checking whether the QMS is effectively implemented and
maintained?
8.2.2
Are there non-conformances identified in the audit reports?
8.2.2
Are the non-conformances well written, that is, are

requirement cited (is it correct); is there objective evidence,
and the nature of the non-conformance?
8.2.2
Are all the elements audited?

If not, check to see that all the elements are audited by a
combination of the entire years audits?
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
8.2.2
Are the nonconformities closed out in a timely manner?
8.2.2
Does the organization go back and audit the problem?
8.2.2
Is there objective evidence of verification results?
8.2.2
Is the internal audit generally finding the same type of

problems as the current audit?
8.2.2
Are the problems well documented?
8.2.2
8.2.2
CURRENTLY IN PLACE
Is there objective evidence for areas of conformance and

nonconformity?
Are the non-conformances closed out on a timely basis
(three-month window at the most)?
8.2.2
Are the problems repeating?
8.2.2
Are the number and type of problems going down?
8.2.2
Are the summary results of the audits communicated to their

respective process owners and Management?
8.2.3
Monitoring and Measurement of Processes
8.2.3
Verify that your organization has defined and is performing

the measuring and monitoring activities needed to confirm
product conformity. Looking at the process data will provide
evidence if process parameters or specifications have been
identified. If not, was corrective action taken?
Compliance would also include observing the measurement
and monitoring processes.

ISO 9001:2008
SECTION
8.2.3
8.2.3
8.2.3
8.2.3
8.2.3
8.2.3
REQUIREMENTS
How are QMS processes monitored? Where are appropriate
measurements identified?
Are results evaluated to determine if the QMS processes are
achieving the planned results?
When the results are not achieved, are corrective actions
taken to confirm conformity of the product?
Are the policies, procedures or requirements (i.e. process
characteristics) clearly identified?
Are the characteristics related to customer or product
requirements for the processes identified?
What are the criteria and methods used to control the
processes?
8.2.3
Are the methods suitable?
8.2.3
How do they ensure that the process is operating effectively

and that the necessary resources and information are
available to support operation and measurement of
processes?
8.2.3
How are the processes measured, monitored and analyzed?
8.2.3
Is there evidence to show that the measurement and

monitoring of the process is satisfactory in meeting customer
requirements?
8.2.3
8.2.3
8.2.3
CURRENTLY IN PLACE
Are actions taken to achieve process goals and for continual

improvement?
Do the criteria and methods used effectively control the
process?
Are the process metrics related to customer requirements
and organizational objectives?

ISO 9001:2008
SECTION
REQUIREMENTS
8.2.3
Is the process improving and is it benefiting the customer?
8.2.4
Monitoring and Measurement of Product
8.2.4
This section includes all measurement activities from

receiving inspection to product delivery. Assess work
instructions, procedures, and records to verify compliance.
Verify that the records provide evidence that product criteria
are met. Do the records also identify the person responsible
for release?
8.2.4
Are the policies, procedures or requirements (i.e. process

characteristics) clearly identified?
8.2.4
Are the characteristics related to customer or product

requirements for the processes identified in General
Requirements (4.1) and Planning of Product Realization
(7.1)?
8.2.4
Is product measured and monitored to verify that product

requirements are met?
8.2.4
Where are planned measurements identified?
8.2.4
8.2.4
CURRENTLY IN PLACE

Do they show conformance with acceptance criteria?
Who is authorized to release product? Is the appropriate
person releasing product?
8.2.4
Is there evidence that product release and service delivery

does not proceed until all activities have been completed
(unless otherwise approved by a relevant authority or
customer)?
8.2.4
What are the criteria and methods used to control the

process?

ISO 9001:2008
SECTION
REQUIREMENTS
8.2.4
Are the methods suitable?
8.2.4
How do they ensure that the process is operating effectively

and that the necessary resources and information are
available to support operation and measurement of
processes?
8.2.4
How is the process measured, monitored and analyzed?
8.2.4
Is there evidence to show that the measurement and

monitoring of the process is satisfactory in meeting customer
requirements?
8.2.4
8.2.4
8.2.4
CURRENTLY IN PLACE
Are actions taken to achieve process goals and for continual

improvement?
Do the criteria and methods used effectively control the
process?
Are the process metrics related to customer requirements
and organizational objectives?
8.2.4
Is the process improving and is it benefiting the customer?
8.3
Control of Nonconforming Product
8.3
A documented procedure is required for this clause. Verify the

correction of nonconforming product and the re-verification by
review of the records.
8.3
How has your organization ensured that product which does

not conform to requirements is identified and controlled to
prevent unintended use?
8.3
Is there a procedure that identifies responsibilities for taking

action?

ISO 9001:2008
SECTION
REQUIREMENTS
8.3
Does the procedure identify the ways that nonconforming

product can be handled?
8.3
8.3
Is nonconforming product re-verified after correction to

demonstrate conformity to requirements?
8.3
What action does your organization take when a

nonconformity is detected after delivery or use has started?
8.3
Is there a documented procedure for dealing with

nonconforming product?
8.3
Is the organization following the procedure?
8.3
Is non-conforming product (including product thought to be

non-conforming) stored separately so that it does not get
mixed with conforming product?
8.3
Does the organization promptly dispose of product that

prevents a large accumulation of non-conforming product? Is
there evidence of this?
8.3
How does the organization deal with nonconforming

product? Check log or file for deviation or concession
records
8.3
8.3
8.3
CURRENTLY IN PLACE
Are records maintained of the nature of nonconformities and

subsequent action?
What actions are taken if product non-conformance is
discovered after shipping?
Are there customer complaints or rejects due to nonconforming product being shipped to customers?

ISO 9001:2008
SECTION
REQUIREMENTS
8.3
Based on internal and external reject and rework data, are

there problems indicated related to handling, packaging,
storage and delivery?
8.4
Analysis of Data
8.4
Assess the methods used to collect and analyze the data

required below. Confirm the analysis of the data is used to
demonstrate the suitability and effectiveness of the QMS and
the system continues to improve.
8.4
How is data from measuring and monitoring activities used to

demonstrate suitability and effectiveness of the QMS?
How is it used to continually improve the QMS?
8.4
8.4
8.4
8.4
8.4
8.4
CURRENTLY IN PLACE
Does the organization analyze data for improvement?

How often?
Does the data provide information on customer satisfaction
and/or dissatisfaction?
Does the data presented clearly indicate the trend in
customer satisfaction?
Is the data analyzed to understand things gone right or things
gone wrong?
Does the organization trace success or failure to projects
performing well or poorly?
Does the organization study opportunities for improvement
and use techniques such as Pareto analysis or critical
requests from customers to decide on new opportunities?

ISO 9001:2008
SECTION
8.4
8.4
8.4
8.4
8.4
8.4
8.4
8.4
REQUIREMENTS
CURRENTLY IN PLACE
Does the organization analyze non- conformance data,

customer complaints and customer returns?
Data analyzed should be collected to allow analysis of all
customer requirements.
Is the data available in a form to allow analysis and
identification of projects?
Is information on characteristics of processes, product and
their trends analyzed?
Is process and product data tracked and trended?
What is the process when a process or product is found not
meeting customer requirements?
Does the organization identify improvement opportunities for
the characteristics?
Does the organization gather and analyzing information on
suppliers?
Does the organization track supplier data as it relates to
deliveries and receiving inspection?
8.4
Is this data used for selecting and evaluating suppliers?
8.4
How is the information used to identify improvement?
8.4
Does the data analysis clearly show what is happening to

customer satisfaction, conformance to customer
requirements, characteristics of processes, product and their
trends, and suppliers?
8.4
Does the data point to improvement opportunities?

ISO 9001:2008
SECTION
REQUIREMENTS
8.4
Does the organization determine, collect and analyze

appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to
evaluate where continual improvement of the effectiveness of
the quality management system can be made?
8.4
Does the organizations data analysis include data generated

as a result of monitoring and measurement and from other
relevant sources?
8.4
Is data compared to competitors or benchmarks?
8.5
Improvement
8.5.1
Continual Improvement
8.5.1
This clause contains many of the requirements already

specified in previous clauses. Verify that the requirements
are being used to plan for continual improvement.
8.5.1
How does your organization, continually improve the

effectiveness of the QMS?
8.5.1
Does the organization continually improve the effectiveness

of the quality management system through the use of the
quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management
review?
8.5.2
Corrective Action
8.5.2
A documented procedure is required for this clause. Review

your records to confirm conformance.
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
8.5.2
What is identified as corrective action?
8.5.2
Are the actions taken appropriate to the impact of the

problems encountered?
8.5.2
Is there a documented procedure for corrective action, and is

there objective evidence that they follow it?
8.5.2
Sample several corrective actions:
8.5.2
Was the non-conformity (i.e. problem) identified?
8.5.2
Was the cause of non-conformity determined?
8.5.2
Was the need for actions to ensure problem do not repeat

evaluated?
8.5.2
Was corrective action implemented?
8.5.2
Were results of the corrective action recorded?
8.5.2
Was the corrective action taken?
8.5.2
Does the data show that the corrective action is effective?
8.5.2
Do problems repeat?
8.5.2
Are corrective action performance trends monitored, analyzed

and improved?
8.5.3
Preventive Action
8.5.3
A documented procedure is required by this clause. Review

records to confirm conformance.
CURRENTLY IN PLACE

ISO 9001:2008
SECTION
REQUIREMENTS
8.5.3
Has your organization established a procedure to eliminate

the cause of potential nonconformities to prevent their
occurrence?
Is there objective evidence it is followed?
8.5.3
What does the organization identify as preventive action?
8.5.3
Are the actions taken appropriate to the impact of the

problems encountered?
8.5.3
Sample preventive actions:
8.5.3
Was a potential non-conformity (i.e. problem) identified?
8.5.3
Was it determined that preventive action was needed?
8.5.3
Were the results of action taken recorded?
8.5.3
Was preventive action taken reviewed?
8.5.3
Does the data show that the preventative action is effective?
8.5.3
Are problems eliminated before they occur?
CURRENTLY IN PLACE

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
Estimated %
Complete
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Process Owner

CONFORMING
Y/N?
Estimated %
Complete
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Process Owner

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
Estimated %
Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Complete
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Process Owner

CONFORMING
Y/N?
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Complete
ITEMS NEEDED
Process Owner
Gap Analysis Schedule

Section
4
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.2.4.1
5
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.5.1
5.5.2
5.5.3
5.6
5.6.1
5.6.2
5.6.3
6
6.1
6.2
6.2.1
6.2.2
6.3
6.4
7
7.1
7.2
7.2.1
7.2.2
7.2.3
7.3
7.3.1
7.3.1.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.6
7.6.1
7.6.2
8
8.1
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.3.1
8.3.2
8.3.3
8.3.4
8.4
8.4
8.5
8.5.1
8.5.2
8.5.3
Description
Quality Management System
General Requirements
Documentation requirements
General
Quality Manual
Control of Documents
Control of Records
Records Retention
Management Responsibility
Management Commitment
Customer Focus
Quality Policy
Planning
Quality Objectives
Quality Management System Planning
Responsibility, Authority, and Communication
Responsibility and Authority
Management Representative
Internal Communication
Management Review
General
Review Input
Review Output
Resource Management
Provision of Resources
Human Resources
General
Competence, Awareness, and Training
Infrastructure
Work Environment
Product Realization
Planning of Product Realization
Customer related processes
Determination of Requirements Related to the Product
Review of Requirements Related to the Product.
Customer Communication
Design and Development
Design and Development Planning
Multidisciplinary approach
Design and Development Inputs
Design and Development Plan Outputs
Design and Development Review
Design and Development Verification
Design Validation
Design Changes
Purchasing
Purchasing Process
Purchasing Information
Verification of Purchased Product
Production and Service Provision
Control of Production and Service Provision
Validation of Processes for Product and Service Provision
Identification, Traceability, and Final Product Serial Number Tracking.
Customer Property
Preservation of Product
Control of Monitoring and Measuring Equipment
Measurement Systems Analysis
Calibration / Verification Records
Measurement, Analysis, and Improvement
General
Monitoring and Measurement
Customer Satisfaction
Internal Audit
Monitoring and Measurement of Processes
Monitoring and Measurement of Product
Control of Nonconforming Product
Control of Nonconforming Product Supplemental
Control of Reworked Product
Customer Information
Customer Waiver
Analysis of Data
Analysis and use of Data
Improvement
Continual Improvement
Corrective Action
Preventive Action
Process
Owner
Scheduled Audit
Date

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Gap Analysis Report Summary

This reference is a quick clause-by-clause summary of the ISO 9001:2008 requirements.

Implement quality system and continually improve it

Gap Analysis Report Summary

7.3.1 Design and Development Planning

Plan design stages, activities, and responsibilities

Gap Analysis Report Summary

Gap Analysis Report Summary

ISO/TS 16949:2009 Gap Analysis Checklist

4 QUALITY MANAGEMENT SYSTEM

This clause asks you to identify how management applies the

Is there a Quality Management System in place that has been

Look for documentation of the processes included in the QMS

Look for information on the relationship and sequence of the

Ask Management if operation and control of processes is

Ask how they are able to know if resources and information

Is there any information on the effectiveness of processes?

How are improvements made to processes?

ISO/TS 16949:2009 Gap Analysis Checklist

This section addresses how you use documents and records

Does your quality system documentation include the

Is the documentation sufficient to ensure adequate operation

Is the documentation sufficient to ensure adequacy for the

Does the quality management system documentation include

Documented procedures required by ISO/TS 16949:2009?

ISO/TS 16949:2009 Gap Analysis Checklist

Documents needed by the organization to ensure the

Records required by ISO/TS 16949:2009?

Is there a list or other means of identifying other

Does the QMS documentation include Quality Records?

Review the Quality Manual if available:

What is the scope of your QMS?

What processes have been excluded? Is this appropriate?

Is a description or illustration of the interrelation of the

Does the Quality Manual include a scope?

Does the Quality Manual adequately describe the QMS?

Does the Quality Manual document or reference the required

A documented procedure is required.

GAP ANALYSIS PAGE 7 OF 115

ISO/TS 16949:2009 Gap Analysis Checklist

Do you have a formal procedure regarding the control of

Are documents approved prior to release?

Are documents updated and re-approved prior to release?

How are changes identified?

Are documents available to those that need to use them?

Can users easily identify documents? Can users easily read

If documents such as reference books, users manuals and

How are old documents handled? Are they removed from

Does the organization adequately document (revision level,

Control of Quality Records

A documented procedure is required by this clause of the

GAP ANALYSIS PAGE 8 OF 115

ISO/TS 16949:2009 Gap Analysis Checklist

Is there a documented procedure in place for records control?

Where are records kept?

How are the retention times, storage requirements, and their

Can they be retrieved?

How long does it take?

Are records disposed of according to the retention times?

If the documents and or records are in the network or

Are records available on demand? Is there evidence that

GAP ANALYSIS PAGE 9 OF 115

ISO/TS 16949:2009 Gap Analysis Checklist

This section asks you to identify how your top management