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QuestionReference

DocumentsNotes

4.1 General Quality System Requirements

Has the organization established, documented, implemented and

maintained a quality management system in accordance with the ISO 9001

Requirements

Is the Quality Management System (QMS) continually improving?

Does the organization:

1) Identified the process needed for the QMS throughout ISO9001 the

organization?

2) Determined the proper interaction between the process ISO9001 Is

there a flow chart that shows the process flow for the entire organization?

3) Determined and document criteria and methods to ensure ISO9001 that

the operations and process control are effective?

4) Have resources and information necessary to support ISO9001 the

operation and maintenance of their process.

5)Measure, monitor and analyze their processes? .

6) Implement corrective and preventive actions needed to achieve the

planned results as documented in the quality plans?

7) Does the company have documentation to show continuous

improvement of their process?

Does the organization have documentation in accordance with therequirements of the ISO 9001 Standard

How does the company control quality processes that are performed

outside of the ISO approved facility?

4.2 Documentation Requirements

4.2.1 General

Does the QMS documentation system include:

1) Quality Manual?

2) Documented company quality policy and quality objectives?

3) Documented level 1 and level 2 procedures as required by ISO 9001?

4) Document how the company can effectively plan, operate and control its

processes?

5) Creation and management of Records that demonstrate compliance the

ISO standard?

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4.2.2 Quality Manual

Has a quality manual been created and maintained the includes:

1) The scope of the quality management system and any justification for

exclusion to the standard (such as obsolete product lines)?

2) Description of the interaction between the process of the quality

management system (usually in the form of a flow chart showing product

flow from design and order to delivery and service)?

3) The procedures required by the ISO standard or references to the

required procedure control numbers (usually the general statements are in

the quality manual and the detailed procedures are separate documents)?

4.2.3 Control of Documentation

Are all QMS documents (manuals, procedures, data sheets, work

instructions, records, and procedures) controlled (including revision

control, controlled access to originals, control of distributed copies)?

Does the company have a document control procedures that including:

1) Notification of the ISO approval body prior to implementation of any

change to a agency controlled document?

2) Approval, update and distribution processes for changes to all quality

documents (May be part of the ECO procedure)?

3) Ensure that the current revision documents (with no confusion about the

current revision) are available at the point of use?

4) Ensure that the documents remain legible and easily identifiable?

5) A process for controlling documents of external origin

6) Control of obsolete documents to assure they are not used in current

production.

4.2.4 Control of Records

Does the company create and maintain records ?

Does the company have records to provide evidence that the QMS is

effective (examples include management review records, corrective and

preventive actions logs, customer survey or feedback records)?

Has a documented procedure been written to define the following record

control mechanisms:

Identification and retrieval?

Storage and protection?

Retention time and Disposition?

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5.0 Management Responsibility

5.1 Management Commitment

Has top management provided evidence of its commitment to the

development and maintenance of the QMS including

a) Communication of the importance of meeting the customer regulatory

and legal requirements.

b) maintaining and communicating the quality policy.

c) Ensuring that quality objectives are established and routinely evaluated.

d) Routinely (once per year minimum) conducting management reviews of

the QMS.

e) Ensuring the QMS is given adequate resources.

5.2 Customer Focus

How does top management ensure that customer requirements are

determined and their needs are meet?

What program exists to increase customer satisfaction?

5.3 Quality Policy

How does top management ensure that the quality policy:

a) meets the need of the organization

b) Continuously improves

c) Is communicated and understood throughout the organization ( Has the

entire organization been trained on the QMS)

d) is periodically reviewed

5.4 Planning

5.4.1 Quality Objectives

Are the Quality objectives consistent with the quality policy?

Are the quality objectives measurable ?

Are quality objective set for appropriate levels of the organization?

5.4.2 Quality Management System Planning

How has top management assured that the resources needed to achievethe quality objectives are identified and planned?

If the output from planning objectives documented (ex. work instructions,

procedures, quality manual, quality plans, etc)?

5.5 Responsibility Authority and Communication

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5.5.1 How has top management ensured that the responsibilities and

Authority are defined and communicated within the organization (Org

Charts and/or Quality responsibly defined in training records)?

5.5.2 Management Representatives

Has top management assigned member of management who have the

responsibility and authority ( and which document defines these tasks):

Ensuring that processes are established, implemented and maintained

(usually engineering and quality personnel)?

Reporting to top management on the status of the QMS including areas

that need improvement ( usually presenter of the QMS status in the

management review meeting)?

Promote the critical nature of meeting the customers requirements in every

level of the organization (usually the quality or customer service

manager)?

5.5.3 Internal Communication

How does top management ensure that communication of quality issues is

communicated throughout the organization (what process or document

defines this flow)?

5.6 Management Review

Does Management review the QMS at planned intervals to ensure the

effectiveness of the plan ?

Are records of the management review kept maintained as quality records?

Are the minimum requirements for a management review described in a

procedure?

Does the management team meet at least once per year?

5.6.2 Management Review Input

Does the management review include the all of the following sources for

quality information:

Customer feedback? What procedure describes how customer feedback is

gathered and presented?

Result of both internal and external audits (including findings and follow-upitems)?

Action items from previous management review meeting?

Corrective and preventive actions?

Any significant items that could effect the QMS (changes in personnel,

training requirements, new products, etc...)?

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Product conformity and process performance metrics?

5.6.3 Management Review Output

Is the feedback from the management review tracked to ensure thatquality is continuously improving (maybe using corrective and preventive

actions system)?

Are the outputs from the management review given the proper resources

for corrective and preventive action?

6.1 Human Resources

Are all employees who effect the quality of product or services qualified or

trained to ensure consistent output?

Has the organization provided appropriate training to satisfy the customer

requirements?

What quality records show training requirements (does the requirement

include a training interval)?

What records show that training is completed?

Has the company provided quality awareness training for employees of the

importance of quality, the quality system, and the importance of meeting

the quality objectives and the customer requirements?

6.2 Infrastructure

How does the organization maintain equipment used to control the quality

of the products and services?

How does the organization control hardware and software used in the

production of product?

6.3 Work Environment

How does the organization assure that the environment is sufficient the

provide consistent product conformity?

7 Product Realization

7.1 Planning

Is the planning of product realization process integrated into the entire

quality system? (specifically management review)

Are the following being reviewed during the product planning:

a) Quality objective, Product specification

b) The need for additional processes, resources, and documentation

c) Requirements for verification, validation, monitoring, inspection, and

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test requirements

d) Are record maintained for all stages of the development process

7.2 Customer Related Processes

Has the organization determined the:

a) Requirements specified by the customer including delivery and post-

delivery activities (training and installation, support, etc)

b) Requirements not specified by the customer but necessary to use the

product for its intended purpose (proper application, safe operation,

integration with other products )

c) Regulatory and statutory requirements related to the product

d) Any additional requirements determined by the organization

(limitations, warranty, special requirements)

7.2.2 Review of the requirements related to the product

Are the requirements reviewed prior to commitment to the customer

(acceptance of contracts or change orders)

Does the company have the following information prior to commitment:

a) Full product specification

b) Contract or order requirements difference from previous orders

c) Ability of the organization to meet the customer requirements

Are the order review and actions from the order review recorded and

maintained as a quality record?

Is the critical order information 100% complete prior to acceptance?

Are changes to the product requirement (including change orders)

communicated to all appropriate levels of the organization?

7.2.3 Customer Communication

What system does the company use for customer communication of:

a) Product specifications and information (salesmen, web site, spec sheets)

b) Inquiries, contracts, change orders and new orders

c) Customer feedback including customer complaints (like Corrective and

Preventive Actions)

7.3 Design and Development

Are product design and development activities planned and controlled?

Using what documents?

Does the design and development plan (sometimes called a quality plan)

include:

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a) Different stages of development

b) Design reviews at appropriate stages

c) Verification of the design to the design specifications

d) Validation (official sign-off) of the design against the critical

specifications

e) Responsibilities and authorities of personnel involved in the design

process

How are the interfaces between different groups defined and managed to

ensure proper communication?

Is the planning output updated as the design progresses (ex: revision

control of specification)

7.3.2 Design and Development Inputs

Are inputs relating to the product design requirement defined documentedand maintained as a record (sometimes call a design specification)?

Does the design and development input include:

a) Functional and performance requirements?

b) Applicable statutory, regulatory, and legal requirements?

c) Applicable information for previous designs (are they learning from their

mistakes)?

d) Other requirement essential to design and development

Are the design inputs review for overall integrity, quality and completeness

(design review)?

Are incomplete, conflicting and ambiguous requirements correct?

7.3.3 Design and Development Outputs

Are the outputs of the design and development process in a form that

allows for verification against the design and development inputs?

Does the design and development output:

a) Meet or exceed the design and development input (

b) Include appropriate information for fabrication, purchasing, production

and service of the product?

c) Contain and reference product acceptance criteria

d) Specify the product characteristics that are essential for the safe and

proper use (limitation)?

7.3.4 Design and Development Reviews

Are systematic reviews completed at suitable stages in accordance with

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Are supplier periodically re-evaluated to determine their compliance with

the requirement of the company?

Are evaluations maintained as quality records?

Are copies of corrective actions sent to suppliers maintained as quality

records?

7.4.2 Purchasing Control

Does the purchasing information describe the requirements for approval of

products, procedures and equipment?

Does the purchasing information describe the requirements for a quality

management system (including ISO 9000 or equivalent)?

How are the specifications for purchased parts and services checked prior

to communication to the supplier?

7.4.3 Verification of Purchased Product

Are inspection and incoming testing requirements specified to ensure that

purchased parts conform to the specification (Give an example)?

Are inspection and incoming testing requirements specified in the

purchasing information whenever the inspection or incoming testing is

completed by the supplier (Give an example)?

7.5.1 Control of Production and Service Provision

Is information about the product requirements available to production and

service personnel?

Are work instructions used where required?

Is suitable equipment available to production and service personnel?

Is monitoring / measuring equipment available to production and service

personnel?

Is information about the release, delivery and post delivery (installation

and service) available to production and service personnel?

7.5.2 Validation of Processes for production and service provision

Does the company validate products and service to assure no latent

failures?

Are process validated against the quality plan?

Are criteria for review and approval of production and service processes

defined?

Is production and service equipment approved for use?

Are production and service personnel qualified for the appropriate

processes?

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Are record requirements established as part of the quality plan?

Are plans made for re-validation if required?

7.5.3 Identification and Traceability

Is the product uniquely identified throughout the product realization

(production process)?

Is the product status (conforming/non-conforming) identified with respect

to measurement and monitoring requirements?

When tracibility is required, is the product uniquely identified and

controlled?

Is the unique identification information maintained as a quality record?

7.5.4 Customer Property

Does the company ever maintain customer property (including units return

for service)?

Does the company exercise care with customer property while it is in the

control of the organization?

Is customer property identified, verified, and protected?

If the customer property is lost, damaged or found unsuitable for use, is

the condition recorded, reported to the customer, and is this information

maintained as a quality record?

7.5.5 Preservation of product

How is the product preserved during internal processing and delivery?

Is the product identified during processing?

Do preservation activities include handling, packaging, storage, and

protection?

Are preservation activities applied to component and sub-assemblies?

7.6 Control of Measuring and Monitoring Devices

Has the company determined the monitoring and measurement

requirements needed to ensure conformity of the product to the

requirements?

Have process been established ( and documented) to ensure that

monitoring and measurement are carried out in a consistent manner?

Is measurement and monitoring equipment calibrated or verified at

specified intervals prior to use?

Is measurement and monitoring equipment calibrated or verified against

traceable international or nation standards (where ever possible)?

Is measurement and monitoring equipment adjusted or re-adjusted as

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necessary?

Is measurement and monitoring equipment identified with a calibration

status?

Is measurement and monitoring equipment safeguarded against improper

adjustment that could invalidate the measurements?

Is measurement and monitoring equipment protected from damage and

deterioration during usage, maintenance and storage?

Has the company ever shipped, installed, or sold any product that was

later found to be invalid due to measurement or monitoring errors? If so,

were the action recorded (and maintained as a quality record)?

Are records of calibration and verification results maintained as quality

records?

Where computer software is used for monitoring and measurement, is the

software confirmed prior to initial use?

Is computer software (used in products) periodically reconfirmed?

Does the company perform monitoring, measurement, analysis and

improvement processes to ensure conformity of the product?

Does the company perform monitoring, measurement, analysis and

improvement processes to ensure proper operation of the quality system?

Does the company continuously improve the effectiveness of the quality

management system?

Where does the company use statistical techniques to evaluate the product

and quality system?

8.2 Monitoring and Measuring

8.2.1 Customer Satisfaction

Is information about customer perception and the ability of the company to

meet the customer requirements monitored by the organization?

What systems is used for obtaining and using information relating to

customer satisfaction?

8.2.2 Internal Audits

Are internal audits performed at periodic planned intervals to determine if

the quality system conforms to the ISO 9001 requirements?

Are internal audits performed to determine if the quality system is

effectively implemented and maintained?

Does the internal audits plan take into consideration previous audit results

(follow up)?

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Is the audit criteria, scope period and method define in a document?

Do auditors ever audit their own work?

How does auditor selection and auditor performance ensure objectivity and

impartiality in the audit process?

What system is in place to ensure that audit non-conformities and their

causes are corrected and eliminated without undue delay?

Do follow-up audit activities include verification of the actions taken and

reporting of the results?

8.2.3 Monitoring and Measurement of Processes

Are suitable methods used to assure that the company processes meet the

customer requirements?

Do these methods demonstrate the ability of the processes to fulfill the

quality plan?

Are corrective actions taken when planned results are not achieved?

8.2.4 Monitoring and Measure of Product

Are product characteristics monitored and measured to confirm that the

product meets the requirements?

Is monitoring and measuring the product done at an appropriate stage in

the product realization (production process)?

Is evidence of conformity with the acceptance criteria documented and

maintained as a quality record?

Are records maintained to indicate the person authorizing the release of

the product?

Are all planned activities completed prior to the release of the product

(unless otherwise approved by the relevant authority or customer)?

8.3 Control of nonconforming Product

How Is nonconforming product identified and controlled to prevent

unintended usage or delivery?

What documented procedure establishes controls, assigns authority and

responsibility for processing of nonconforming materials?

Are actions taken to eliminate the source of nonconforming products?

What process is used to authorize use, release or accept nonconforming

product with concessions?

Are records maintained identifying the non conformities and any

subsequent actions taken to use the product with concessions?

When nonconforming product is corrected, is it subject to re-verification or

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re-test to confirm conformity?

If nonforming product is detected after delivery or use, is appropriate

action taken by the organization to correct the problem?

8.4 Analysis of Data

Is appropriate data collected and analyzed to demonstrate the effective of

the quality management system and continuous improvement system?

Is the data from multiple sources like product, process, quality system,

customer or information from other relevant sources?

Does the analysis of this data provide information about customer

satisfaction

Does the analysis show conformance to the product requirements?

Does the analysis show trends of process and products including

opportunities for continuous improvement (corrective and preventive

actions)?

Does the analysis provide information about the performance and trend for

suppliers?

8.5 Improvement

8.5.1 Continual Improvement

What systems does the organization use to continually improve the

effectiveness of their QMS?

Are results of audit, management reviews, corrective and preventive

actions, and analysis of data used for continuous improvement of the QMS,processes and products?

8.5.2 Corrective Actions

Are corrective actions taken to eliminate the cause of nonconformities and

to prevent further nonconformities?

Are corrective actions appropriate based on the non conformities

encounters?

What is the documented procedure for reviewing nonconformities including

customer complaints?

What is the documented procedure for determining the cause of

nonconformities?

What is the documented procedure ( part of a documented procedure) for

determining the implementing actions?

Are corrective actions recorded and maintained as a quality record?

Are corrective actions reviewed to confirm that the action was successful?

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8.5.3 Preventive Actions

What procedure describes how the organization takes actions to eliminate

potential non conformities before they happen?

What is the documented procedure for determining potential

nonconformities?

What is the documented procedure for determining the cause of

nonconformities?

What is the documented procedure ( part of a documented procedure) for

determining and implementing actions?

Are preventive actions recorded and maintained as a quality record?

Are preventive actions reviewed to confirm that the action was successful?