Preparing for Quality System Certification

8/3/2019 Preparing for Quality System Certification

1/104

Preparing for Quality SystemCertification

U.S. Senator Byron DorgansAerospace & Defense Manufactures Roundtable


2/104

Discussion Topics

Quality system development

Certification process

ISO 9001 myths and misconceptions

ISO 9001 interpretation of requirements


3/104

Quality System Development

Establish unity of purpose throughout the organization What are we try to achieve with ISO 9001?

How do we want to improve our business performance?

Eight Quality Management Principles(ISO 9000:2000)

Customer focus

Leadership

Involvement of people

Process approach

Systems approach to management Continual improvement

Factual approach decision making

Mutually beneficial supplier relationships


4/104


Prepare a project plan to manage implementation Establish scope for the quality management system

Design and manufacture of fluid power controls

Establish quality policy

Identify processes required to satisfy the scope

Customer orientated Product realization processes

Support processes

Management processes

Start defining process details, resources and implementation actions(See 4.1 General requirements)

Monitor, measure and analyze process performance Set initial quality objectives, plans and communication

Monitor the project progress at the management level


5/104

Quality Systems Development

Tips for developing your quality system

Establish awareness that the QMS is the foundation for

managing the business

No single business related activity should exist outside of thescope of the system

Include the management staff in the initial development

of the system

Include the internal auditors in the system development Work according to a project plan

Identify information technology (IT) needs up front


6/104


Tips for developing your quality system

Keep the documentation light, easy to use and

to the point. Use mix of text and graphical formats

Use simple systems to control the documentation

A picture says a thousand words


7/104


Build working engines before buildingdocumentation

Engines are vital and essential work processesthat make the ISO 9001 system work

Management processes

Information collection and analysis processes

Supplier management processes Improvement processes (C/A, P/A, auditing)

Employee development processes


8/104


Quality Policy

Plan

QualityImprovement

Productivity

Improvement

Do

Check

Act

Plan

Do

Check

Act

Establish a culture for planning and execution of improvement actions


9/104


Critically examine legacy documentation

May not contain vital information

See ISO 9001:2000 4.1 General requirements

May not be user friendly

May cause challenges for internal auditors

Dont be afraid to start over!


10/104

Quality System Development(ISO 9001:2000)

Plan

Act Do

Check

PLAN: establish the objectivesand processes necessary to deliver

results in accordance with customer

requirements and organizational policies

DO: implement the processes

CHECK: monitor and measureprocesses and product against

policies, objectives and requirementsACT: take actions to continuallyimprove process performance.

ISO 9001:2000 promotes the PDCA methodology for processes(See ISO 9001:2000 page VI)


11/104

Quality System DevelopmentThe Process Approach

ISO 9001:2000 promotes the adoption of a process approach

to manage the organization. (see ISO 9001:2000 page V)

Provides a focus on inputs, process, and outputs Enables a systems view by looking at the interconnection

and interaction of individual processes

Processes are planned, resourced, implemented and

validated/verified.

Input Process Output


12/104


4.1 General requirements The organization shall establish, document, implement and

maintain a quality management system and continually improve itseffectiveness in accordance with the requirements of this

International Standard The organization shall;

Identify the processes needed for the QMS and their application

Determine the sequence and interaction of these processes

Determine criteria and methods needed to ensure both the operationand control of processes are effective

Ensure the availability of resources and information as necessary

Monitor, measure and analyze these processes

Implement actions necessary to achieve planned results and continualimprovement of these processes

The Process Approach


13/104

ISO 9001 Myths and

Misconceptions Documentation efforts will cripple my company!

Quality manual

Quality policy and objectives Six required procedures

Other documents needed by the organization

The organization is responsible to determine the

level of documentation required

Document format and media is company choice


14/104

ISO 9001 Myths and

Misconceptions ISO 9001 will require us to change the way

we manage our business!

ISO 9001 provides a framework

Management determines the methods and

manner of operations

Helps management to mitigate risks Based on Plan-Do-Check-Act cycle


15/104

ISO 9001 Myths and

Misconceptions Well spend all of our time filling out

records!

Twenty (20) record categories

Records are determined by the organization

Used as collectors for process performance

information Channels information into analysis processes

Enables management to make improvements


16/104

ISO 9001 Myths and

Misconceptions Well I have to hire more employees to

manage the system?

The ISO 9001 requires management to provideresources necessary to achieve customersatisfaction

Resources are a business case decision

The resources are an investment in achievingthe organizations goals and customersatisfaction


17/104

Certification Process

Selection of a registrar

Initial visit and document review

Pre-audit

Registration audit

Post audit corrective actions

Verification of actions Certificate released, registered in public listing

Surveillance auditing begins at appropriate intervals


18/104

What is ISO 9001:2000?

ISO 9001:2000 is a quality management

system

Interconnected and interdependent processes

Provides a systematic approach to delivering

products or services meeting customer

requirements Enables continuous improvement in achieving

defined objectives


19/104


20/104

Overview of ISO 9001:2000

Product Realization Processes Design, purchasing, manufacturing, maintenance,

packaging, warehousing.

Customer Orientated Processes Sales, marketing, contracting, after sales support,

invoicing, managing complaints, product literature

Support Processes

Training, Calibration, document control, records Management Processes (PDCA)

Strategic planning, management review, internal audits


21/104

ISO 9001:2000 Overview

ISO 9001:2000 is contained in threeprimary documents

ISO 9000:2000 Quality management systemsFundamentals and vocabulary

ISO 9001:2000 Quality management systemsRequirements

ISO 9004:2000 Quality management systemsGuidelines for performance improvements

A few guidance documents


22/104

ISO 9001:2000 Requirements

ISO 9001:2000 contains five (5) main

clauses defining the requirements

4 Quality management system

5 Management responsibilities

6 Resource management

7 Product realization 8 Measurement, analysis and improvement


23/104

ISO 9001:2000Balancing the Equation

6.2 Human

Resources

6.3

Infrastructure

6.4 Work

Environment

7 ProductRealization

8

Measurement,

Analysis andImprovement

8.2.1 Customer

Satisfaction

5.4.1 Quality

Objectives

+

+

+

=

=

A B C=+


24/104

4 Quality Management System

4.1 General requirements The organization shall establish, document, implement and

maintain a quality management system and continually improve itseffectiveness in accordance with the requirements of this

International Standard The organization shall;

Identify the processes needed for the QMS and their application

Determine the sequence and interaction of these processes

Determine criteria and methods needed to ensure both the operationand control of processes are effective

Ensure the availability of resources and information as necessary

Monitor, measure and analyze these processes

Implement actions necessary to achieve planned results and continualimprovement of these processes

The Core Requirement


25/104


4.2 Documentation requirements

The quality management system documentation shall

include;

Documented statements of quality policy and quality objectives A quality manual

Documented procedures required by this International Standard

Documents needed by the organization to ensure the effective

planning, operation and control of its processes, and

Records required by this International Standard (see 4.2.4)


26/104


4.2.1 General (Cont.) Note 1: The term documented procedure means that the

procedure is established, documented, implemented and

maintained. Note 2: The extent of the quality management system

documentation can differ from one organization to anotherdue to; The size of the organization and type of activities

The complexity of processes and their interactions The competence of personnel

Note 3: The documentation can be in any medium


27/104


4.2.2 Quality Manual

The organization shall establish and maintain a quality

manual that includes;

The scope of the quality management system, including details ofand justification for any exclusions (see 1.2)

The documented procedures established for the quality

management system, or reference to them, and

A description of the interaction between the processes of the

quality management system (see handout)


28/104


4.2.3 Control of documents Documents required by the quality management system shall be

controlled. Records are a special type of document and shall becontrolled according to the requirements given in 4.2.4

A documented procedure shall be established to define controls

To approve documents for adequacy prior to issue To review and update as necessary and re-approve documents

To ensure that changes and the current revision status of document areidentified

To ensure that relevant versions of applicable documents are availableat points of use

To ensure that documents remain legible and readily identifiable To ensure that documents of external origin are identified and their

distribution controlled

To prevent the unintended use of obsolete documents, and to applysuitable identification to them if they are retained for any purpose.


29/104


4.2.4 Control of records Records shall be established and maintained to provide

evidence of

Conformity to requirements Effective operation of the quality system

Records shall remain Legible

Ready retrievable

Documented procedure must be established to define; Identification, storage, protection, retrieval, retention time and

disposition


30/104


Key points;

Document control enables creation and

revision, must not curtail change. Record control prevents loss of company

information


31/104


Documented procedures =6

Quality records categories = 20


32/104


Alternatives to documented procedures

Competent employees - having defined

education, skills and experience Employee training - trained for specific tasks

Process controlscalibrated monitoring andmeasuring equipment, mistake proofing

Verification and validationproductevaluations that separate good products frombad


33/104


34/104

5 Management Responsibility

5.1 Management commitment Top management shall provide evidence of its

commitment to the development and implementation of

the quality management system and continually

improving its effectiveness by; Communicating to the organization the importance of

meeting customer as well as statutory and regulatory

requirements

Establishing the quality policy Ensuring that quality objectives are established

Conducting management reviews and

Ensuring the availability of resources


35/104


5.2 Customer focus

Top management shall ensure that customer

requirements are determined and are met with

the aim of enhancing customer satisfaction (see

7.2.1 and 8.2.1)


36/104


5.3 Quality policy Top management shall ensure that the quality policy

Is appropriate to the purpose of the organization

Includes a commitment to comply with requirements and

continually improve the effectiveness of the qualitymanagement system

Provides a framework for establishing and reviewing quality

objectives

Is communicated and understood within the organization

Is reviewed for continuing suitablity


37/104


38/104


Quality Policy

Plan

Quality

Improvement

Productivity

Improvement

Do

Check

Act

Plan

Do

Check

Act

5.4.2 Organizations must plan on how to meet objectives


39/104


Corporate

Objectives

Plant 1

Objectives

Plant 2

Objectives

Plant 3

Objectives

PurchasingObjectives

ProductionObjectives

EngineeringObjectives

5.4.1 Quality objectives established at relevant

functions and levels with the organization.


40/104


5.4 Planning

5.4.2 Quality management system planning

Top management shall ensure that

The planning of the quality management system is carried

out in order to meet the requirements given in 4.1, as well

as the quality objectives, and

The integrity of the quality management system is

maintained when changes to the quality management

system are planned and implemented.


41/104


A simplified view of the components of

planning;

Objectives (results expected) Quality management processes affected or required

Resources

Measurement

Continual improvement


42/104


Quality Management Systems Approach Determine customer needs and expectations

Establish quality policies and objectives

Determine (and implement) required processes andresponsibilities

Determine and provide necessary resources

Establish measurement methods for each process

Apply measurements to check effectiveness andefficiency

Determine means of preventing nonconformancesand elimination of their causes

Establish and apply a process for continualimprovement

Plan

Do

Check

Act


43/104


Business Strategy

Plan

Do

Check

Act

Planning considerations;

Objectives for the strategyQMS processes required

Resources required

Measurement and analysis

Improvement opportunities

Leadership!


44/104


The Shall plan requirements found in

clauses;

5.4.2 Quality Management System Planning 7.1.1 Planning of Product Realization

7.3.1 Design and Development Planning

8.1 Plan for Measurement and Monitoring Activities

8.5.1 Planning for Continual Improvement


45/104


46/104


47/104


5.5 Responsibility, authority and communication

5.5.2 Management representative

Top management shall appoint a member of management

who, irrespective of other responsibilities, shall have

responsibility and authority that includes;

Ensuring that processes needed for the quality management

system are established, implemented and maintained;

Reporting to top management on the performance of the

quality management system and need for improvement, and Ensuring the promotion of awareness of customer requirements

throughout the organization


48/104


5.5 Responsibility, authority and communication

5.5.3 Internal communication

Top management shall ensure that appropriate

communication processes are established within the

organization and that communication takes place

regarding the effectiveness of the quality

management system.


49/104


50/104


5.6 Management review

5.6.2 Review input

The input to management review shall include; Results of audits

Customer feedback

Process performance and product conformity

Status of preventive and corrective actions Follow-up action from previous management reviews

Changes that could affect the quality management system

Recommendations for improvement


51/104


5.6 Management review

5.6.3 Review output

The output from management review shall includeany decisions and actions related to;

Improvement of effectiveness of the QMS and its

processes

Improvement of product related to customer requirements

Resource needs


52/104

6 Resource Management

6.1 Provision of resources

The organization shall determine and provide

the resources needed To implement and maintain the quality management

system and continually improve its effectiveness

To enhance customer satisfaction by meeting

customer requirements


53/104


6.2 Human Resources

6.2.1 General

Personnel performing work affecting product qualityshall be competent on the basis of appropriate

education, training, skills and experience.

Competence: demonstrated ability to applyknowledge and skills (ISO 9000:2000 3.9.12)


54/104


6.2 Human resources

6.2.2 Competence, awareness and training

The organization shall

Determine the necessary competence for personnel performing

work affecting product quality,

Provide training or take other actions to satisfy these needs

Evaluate the effectiveness of the actions taken,

Ensure that its personnel are aware of the relevance and

importance of their activities and how they contribution to the

achievement of the quality objectives, and

Maintain appropriate record of education, training, skills and

experience (see 4.2.4)


55/104


6.3 Infrastructure

The organization shall determine, provide and maintain

the infrastructure needed to achieve conformity to

product requirements. Infrastructure includes, as

applicable;

Buildings, workspace and associated utilities

Process equipment (both hardware and software)

Supporting services (such as transport or communication)


56/104


57/104

7 Product Realization

7.1 Planning of product realization

The organization shall plan and develop the

processes needed for product realization. Planning of product realization shall be

consistent with the requirements of the other

processes of the quality management system

(see 4.1)


58/104


7.1 Planning of product realization In planning product realization, the organization shall

determine the following, as appropriate: Quality objectives and requirements for the product

The need to establish processes, documents and provideresource specifics to the product

Required verification, validation, monitoring, inspection andtest activities specific to the product and the criteria for productacceptance

Records needed to provide evidence that the realizationprocesses and resulting product meet requirements (see 4.2.4)

The output of this planning shall be in a form suitablefor the organizations method of operations.


59/104


7.2 Customer-related processes

7.2.1 Determination of requirements related to product

The organization shall determine

Requirements specified by the customer, including the

requirements for delivery and post-delivery activities

Requirements not stated by the customer but necessary for

specified or intended use,where known

Statutory and regulatory requirements related to the product, and

Any additional requirements determined by the organization


60/104


61/104


7.2 Customer-related processes

7.2.2 Review of requirements related to product

Records of the results of the review and actions arising from

the review shall be maintained (see 4.2.4)

Where the customer provides no documented statement of

requirement, the customer requirements shall be confirmed by

the organization before acceptance.

Where product requirements are changed, the organization

shall ensure that relevant documents are amended and that

relevant personnel are made aware of the changed

requirements.


62/104


63/104


7.3 Design and development 7.3.1 Design and development planning

The organization shall plan and control the design and

development of product

During the design and development planning, theorganization shall determine

The design and development stages,

The review, verification and validation that are appropriate

to each stage, and

The responsibilities and authorities


64/104


7.3.2 Design and development inputs

Inputs relating to product requirements shall be

determined and records maintained (see 4.24.) This

inputs shall include;

Functional and performance requirements

Applicable statutory and regulatory requirements

Where applicable, information derived from

previous similar designs, and

Other requirements essential for design and

development


65/104


7.3.3 Design and development outputs

The outputs of design and development shall beprovided in a form that enables verification against thedesign and development input and shall be approved

prior to release. Design and development outputs shall

Meet the input requirements for design and development

Provide appropriate information for purchasing, productionand for service provision

Contain or reference product acceptance criteria, and Specify the characteristics of the product that are essential for

its safe and proper use.


66/104


7.3.4 Design and development review

At suitable stages, systematic reviews of design and development

shall be performed in accordance with planned arrangements (see

7.3.1 planning)

To evaluate the ability of the results of design anddevelopment to meet requirements, and

To identify any problems and propose necessary actions.

Participate in such reviews shall include representatives of

functions concerned with the design and development stage(s)

being reviewed. Records of the results of the reviews and any necessary actions

shall be maintained (see 4.2.4)


67/104


7.3.5 Design and development verification Verification shall be performed in accordance with

planned arrangements (see 7.3.1) to ensure that the

design and development outputs have met the design

and development input requirements.

Records of the results of the verification and any

necessary actions shall be maintained (see 4.2.4)


68/104


7.3.6 Design and development validation

Design and development validation shall be performed in

accordance with planned arrangements (see 7.3.1) to ensure

that the resulting product is capable of meeting therequirements for the specified application or intended use,

where known.

Wherever practicable, validation shall be completed prior to

the delivery or implementation of the product.

Records of the results of validation and any necessary

actions shall be maintained (see 4.2.4)


69/104


7.3.7 Control of design and development changes

Design and development changes shall be identified

and records maintained.

The changes shall be reviewed, verified and validated,

as appropriate, and approved before implemented.

The review of design and development changes shall

include evaluation of the effect of the changes on

constituent parts and product already delivered.

Records of the results of the review of changes and anynecessary actions shall be maintained (see 4.2.4)


70/104


7.4.1 Purchasing process The organization shall ensure that product conforms to

specified purchase requirements.

The type and extent of control applied to the supplier

and the purchased product shall be dependent upon the

effect of the purchased product on subsequent product

realization or final product.


71/104


7.4.1 Purchasing process The organization shall evaluate and select suppliers

based on their ability to supply product in accordance

with the organizations requirements.

Criteria for selection, evaluation and re-evaluation shall

be established.

Records of the results of evaluations and any necessary

actions arising from the evaluation shall be maintained

(see 4.2.4)


72/104


73/104


7.4.3 Verification of purchased product The organization shall establish and implement the

inspection or other activities necessary for ensuring that

purchases product meets specified purchase

requirements.

Where the organization or its customer intend to

perform verification at the suppliers premises, the

organization shall state the intended verificationarrangements and method of product release in the

purchasing information.


74/104


7.5.1 Control of production and service provision The organization shall plan and carry out production

and service provision under controlled conditions.

Controlled conditions shall include, as applicable

Availability of information that describes the characteristics ofthe product

Availability of work instruction, as necessary

Use of suitable equipment

Availability and use of monitoring and measuring devices

Implementation of monitoring and measurement, and

Implementation of release, delivery and post-delivery

activities


75/104


7.5.2 Validation of processes for production andservice provision

The organization shall validate any processes for

production and service provision where the resulting

output cannot be verified by subsequent monitoring ormeasurement.

This includes any processes where deficiencies become

apparent only after the product is in use or the service

has been delivered.


76/104


7.5.2 Validation of processes for production and serviceprovision

Validation shall demonstrate the ability of these

processes to achieve planned results

The organization shall establish arrangements for theseprocesses including

Defined criteria for review and approval of the processes

Approval of equipment and qualification of personnel

Use of specific methods and procedures Requirements for records

Revalidation


77/104


7.5.3 Identification and traceability

Where applicable, the organization shall identify the

product by suitable means throughout product

realization.

The organization shall identify the product status with

respect to monitoring and measurement requirements

Where traceability is a requirements, the organization

shall control and record the unique identification of the

product (see 4.2.4)


78/104


7.5.4 Customer property The organization shall exercise care with customer

property while it is under the organizations control or

being used by the organization.

The organization shall identify, verify, protect and

safeguard customer property provided for use or

incorporation into the product.

If any customer property is lost, damaged or otherwise

found to be unsuitable for use, this shall be reported tothe customer and records maintained (see 4.2.4)


79/104


7.5.5. Preservation of product

The organization shall preserve the conformity of

product during internal processing and delivery to the

intended destination.

This preservation shall include identification, handling,

packaging, storage and protection. Preservation shall

also apply to the constituent parts of a product.


80/104


81/104


7.6 Control of monitoring and measuring devices Where necessary to ensure valid results, measuring equipment

shall

Be calibrated or verified at specified intervals, or prior to use,

against measurement standards traceable to international or

national measurement standards; where no such standardsexist, the basis for calibration or verification shall be recorded;

Be adjusted or re-adjusted as necessary

Be identified to enable the calibration status to be determined

Be safeguarded from adjustments that would invalidate the

measurement result

Be protected from damage and deterioration during handling,

maintenance and storage.


82/104


7.6 Control of monitoring and measuring devices In addition, the organization shall access and record the

validity of the previous measuring results when the

equipment is found not to conform to requirements.

The organization shall take appropriate action on the

equipment and any product affected. Records of the resultsof calibration and verification shall be maintained (see 4.2.4)

When used in the monitoring and measurement of specified

requirements, the ability of computer software to satisfy the

intended application shall be confirmed. This shall beundertaken prior to initial use and reconfirmed as necessary.

See ISO 10012-1 and ISO 10012-2 for guidance


83/104

8 Measurement, analysis, and improvement

8.1 General

The organization shall plan and implement the

monitoring, measurement, analysis and improvement

processes needed

To demonstrate conformity of the product,

To ensure conformity of the quality management system, and

To continually improve the effectiveness of the quality

management system

This shall include determination of applicable statisticalmethods, including statistical techniques, and the extent

of their use.


84/104


8.2 Monitoring and measurement 8.2.1 Customer satisfaction

As one of the measurements of the performance of the

quality management system, the organization shall

monitor information relating to customer perception as

to whether the organization has met customer

requirements.

The methods for obtaining and using this information

shall be determined.


85/104


Add examples of customer satisfaction

measurement

Expectations for managing the use of theinformation

8 M l i d i


86/104


8.2.2 Internal audit The organization shall conduct internal audits at

planned intervals to determine whether the quality

management system

Conforms to the planned arrangements (see 7.1), tothe requirements of this International Standard and

to the quality management system requirements

established by the organization, and

Is effectively implemented and maintained

8 M l i d i


87/104


8.2.2 Internal audit An audit program shall be planned, taking into account the status

and importance of the processes and areas to be audited, as well as

the results of previous audits.

The audit criteria, scope, frequency and methods shall be defined.

Selection of auditors and conduct of audits shall ensure objectivity

and impartiality of the audit process. Auditors shall not audit their

own work.

The responsibilities and requirements for planning and conducting

audits, and for reporting results and maintaining records (see 4.2.4)

shall be defined in a documented procedure.

8 M t l i d i t


88/104


8.2.2 Internal audit The responsibilities and requirements for planning and

conducting audits, and for reporting results and

maintaining records (see 4.2.4) shall be defined in a

documented procedure. The management responsible for the area being audited

shall ensure that actions are taken without undue delay

to eliminate detected nonconformities and their causes.

Follow-up activities shall include the verification of theactions taken and the reporting of verification results

(see 8.5.2)

8 Measurement analysis and improvement


89/104


Effective implementation of

processes

Opportunities for improvement

Capability of processes Effective and efficient use of

statistical techniques

Use of information technology

Relationships with interestedparties

Analysis of quality cost data

Effective and efficient use of

resources

Process and productperformance results and

expectations

Know events

Adequacy and accuracy of

performance measurement

Improvement activities

ISO 9004:2000 recommendations for internal auditing

(see ISO 9004:2000 8.2.1.3)

8 M t l i d i t


90/104


8.2.3 Monitoring and measurement of processes The organization shall apply suitable methods for

monitoring and, where applicable, measurement of the

quality system processes.

These processes shall demonstrate the ability of theprocesses to achieve planned results.

When planned results are not achieved, correction and

corrective action shall be taken, as appropriate, to

ensure the conformity of product.

8 M t l i d i t


91/104


8.2.4 Monitoring and measurement of product The organization shall monitor and measure the characteristics of

the product to verify that product requirements have been met.

This shall be carried out at appropriate stages of the product

realization process in accordance with the planned arrangements

(see 7.1) Evidence of conformity with the acceptance criteria shall be

maintained. Records shall indicate the person(s) authorizing

release of product (see 4.2.4)

Product release and service delivery shall not proceed until the

planned arrangements (see 7.1) have been satisfactorily completed,unless otherwise approved by a relevant authority, and where

applicable, the customer.

8 M t l i d i t


92/104


8.3 Control of nonconforming product The organization shall ensure that product which does

not conform to product requirements is identified and

controlled to prevent its unintended use or delivery.

The controls and related responsibilities and authoritiesfor dealing with nonconforming product shall be

defined in a documented procedure.

8 Meas rement anal sis and impro ement


93/104


8.3 Control of nonconforming material The organization shall deal with nonconforming

product by one of the following ways;

By taking action to eliminate the detected nonconformity

By authorizing its use, release or acceptance under concessionby a relevant authority, and where applicable, by the customer

By taking action to preclude its original intended use or

application

Records of the nature of nonconformance and anysubsequent actions taken, including concessions

obtained, shall be maintained (see 4.2.4)



94/104


8.3 Control of nonconforming material When nonconforming product is corrected it

shall be subject to re-verification to

demonstrate conformity to the requirements. When nonconforming product is detected after

delivery or use has started, the organization

shall take action appropriate to the effects, or

potential affects, of the nonconformity.



95/104


8.4 Analysis of data The organization shall determine, collect and

analyze appropriate data to demonstrate thesuitability and effectiveness of the quality

management system and to evaluate wherecontinual improvement of the effectiveness ofthe quality management system can be made.

This shall include data generated as a result of

monitoring and measurement and from otherrelevant sources.



96/104


8.4 Analysis of data The analysis of data shall provide information

relating to;

Customer satisfaction (see 8.2.1) Conformity to product requirements (see 7.2.1)

Characteristics and trends of processes and products

including opportunities for preventive action, and

Suppliers


97/104



98/104


8.5.1 Continual improvement The organization shall continually improve the

effectiveness of the quality management systemthrough the use of the;

quality policy

quality objectives

audit results

analysis of data

corrective and preventive actions

management review.



99/104


8.5.2 Corrective action The organization shall take action to eliminate the

cause of nonconformities in order to prevent

recurrence. Corrective actions shall be appropriate to the

effects of the nonconformities encountered


100/104



101/104


8.5.3 Preventive action The organization shall determine action to

eliminate the causes of potential

nonconformities in order to prevent theiroccurrence.

Preventive actions shall be appropriate to the

affects of the potential problems.



102/104


8.5.3 Preventive action A documented procedure shall be established to

define requirements for

Determining potential nonconformities and theircauses

Evaluating the need for action to prevent occurrence

of nonconformities

Determining and implementing action needed, Recording the results of action taken (see 4.2.4)

Reviewing preventive action take.


103/104


104/104

Acknowledgements(Suggested reading)

ANSI/ASQ 9000:2000 Quality Management Systems

Fundamentals and Vocabulary

ANSI/ASQ 9001:2000 Quality Management Systems

Requirements, December 13,2000

Date post:	07-Apr-2018
Category:	Documents
Upload:	pravin9319789560
View:	225 times
Download:	0 times