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ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS

REQUIREMENTS1.0 SCOPEISO 9001:2000 – Clause 1.1 “General” This clause includes also the requirement to

address customer satisfaction “through the effective application of the system, including processes for continual improvement and prevention of non-conformity.

ISO 9001:2000 – Clause 1.2 “Application”This clause is a general description of the use of

the term “Application”

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INTENT: All requirements of this international standard are generic and are intended to be applied to all organizations

Regardless ofTYPE, SIZE AND PRODUCT provided:WHY: Where any requirement of this

international standard cannot be applied due to the nature of the organization or product, THIS CAN BE CONSIDERED FOR EXCUSION.

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WHAT: Where exclusions are made,claims of conformity of this international standard are are not acceptable unless:

Exclusions are limited to requirements within CLAUSE 7

WHEN:…And such exclusions do not affect the organization’s ability and responsibility to provide product that fulfills customer and applicable regulatory requirements

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TERMS AND DEFINITIONS

This clause states that the terms and definitions given in ISO 9000:2000 QMS fundermentals and vocabulary apply to ISO 9001:2000

The following diagram applies: SUPPLIER ORGANIZATION

CUSTOMER

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REQUIREMENTS4.1 General Requirements More emphasis has been put on the

need for continuous improvement Clarification on the necessary steps

to implement the QMS is given

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Steps;- Identify the processes needed for QMS- Determine the sequence and interaction

of these processes-Determine criteria and methods required

to ensure the effective operation and control of these processes

- Ensure the availability of information necessary to support the operation and monitoring of these processes I.e.provide necessary information to the right personnel.

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4.2 Documentation requirements4.2.1 GeneralThe QMS documentation shall include:a) Documented statement of QUALITY POLICY and

QUALITY OBJECTIVESb) Quality Manualc) Documented procedures required by the standardd) Documents needed by the organization to ensure

effective planning, operation and control of its processes

e) Quality records required by the international standard.

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The documented procedures required by the standard are:

1. CONTROL OF DOCUMENTS (4.2.3)2. CONTROL OF QUALITY RECORDS (4.2.4)3. INTERNAL AUDIT (8.2.2)4. CONTROL OF NON-CONFORMING

PRODUCT (8.3)5. CORRECTIVE ACTION (8.5.2)6. PREVENTIVE ACTION (8.5.3)

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4.2.2 QUALITY MANUALThe term “Quality Manual” is defined as “a

document specifying the QMS of an organization”

There are no requirements here for the inclusion of the following in this sort of quality manual:

Quality Policy Quality objectivesNOTE: Although it is not required here, nothing

prevents the organization from doing so.

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5.0 MANAGEMENT RESPONSIBILITYAll the sub clauses of the main clauses

start with “Top management shall…”Provide - see clause 5.1Ensure – see clause 5.2, 5.3, 5.4.1, 5.4.2,

5.5.1, 5.5.3Appoint – see clause 5.5.2Review – see clause 5.6.1

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5.1 “MANAGEMENT COMMITMENT”Requires that Top Management shall provide

evidence of its commitment of the Development of the QMS Implementation of the QMS Continually improving its effectiveness

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By: Communicating to the organization the

importance of meeting customer as well us statutory and regulatory requirements

Establishing the quality policy Providing a frame work for establishing and

reviewing quality objectives Requires that the quality policy is

communicated and understood within the organization.

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5.1 QUALITY OBJECTIVES

QUALITY OBJECTIVES shall be measurable and consistent with the Quality Policy

Under 5.4.1, requirement for quality objectives at relevant functions and levels within the organization has been stressed.

5.4.2 QMS PLANNING

Top management shall ensure that:-

Planning of the QMS is carried out in order to meet the requirements given in 4.1; as well as quality objectives and

The integrity of the QMS is maintained when changes to the QMS are planned and implemented

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.5.2 MANAGEMENT REPRESENTATIVE (MR)

Management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes: -

5.5.2 (C) Ensuring the promotion and awareness of customer requirements throughout the organization.

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5.5.3 – INTERNAL COMMUNICATION

Top management has been made responsible for the establishment of appropriate communication process” within the organization.

Communication has been focused on the“EFFECTIVENESS of the QMS” and not

the processes of the QMS.

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5.6 “MANAGEMENT REVIEW”

5.6.1 General

The following requirements have been included here:

“This review shall include assessing opportunities for improvement of the QMS…

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5.62 REVIEW INPUT

Attention should be given to input and output related sub-clauses:-

INPUT RELATED SUB-CLAUSES:Focus on very specific “information”a. Customer feedbackb. Process performance and product conformity; and c. Status of preventive and corrective actionsd. Planned changes that could affect the QMS.

The inputs to management review shall include information on recommendations for improvement.

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.5.3 REVIEW OUTPUT RELATED SUB-CLAUSES: -

Improvement of the effectiveness of QMS and its processes

a) Improvement of product related customer requirements, and

b) Resource needs

“Decisions” also needs to result as outputs from the review process

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6 – RESOURCE MANAGEMENT

6.1 “PROVISION OF RESOURCES”

The requirement for an organization to determine and provide resources needed:-

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To implement and maintain the QMS and continually improve its effectiveness and,

Enhance customer satisfaction.

6.2.1 GENERAL

HUMAN RESOURCES

The focus of this clause is on “personnel performing work affecting product quality”.

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6.2.2 “COMPETENCY, AWARENESS AND TRAINING

The organization shall: -

Determine the necessary competence for personnel performing work affecting 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 contribute to the achievement of the quality objectives, and

Maintain appropriate records of education, training, skills and experience (see 4.2.4)

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6.3 – “INFRASTRUCTURE”

The organization to determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.

Infrastructure includes: -

1. Building, workshops and associated utilities2. Process equipment both hardware and software3. Supporting services such as transport or

communication.

The primary requirements is to ensure processes are carried out under controlled conditions.

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6.4 “WORK ENVIRONMENT”

The organization to determine and manage the conditions of the work environment needed to achieve conformity to product requirements.

The terms “conditions” provides flexibility to the organization in deciding WHICH “Work place conditions” they need to “determine and manage” here.

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7. PRODUCT REALIZATION

7.1 PLANNING

Organization to plan and develop processes (documented procedures) by determining:

Quality objectives Requirements of the product. Processes Documents Resources specific to the process.

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7. PRODUCT REALIZATION

7.1 PLANNINGOrganization to plan and develop processes

(documented procedures) by determining:

Quality objectives Requirements of the product. Processes Documents Resources specific to the process. Verification

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Validation Monitoring Inspection and test activities Criteria for product acceptance Appropriate records (evidence of planning and

product meeting requirements)

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7.2 CUSTOMER RELATED PROCESSES

Organization to determine

7.2.1 Customer requirements (related to the product)

• stated (delivery and post Delivery)• not stated (necessary for intended use)• Statutory and regulatory requirements• records to be maintained

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7.2.2 REVIEW

• For adequacy of the requirements• Records of review to be maintained

7.2.3 CUSTOMER COMMUNICATION

Organization to determine and effect effective arrangements for communicating with customers in relation to

• Product information• Enquiries• Customer feedback including complaints

The arrangements should be formal.

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DESIGN AND DEVELOPMENT

7.3.1 PLANNING

Plan and control design and development of the product by determining

• Design and development stages• Review, verification and validation

appropriate at each stage• Responsibilities and authorities

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7.3.2 INPUTS

Determined and recorded

• Functional and performance requirements

• Applicable statutory and regulatory requirements

• Information derived from previous similar designs.

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7.3.3 OUTPUTS

• To be provided in a form that enables verification against inputs

• Approved prior to release

SHALL

• Meet input requirements• Provide information for purchasing, production and

service provision• Contain/reference product acceptance criteria• Specify characteristics essential for safe and proper

use.

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7.3.4 REVIEW

• Be systematic and at suitable stages

• Identify any problems

• Propose all necessary actions.

7.3.5 VERIFICATION

according to planned arrangements

ENSURE: OUTPUTS meets input requirements.

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7.3.6 VALIDATIONAccording to planned arrangements

ENSURE: Product is capable of meeting specified application requirements

(prior to delivery or implementation of the product.)

7.3.7 CONTROL OF (CHANGES)

• Changes be identified

• Records maintained

• Reviewed

• Effective of changes on constituent parts be evaluated

(if already delivered)

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7.4 PURCHASING

7.4.1 PROCESS

• Ensure a system of ensuring purchasing products conforms to specified purchase requirements

• Establish criteria for selection, evaluation (re-evaluation) of suppliers

• Evaluate, and select suppliers

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7.4.2 INFORMATION• Describe product to be purchased• Indicate requirements for approval of product• State QMS requirements• (Ensure adequacy of specified purchase

requirements prior to communicating to the supplier)

7.4.3 VERIFICATION OF PURCHASED PRODUCTS

• Establish & implement inspection activities• Ensure purchased product meets specified

purchase requirements

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7.5 PRODUCTION & SERVICE PROVISION

7.5.1 CONTROLPlan and carry out activities under controlled conditions by

ensuring

• Availability of information (describe product characteristics)

• Availability of work instructions• Use of suitable equipment• Availability/use of Monitoring and Measurement devices• Implement Monitoring and Measurement• Implement release, delivering/post delivery activities

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7.5.2 VALIDATION OF PROCESSES:

(VALIDATE SPECIAL PROCESSES – Process where resulting output cannot be verified by subsequent Monitoring and Measurement or where deficiencies become apparent only after the product is in use).

Establish arrangements for these processes by.

• Define criteria for review/approval• Approval of Equipment and Qualification of

personnel• Use of specified methods, procedures• Re-validation

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7.5.3 IDENTIFICATION & TRACEABILITY

Shall

• Identify product by suitable means throughout product realization

• Identify product status with respect to Monitoring/Measuring requirements.

FOR TRACEABILITY

Shall Record and control the unique identification

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7.5.4 CUSTOMER PROPERTY

ShallExercise care with customer property

• Identify, verify, protect and safeguard• Record any loss, damage, unsuitability for

use• Report to the customer• Records maintained

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7.5.5 PRESERVATIONShallPreserve conformity (of product)

Throughout Internal processing

• Delivery to intended destinationShall include Identification

• Handling• Packaging• Storage• Protection

(Apply to constituent parts of the product)

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7.6 CONTROL OF MONITORING/MEASUREMENT DEVICES

Shall determine:-

• Monitoring/measurement to be undertaken

• Monitoring/measurement devices needed

Shall establish

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Process to ensure monitoring/measurement is carried out in Constituent with monitoring/measuring requirements.

Measuring equipment shall Be calibrated (or verified at specified intervals) prior to

use.

• Traceability to international or national standards

• Be adjusted/re-adjusted as necessary

• Be identified to enable calibration status to be determined

• Be protected from damage

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8. MEASURING, ANALYSIS AND IMPROVEMENT

8.1 GeneralPlan, implement monitoring, measurement analysis

and improvement processesTO:Demonstrate conformity of product

• Ensure conformity and continued improvement of QMS

• By applicable methods

(e.g. statistical technique)

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8.2 MEASUREMENT AND MONITORING

8.2.1 (Customer Satisfaction)

Top management to ensure

Effective, Efficient methods are used to identify areas of improvement.

• Information relating to customer perception. e.g. satisfaction surveys for customer and other interested parties

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8.2.2 INTERNAL AUDIT.

Shall Conduct Internal Audit at Planned intervals

• Plan audit program

• Define audit criteria, scope, frequency

• Clarify auditors impartially

• Define responsibilities for various audit activities

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8.2.3 OF PROCESSShall apply suitable methods for

monitoring (and where possible) measurements of QMS processes

When planned results not achieved

Correction & corrective action to be taken

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8.2.4 OF PRODUCT

Monitor & Measure

• Product characteristics• Maintain evidence of conformity with acceptance

criteria• Indicate authority for release and service deliveryCondition

No proceeding until planned arrangements have been satisfactorily completed

Or

Approved by relevant authority (or by customer)

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8.3 CONTROL OF NON-CONFORMING PRODUCTS

• Establish a documented procedure for specific activities.

• Take action to eliminated detected nature of non-conformity

• Authorize use, release/acceptance under concession (relevant authority/or customer

• Take action of preclude original intended use• Record nature of non-conformity subsequent

actions taken• Maintain the records

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Detection after delivery/use

Take action appropriate to the effects, potential effects, of the non-conformity

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8.4 ANALYSIS & DATAShall Determine

• Collect• Analyze

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Appropriate data (Data to include results of monitoring/measurement)

Evaluate Areas of continual improvement (within

QMS)• Analysis to provide information about• Customers satisfaction• Conformity to product requirements• Suppliers• Trends/characteristics of process/product

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8.5 IMPROVEMENT

8.5.1 CONTINUAL

Shall continually improve the effectiveness of QMS through use of

• Quality policy

• Quality Objectives

• Audit results

• Analysis of data

• Corrective action

• Management reviews.

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8.5.2 CORRECTIVE ACTION

Establish a documented procedure

Define requirements for

• Review non-conformities

• Customer complaints

• Determine the causes

• Evaluate need for corrective action

• Determine and implement action

• Record results of actions

• Review correction action takenEliminate the cause (of nature) of non-conformance in order to

prevent recurrence

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8.5.3 PREVENTIVE ACTIONEstablish a documented procedure

Determine action to eliminated causes of potential non-conformities in order to prevent their occurrences.

Define requirements for Determine potential non-conformance and their causes

• Evaluate the need for preventive action to prevent occurrence

• Determine/improvement preventive action

• Keep record of preventive action taken

• Review preventive action taken.