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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.