1. ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
1.0 SCOPE
ISO 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”

2. INTENT: All requirements of this international standard are generic and are intended to be applied to all organizations
Regardless of
TYPE, 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.

3. 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

4. The following diagram applies:
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

5. REQUIREMENTS
4.1 General Requirements
More emphasis has been put on the need for continuous improvement
Clarification on the necessary steps to implement the QMS is given

6. 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.

7. 4.2 Documentation requirements 4.2.1 General
The QMS documentation shall include:
Documented statement of QUALITY POLICY and QUALITY OBJECTIVES
Quality Manual
Documented procedures required by the standard
Documents needed by the organization to ensure effective planning, operation and control of its processes
Quality records required by the international standard.

8. The documented procedures required by the standard are:
CONTROL OF DOCUMENTS (4.2.3)
CONTROL OF QUALITY RECORDS (4.2.4)
INTERNAL AUDIT (8.2.2)
CONTROL OF NON-CONFORMING PRODUCT (8.3)
CORRECTIVE ACTION (8.5.2)
PREVENTIVE ACTION (8.5.3)

9. 4.2.2 QUALITY MANUAL
The 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 objectives
NOTE: Although it is not required here, nothing prevents the organization from doing so.

10. 5.0 MANAGEMENT RESPONSIBILITY
All the sub clauses of the main clauses start with “Top management shall…”
Provide - see clause 5.1
Ensure – see clause 5.2, 5.3, 5.4.1, 5.4.2, 5.5.1, 5.5.3
Appoint – see clause 5.5.2
Review – see clause 5.6.1

11. 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

12. 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.

13. 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.
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

14. .5.2 MANAGEMENT REPRESENTATIVE (MR)
Management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes: -
(C) Ensuring the promotion and awareness of customer requirements throughout the organization.

15. 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.

16. 5.6 “MANAGEMENT REVIEW”
General
The following requirements have been included here:
“This review shall include assessing opportunities for improvement of the QMS…

17. 5.62 REVIEW INPUT
Attention should be given to input and output related sub-clauses:-
INPUT RELATED SUB-CLAUSES:
Focus on very specific “information”
Customer feedback
Process performance and product conformity; and
Status of preventive and corrective actions
Planned changes that could affect the QMS.
The inputs to management review shall include information on recommendations for improvement.

18. Improvement of the effectiveness of QMS and its processes
.5.3 REVIEW OUTPUT RELATED SUB-CLAUSES: -
Improvement of the effectiveness of QMS and its processes
Improvement of product related customer requirements, and
Resource needs
“Decisions” also needs to result as outputs from the review process

19. 6 – RESOURCE MANAGEMENT
6.1 “PROVISION OF RESOURCES”
The requirement for an organization to determine and provide resources needed:-

20. To implement and maintain the QMS and continually improve its effectiveness and,
Enhance customer satisfaction.
GENERAL
HUMAN RESOURCES
The focus of this clause is on “personnel performing work affecting product quality”.

21. Provide training or take other actions to satisfy these needs
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)

22. 6.3 – “INFRASTRUCTURE”
The organization to determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.
Infrastructure includes: -
Building, workshops and associated utilities
Process equipment both hardware and software
Supporting services such as transport or communication.
The primary requirements is to ensure processes are carried out under controlled conditions.

23. 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.

24. 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.

25. 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.
Verification

26. Validation
Monitoring
Inspection and test activities
Criteria for product acceptance
Appropriate records
(evidence of planning and product meeting requirements)

27. 7.2 CUSTOMER RELATED PROCESSES
Organization to determine
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

28. REVIEW
For adequacy of the requirements
Records of review to be maintained
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.

29. DESIGN AND DEVELOPMENT
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

30. INPUTS
Determined and recorded
Functional and performance requirements
Applicable statutory and regulatory requirements
Information derived from previous similar designs.

31. 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.

32. REVIEW
Be systematic and at suitable stages
Identify any problems
Propose all necessary actions.
VERIFICATION
according to planned arrangements
ENSURE: OUTPUTS meets input requirements.

33. 7.3.6 VALIDATION
According to planned arrangements
ENSURE: Product is capable of meeting specified application requirements
(prior to delivery or implementation of the product.)
CONTROL OF (CHANGES)
Changes be identified
Records maintained
Reviewed
Effective of changes on constituent parts be evaluated
(if already delivered)

34. 7.4 PURCHASING
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

35. 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)
VERIFICATION OF PURCHASED PRODUCTS
Establish & implement inspection activities
Ensure purchased product meets specified purchase requirements

36. 7.5 PRODUCTION & SERVICE PROVISION 7.5.1 CONTROL
Plan 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

37. 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

38. 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
Record and control the unique identification

39. CUSTOMER PROPERTY
Shall
Exercise care with customer property
Identify, verify, protect and safeguard
Record any loss, damage, unsuitability for use
Report to the customer
Records maintained

40. PRESERVATION
Shall
Preserve conformity (of product)
Throughout
Internal processing
Delivery to intended destination
Shall include
Identification
Handling
Packaging
Storage
Protection
(Apply to constituent parts of the product)

41. 7.6 CONTROL OF MONITORING/MEASUREMENT DEVICES
Shall determine:-
Monitoring/measurement to be undertaken
Monitoring/measurement devices needed
Shall establish

42. 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

43. Demonstrate conformity of product
8. MEASURING, ANALYSIS AND IMPROVEMENT
8.1 General
Plan, implement monitoring, measurement analysis and improvement processes
TO:
Demonstrate conformity of product
Ensure conformity and continued improvement of QMS
By applicable methods
(e.g. statistical technique)

44. 8.2.1 (Customer Satisfaction) Top management to ensure
8.2 MEASUREMENT AND MONITORING
(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

45. Conduct Internal Audit at Planned intervals
Shall
Conduct Internal Audit at Planned intervals
Plan audit program
Define audit criteria, scope, frequency
Clarify auditors impartially
Define responsibilities for various audit activities

46. OF PROCESS
Shall apply suitable methods for monitoring (and where possible) measurements of QMS processes
When planned results not achieved
Correction & corrective action to be taken

47. Product characteristics
OF PRODUCT
Monitor & Measure
Product characteristics
Maintain evidence of conformity with acceptance criteria
Indicate authority for release and service delivery
Condition
No proceeding until planned arrangements have been satisfactorily completed Or
Approved by relevant authority (or by customer)

48. 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

49. Detection after delivery/use
Take action appropriate to the effects, potential effects, of the non-conformity

50. 8.4 ANALYSIS & DATA
Shall
Determine
Collect
Analyze

51. Areas of continual improvement (within QMS)
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

52. 8.5 IMPROVEMENT
CONTINUAL
Shall continually improve the effectiveness of QMS through use of
Quality policy
Quality Objectives
Audit results
Analysis of data
Corrective action
Management reviews.

53. 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 taken
Eliminate the cause (of nature) of non-conformance in order to prevent recurrence

54. PREVENTIVE ACTION
Establish 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.