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”

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.

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

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

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

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.

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.

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)

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.

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

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

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.

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

.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.

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.

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…

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.

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

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

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”.

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)

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.

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.

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.

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

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

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

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.

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

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

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.

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.

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.) 7.3.7 CONTROL OF (CHANGES) Changes be identified Records maintained Reviewed Effective of changes on constituent parts be evaluated (if already delivered)

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

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

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

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

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

7.5.4 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

7.5.5 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)

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

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

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)

8.2.1 (Customer Satisfaction) Top management to ensure 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

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

8.2.3 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

Product characteristics 8.2.4 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)

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

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

8.4 ANALYSIS & DATA Shall Determine Collect Analyze

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

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.

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

8.5.3 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.