Professional Documents
Culture Documents
OF ISO 9001:2000
Structure
6.0 Objectives
6.1 Introduction
6.2 Clause-wise Explanation of ISO 9001:2000
6.2.1 Clause 1: Scope
6.2.2 Clause 2: Normative Reference
6.2.3 Clause 3: Terms and Definitions
6.2.4 Clause 4: Quality Management System
6.2.5 Clause 5: Management Responsibility
6.2.6 Clause 6: Resource Management
6.2.7 Clause 7: Product Realization
6.2.8 Clause 8: Measurement, Analysis and Improvement
6.3 Let Us Sum Up
6.4 Key Words
6.5 Answers to Check Your Progress Exercise
6.6 Suggested Reading
6.0 OBJECTIVES
After reading this unit, we shall be able to:
• state the requirements of each clause of ISO 9001: 2000;
• deduce the interrelationship between different clauses;
• explain the mandatory procedures required to be maintained; and
• specify the mandatory records required to be maintained.
6.1 INTRODUCTION
The ISO 9001:2000 uses the process approach to implement the Quality
Management System (QMS). The process approach includes: (i) identifying
the processes necessary for the effective implementation of the quality
management system, (ii) understanding the interactions between these
processes and (iii) documenting the processes to the extent necessary to assure
their effective operation and control documenting. The standard has eight
clauses. The interpretation of each requirement manifested in different clauses
is explained with the aim of suitably deploying the same in respective food
safety related application areas.
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ISO 9001:2000 2. Normative Reference
3. Terms and Definitions
4. Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness and Training
6.3 Infrastructure
6.4 Work Environment
7. Product Realization
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
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7.3.3 Design and Development Outputs Clause Wise Interpretation
of ISO 9001:2000
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service
provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices
8. Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Non-conforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
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ISO 9001:2000 1.2 Application
All requirements of ISO 9001:2000 are generic and are intended to be
applicable to all organisations regardless of type, size and product provided.
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• Implement actions necessary to achieve planned results (objectives with Clause Wise Interpretation
of ISO 9001:2000
respect to effectiveness, efficiency, cost etc.).
If the company chooses to outsource any of the processes, it must ensure that
it retains control over them. These controls should be identified within the
company’s quality system. This may include how to control subcontract
work, printing of material before delivery to client, installation of the goods to
make sure that the customer is happy when they think the job is done.
4.2 Documentation Requirements
4.2.1 General: The quality management system documentations system must
include:
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• Is appropriate to the purpose of the company (this need be in congruence Clause Wise Interpretation
of ISO 9001:2000
with the vision, mission and values cherished by your company).
• Includes a commitment to comply with requirements and continually
improve of the QMS.
• Provides a framework for establishment and review of quality objectives
(there need be coherence between the two).
• Is communicated and understood by the entire company (this could be
accomplished through displays, screen-savers, printing on backside of
identity documents etc).
• Is reviewed for continuing stability (the periodicity may match with
frequency of management reviews).
This becomes one of the prime focuses of the standard and should not be
undertaken lightly. The policy must link to the organisation’s objectives for
commitment to quality goals. The policy must link to defined customer needs
and expectations.
5.4 Planning
5.4.1 Quality objectives: Top management must ensure quality objectives
are established at relevant functions and levels within the company.
These objectives must be measurable and consistent with the quality
policy. (Each process may take relevant objectives which if achieved
help accomplish organisational objectives).
5.4.2 Quality management system planning: Top management must ensure
that the planning of the quality system is carried out in order to meet
the requirements. The integrity of the QMS when changes are planned
and implemented. This need be done at both macro and micro level. At
macro level it is achieved through preparation of quality plans for new
project, product or contract and reviewing and revising the QMS based
on the effectiveness of the quality plans. At micro level it is achieved
by following the change control mechanism documented in control of
document procedure.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and authority: Top management must ensure
responsibilities and authorities are defined and communicated to all
concerned. The role specific activities in terms of providing
information, participating, reviewing and signing off may be
documented.
5.5.2 Management representative: Top management must appoint a
representative (from own management) responsible and authorized for:
• Ensuring processes needed are established implemented and maintained
(assessed through internal audits).
• Reporting to top management on the performance of the QMS and any
need for improvement (e.g. in management review meetings).
• Ensuring promotion of awareness of customer requirements throughout the
company (e.g. through defining the customer order fulfillment process
interfaces appropriately).
This person does not necessarily have to report to the general manager or chief
executive officer (although desirable), and can have other responsibilities.
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ISO 9001:2000 5.5.3 Internal communication: Top management shall ensure appropriate
communication processes are established and take place. This could
consist of planned meeting on specified agenda w.r.t. intra and inter
process participation.
5.6 Management Review
5.6.1 General: Top management must review the QMS at planned intervals
to ensure continued suitability, adequacy and effectiveness. This
includes assessing opportunity for improvement and changes including
the quality policy and quality objectives.
Records of these reviews must be maintained.
5.6.2 Review input: Inputs to management review must include:
• Results of audits,
• Customer feedback,
• Process performance (effectiveness calculations) and product conformity,
• Status of preventive and corrective actions,
• Follow up of previous meetings,
• Planned changes which could affect the QMS,
• Recommendation for improvement,
• Suitability of quality policy and objectives, and
• Resource statement (current utilization level and new requirements).
5.6.3 Review output: Outputs from management review shall include
decisions and actions related to:
• Improvements to the QMS and processes,
• Improvement of product related to customer requirements, and
• Resource needs.
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ISO 9001:2000 7.2 Customer – Related Processes
7.2.1 Determination of requirements related to the product: The
company must determine:
• Customer specified requirements.
• Requirements not stated by the customer, but necessary for intended use.
• Statutory and regulatory requirements.
• Any additional requirements.
7.2.2 Review of requirements related to the product: The company must
review these requirements prior to commitment to supply and in doing
so must also ensure that:
• Product requirements are defined.
• Contract/order requirements differing are resolved.
• The company can meet these requirements.
Records of the above must be maintained.
If the customer does not provide documentary evidence of requirements, these
must be confirmed by your company before committing. The company must
ensure all affected staff members are made aware of any relevant changes to
requirements.
7.5.4 Customer property: The company must exercise care with customer’s
property. This includes identifying, verifying, protecting and
safeguarding. This can include intellectual property like customer
supplied drawings, data, standards etc.
Records must be maintained and the customer reported to if customer
property is lost, damaged or unsuitable for purpose.
8.5.2 Corrective action: The Company must eliminate the cause of non-
conformities to prevent their recurrence. A documented procedure must
be established to define the requirements for:
• Reviewing non-conformities (including customer complaints).
• Determining the causes of non-conformities.
• Evaluating the need for action to prevent recurrence.
• Determining and implementing actions required.
• Recording the results of actions taken.
• Reviewing corrective actions taken.
This is one of the mandatory documented procedures.
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ISO 9001:2000 2) List any five essential MRM inputs.
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4) List any five (sub) clauses in ISO 9001:2000 which refer to customer
related aspects.
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The intent of the clauses and the internal congruence between the clauses has
been explained. The contents cover mandatory documents including plans,
procedures and records. The overall focus is on customer satisfaction and
continual improvement.
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Clause Wise Interpretation
6.4 KEY WORDS of ISO 9001:2000
1) ● Control of documents
• Control of records
• Internal audits
• Control of non-conforming products
• Corrective actions
• Preventive actions
2) ● Result of audits
• Status of corrective and preventive actions
• Improvement suggestions
• Customer feedback
• Process performance and product conformity
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ISO 9001:2000 3) ● Record of MRM (Clause 5.6)
• Record of effectiveness of training (Clause 6.2)
• Record of monitoring and measuring device (7.6)
• Record of design verification (Clause 7.3.5)
• Record of action taken on nonconformities (Clause 8.3)
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