UNIT 6 CLAUSE WISE INTERPRETATION
OF ISO 9001:2000
Clause Wise Interpretation
of ISO 9001:2000
Structure
6.0
6.1
6.2
Objectives
Introduction
Clause-wise Explanation of ISO 9001:2000
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.2.6
6.2.7
6.2.8
6.3
6.4
6.5
6.6
Clause 1: Scope
Clause 2: Normative Reference
Clause 3: Terms and Definitions
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis and Improvement
Let Us Sum Up
Key Words
Answers to Check Your Progress Exercise
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.
6.2 CLAUSE-WISE EXPLANATION OF ISO
9001:2000
The ISO 9001:2000 outlines the requirements of the quality management
systems. The Quality Management System. The eight clauses are as follows:
1.
Scope
1.1
General
1.2
Application
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ISO 9001:2000
2.
Normative Reference
3.
Terms and Definitions
4.
Quality Management System
5.
6.
7.
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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
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
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
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
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
8.
Design and Development Outputs
Design and Development Review
Design and Development Verification
Design and Development Validation
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
Clause Wise Interpretation
of ISO 9001:2000
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
6.2.1 Clause 1: Scope
The contents and interpretation are given here.
1.1 General
ISO 9001:2000 International Standard specifies requirements for quality
management system. The requirements covers the following:
•
•
Demonstrating its ability to consistently provide product which meets
customer and applicable regulatory requirements, and
Aiming to enhance customer satisfaction through the effective application
of the system, including processes for continual improvement of the system
and the assurance of conformity to customer and applicable requirements.
The term “product” means the product intended for, or required by, a customer.
49
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.
Where any requirement of ISO 9001:2000 standard cannot be applied due to
the nature of an organisation and its product, this can be excluded from the
scope. However the requirements falling under clauses 4, 5, 6 and 8 cannot be
excluded.
The rationale for exclusion must be established. Such exclusions must not
affect the organisation’s ability, or responsibility, to provide product that meets
customer and applicable regulatory requirements.
6.2.2 Clause 2: Normative Reference
The contents and interpretation are given here.
ISO 9000:2000, Quality management systems – Fundamentals and Vocabulary is the
reference document for ISO 9001:2000 standard.
6.2.3 Clause 3: Terms and Definitions
The contents and interpretation are given here.
For the purposes of this International Standard, the definitions given in ISO
9000:2000 apply.
Throughout ISO 9001:2000 standard, whenever the term “product” occurs, it
can also mean “service”.
6.2.4 Clause 4: Quality Management System
The contents and interpretation are given here.
4.1
General Requirements
The company shall establish, document, implement and maintain a quality
management system. It shall also need to continually improve it.
The company must:
• Identify the processes needed by the system to enable them to meet
customer requirements and identify their application toward this task. This
includes broad business processes as well as work processes,
50
•
Determine the sequence and any interaction between these processes (It
needs to map out the processes),
•
Determine criteria and methods by which will ensure proper operation and
control of these processes. For determining criteria the company can focus
on outputs and objectives of the process concerned,
•
It must measure the performance of the processes as a tool to continuously
improve them,
•
Ensure availability of resources of all kinds to support these processes
to make sure that everything that is needed is available, otherwise this
commitment to a quality system is futile,
•
Monitor, measure and analyze these key processes, and
•
Implement actions necessary to achieve planned results (objectives with
respect to effectiveness, efficiency, cost etc.).
Clause Wise Interpretation
of ISO 9001:2000
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:
•
Documented statements of quality policy and quality objectives.
•
A quality manual (which will explain how the company has planned to
fulfill the requirements of ISO 9001:2000 standard.).
•
Documented procedures required by ISO 9001:2000. There are six of them.
•
Documents required by the company to ensure effective planning,
operation and control of the processes. This consists of process profiles
(which outlines the characterization of identified processes in terms of
objectives, resources, roles, responsibilities, inputs, outputs, procedures,
suppliers, customers, monitoring, documents and records pertaining to the
process concerned) and associated documents.
•
Quality records required by ISO 9001:2000.
4.2.2 Quality manual: The organisation must establish a quality manual that
includes:
•
The scope of the quality system including details of/justification for any
exclusions.
•
The documented procedures or reference to them.
•
A description of the interaction between the processes. You may use any
topological representation e.g. charts, tables, schematics, relation diagram
etc., for the same.
The generation, use and control of documentation should be evaluated with
respect to the effectiveness and efficiency of the organisation against following
criteria:
•
Functionality (e.g. speed of processing),
•
User friendliness,
•
Resources needed,
•
Policies and objectives,
•
Current and future requirements related to managing knowledge,
•
Benchmarking of documentation system, and
•
Interfaces used by organisation’s customers, suppliers and other interested
parties.
4.2.3
•
Control of documents: Documents must be controlled. A documented
procedure must be established to define controls for:
Approving documents (who approves which document).
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ISO 9001:2000
•
Reviewing and updating documents (frequency may be defined for the
same).
•
Ensuring changes and current revision status of documents are identified
(an amendment register may be maintained for the same).
•
Ensuring relevant versions of documents are available at point of use
(controlled copies may be made available to the concerned).
•
Ensuring documents remain legible and identifiable (the documents need to
be properly protected and maintained from getting damaged from heat,
dust, fire, dirt etc.).
•
Ensuring documents of external origin are identified and distribution is
controlled e.g. ISO 9001:2000, ISO 9000:2000 etc.
•
Preventing unintended use of obsolete documents (retain them in a separate
file or folder if they are to be retained for any specific purpose. Otherwise
destroy them.
This is one of the mandatory documented procedures.
4.2.4
Control of records: Records must be established and maintained to
provide evidence of conformity of the quality system. Records must
remain legible, identifiable and retrievable. Procedures must exist to
establish controls for identification, storage, protection, retrieval,
retention time, and disposition of
records. The formats used for
records may be appropriately controlled e.g. by maintaining their
master copies in a separate file and tracking the changes if any.
This is one of the mandatory documented procedures.
6.2.5 Clause 5: Management Responsibility
The contents and interpretation are given here.
5.1
Management Commitment
Top management must provide evidence to support development and
implementation of the QMS and its continual improvement by:
•
Communicating to the company, the importance of meeting customer,
statutory and regulatory requirements. (this could be through meetings or
documents)
•
Establishing the quality policy.
•
Ensuring quality objectives are established.
•
Conducting management reviews.
•
Ensuring the availability of resources.
5.2
Customer Focus
Top management must ensure that customer requirements are determined and
fulfilled to enhance customer satisfaction. A separate role may be defined for
the same depending on the criticality of accuracy and speed required for the
same.
5.3
Quality Policy
Top management shall ensure that the quality policy:52
•
Is appropriate to the purpose of the company (this need be in congruence
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
Clause Wise Interpretation
of ISO 9001:2000
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.
53
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.
6.2.6 Clause 6: Resource Management
Contents and Interpretation
6.1
Provision of resources
The company must determine and provide resources needed to implement the
QMS and continually improve effectiveness. The resources include money,
machinery, manpower and material.
6.2
Human Resources
6.2.1
General: Personnel performing tasks affecting quality must be
competent on the basis of appropriate education, training, skills and
experience. The skills could be managerial, core-technical, behavioral.
They could have current compatibility or future applicability.
Competence, awareness and training: Identifying and providing
resources will include trained personnel for:
1) Management activities.
2) Performance of work activities.
3) Verification activities (i.e.: inspection and test, audit and monitoring
activities).
6.2.2
54
The company must:
•
Determine competence of personnel.
•
Provide training to satisfy their needs or take other actions like jobrotation etc.
•
Evaluate the effectiveness of training through operational results.
•
Ensure it's personnel are aware of the relevance of their activities and how
they contribute to quality objectives.
Clause Wise Interpretation
of ISO 9001:2000
Records must be maintained to support the above.
This points to an appraisal system, by which staff members set objectives and
are developed through appropriate training plans developed as a result of these
appraisals. This appraisal system should be aligned with your objectives and
business plans.
6.3 Infrastructure
The company must determine, provide and maintain infrastructure needed to
achieve conformity to product requirements including:
•
Buildings (area, separation between activities, approach, safety etc.),
workspace and associated utilities (water, power etc).
•
Process equipment, both hardware and software.
•
Supporting services such as transportation or communications.
6.4 Work Environment
The company must determine and manage the work environment to achieve
conformity to product requirements. The motivational aspects with regard to
(w.r.t.) work also need attention to keep the job-satisfaction level above
threshold.
6.2.7 Clause 7: Product Realization
The contents and interpretation are given here.
7.1 Planning of Product Realization
This requires your company to plan and develop your processes needed to
realize (make/generate) the product in line with your QMS. In doing so you
need to determine, where applicable:
Your quality objectives and requirements (and possibly those of your
customers) for each product.
•
The need to establish processes, documents to support those processes
(You still need to use forms of some type be they paper or electronic, but
no requirement here for documented procedures) and the need to provide
adequate resources to fulfill these requirements.
•
The verification, validation, monitoring, inspection and test activities
specific to the product and criteria for product acceptance (the final check
before handing over to the customer).
•
Records to provide evidence that the above has taken place in the manner
described in the QMS.
55
ISO 9001:2000
7.2 Customer – Related Processes
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.
7.2.1
•
•
•
•
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.
7.2.2
•
•
•
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.
Customer communication: The company must determine the need
and implement systems in order to communicate with customers about:
Product information
Enquiries, contracts, order handling (including changes)
Feedback and complaints
7.2.3
•
•
•
7.3
Design and Development
7.3.1 Design and development planning: The company must plan:
• The stages of design and development.
• Any review, verification or validation that may be appropriate for each
stage.
• The responsibilities for design and development and how interfaces are
managed.
Since any design is a reiterative process, the planning output must be updated,
as appropriate, as the design and development progresses. The design plan
need be updated to reflect the latest status of impacting parameters.
Design and development inputs: These must be recorded and
maintained and may include:
Functional and performance specifications.
Statutory/regulatory requirements (with regard to the geographic area
where the product-application is planned).
Experience with regard to (w.r.t.) previous (similar) designs.
Other requirements which your company follows e.g. aesthetic, packaging,
etc.
7.3.2
•
•
•
•
7.3.3
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Design and development outputs: These must be provided in a
manner which allows verification against inputs and must:
•
•
•
•
Meet input requirements.
Provide information for other related activities (e.g. purchase and
production) post development.
Contain product acceptance criteria (test standards, methods, sampling
plans etc.).
Specify characteristics for safe and proper use (with regard to user,
product and environment).
7.3.4
Clause Wise Interpretation
of ISO 9001:2000
Design and development review: Review is carried out as per the plan
in order to determine that the design will meet the requirements and to
identify any perceived problems and propose actions for their
rectification.
Records of reviews must be maintained.
7.3.5 Design and development verification: This should occur in order to
ensure design/developments have met the input requirements.
Records of verification must be maintained.
7.3.6
Design and development validation: This must be in line with
acceptance as guided by planning above and where practical should be
completed prior to delivery or implementation. Validation must ensure
that the development meets intended use of the outcome of
development.
Records validation must be maintained.
7.3.7
Control of design and development changes: The changes must be
reviewed, verified and validated as appropriate, the documented review
must include the effect of changes on constituent parts and delivered
product. In short each change may be required to go through the entire
design and development cycle.
Records of changes must be maintained.
7.4
Purchasing
7.4.1
Purchasing process: The company must ensure purchased product/
service conform to requirements. Controls are dependent upon the
effect of the purchased product/service on the final product. The
company must select suppliers based upon their ability to supply in
accordance with requirements and criteria for selection, evaluation and
re-evaluation must be established.
Records of evaluation must be maintained.
7.4.2 Purchasing Information: Purchasing information (e.g. purchase
order) must be reviewed before release. Verbal purchase orders must be
recorded. This must include in addition to product specifications where
applicable:
• Requirements for approval of product, procedures, processes and
equipment.
• Qualifications of personnel.
• Quality management system requirements.
7.4.3
Verification of purchased product: The company must establish
inspections to ensure purchases meet specified requirements. Where the
company or its customer intend to visit the supplier these arrangements
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need to be pre-intimated through the purchasing information. The
company may enter into quality agreement with suppliers to avoid
duplication of verification and also to have necessary transparency with
regard to (w.r.t) inspection methodology.
ISO 9001:2000
7.5
Production and Service Provision
7.5.1 Control of production and service provision: The company must
carry out production and service under controlled conditions including
where applicable:
•
Information describing
specifications).
•
Work instructions (process sheets).
•
Suitable equipment (production environment configuration).
•
Monitoring and measuring devices (calibration and setting verification).
•
Implementation of monitoring and measurement activities (process
capability tracking).
•
Implementation of release, delivery and post delivery activities (including
necessary records to be maintained).
7.5.2
characteristics
of
the
product
(product
Validation of processes for production and service provision: The
company must validate any processes where resulting output cannot be
verified by subsequent monitoring or measurement such as where
deficiencies only come to light after delivery (e.g. soldering, welding,
imaging etc.). Validation must demonstrate the ability of these
processes to achieve planned results using:
•
Defined criteria for review and approval of processes (e.g. by conducting
design of experiments studies),
•
Approval of equipment and qualification of personnel,
•
Use of specific methodology,
•
Requirements for records, and
•
Revalidation (at defined frequency).
7.5.3
Identification and traceability: The company must be able to suitably
trace a product throughout product realization spectrum and identify
product status with regard monitoring and measurement activities.
Where traceability is a requirement, the company must control and
record the unique identification of the product.
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.
7.5.5
58
Preservation of product: The company must preserve product during
processing and delivery including identification, handling, packaging,
storage and protection. This applies to component parts of a product.
This ensures that intentional and non-intentional damage to the stored
material is prevented.
7.6
Control of Monitoring and Measuring Devices
The company must determine where monitoring and measurement are required
in order to meet determined requirements and establish processes to facilitate
this. Measuring equipment must be (where applicable):
• Calibrated/verified at specified intervals or prior to use against national/
International standards or where no standards exist, the means of
verification shall be recorded. The external laboratories need be accredited
ones.
• Adjusted as necessary.
• Identified to establish calibration status (through suitable means like color
coding etc.).
• Safeguarded from adjustments invalidating results.
• Protected from damage/deterioration during handling/storage/
maintenance.
Clause Wise Interpretation
of ISO 9001:2000
The company must record and assess the validity of the previous results when
the equipment is found not to conform to requirements and take appropriate
actions on the products affected.
Records of results of calibration and verification must be maintained.
If the company uses computer software, its ability must be confirmed prior to
initial use and reconfirmed as necessary. This may include anti-virus software.
6.2.8 Clause 8: Measurement, Analysis and Improvement
The contents and interpretation are given here.
8.1
General
Your company must plan and implement monitoring, measuring, analysis and
improvement processes required to:
• Demonstrate conformity of product.
• Ensure conformity of the QMS.
• Continually improve the effectiveness of the QMS.
This must include determination of applicable methods including statistical
techniques and the extent of their use.
8.2
Monitoring and Measurement
8.2.1
Customer satisfaction: As one of the measurements of the QMS, the
company must measure customer perceptions to assess whether it has
fulfilled requirements. The methods for collection and use of data must
be determined. Some of the methods used could be customer surveys,
visiting customers, noting key points in customer communication,
customer suggestions, customer complaints, etc.
8.2.2
Internal audit: The company must conduct planned internal audits to
ensure conformance with planned arrangements for product realization,
the requirements of ISO 9001:2000 standard and the requirements of
the QMS and also to ensure that the QMS is implemented and
maintained.
Audit must be planned with consideration to the status and importance
of the processes and areas as well as the results of previous audits. The
audit criteria, scope, frequency and methods must be defined. Auditors
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should conduct audits objectively and impartially and not audit their
own work. Audit principles like ethical behavior, fair presentation, due
professional care etc., must be followed.
ISO 9001:2000
Responsibilities and requirements for planning and conducting audits,
reporting results and maintaining records must be defined in a
documented procedure. Management responsible for the area under
audit must ensure corrective actions are undertaken without delay.
Follow up activities must include verification of actions taken and
reporting verification results.
Records must be maintained.
This is one of the mandatory documented procedures.
8.2.3
Monitoring and measurement of processes: These methods must
demonstrate the ability of processes to achieve planned results and
where this is not the case corrective actions must be taken to ensure
conformity. The process effectiveness measurement could be based on
achievement of objectives as well as following the documented QMS.
8.2.4
Monitoring and measurement of product: The company must
conduct this to ensure characteristics of product meet requirements.
Evidence of such processes must be maintained indicating the person
authorizing release. This must not occur until planned arrangements
have been completed unless otherwise approved by a relevant
authority, and where applicable the customer.
Record must be maintained.
8.3 Control of Non-conforming Product
The company must ensure that product not conforming to requirements is
identified and controlled to prevent unintended use or delivery. Controls and
responsibilities must be defined within a documented procedure. The company
will deal with non-conforming product in one or more of the following ways:
•
Take action to eliminate the non-conformity.
•
Authorize its use by way of a concession by relevant authority and where
applicable the customer.
•
Taking action to exclude its original intended use.
Records of such non-conformances and subsequent actions and re-verification
must be maintained.
This is one of the mandatory documented procedures.
8.4 Analysis of data
The company must collate suitable data to demonstrate the effectiveness of
the quality system and to evaluate where continual improvement can be
made. Analysis must provide information relating to:
60
•
Customer satisfaction.
•
Conformance to product requirements.
•
Characteristics and trends of processes and products including
opportunities for preventive actions.
•
Suppliers.
Clause Wise Interpretation
of ISO 9001:2000
8.5 Improvement
8.5.1
Continual improvement: The Company must continually improve the
effectiveness of the implemented quality system through the use of
quality policy, quality objectives, audit results, analysis of data,
corrective and preventive actions and management review. This could
be done periodically through decisions and actions noted in
management review meeting output minutes.
8.5.2
Corrective action: The Company must eliminate the cause of nonconformities 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.
8.5.3
Preventive action: The company must determine actions to eliminate
potential non-conformities in order to prevent their occurrence. What
this means is that when it plans a new product or service, it needs to
think about what could go wrong and "mistake proof" it, so that the
likelihood of its happening will be eliminated. These actions must be
appropriate to the impact the potential problems may cause. A
documented procedure must be established to define requirements for:
•
Determining potential non-conformities and their causes.
•
Evaluating the need for action to prevent their occurrence.
•
Determining and implementing action needed.
•
Recording the action taken.
•
Reviewing preventive action taken.
This is one of the mandatory documented procedures.
Check Your Progress Exercise 1
"
Note: a) Use the space below for your answers.
b) Compare your answers with those given at the end of the unit.
1) List six mandatory procedures required to be documented as per ISO
9001:2000.
……………………………………………………………………………..
…………………………………………………………………………..…
……………………………………………………………………………..
……………………………………………………………………………..
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ISO 9001:2000
2) List any five essential MRM inputs.
……………………………………………………………………………..
……………………………………………………………………………..
……………………………………………………………………………..
……………………………………………………………………………..
3) List any five mandatory records as per ISO 9001:2000.
……………………………………………………………………………..
……………………………………………………………………………..
………………………………………………..……………………………
…………………………………………………...…………………………
4) List any five (sub) clauses in ISO 9001:2000 which refer to customer
related aspects.
……………………………………………………...………………………
………………………………………………………..……………………
………………………………………………………..……………………
………………………………………………………..……………………
5) Explain the main purpose of conducting internal audits.
………………………………………………………..……………………
………………………………………………………..……………………
…………………………………………………………………………….
..……………………………………………………………………………
6.3 LET US SUM UP
ISO 9001:2000 standard covers all aspects of quality management related
applicable areas in an industry. The standard harmonizes its structure with ISO
14001 EMS standard. The standard consists of eight clauses further divided
into twenty three sub-clauses. This structure follows PDCA (Plan-Do-CheckAct) approach in the organisation and sequence of the clauses.
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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6.4 KEY WORDS
Competence
: Demonstrated ability to apply knowledge and skills.
Corrective
Action
: Action to eliminate the cause of a detected non-conformity
or other undesirable situation.
Customer
Satisfaction
: Customer’s perception of the degree to which the
customer’s requirements have been fulfilled.
Document
: Information and its supporting medium.
Effectiveness
: Extent to which planned activities are realized and planned
results achieved.
Preventive
Action
: Action to eliminate the cause of a potential non-conformity
or other undesirable potential situation.
Product
: Result of a process.
Quality
: Degree to which a set of inherent characteristics fulfils
requirements.
Quality
Management
System
: Management system to direct and control an organisation
with respect to quality.
Record
: Document stating results achieved or providing evidence of
activities performed.
Requirement
: Need or expectation that is stated, generally implied or
obligatory.
6.5 ANSWERS TO CHECK YOUR PROGRESS
EXERCISE
Clause Wise Interpretation
of ISO 9001:2000
"
Your answer should include the following:
Check Your Progress Exercise 1
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)
4) ●
Clause 5.2 (customer focus)
•
Clause 7.2.1 (customer requirements)
•
Clause 7.4.3 (customer communication)
•
Clause 8.2.1 (customer satisfaction)
•
Clause 8.5.2 (customer complaints)
5) ●
Assessing adequacy of QMS documentation
•
Assessing level of consistency of implementation of QMS
•
Assessing effectiveness of implemented QMS
•
Assessing the level of understanding of QMS among the staff
•
Fulfilling the mandatory requirement of ISO 9001:2000 (Clause 8.2.2)
6.6 SUGGESTED READING
http://www.iso.org
ISO 19011:2002 – Guidelines for Quality and/or Environmental Management
Systems Auditing.
ISO 9000:2000 – Quality Management Systems - Fundamentals and
Vocabulary.
ISO 10012:2003 – Quality Assurance Requirements for Measuring Equipment.
ISO 9004:2000 – Quality Management Systems - Guidelines for Performance
Improvements.
ISO 10013:1995 – Guidelines for Developing Quality Manuals.
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