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Unit 3 Lecture 2

The document outlines the requirements for an ISO 9001 quality management system certification. It describes the eight major clauses that must be satisfied, including scope, documentation, management responsibility, and measurement and improvement. It also lists the ten steps an organization must follow to achieve ISO 9001 certification.

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19 views

Unit 3 Lecture 2

The document outlines the requirements for an ISO 9001 quality management system certification. It describes the eight major clauses that must be satisfied, including scope, documentation, management responsibility, and measurement and improvement. It also lists the ten steps an organization must follow to achieve ISO 9001 certification.

Uploaded by

piyush bhandari
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Unit 3

ISO 9001:2008
Quality Management system
ISO 9001 requirements
The ISO 9001 document is the set of requirements that organization must satisfy in order to
achieve ISO 9001 certification.
It has eight major clauses. They are:
1. Scope
2. Normative reference
3. Terms and definitions
4. QMS requirements
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
First three clauses are general clauses which provides information and remaining five clauses
are technical clauses and they are the actual requirements which organization must meet.

1. Scope
This clause specifies the requirements for adapting quality management system.
So that organization could provide product that meets customer requirements.
And enhance the customer satisfaction level by effective application of the system

2. Normative Reference
This clause consists the necessary concept & definition for QMS

3.Terms and Definition


All the definitions and terms given in ISO 9000:2000 are mentioned in this clause. E.g. Supplier,
Organization, Customer.

4. Quality Management System Requirements


Maintain proper documentation to ensure that a product or service fulfills customer requirements
specifically. It includes,
4.1. The QMS: It should be implemented, maintained & continually improved by the
organization.
4.2. The Quality Manual: Also called organizational 'Rule book’. It includes scope of QMS, its
details and justifications for any exclusions in applying QMS.
4.3. The Control of Documents : Review & approve document before issue. Changes & current
revision status must be clearly identified.
4.4. Quality Records: The Records must be legible, readily identifiable & easily retrievable.
E.g.: mgt. review records, training records, purchase evaluation records, audit records, customer
complaints and other process related records.

5. Management Responsibility
This contains following sub-clauses:
Management Commitment: Top (senior) management must be fully committed for the
development & improvement of the QMS.
Customer Focus: Determine, fully understand and document customer requirements & ensuring
compliance with statutory laws.
Quality Policy: Ensure that process is appropriate for the purpose, understood by everyone and
reviewed for continued standard.
Planning: the managements quality objectives and quality policy.
Responsibility: of identifying and planning the activities and resources required to achieve
quality objectives
Management Representative: Appointing person for implementing an improvement through
QMS.
Management Review: Regular review to check, QMS is functioning continually and find areas
of improvement

6. Resource Management
This clause discusses regarding defining and availability of resources.
6.1. Provision of Resources: Provide resources to implement, maintain and improve the QMS.
Also to enhance customer satisfaction
6.2. Human Resources: Ensure employees are adequately competent & trained for assigned
roles. Maintain training records.
6.3. Infrastructure: Determine, provide & maintain infrastructure (which include bldg.,
workspace, equipment and supporting services) as per product requirement
6.4. Work Environment: Determine & manage the work environment (which include factors
such as noise, lighting, temperature, humidity and weather) as per product requirement

7. Product Realization
Organizations’ have to plan & develop the processes needed for:
7.1. Planning of product realization: Determine quality objectives & requirements for product
7.2. Customer-related processes: Determination of requirements related to the product: such
Post-delivery activities, maintenance activities etc.
7.3 Design and development: Update the plan as design and development progresses. Perform
Review, Verification and Validation of design.
7.4 Purchasing: Evaluate and select suppliers based on their ability to meet purchase
requirements.
7.5 Production and service provision: During servicing safeguard the customer property.
Preserve conformity of product during internal testing up to product delivery.
7.6 Control of monitoring and measuring devices: Measuring devices must be calibrated at
specific intervals. And maintain the Calibration records.

8. Measurement, Analysis and Improvement


It includes
8.1 Monitoring and measurements: Perform Internal audit to determine implementation of QMS.
Also find Customer satisfaction through feedback channels.
8.2 Control of nonconforming product by identifying and segregation.
8.3 Determine, collect and analyze appropriate data to demonstrate suitability and effectiveness
of the QMS.
8.4 Improvement:
Continual improvement of QMS through quality policy, objectives, audit results, analysis of data,
corrective / preventive actions and mgt. review.
Corrective action taken to find non-conformities and take corrective actions
Preventive action taken to avoid non-conformities which should be recorded & their
effectiveness is verified.

Steps of ISO 9001 Certification


Following are the Ten Steps to be followed for ISO 9001 Certification:
1. Identify key drivers
2. Obtain the standard and Purchase a copy of the standard
3. Define the strategy
4. Planning
5. Know processes
6. Determine training needs
7. Develop management system documentation
8. Implement Quality Management System
9. Consider a pre-assessment audit
10. Go for certification

1. Identify Key Drivers:


At senior management level, First of all find the key drivers i.e. main purpose behind
implementing a QMS. The main purpose may be to improve the performance of process, or a
need for continual improvement, or satisfying a specific customer requirement

2. Obtain the standard and Purchase a copy of the standard:


On website www.iso.org search for ISO 9000 family to find standard relating to particular sector.
In this case purchase document related to ISO 9001

3. Define the Strategy:


commitment of senior management is most important for successful implementation of QMS.
Maintain formal documentation as per ISO 9001 requirements. Decide the policy and objectives
for quality of process. And ensure that, requirements of the quality policy must be measureable
and there is scope for continuous improvements.

4. Planning to provide Resources for Developing the Quality Management System


Prepare project plan to identify needs and to measure the progress. And it should be periodically
reviewed by senior management and kept updated from time to time

5. Know the Processes


As per ISO 9001, prepare process map. This map will identify the key processes and indicate the
resources, controls, documentation and records needed to meet the customers' requirements.
This process map should be used, reviewed and updated regularly so that it can be finally
included in the Quality Manual.

6. Determine Training Needs


Different courses, workshops and seminars are organized to provide training to Team leaders,
employees and internal auditors. Also mention the benefits derived by conduction of training

7. Develop Management System Documentation


ISO 9001 requires documentation of policy, manual, procedures and records. There are six
documented procedures specifically required by ISO 9001 as well as those needed and identified
for the organization.

8. Implement the Quality Management System


Proper implementation of QMS is recorded by internal audits. A management review must also
be conducted to ensure the system's suitability, adequacy and effectiveness. The main review is a
key driver to demonstrate the effective implementation of the QMS. Any corrective and
preventive actions should be identified, progressed and recorded

9. Consider a Pre-assessment Audit


It will help to identify any gaps that exist between the requirements of the standard and the
organization's existing processes. This audit can be carried out at any stage and is independent of
the certification process. It is performed to fulfill tow requirements.
Stage 1: The purpose of the auditor visit is to check the readiness of the organization for full
assessment.
Stage 2: The purpose of the auditor visit is to confirm that the QMS fully conforms to the
requirements of ISO 9001:2008 in practice.

10. Go for Certification


Go for certification by approaching registrar or certification body (CB) who should be a member
of the International Accreditation Forum (IAF), and additionally need to be ISO 17021: 2015
certified i.e. eligible to provide certification

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