ISO 9001: Quality Management System [QMS]

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Overview

ISO 9001:2015 is a generic standard for Quality Management System Implementation prepared by Technical Committee ISO/TC 176. The fifth edition ISO 9001:2015 is compatible to ISO 14001:2015 and replaces ISO 9001:2008.

ISO 9000 is the most widely used international standard that provides a framework for an effective QMS. ISO 9001 is implemented by more than one million organizations in 178 countries worldwide.

ISO 9001 is set of requirements for a quality management system implementation & certification. Three pillars of ISO 9001 are Customer satisfaction, Management responsibility and continual improvements.

ISO 9001: 2015 is applicable to the processes for Design, manufacturing & supply of products and realization of services an organization supplies.

The ISO 9000 family is primarily set standards for "quality management". This means what the organization does to meet:

  • The customer's quality requirements
  • Applicable regulatory requirements,
  • Customer satisfaction, and
  • Achieve continual improvement of its performance.

The major clauses in the ISO 9001:2015 are:

  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement

Scope & Application

ISO 9001:2015 is set of requirements for a quality management system where an organization

  1. Needs to demonstrate its ability to consistently supply product that meets customer requirements while meeting all applicable Statutory and regulatory requirements, and
  2. Set objectives to enhance customer satisfaction through the effective application of the system and continual improvement of the same.

Requirements of ISO 9001:2015 are generic and are intended to be applicable to all organizations, irrespective of type, size and products and services provided

  1. Exclusions are considered for where any requirement(s) of the Standard cannot be applied due to the nature of an organization and its product or services.
  2. Exclusions are limited to requirements specified in Clause 7 and not affecting customer requirements and applicable statutory and regulatory requirements.

ISO 9001 Requirements

General Requirements
The organization shall establish, document, implement & maintain a QMS and demonstrate continual improvement in implementation of the requirements.

The organization shall,

  1. Identify processes
  2. Identify sequence & interaction of processes
  3. Determine Criteria and methods for effective operation control of processes
  4. Provide Resources and information for operation and monitoring the processes
  5. Monitor, Measure and analyze the processes
  6. Plan Actions to achieve planned results and continual improvement of these processes

The organization shall control outsourced process that affects product conformity with requirements and same shall be documented and recorded.

Documentation Requirements

The ISO 9001:2015 documentation shall include:

  1. Quality policy and Quality Objectives
  2. Quality Manual
  3. Management System Procedures & Records requires by this international standard
  4. Work instructions and records, necessary to ensure the effective planning, operation & control of its processes.

ISO 9001:2015 Implementation Benefits

  • Policies & Objectives set by 'top management'
  • Understanding of customer's requirements with a view to achieving Customer Satisfaction
  • Improved internal and external Communications
  • Greater understanding of the organization's processes
  • Understanding how statutory and regulatory requirements impact on the organization and your customers
  • Clear responsibilities and authorities agreed for all staff
  • Improved use of time and resources
  • Reduced wastage
  • Greater consistency and traceability of products and services
  • Improved morale and motivation
  • Customer Confidence, Satisfactionand Trust
  • Level of Assurance in Organisational Quality
  • Conformance to Legal and Regulatory Requirements
  • Organisational Profitability
  • Ability to Differentiate Organisation for Competitive Advantage
  • Organisational Credibility & Reputation

Why Choose 4C Consulting ?

  • Team 4C has IRCA certified ISO 9001 auditors for Consulting Services
  • 400+ QMS implementation in 12 different industries
  • Hands on experience of Team 4C in implementing other Quality tools such as LEAN, TQM, FMEA, PPAP would help to gain early benefits
  • Management System Consulting division has assisted organization to implement QMS for Aerospace - AS9100 , Automobile - IATF 16949 and Medical device - ISO 13485.

Training

We offer a customized training program on ISO 9001:2015 for


ISO 9001 Know More

To whom ISO 9001:2015 Applicable??

ISO 9001:2015 is applicable to :

  1. Manufacturing Companies
  2. Trading and distribution companies
  3. Services companies like IT, retail, education, facility services etc.
  4. Government, Semi-Government, Private & Public Organizations.

We are a very small company. Can we get certified?

Yes, you can. The ISO 9001 requirements are specifically intended to apply to all organisations, regardless of type, size or services/products.

Where does ISO fit into the organization's quality management system?

The ISO standard offers best practices that can be used to implement a quality system in any organization. Many organizations who attempt to implement improvement efforts find the efforts can be disjointed without a structure such as ISO 9001. ISO provides a way to focus the management team on what they need to do to successfully implement change in ways that satisfy customers.