ISO 9001 (Quality Management System)  

What is ISO 9001 QMS?
ISO 9001:2008 is the International standard for Quality Management Systems (QMS) Requirements. It is based on process approach.

Process approach

  • Identify the processes necessary for effective implementation
  • Understand interactions between these processes
  • Document the processes to assure effective operation and control

Aim of the standard
Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvements of the system and the assurance of conformity to customer and applicable statutory & regulatory requirements

Benefits of ISO 9001:

  • It reduces rejection/rework
  • It improves housekeeping
  • It increases morale of the company
  • It ensures Quality and after sales service to customers
  • It improves team work
  • It saves cost by :
  • avoiding repetition of work
  • avoiding unnecessary records
  • monitoring processes
  • ….and many other ways
  • Opportunities for export market
  • Due to increased confidence of customers in you, you get more & more orders
  • It improves discipline in the organization
  • It increases credit in the market

What you must do for effective implementation of ISO 9001:

  • You must know the complete details of the work we are doing
  • You must know our Work Procedures in detail
  • Our work place must be neat and clean
  • Every thing must be attached with a label/tag/colour along with its status i.e. For Inspection/Accepted/ Rejected /For rework etc.
  • All the inspection, measuring & test equipment must be calibrated
  • You must maintain records, wherever written in the work procedures
  • You must be ready for change

Eight Quality Management Principles are as follows, based on which this international standard is framed:

  1. Customer focus
  2. Leadership
  3. Involvement of people
  4. Process approach
  5. System approach to management
  6. Continual improvement
  7. Factual approach to decision-making
  8. Mutually beneficial supplier relationships

Documentation requirement by ISO 9001:2008

List of documents required by the standard

Quality policy (clause 4.2.1.a)
Quality objectives (clause 4.2.1.a)
Quality manual (clause 4.2.1.b)
Documented procedures as required by the standard as follows
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action

List of Records required by the standard

  1. Management reviews (5.6.1)
  2. Education, training, skills and experience (6.2.2e)
  3. Evidence that the realization processes and resulting product fulfill requirements (7.1d)
  4. Design and development inputs (7.3.2)
  5. Results of design and development reviews (7.3.4)
  6. Results of design and development verification
  7. Results of design and development validation
  8. Results of review of design and development changes (7.3.7)
  9. Results of supplier evaluations (7.4.1)
  10. To demonstrate process validity where output cannot be measured (7.5.2d)
  11. The unique identification of a product (7.5.3)
  12. Customer property (7.5.4)
  13. Basis for calibration of measuring equipment (7.6a)
  14. Results of calibration (7.6)
  15. Internal audits (8.2.2)
  16. Release of product (8.2.2)
  17. Nonconforming product (8.3)
  18. Results of corrective action (8.5.2)
  19. Results of preventive action (8.5.3)

Integrate ISO 9001 with other management system standards
ISO 9001 is designed in a harmonized manner with other management systems standards, such as OHSAS 18001, ISO 14001, ISO 22000, ISO 17025, ISO 27001, ISO 13485.

Clauses of ISO 9001 standard
Clause 1: Scope
Clause 2: Normative Reference
Clause 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)'
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, analysis and improvement

How to achieve ISO 9001 certification - ISO 9001 implementation / Certification steps

Steps to achieve ISO 9001 certification

  1. Gap Analysis/ status appraisal
  2. Awareness Training to all employee
  3. Documentation Design and finalization
  4. Implementation
  5. Conduct of internal audit
  6. Management Review Meeting
  7. Review of Implementation
  8. Stage 1 – certification audit
  9. Stage 2 – certification audit
  10. Recommendation for ISO 9001 certification
  11. Receiving certificate