ISO 9001:2015 certification is acclaimed for being a management tool worldwide. With eight management principles as its base, this certification deals with the fundamentals of quality management of products in any sector, regardless of its type and size. It is claimed to be the sole standard of the 9000 family against which an organization can be certified. Innumerable organizations in India adopt a quality management system as a strategic growth policy. Its benefits include the enhancement in customer satisfaction by meeting their requirement, effective resource management, improvement in procedures, and others. You can confirm the declaration of your product/service by turning to Ideal Quality Certifications.
Main Requirements of the ISO 9001 Standard : Clause 1. Scope Clause 2. Normative References Clause3. Terms and Definitions Clause 2. Normative References Clause3. Terms and Definitions Clause 4. Quality Management System (2 Elements) Clause 5. Management Responsibility (6 Elements) Clause 6. Resource management (4 Elements) Clause 7. Product / Service Realization (6 Elements) Clause 8. Measurement, Analysis and Improvement (5 Elements) Clause 2. Normative References Clause3. Terms and Definitions Clause 4. Quality Management System (2 Elements) Clause 5. Management Responsibility (6 Elements) Clause 6. Resource management (4 Elements) Clause 7. Product / Service Realization (6 Elements) Clause 8. Measurement, Analysis and Improvement (5 Elements) Meet your needs and expectations Comply with applicable regulations
The requirements cover a wide range of topics, including your supplier's top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides. ISO 9001 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, National or International product standards, supplier’s catalogues or other documents as appropriate.
What does "Conformity to ISO 9001 mean? : This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001 should not, however, be considered as a substitute for a declaration or statement of product conformity.
How does ISO 9001 help you in selecting a supplier? : ISO 9001 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics - Requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers' needs. the ways in which supplied products can be verified as meeting the requirements of the customer.
Note that whenever ISO 9001 refers to “products? this also includes intangible products like services, or software. You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.
To help in this task you may consider the following :
What is the specific product (goods or service) you are buying?
What impact does this product have on your own business?
What are the risks to your business if you experience problems with this product?
How can you be sure that the product you receive will actually meet your requirements?
What do you know about the reputation and historical performance of your supplier?
What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
If you decide that conformity to ISO 9001 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001 requirements?
Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)
How can you have confidence that your supplier meets ISO 9001? :
There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001. These include :
Supplier’s declaration of conformity? A declaration by your supplier itself affirming that its QMS meets ISO 9001 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier’s internal audit system, or on second party or third party audits;
Second party assessment: your supplier has been assessed directly by its customer (for example by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001 requirements and your own requirements - sometimes used in contractual “business-to-business?transactions;
Third party assessment: (often referred to as certification or registration): your supplier hires an impartial third party (a Certification Body, or “Registrar? to conduct an assessment to verify conformity to ISO 9001 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001
Additional confidence may be derived from the fact that some Certification Bodies (“Registrars? are accredited by nationally or internationally recognized Accreditation Bodies, who verify the certification body’s independence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the IAF (International Accreditation Forum) to promote worldwide mutual recognitions in support of WTO (World Trade Organization) free trade principles.
Can suppliers claim that their goods or services meet ISO 9001? No. The reference to ISO 9001 indicates that the supplier has a quality management system that meets the requirements of ISO 9001. As mentioned earlier, this should provide you with confidence in your supplier’s ability to provide consistent, conforming goods or services. ISO 9001 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.