COMMUNIQUÉ
Expected Outcomes for Accredited Certification to ISO 9001
Expected Outcomes for Accredited Certification to ISO 9001
TheInternational Accreditation Forum (IAF) and the International Organization forStandardization (ISO) support the following concise statement of outcomes thatare to be expected as a result of accredited certification to ISO 9001. Theintent is to promote a common focus throughout the entire conformity assessmentchain in order to achieve these expected outcomes and thereby enhance the valueand relevance of accredited certification.
ISO9001 certification is frequently used in both private and public sectors toincrease confidence in the products and services provided by organizations,between partners in business-to-business relations, in the selection ofsuppliers in supply chains and in the right to tender for procurement contracts.
ISOis the developer and publisher of ISO 9001, but does not itself carry outauditing and certification. These services are performed independently of ISOby certification bodies. ISO does not control such bodies, but does developvoluntary International Standards to encourage good practice in theiractivities on a worldwide basis. For example, ISO/IEC 17021 specifies the requirementsfor bodies providing auditing and certification of management systems.
Oneoption for certification bodies wishing to provide further confidence in theirservices is to apply to be accredited as competent by an IAF recognizednational accreditation body. The IAF is an international association whosemembership includes the national accreditation bodies of 49 economies. ISO doesnot control such bodies, but does develop voluntary International Standards suchas ISO/IEC 17011 which specifies the general requirements for carrying outaccreditation.
NOTE:Accredited certification is only one way that an organization may demonstrateconformity to ISO 9001. ISO does not promote accredited certification overother conformity assessment methodologies.
Expected Outcomes for AccreditedCertification to ISO 9001
(From the perspective of theorganization’s customers)
“For the defined certification scope, an organizationwith a certified quality management system consistently provides products thatmeet customer and applicable statutory and regulatory requirements, and aims toenhance customer satisfaction.”
Notes:
a. “Products”also include “services.”
b. Customerrequirements for the product may either be stated (for example in a contract oran agreed specification) or generally implied (for example in the organization’spromotional material, or by common practice for that economic/industry sector).
c. Requirementsfor the product may include requirements for delivery and post-deliveryactivities.
Whataccredited certification to ISO 9001 means
Toachieve conforming products, the accredited certification process is expectedto provide confidence that the organization has a quality management systemthat conforms to the applicable requirements of ISO 9001. In particular, it isto be expected that the organization:
A. has established aquality management system that is suitable for its products and processes, andappropriate for its certification scope
B. analyzes andunderstands customer needs and expectations, as well as the relevant statutory andregulatory requirements related to its products
C. ensures thatproduct characteristics have been specified in order to meet customer and statutory/regulatoryrequirements
D. has determinedand is managing the processes needed to achieve the expected outcomes (conformingproducts and enhanced customer satisfaction)
E. has ensured theavailability of resources necessary to support the operation and monitoring of theseprocesses
F. monitors andcontrols the defined product characteristics
G. aims to preventnonconformities, and has systematic improvement processes in place to
1. Correct any nonconformitythat do occur (including product nonconformities that are detected afterdelivery)
2. Analyze the causeof nonconformities and take corrective action to avoid their recurrence
3. Address customercomplaints
H. has implementedan effective internal audit and management review process
I. is monitoring,measuring and continually improving the effectiveness of its quality managementsystem
Whataccredited certification to ISO 9001 does not mean
1) It is importantto recognize that ISO 9001 defines the requirements for an organization’squality management system, not for its products. Accredited certification toISO 9001 should provide confidence in the organization’s ability to “consistentlyprovide product that meets customer and applicable statutory and regulatoryrequirements”. It does not necessarily ensure that the organization will alwaysachieve 100% product conformity, though this should of course be a permanentgoal.
2) ISO 9001accredited certification does not imply that the organization is providing asuperior product, or that the product itself is certified as meeting therequirements of an ISO (or any other) standard or specification.