Expected Outcomes of ISO 9001 Certification

“For the defined certification scope, an organization with a certified quality
management system consistently provides products that meet customer and
applicable statutory and regulatory requirements, and aims to enhance
customer satisfaction.”

Notes:

a. “Products” also include “services.”

b. Customer requirements for the product may either be stated (for example in a contract or an agreed specification) or generally implied (for example in the organization’s promotional material, or by common practice for that economic/industry sector).

c. Requirements for the product may include requirements for delivery and post-delivery activities.

What Accredited Certification to ISO 9001 Means

To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:

A. has established a quality management system that is suitable for its products and processes, and appropriate for its certification scope

B. analyzes and understands customer needs and expectations, as well as the relevant statutory and regulatory requirements related to its products

C. ensures that product characteristics have been specified to meet customer and statutory/regulatory requirements

D. has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction)

E. has ensured the availability of resources necessary to support the operation and monitoring of these processes

F. monitors and controls the defined product characteristics

G. aims to prevent nonconformities, and has systematic improvement processes in place to

1. Correct any nonconformities that do occur (including product nonconformities that are detected after delivery)
2. Analyze the cause of nonconformities and take corrective action to avoid their recurrence
3. Address customer complaints

H. has implemented an effective internal audit and management review process

I. is monitoring, measuring and continually improving the effectiveness of its quality management system

What Accredited Certification to ISO 9001 Does Not Mean

1) It is important to recognize that ISO 9001 defines the requirements for an organization’s quality management system, not for its products. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide a product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal.

2) ISO 9001 accredited certification does not imply that the organization is providing a superior product, or that the product itself is certified as meeting the requirements of an ISO (or any other) standard or specification.