What are the requirements for ISO 9001 certification?

ISO 9001:2008 was published on November 14, 2008, replacing ISO 9001:2000.  The 2008 version became obsolete effective September of 2018 and was replaced by ISO 9001:2015.

Click here to compare ISO 9001:2000 to ISO 9001:2008.

List of significant changes the 2008 version brought to ISO 9001 (from the 2000 version):

Clause 0.2 (Process approach):

• Text added to emphasize the importance of processes being capable of achieving desired outputs

Clause 1.1 (Scope)

• Clarification that “product” also includes intermediate product
• Explanation regarding statutory, regulatory and legal requirements

Clause 4.1 (General requirements)

• Notes added to explain more about outsourcing
• Types of control that may be applied to outsourced processes
• Relationship to clause 7.4 (Purchasing)
• Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system

Clause 4.2.1 (Documentation)

• Clarification that QMS documentation also includes records
• Documents required by the standard may be combined
• ISO 9001 requirements may be covered by more than one documented procedure

Clause 4.2.3 (Document control)

• Clarification that only external documents relevant to the QMS need to be controlled

Clause 4.2.4 (Records control):

• Editorial changes only (better alignment with ISO 14001)

Clause 5.5.2 (Management rep)

• Clarifies that this must be a member of the organization’s own management

Clause 6.2.1 (Human resources)

• Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system

Clause 6.3 (Infrastructure): 

• Includes information systems as example

Clause 6.4 (Work environment)

• Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather

Clause 7.2.1 (Customer related processes)

• Clarifies that post-delivery activities may include:
  • Actions under warranty provisions
  • Contractual obligations such as maintenance services
  • Supplementary services such as recycling or final disposal

Clause 7.3.1 (Design & development planning)

• Clarifies that design and development review, verification and validation have distinct purposes
• These may be conducted and recorded separately or in any combination as suitable for the product and the organization

Clause 7.3.3(Design & development outputs):

• Clarifies that information needed for production and service provision includes preservation of the product

Clause 7.5.4 (Customer property): 

• Explains that both intellectual property and personal data should be considered as customer property

Clause 7.6 (Now retitled Control of Monitoring and Measuringequipment)

• Explanatory notes added regarding the use of computer software:   “Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”

Clause 8.2.1 (Customer satisfaction)

• Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports

Clause 8.2.3 (Monitoring / Measurement of process)

• Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

ISO Organization’s Introduction and support package(© 2008 ISO)

In conjunction with the publication of ISO 9001:2008, Quality management systems – Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 2, Quality systems, has published a number of guidance modules:

• Guidance on ISO 9001 sub-clause 1.2 “Application”
• Guidance on the documentation requirements of ISO 9001:2008
• Guide to the Terminology used in ISO 9001 and ISO 9004
• Guidance on the concept and use of the process approach for management systems
• Guidance on ‘Outsourced processes’
• Implementation guidance for ISO 9001:2008
• Frequently Asked Questions (FAQ’s)

ISO Management Systems articles

• Advice for users on implementing ISO 9001:2008

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