ISO 9001:2008
ISO 9001:2008 Updates
Every seven years, ISO reviews the ISO 9000 series of standards. The committee responsible for this issues drafts at various stages. The latest draft shows what is intended for release, pending comment from the public. It is expected to be released as an International Standard in August 2008.
The intent of the latest Draft of ISO 9001 is to clarify requirements without adding to them. At Quality Award Partners®, we have always seen these amendments as the correct interpretation of the standard’s intent. Our experience as implementers and certification auditors of systems support these changes as valuable.
ISO 9004, as the companion standard to 9001, is undergoing extensive revision and will be issued after 9001. Quality Award Partners® encourages clients to use 9004, as it has many useful tips on how to make 9001 work effectively for business.
In preparing for the new ISO 9001 standard, we suggest looking at your current system in the context of this article and make sure the needed controls are in place. Here’s a summary of the main points:
1.1 (Scope)
- Clarification that “product” also includes intermediate product. This also means purchased product.
- Explanation about statutory, regulatory and legal requirements.
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
4.2.1 (Documentation)
- Clarification that QMS documentation also includes records
- Documented procedures may be combined in one document or more than one document may describe a procedure.
4.2.3 (Document control)
- Clarification that only external documents relevant to the QMS need to be controlled
4.2.4 (Records control)
- Editorial changes only (better alignment with ISO 14001)
6.2.1 (Human resources)
- Clarification that competence requirements are relevant for any personnel involved in the operation of the quality management system
6.3 (Infrastructure)
- Includes information systems as example
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
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
7.3.1 (Design & development planning)
- Clarifies that design and development review, verification and validation have distinct purposes
- They may be conducted and recorded separately or in any combination as suitable for the product and the organization
7.3.3 (Design & development outputs)
- Clarifies that information needed for production and service provision may include preservation of the product
7.5.4 (Customer property)
- Explains that both intellectual property and personal data should be considered as customer property
7.6 (Now retitled Control of Monitoring and Measuring equipment)
- 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.” ISO 10012-1/2 are mentioned for guidance.
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, warranty claims and dealer reports.
8.2.2 (Internal Audit)
- Rewording and change of reference to ISO 19011 for guidance.
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.
In Summary…
The changes to ISO 9001 are relatively minor in most cases, and serve to remove ambiguity.
The main areas to consider strengthening your system are:
- How risk-proof are your outsourcing processes? The way you handle these, and your internal controls, need to be clearly defined.
- Have you fully defined the competency requirements for ALL people working within the quality management system?
- Your information systems are part of your infrastructure. Have you thoroughly identified the necessary internal controls in this potentially high risk area?
- Are your post-delivery activities adequately defined, controlled and auditable?
- Are your design/development processes clearly and fully defined and documented?
- Do you have adequate controls over intellectual property and personal data? Are they clearly documented and auditable?
- Is your approach to customer satisfaction in need of refreshment?
- Are your internal process monitoring methods adequate, particularly for services?
Now may be a good time to review your quality system, and consider improvements that will both strengthen it to deliver better outcomes for your organisation, as well as readying yourself for a prompt change to the new ISO 9001:2008 standard.
Quality Award Partners® have extensive experience in the application of ISO 9001, that delivers excellent results for our clients. Our skills include staff who are ASQ-certified quality engineers, RABQSA-registered Lead Auditors, and MBA qualified majoring in marketing, to bring business focus to your quality system, particularly in the area of customer feedback.
Find out how easy it can be to go to the next level. Call us now.