What will be the new revisions to ISO 9001?
The development and revision of ISO standards is work done by volunteer committees made up of people from ISO member countries. The work is organized and managed by a Technical Committee (TC) formed by ISO in the subject area. The TCs are structured in Sub-Committees (SC) and Working Groups (WG) as determined by the TC. Documents including International Standards (IS) such as ISO 9001; Technical Specifications (TS) such as ISO/TS 16949; and Technical Reports (TR) go thru a draft, review, approval and 5 year review and revision process. ISO 9001:2008 started into the 5 year review/revision process about a year ago and has reached the stage where we need to give our customers an update.
The review/revision process starts with the TC deciding either 1. No revision necessary or 2. formation of a WG. In this case ISO 9001:2008 had to be revised due to a mandate from the Technical Management Board (TMB). The TMB a few years ago formed a group to look at management system standards, there are several for example ISO 9001, ISO 14001, ISO/TS 16949, ISO 13485, and propose any changes that were necessary to ensure compatibility of the standards. The group proposed and TMB accepted that all management system standards would have the same high level structure, common core text, and common terms and core definitions.
This has forced a revision to both ISO 9001 and ISO 14001. The TMB also included a mechanism for standards committees to get approval to deviate from this policy, which the IATF has used to get approval to not change ISO/TS 16949. So at this point in time ISO/TS 16949 will not be revised. The situation with AS9100 is not clear, Since AS9100 is not an ISO standard, the aerospace industry does not have to abide by the TMB mandate.
The draft document starts in the WG that develops a Working Draft (WD); when the WD is sufficiently mature it is raised to a Committee Draft (CD), which gets a wider distribution for comment and vote. When the CD is revised and approved it is raised to a Draft International Standard (DIS) and when the DIS is revised and approved it is raised to a Final Draft International Standard (FDIS). The Final Draft International Standard is only subject to editorial change but does go thru a final vote and is then issued as an International Standard (IS)
ISO 9001:2015 timelineThe current timeline for the revised ISO 9001 is shown in this figure.
This timeline could change. The Technical committee has received 381 pages of comments on the CD and is in the process of resolving all comments. This could take the DIS beyond the April 2014 goal or the TC could decide that the document is not ready to be a DIS and could issue it as a CD2 (second CD).
Assuming that the timeline is maintained then there will be an implementation period.
ISO 9001:2015 Certification Transition Timeline
So that all certified organization would have to complete the transition of their management system within that three year period.
Major changes at this point in time
- The clause structure of the standard will change from the current eight clauses to the TMB mandate of a 10 clause structure: see below
- Context of the organization will have to be defined for each organization
- Identification and addressing of risks will have to be added to the system
- Design and development (clause 7.3) has been changed to Development and broadened to include not just product design & development but also process development so that the new clause 8.6 will most likely apply to most organizations
The new ISO 9001 clause structure1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system
5.1 Leadership and commitment
5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.5 Documented information
8.1 Operational planning and control
8.2 Determination of market needs and interactions with customers
8.3 Operational planning process
8.4 Control of external provision of goods and services
8.5 Development of goods and services
8.6 Production of goods and provision of services
8.7 Release of goods and services
8.8 Nonconforming goods and services
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal Audit
9.3 Management review
10 .1 Nonconformity and corrective action
What should we NOT do at this time?
- Do not revise your manual or procedures at this point in time; it is too early to change any detail in your system.
- Do not change the numbering of your documents just because the clause numbers have changed; there is no requirement that your manual or procedures reflect the structure of the standard. Your system just has to meet the requirements.
What should we do now to start getting ready for the iso 9001 change?
1. Start the consideration and definition of the context of your company
- Any Vision and Mission statements that you may have
- Markets that you serve and markets that you may intend to enter
- Present customers and potential future customers and any supplier manuals & quality clause that you may have to comply with
- Any regulatory requirements associated with the markets or products
- End users of your product and how you impact them
1. Document that identifies issues such as customer specific requirements, end user requirements; regulatory requirements, and risks arising from the market and the product.
2. Process for updating your system as the markets, your customers and regulations change
3. Process for updating your system as your strategic direction changes and new customers are brought on board or new markets entered
2. Start considering risks in four areas
- Markets, customers and products
- Product realization processes
Both of these areas are not going to go away from the standard and both can help your business.