The new version of ISO 9001 is out in draft form. With around 40% of the Standard changing this is a major revision due to be released in September 2015. There will then be a three-year transitional period. During this period, companies have time to adjust their management system to the new standard. Click here if you wish to purchase the draft.
In ISO 9001:2015 there will be 10 clauses (in ISO 9001:2008 there are 8 clauses). Clauses 1 to 3 will contain the background information, as in the current version of ISO 9001. Clauses 4 to 10 will contain the requirements organisations need to implement.
- Scope: the boundaries of the Standard itself.
- Normative references: refers to other ISO documents considered necessary when interpreting ISO 9001.
- Terms and definitions: hinting at the general terms presented in the Annex SL as well as any specific terms in the Standard.
- Context of the organisation: understanding the internal and external affairs, the requirements and expectations of relevant interested parties, the management system and its scope.
- Leadership: management responsibility and commitment, policy, organisational functions, responsibility and authority.
- Planning: measures for identifying risks and opportunities, the relevant objectives and targets of the Standard and plans helping to achieve these objectives and targets.
- Support: resources needed for the respective Standard, competence, awareness, communication and documented information.
- Operation: operational planning and control.
- Performance rating: monitoring, measurement, analysis and assessment, internal audit and management review.
- Improvement: nonconformity, corrective action and improvement.
The reason for the change in structure is to better align ISO 9001 with other management system standards published by ISO such as:
- ISO 14001 for environmental management systems
- ISO 50001 for energy management systems
- ISO 22000 for food safety management systems
By changing the structure, terms and definitions in ISO 9001 they are increasing consistency across the management system standards. This, in turn, makes it easier to integrate standards such as ISO 900y Quality Management System Requirements with ISO 14001 Environmental Management System Requirements and ISO 50001 Energy Management System Requirements.
The main changes to ISO 9001 will be as follows.
The draft of ISO 9001:2015 places much more emphasis on risk which it needs to do if it is to be aligned with other management system standards. However, formal risk management (e.g. according to ISO 31000) is not required. Reference to risk is made in nearly every clause of the draft – from corporate planning, business processes, and internal audits, through to supplier management. Analysing risks is also linked to opportunities for the company. Personally I think this is a great change, a better fit with how business owners instinctively think about and manage their enterprises.
Context of the Organisation
This is a new requirement in which the organisation is required to demonstrate that it understands the internal and external factors that influence it and which may affect its strategic direction e.g. where it sits in the marketplace and what effect changes in the marketplace may have on its future. This is logical as you cannot build a management system based on risk if you don’t know the factors that affect your risks.
ISO 9001:2008 does mention processes but in ISO 9001:2015 a whole clause is devoted to it. Although it is now a stated requirement, the content is largely the same as in the current version apart from a requirement to determine the risks to the conformity of goods and services if processes are ineffective.
Gone! Just as well as most people found it confusing and made up things the day before their audit. In a management system based on risk it isn’t necessary as by considering risk one is integrating preventive action into all the activities of the organisation. More specifically, in the draft version of ISO 9001:2015 preventive action is incorporated into clause 6.1 Actions to address risks and opportunities.
There is a new clause – 7.1.5 Knowledge. It is concerned with ensuring that your organisation has identified the knowledge needed to satisfy customers with the goods and services they provide, to operate your quality management system effectively, and to ensure that this knowledge is available to those who need it. Kind of what I always thought a good management system was all about really! It is a means of communicating to staff how you want your organisation to be run. It is also recognition of the fact that much of an organisation’s capital resides not in their land and equipment but in the heads of their staff. Good idea to document that information before it walks out the door.
In recognition of the fact that ISO 9001 is widely used by non-manufacturers, the term ‘product’ has been replaced with ‘goods and services’. This also recognises the fact that manufacturers provide services, such as delivery, not just products.
Continual improvement has become just improvement. The word “continuous” always was superfluous in my view anyway.
Documents and records are now referred to as documented information and it’s about time. Halleluiah, they have finally realised that we are living in the electronic age in which images and videos may be a far better way of communicating information to others in our organisation, procedures need never be printed, forms can be completed on-line, and process mapped using smart software. Others are saying this is a big change to the new standard. I don’t think so. I’ve always read “documented” to include electronic information but it’s nice to see my approach validated by this change.
The next stage (Draft International Standard) is expected in April 2014. The content can still change after that therefore , if I were you I would wait before making any specific preparations in my organisation. I’ll keep you up-to-date so that you can make the changes required with plenty of time to spare.