The ISO 9001:2015 Quality Management System was updated and re-issued in September 2015.
The standard has been revised and re-written to encompass the goods and service sector businesses as well as the manufacturing and production activities. This means more businesses can develop and have recognised a full quality management system that meets the requirements of ISO 9001:2015.
The key changes that have been made to the standard are:
The standard has been re-written according to the Annex SL High Level Structure (HLS).
This meant that the ISO 9001:2015 standard has been restructured: chapter and subchapter titles, as well as the order of clauses and paragraphs, were completely revised.
With this new common structure, ISO aims to help businesses and organisations more easily integrate all or parts of their various management systems and ultimately achieve a truly unified management system.
This consistent common structure makes it easier for companies to include components of other standards that it deems relevant: parts of the environmental standard ISO 14001:2015, and the forthcoming ISO 45001 Occupational Health and Safety standard.
Importance given to the context of the system
Two new clauses (4.1 and 4.2) require greater consideration of the context surrounding the organisation. They require a context analysis, as well as the stakeholder identification and the understanding of their expectations. All external and internal issues that may have an affect positive or negative on the system need to be considered and balanced as part of a business risk / opportunities review. These considerations along with the interested parties internal and external should be considered and all areas considered to improve the Quality Management System (QMS).
The commitment to quality through strong and visible leadership is strengthened:
- The idea of a “management representative” disappears completely.
- The quality policy and stated goals must be deeply in keeping with the strategic orientations.
- QMS requirements must be merged into business processes.
- External auditors will want to see evidence of top management involvement and may even wish to interview them during an audit.
No more quality manual or written procedures
Once an integral part of the ISO standard, will the quality manual disappear?
Indeed, it is quite possible, but not in the near future, as the idea of the quality manual is deeply rooted into the culture of quality.
The revision no longer requires certified organisations to maintain an up-to-date quality manual. Be aware, however, that the documentation requirement is still part of the standard. It is still necessary to document, maintain and preserve relevant information. A quality manual therefore remains one possibility for fulfilling this requirement, albeit not the sole solution.
The purpose of the standard is to take account of technological and societal changes. Information is no longer created, organized, managed, maintained, disseminated and accessed as it was 20 years ago when paper was the primary medium.
This change also allows for greater flexibility in companies’ organisation. It is now possible to comply with the standard without jeopardizing managerial agility, as long as the fundamental principles are respected.
There is not a requirement to have documented procedures – however it would be very short sighted to scrap written procedures or processes as the new requirements still require documented information to support the system and these are still excellent ways to demonstrate how the system operates
The revised standard is very process based and requires inputs and outputs to be considered, recorded and reviewed. Targets and objectives will need to be set taking into consideration the context of the system.
As per the old standard, however greater detail is required on the boundaries of the scope and the exact activities cover. For example previously “Civil Works” may have been acceptable, but in the new standard a breakdown of what the civil works covers would be required, e.g, land preparation, drain and gulley installation, ground marking, kerb and pavement construction, road building, bridge erection etc.
Any exclusions from the standard also have to be fully justified with reasons why the exclusion applies and the guarantee that any omissions from the standard will not affect customer satisfaction.
So why QSC ?
- We offer specific bespoke help to all clients in implementing full requirements to ISO 9001:2015.
- QSC have a proven track record in achieving ISO 9001, 14001 and OHSAS 18001 certification for all its clients.
- We take the time to listen to what the client requires and implement what the client needs ensuring full communication is open and clear.
- QSC work very closely with certification bodies to ensure the systems that QSC create meet all the standard requirements.
- We take pride in the work we do and in particular we want our clients to own the Quality Management System which they can update and maintain as the business changes.
- We advise all our clients on legislation changes to ensure they are always aware of their obligations.
- We offer up to 1 hour free advice.
So if you want to achieve ISO 9001:2015 or need some advice call 01889 881887 now.
1.When do I have to be registered to the new standard?
All companies who are registered to the old ISO 9001:2008 standard have until September 2018 to transfer. However, it would be very beneficial to be registered well before then, because if companies wait until the last minute, their current ISO certificate will only be valid until September 2018, and if they get non compliances at the audit the old certificate will be invalid and a new certificate may not be issued until all non-compliances are closed out.
- Can I transfer before September 2018?
Yes, is the simple answer. However, you need to do a gap analysis between the new and old standard to identify what needs to be added, amended, changed etc to meet the new clauses. Your current system (if accredited) will already be about 75% compliant to the new requirements, but will need to be revised and changes made accordingly.
- What is context?
Context of the organisation is a new requirement in ISO 9001:2015 stating an organisation must consider both the internal and external issues that can impact its strategic objectives and the planning of the QMS. It pretty much changes the concept and application of clause 4, and requirements regarding the context of the organisation do sound a little bit vague, so what does this clause actually require?
Clause 4 of ISO 9001:2015 Context of the organisation requires the organisation to evaluate itself and its context. This means that you need to define influences of various elements on the organisation and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organisation, markets, customers, etc. It is also a means to detect risks and opportunities regarding the business context.
- Why do we have to identify business risks and opportunities?
New requirement in the ISO 9001:2015 standard referenced in clause 6.
It is important to note that there are no requirements for a formal process to monitor and control risks and opportunities within the Quality Management System. Just like risk-based thinking, there is not a requirement for full risk management, only the identification of the risks and opportunities and decisions on what action to take. This does not even need to be maintained as documented information within the QMS.
As with any new requirements for ISO 9001:2015, it is a good practice to look at what you already do within your organisation to see if you address these requirements with your current business practices. For instance, many companies have business planning processes that look at the risks to the business and the opportunities that could be present, such as the use of a SWOT analysis (strengths, weaknesses, opportunities, and threats).
The use of a SWOT analysis in business planning will also include making plans to address the risks and opportunities identified, which is also required by the ISO 9001:2015 standard requirements. For instance, if you identify a risk that a key component in your product or service will become obsolete, you can make the plans necessary to find a replacement before your customers are impacted by your product becoming unavailable.
If you already do this as part of your business capture strategy, then you are already meeting the requirements of the ISO 9001:2015 standards; if not, then this is certainly an industry best practice that you could be adopt. Remember, the format of this identification is not mandated, so you can look at these risks and opportunities in any fashion you wish.
- I need some help with our system, who do I contact?