This date is important for all holders of ISO 9001:2008, ISO 14001:2007, AS9100,
AS9110 or AS9120 that have not transitioned to the latest standards will find themselves automatically without certification. 

There will be no excuses and no extensions.  Recently I heard that some 40-50% of holders of these standards have not yet transitioned; one Certification Body (who shall remain anonymous) told a client that UKAS would not impose the deadline………….wrong.  A head in the sand approach could be costly.

Loss of certification may mean that tenders are ignored, positions on Approved Supplier lists may be lost and existing contracts may be lost.

We have been taking calls from ma number of organisations asking for help in the transition and unless the system is relatively simple then the timescales are very tight; in addition, the availability of Certification Body auditors is causing some concern. It could be that an organisation has done the necessary changes but the non-availability of an auditor could mean that they miss the deadline.

Realistically, if all the preparatory work has not been completed by July then transition is a non-starter.  Remember an auditor can only audit what you have done and not what you plan to do.

What can organisations do if they miss the deadline?   They are treated as though they never had a certificate and must start from scratch; application, Stage one and then Stage two Assessment.  In addition to these cost implications there is the loss of status and reputation which would accompany the loss of certification.  Competitors would not be kind enough to keep this news to themselves, would they?

Don’t leave it to the last minute or you could regret it.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

First of all, we wish our readers a very Happy and Prosperous New Year.

There are a number of milestones that will need to be met during 2018.

  • GDPR (General data Protection Regulation) This important legislation comes into force on 25 May 2018.  It requires companies to follow a number of steps in protecting data held and also requires them to have positive permission to hold and process data.  All employers hold data on their employees so it is vital that permission is sought to continue to hold and /or process this data.  Failure to meet the requirements of the GDPR are very high. Up to 20 million Euros or up to 4% of Global turnover.  We suggest that action is taken now to be ready for the GDPR. 
  • ISO 9001:2015.  Quality Management Standard The transition period for migrating to this Standard is 15 September 2018
  • ISO 14001:2015 Environmental Management Standard The transition period for migrating to this Standard is 15 September 2018
  • AS9100, AS9110 and AS9120 Aircraft, Space and Defence Standards These Standards must be migrated to the 2016 version by 15 September 2018.  Failure to do this will result in withdrawal of certification. 
  • ISO 135485 :2016 Medical Devices Standard. The previous versions followed ISO 9001 closely but the 2016 version has moved away from this.  Now if companies want to have 9001 and 13485 they must have separate certifications, the old version meant that a company being awarded 13485 automatically received 9001 as well.  This is not the case now.  It is becoming clear that a number of companies will drop 9001.
  • ISO 45001:2018 Occupational Health and Safety Standard.  This Standard reached the Final Draft stage in November (at last)  and if all goes to plan, the Standard will be issued formally in Feb/March 2018.  This a will be a new Standard so there will not be a transition period, however companies moving to 45001 will have three years to adopt the new Standard when OHSAS 18001 ceases to be available.
  • And finally, the Auditing Standard ISO 19011 is under review and should be issued this year.  It brings this Standard in line with Annex SL.

All in all, it looks as though 2018 is going to be another busy year.  Bring it on!!

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

Readers of this blog will be aware that the deadline for transition of 9001 and 14001 is 14 September 2018 and know that there are quite a few companies leaving this to the last minute.

There is yet another spanner in the works in that certification bodies have been told that they may not carry out any new certifications or surveillance visits to the old standards after March 2018.  This has effectively moved the goalposts again.

Any Organisation planning to have a 2008/2004 surveillance in the second quarter of 2018 is going to find out that this is not possible and the assessor will be obliged to audit to the 2015 standards.  This will inevitably result in non-conformities and if these are classified as majors then a return visit may be required. Not only will this be inconvenient it can be costly.

We are recommending our few remaining clients that have not transitioned to make all efforts to do so before March next year.

We are getting a number of new clients that have yet to transition and are finding the way that the standards have been written is confusing and at face value contradicts the way that organisations have been working.  The removal of the requirement for a Management Representative has caused some concern amongst Quality & Environment Managers who mistakenly believe that they are no longer needed.  The function carried out by these managers still exists but the responsibility moved upwards to Top Management.

In addition, the requirement for a Quality and/or Environmental Manual also has been confusing.  The Standard says that these are not needed but documented information is required. Most of my clients have retained many of their previous systems and   adjusted them to meet the requirements of the new standards.

We are here to advise if required.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

The deadline for transition to ISO 9001:2015, ISO 14001:2015 and the Aircraft, Space and Defence Standards AS 9100D, AS9110C and AS 9120B is 15 September 2018.

While this may seem a long way off it is important to remember that the transition and correction and acceptance of any corrective action identified by an assessor must be completed satisfactorily by the deadline date.

Both UKAS for the quality and environmental standards and IAQG for the Aircraft, Space and Defence standards have made it very clear that there can be no extensions or relaxation of the deadlines for any reason.  Any organisation missing the deadline will be deregistered.

There is no appeal mechanism.  The organisation will lose certification and will have to start from scratch to regain certification.  There is a fairly big cost involved in this and loss of certification in the intervening period may result in inadmissibility for tenders and/ or cancellation of contracts requiring one or more of the standards as a mandatory requirement.

The revised Standards are quite different in their approach and require more involvement from Senior Directors and Managers.  This can be a problem where the requirement for understanding and operating the standards has, historically, been delegated to others lower down the organisation.
We at Quality Matters have helped a number of Clients to effect the transition and while we have sought to make it simple to use there have been a number of top management who have been  forced to become engaged in the systems.

The Aircraft, Space and Defence Standards were issued at the end of 2016 but the transition dates have been aligned with the ISO standards. I.E.  15 September 2018 ; a fairly tight schedule.

We urge all holders of certification that are affected by these changes to ensure that their transition is carried out in good time to avoid loss of certification.  Remember you may be ready, but assessors are committed to the stage one for transition followed by stage two on site.  Availability may be a governing factor.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

All management standards issued since 2012 follow the Hi Level structure (HLS) set out in Annex SL of the ISO systems standard and each will have ten identical clauses.  This will make it easier to integrate standards and will simplify documentation. 

The ten clauses are:
 

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

ISO 9001 is a Model for quality management systems. It is a quality system certification scheme where a company’s processes are assessed to a quality standard.  This standard has been agreed in this country, the European Union and Internationally.

The Standard, which is now on its sixth generation, was first known as BS 5750.

Formal assessment of an organisation’s quality management system is carried out by an independent and accredited third party certification body.  If all the requirements are met, a certificate of conformity is issued.  Regular surveillance visits are carried out, subsequently, to ensure that the standard is being maintained.

Accreditation of the Certification Bodies (CB’s)  in the UK is carried out by UKAS (United Kingdom Accreditation Service)  UKAS is the sole accreditor in the UK.

A register of quality competent firms is maintained by the Stationery Office (TSO) under subscription and is used as a reference for purchasing authorities.

The market-place is becoming ever more competitive. It is clear that only the companies providing goods or services of the required quality are going to be able to compete.

Put very simply BS EN ISO 9001 sets out the requirements of a quality management system which supports the delivery of a product or service, through the application of effective and continually improving systems, assuring conformity to customer and applicable legal requirements, whilst enhancing customer satisfaction.

Today’s Global Market means that companies throughout the world are able to offer their goods and services on equal terms.   The use of the internet and E-commerce for business makes it vital that we are able to compete.

        ISO 9001 makes it easier to compete in that market-place.

Product liability laws require a company to prove that it has taken all necessary and reasonable steps to produce safe products that minimise the risk to users.

  • ISO 9001 helps provide such assurance.
  • ISO 9001 requires 7 main sections (4-10) to be addressed before certification can take place.  

The 2015 standard does not allow any clauses to be excluded, unlike previous versions.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

The quality Management Standard ISO 9001:2015 was finally published on 23 September 2015 and all organisations holding ISO 9001:2008 must transition to the new standard by the deadline date of 22 September 2018. 

This may seem a long way off but if there are problems at the transition assessment then it is possible that the organisation will be de-registered.  A new certification would then be necessary. A break in certification plus the additional costs would make leaving it to the last minute a risky business.

The Environmental Management Standard ISO 14001:L2014 was published on 15 September 2015 and organisations holding ISO 14001:2004 must transition to the new standard by the deadline date of 14 September 2018.  Again leaving it to the last minute is inadvisable.

Both of these revised standards use the new format Annex SL which have 10 identical clauses.
The standards are quite different in their approach from the previous versions and although the requirements for lots of paperwork are reduced there is a greater requirement to identify the “context” of the organisation, Provide “Leadership” (with evidence) from top management and use “Risk based thinking”.  Measurements of effectiveness use KPI’s and these need to be well thought out to stop a “paper-chase”.

We can help in the transition to either or both of these standards and, with your involvement, produce the documented information required. 

We have been helping organisations with Standards for many years (since 1991) and have many satisfied clients.  They often comment that we go the extra mile for our clients.

Naturally we guarantee that you will pass the transition assessment(s), if you use our services.
Please note that OHSAS 18001 (Occupational Health & Safety Management) will transition to
ISO 45001:2016 next year.

Please feel free to contact us on our email info@quality-matters.com or telephone 01621 857841 and we will be glad to advise the best way forward.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

Both Standards have now been issued as Final Drafts:

FDIS 14001  Environmental Management Systems  – Requirements with guidance for use
Issued on 2 July 2015

FDIS 9001 Quality Management Systems- Requirements
Issued 9 July 2015.

We are told that the only changes that will be made are editorial or corrections but the main elements will be unchanged.

Actual publication of the Standards is still expected in September but training and preparation can be made using these Final Drafts.  Final Systems should wait until actual publication.

The Standards both follow the annex SL format with 10 sections that will allow for direct comparison and integration.

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement.

Naturally the sub sections for each standard are specific to the Quality / Environmental system.

Copies of the Standards are available from BSI Standards and ISO.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

We at Quality Matters wish our Clients and potential new Clients a Very Happy and Prosperous New Year.

Obviously there are a number of actions to be taken on the first day back at work:

  1. Review the email in box; there are loads to look at; most are junk but it does take time to sort the wheat from the chaff.
  2. Watch out for the inevitable virus attachments; we received a remittance advice from a company in Essex (not one of our Clients) which if opened would have infected our computer system.  In case you wondered, we didn’t open it.
  3. Get prepared for the two main Standards, ISO 9001 and ISO 14001, to progress towards publication. 

We have yet to hear what impact the International DIS being rejected by the USA and one other country will have on the proposed publication dates. 

These proposed dates are June 2015 for ISO 14001:2015 and September for ISO 9001:2015.
Certificated holders of 9001 and 14001 will have a generous transition period once these Standards are published.  If you need help with these then please let us know.

Finally, we suggest that you review your processes and look for ways to make these more efficient and effective.  Continual improvement and awareness of new legislation plus vigilance for cyber issues will ensure that 2015 is a good year. It will also be our 24th year in business.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.