Regarding the new standards, one of the first new concepts you will identify is the establishment of context at Clause 4. We are frequently asked by our clients ‘what are we supposed to do here?’ and ‘Do we need to create new documented information or records?’.
Many organisations already have a good understanding of the market place within which they operate. The market place should be considered in its broadest sense as it may not always be a commercial one and includes public sector and third sector activities. To operate you need to understand the market, your clients, what your competitors are doing and what you might have to do to survive! This is part of any organisation’s ‘thought process’ and is not something new to be done as part of ISO 9001 and ISO 14001.
The standard requires you to consider what is the context within which you operate. This means, for example, demonstrating an understanding of key legal issues, technological change, market trends, environmental concerns, society’s view of your activities, political change etc. The exact list of issues will depend on your organisation, what you do and how integrated you are with external bodies.
To meet the requirements of clause 4 you must show that you have considered such issues and how they may, or may not, have an impact on your quality and/or environmental management system. This can be done on a document presented at management review; a distinct piece of work by your quality/environmental departments etc. It could, however, simply be top management providing robust and detailed understanding of these issues verbally, during audit. We would recommend having documented evidence that shows you have identified your key issues. A simple list of items under broad headings on economics, market, technology etc. will suffice.
The second part of clause four then asks you to consider interested parties. This means identifying all individuals and organisation who can have an impact on the QMS/EMS or who may be affected by it. There are obvious interested parties such as customers, suppliers, neighbours etc.
The clause also requires you to think what requirements are linked to each, for example, customers’ requirements might include the receipt of goods of the correct type, quantity and price, on time and without faults. A Neighbour may expect to not be adversely affected by your poor environmental performance, suffering from your pollution for example. For each requirement of an interested party you need to consider and demonstrate this requirement is fulfilled.
Note that the context you establish and understand makes it easier for you to consider risk and other unforeseen circumstances. Actions against these risks must be considered and relevant actions taken under the risk management clause of the standards (clause 6).
If you need some guidance on what the new clauses mean to your organisation, then you may be interested in attending one of our one-day courses on the new standards. These are great value and can be booked on our website or by giving us a call on 01236-734447
The new ISO 9001 and ISO 14001 standards look very different from their predecessors, with new terminology, structure and requirements. However, if you look closely you will find that much of what went before is still there and the new standards have, in most cases simply added on some new elements.
Our consultants have found that if you have a well maintained and up to date system certified to the current standards this will make the transition easier. If, however, you have fallen behind on the maintenance of your Quality or Environmental Management system we recommend you get things back on track before you start transition work.
When you are ready to begin transition, the first thing to do is to review your current management system in light of the new requirements. This approach is sometimes called a Gap Analysis. It allows you to see what may already be meeting the requirements of the standards and what does not – the gaps. It is only by understanding what these gaps are that you can begin to establish what actions to take to address them.
You will need a copy of the standard(s) to do the Gap Analysis or use one of the other review or gap tools some of the Certification Bodies are supplying to their clients. Sometimes they give suggestions on what you can do address the gaps.
You should also read ISO 9002:2016 (about to be published) and ISO 14004:2016 – Guidelines on Implementing a QMS/EMS as they also describe the types of activities, processes and documents you may need for the new standards
When you have a list of the gaps and actions to address them you can then consider the programme to introduce and implement the changes that are required.
Experience suggests that you need up to 12 months to complete this process – hence the need to begin now with the deadline approaching in Autumn 2018.
Note that you will also have to begin auditing to the new standards as well as introduce and follow new processes so that you can demonstrate that the new system is applied to your organisation.
It is not simply updating the system – it needs to be working!
If you feel that you don’t have enough hours in the day to train your staff in the new clauses, click on our training programme on www.qcsl.co.uk and check out our great value 1 day Introduction courses, or alternatively half day in house courses for your team are proving very successful.
Meantime, if you think you need advice or guidance on your transition process you can call us at QCS International for a friendly chat, advice or assistance, or check out our websites and blogs on …
Thirty years ago, Quality Consulting Services started business in Cumbernauld, delivering consultancy services for BS 5750 Parts 1,2 & 3; a Scottish-based company for Scottish clients. Within a few years QCS had a growing market share and a reputation for ‘quality’ and personal service. Our highly experienced consultants covered a wide range of sectors, from Oil and Gas – Construction – Service Sector.
Always at the forefront, QCS identified a gap in the Scottish market for IRCA Registered Training. At that time, Internal and Lead Auditor courses were not delivered in Scotland, which added a financial burden to clients implementing a BS 5750 quality management system north of the border. QCS launched The Quality College of Scotland with a bespoke training venue in Central Scotland and gained IRCA Training Organisation status to deliver IRCA Registered Internal and Lead auditor courses together with foundation and implementation courses. Such was our success that we were soon delivering IRCA Registered courses in USA, Dominican Republic, Seychelles, Mauritius, Arab Emirates throughout Europe and opened a QCS offices in Phoenix and Vermont.
As a progressive company our expertise allowed us to add ISO 14001 (Environmental) and OHSAS 18001 (Health & Safety) consultancy to our portfolio and once again we were a forerunner for IRCA training in Scotland and overseas for Environmental and Health & Safety Auditor courses. With our increased global presence, we were renamed as QCS International allowing us to fully capitalise on the worldwide services we were delivering.
To say we have been a forerunner is perhaps easy, but looking at our medical device portfolio lets you see just how much of a forerunner we are. With advanced medical device management system specialists in house, we developed the first IRCA Registered Internal and Lead Auditor training courses – not only in the UK, but also worldwide and we have trained medical device professionals both at our public training venue in Scotland and at clients’ organisations all over the world.
How do we do this?
- Our consultants are fully employed by QCS – we don’t need to use sub-contractors like many other training and consultancy organisations
- We deliver high quality consultancy to the medical device industry from implementation of ISO 13485 – Technical File preparation – CE marking – Regulatory Advice and much more
- QCS consultants are not only highly qualified in their field, but they all have up to date working experience
At QCS it is important for us to work in partnership – we don’t sit in a corner of your office and work in isolation. We become part of your management team and we spread our knowledge to meet your objectives and ensure your personnel have the skills to continually manage the systems after certification.
We are a one stop should for all your Quality, Environmental, Health & Safety and Medical Device Management Systems covering:
Consultancy, Training, Integrated Management, Risk Assessment, Audit, Regulatory Advice, CE Marketing, Legal Compliance, Outsource Management and much, much more.
The QCS Team look forward to working with you for the next 30 years …….
In 2015 the new ISO 9001 and ISO 14001 standards for quality and environmental management were published. These new standards were updated to reflect new thinking associated with management systems, the adoption of a more integrated approach and a greater emphasis on risk appraisal.
We are now half-way through the three-year period during which transition to the new standards must be completed. Given the amount of work required by some organisations, the time limit will become increasingly difficult.
Over the next 18 months, as we approach the September 2018 deadline, QCS will be sending out monthly update blogs on the new standards, of which this is the first. The blogs will include pointers to the kind of actions you need to be taking to meet the new requirements and some useful tips on where you should be to make a successful transition.
Note that for a successful transition you need to be speaking with your Certification Bodies now.
Waiting until 2018 means you could encounter difficulties securing the services of Certification Body Auditors, who will be extremely busy as the deadline approaches. Each Certification Body offers help and guidance through the process and should be able to explain their approach to transition to you.
If your current certificates (to ISO 9001:2008 or ISO 14001:2004) are set to expire in the next 18 months, then there is little or no value in having these maintained. Any new certificates will not be valid beyond September 2018 meaning that the costs of recertification will not give you the normal 3-year registration. In such circumstances transition and certification to the new standards now is desirable and cost effective.
Blog 17 (April release), will begin to explain what the structure of the new standards mean to those of you with certification to more than one standard:
Is integration the way ahead?
Meantime, if you think you need advice or guidance on your transition process you can call us at QCS International for a friendly chat, advice or assistance, or check out our websites and blogs on …
We are pleased to let all of our current and prospective clients know that QCS International is, from 1st January 2017, an Approved Training Partner of the Chartered Quality Institute/International Register of Certified Auditors. This new status provides all of our training delegates the assurance that our training is delivered to the highest possible standard, against a set of industry-recognised criteria.
All of our courses, previously approved by IRCA, are now recognised as part of a new structure of training reflecting different grades or levels of training required for differing roles or responsibilities of delegates within their organisations. QCS is pleased to offer training at all grades: foundation, practitioner and professional. The auditor training for which we are well known has not changed – it still reflects the grades of internal and lead auditor standing – but for CPD these are known as practitioner and professional courses within the CQI/IRCA framework.
Our new training programme for 2017 is now available to see on our website. We continue to offer the best value training in the market. Given our approved status you can be assured that whilst we may offer the lowest prices we have not compromised in the content or quality of what we deliver.
Should you ever have any questions about our training services, or want to find out about hosting an in house course at your premises which is a cost-effective way in providing your staff with the best training around, then do get in touch with Audrey Smith, Training Sales Director [email protected] or tel 01236-734447.
We reported in April that the new ISO 45001 would be delayed after the committee steering the new standard had not gained sufficient support in the vote to accept the draft. A final draft was not issued and the expected publication date was thrown in to doubt.
A new committee draft has, apparently been developed but not yet ready to be issued as a new Draft International Standard ‘2’. It appears some of the issues still to be ironed out relate to a desire amongst some members of the committee to add in further elements that do not necessarily fit in with the Annex SL, high level structure; for example the need to reflect more on the rights of ‘workers’ as specific interested parties.
Having said this we remain hopeful that a DIS2 will be issued in January 2017 to be made available for comment through consultation before a new vote on content, which may not take place until approximately May. This means that the date for a final draft and full publication is probably not going to take place before Autumn 2017. Some observers even suggest that there may be final delays – so keep an eye on our website and we shall publish news as we hear it.
Meantime, the British standard OHSAS 18001 remains in place and continues to be the most widely recognised standard for Health and Safety management throughout the world. We at QCS will continue to monitor progress on ISO 45001 and will provide feedback and comments as the process continues.
The MDSAP Pilot was intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
International partners that participated in the MDSAP Pilot included:
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
Following successful completion of the pilot Health Canada has been the first of the international partners to announce that they will be fully adopting the scheme.
As of January 1st 2019, Health Canada will only accept MD-SAP style audits to show compliance with Canadian regulations and conformity with the requirements if ISO 13485.
An interesting feature of these audits is the grading assigned to non-conformities which follows the GHTF guidelines (SG3/N19:2012).
When the nonconformity has the potential to affect safety or performance, it should be written against the specific requirement in ISO 13485 found in clauses 6.4 through 8.5, because it has direct QMS impact.
When the nonconformity is against the manufacturer’s quality manual, procedures or requirements, is not specifically required in ISO 13485 or does not impact safety or performance, then the nonconformity should be assigned to clauses 4.1 through 6.3, because it has indirect QMS impact.
If the nonconformity that has previously been identified in either of the two previous QMS audits (against the same sub-clause (X.X.X))
The nonconformity poses an increased risk because it is an indicator that a corrective action has not been adequately taken or implemented
Scoring and Escalation
The score can be further escalated by the two following scenarios;
- The absence of a documented procedure or process (the score is escalated by 1)
- The release of a non-conforming medical device as a result of the non-conformity (the score is escalated by 1)
Contact should be made as soon as possible with your certification body to ensure that you have planned arrangements for the assessment based on MDSAP criteria to take place if you sell medical devices into the Canadian market.
Britain decided to leave the European Union on the 23rd of June 2016 following a national referendum.
The main non-economic impact on medical device manufacturers in the UK is compliance with current European legislation on medical devices. There is no doubt that to sell medical devices to customers in one of the 27 member states of the EU or the 4 EFTA countries (Switzerland, Norway, Iceland & Lichtenstein) that the products will need to comply with the new European Medical Device Regulations (still in draft).
The question is, will the UK be treated like a non EEA member in which case UK manufacturers would require a European Authorised Representative (EAR) to sell into the EU or will we be able to become an EFTA (European Free Trade Agreement) member along with Switzerland, Norway, Iceland & Lichtenstein. Appointing an EAR will undoubtedly have a cost and a logistics impact for manufacturers. However the suggestion from Brussels is that free trade with Europe (EFTA membership) goes hand in hand with free movement of people, a position that might be politically difficult to reconcile.
These seem to be two most likely options available to access the European market.
We won’t know the answer to this question until clause 50 of the Lisbon treaty is activated and the future arrangements for a relationship are negotiated.
See extract from article 50 below:
“A Member State which decides to withdraw shall notify the European Council of its intention. In the light of the guidelines provided by the European Council, the Union shall negotiate and conclude an agreement with that State, setting out the arrangements for its withdrawal, taking account of the framework for its future relationship with the Union. That agreement shall be negotiated in accordance with Article 218(3) of the Treaty on the Functioning of the European Union. It shall be concluded on behalf of the Union by the Council, acting by a qualified majority, after obtaining the consent of the European Parliament.”
The requirements of Medical Devices Manufacturers will be considered along with all other UK based manufacturers and service providers to conclude a deal that will allow us access to our biggest market.
QCS will continue to keep you updated through our Newsletters & Blogs throughout 2017.
Two items of environmental enforcement caught our attention this month. The first is close to home, with SEPA reporting the following:
A Director of McIntyres, operating at sites across the central belt of Scotland has been fined £34,000 for offences to poor storage and recycling activity of waste tyres. The company pled guilty to:
- Exceeding the maximum permitted storage height for tyres, failing to install fire resistant walls, storing a quantity of tyres without the authority of a waste management licence, and keeping tyres on site for a period exceeding three months
- Keeping in excess of 15,000 end of life tyres at a site in Alloa.
- Keeping in excess of 1,000 tyres and burned tyre residue in Dundee.
- Keeping in excess of 1,180 loose tyres and in excess of 14,340 baled in Huntly.
- Keeping in excess of 6,900 tyres in Lathalmond in Fife.
The matter was investigated by the Scottish Environment Protection Agency (SEPA) and reported to the Procurator Fiscal. Essentially, the company was in breach of its Waste Management Licence and was also excessive volumes of tyres. Despite several warnings and enforcement notices the company failed to act and, therefore had no defence.
The lesson here – remember to react to official documentation and requests.
Further afield, a US cruise liner is to pay a record fine of $40m (£31m) for dumping oil-contaminated waste, the US Department of Justice has said.
The investigation into Princess Cruise Lines followed a tip-off that the company had illegally discharged oily waste off the coast of England in 2013 after a ships engineer quit his position when the ship reached Southampton.
US investigators began to probe the ship’s actions after an engineer reported an illegal dump off the English coast using equipment including a so-called “magic pipe” to bypass pollution-prevention tools that separate oil and monitor oil levels in the ship’s water. The firm had also tried to cover up other waste dumping investigations found.
The charges relate to the Caribbean Princess cruise ship, which the department said had been making illegal discharges since 2005, one year after the vessel started operations.
It agreed to plead guilty to seven charges related to stops at ports in nine US states and two territories.
There remains lots of uncertainty about what leaving the EU will mean to businesses in the UK and, from our perspective, how those organisations with management system certification may have to react. There are probably two main areas we think organisations holding certification may have to consider.
First, if you have made transition to the new ISO 9001 or ISO 14001 one of the requirements is the identification of issues that may affect your management system (Clause 4.1) and what risks you may face (Clause 6.1). Anyone with a Certified Management System should now have realised that the uncertainties relating to Brexit should be reflected in your Risk Management processes – and what you can begin to put in place to address this risk. Whilst you cannot be sure what to do at present you should have, as a minimum, identified this as a risk.
Secondly, the Regulatory Framework and ensuring you deliver your services in accordance with the law may be an area of considerable upheaval in the years ahead. If you have ISO 14001 you must ensure you have an awareness of, and react to, environmental legislation. Currently all Environmental Law in the UK, is based on EU Regulations and Directives. Furthermore, here in Scotland it is the government that applies local interpretation of these European requirements – leading to subtle, but not significant, change to the rest of the UK.
A further consideration relates to your relationship to the EU marketplace. If you export to the EU it is likely that you will have to continue to meet all EU requirements if you are to gain access to that market (this is irrespective of what negotiations develop in the Brexit process). This means that you may have to differentiate between what you must do for the Local Regulator as well as the Regulator in the market in the remaining EU. Furthermore, the Scottish Government, with full devolution on this matter, will no longer have to just follow EU rules but may begin, also, to diverge from the rest of the UK. (There is significant potential for confusion in this area).
Within certain sectors you may also have further cause for concern as many regulations about products and services are also based on EU-wide agreements. For example, those within Pharmaceuticals, Medical Devices, Aerospace and Automotive sectors have no clarity yet on how their regulations may be affected.
As things become clearer QCS will be able offer guidance and support to ensure you continue to operate as effectively as possible in a changing world.