Sample of Batch Manufacturing Record (BMR) – Atorvastatin


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Sample Batch Manufacturing Record (BMR)

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How to structure quality management system documentation


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Usually, when people think of quality management system documentation, they envision loads of documents, and unnecessary and bureaucratic procedures. This is because companies often go overboard when documenting their quality management systems. However, this doesn’t need to be the case.

It is true that the international standard for quality management systems (ISO 9001) requires certain documentation (see this article: List of Mandatory Documents for ISO 9001). The purpose and the benefits of the QMS documentation are manifold: it provides a clear framework of the operations in an organization, it allows consistency of processes and better understanding of the QMS, and it provides evidence for achievement of objectives and goals. When designing QMS documentation, you should focus on efficiency and create processes and documents that are applicable in your organization.

QMS documentation hierarchy

The QMS documentation can consist of different types of documents. Usually, it includes documents such as quality policy, quality manual, procedures, work instructions, quality plans, and records. The QMS documentation can be represented as a hierarchy as shown in the diagram below:


ISO 9001 requires different types of information to be documented; however, not all information needs to be documented as separate documents. It is flexible so that the organization to decide on the size of the documentation and the level of details documented. For example, small companies can have documented procedures that will be included in the QMS manual.

How to structure your QMS documentation

The international standard ISO 10013:2001 Guidelines for quality management system documentation gives directions for effective dimensioning of the QMS documentation, as well as an overview of recommended contents and structure of the different QMS document types. The following recommendations take into consideration the ISO 10013 guidelines.

1) Quality manual. The manual should fit your organization. The structure and the content of the manual can vary depending on the size of the organization, the complexity of operations, and the competence of the personnel. Small organizations can document the entire QMS in one manual. On the other side, large international organizations may have several different quality manuals. Generally, the manual includes the QMS scope, exclusions from the standard, references to relevant documents, and the business process model. The quality policy and the objectives can be part of the manual as well.

The quality manual should include most of following elements: title and table of contents; scope of the QMS; exclusions from ISO 9001, versioning information and approval; quality policy and objectives; QMS description, the business process model of the organization; definition of responsibilities for all personnel; references to relevant documents and relevant appendices. More information on how to document an effective quality manual can be found in this article: Writing a short Quality Manual.

2) Quality policy. A policy represents a declarative statement by an organization. A Quality policy should state the commitment of the organization to quality and continual improvement. Usually, this policy is used for promotional purposes and should be displayed in the organization’s premises and posted on websites, so a clear and short quality policy is convenient and is the general practice.

The Quality policy defines the quality objectives to which the organization strives. The quality goals of organizations are defined by quantifying the quality objectives.

3) Quality procedures. Quality procedures can have different formats and structures. They can be narrative, i.e., described through text; they can be more structured by using tables; they can be more illustrative, i.e., flow charts; or they can be any combination of the above.

Quality procedures should include the following elements:

  • Title – for identification of the procedure;
  • Purpose – describing the rationale behind the procedure;
  • Scope – to explain what aspects will be covered in the procedure, and which aspects will not be covered;
  • Responsibilities and authorities of all people/functions included in any part the procedure;
  • Records that result from the activities described in the procedure should be defined and listed;
  • Document control – identification of changes, date of review, approval and version of the document should be included in accordance with the established practice for document control;
  • Description of activities – this is the main section of the procedure; it relates all the other elements of the procedure and describes what should be done, by whom and how, when and where. In some cases, “why” should be clarified as well. Additionally, the inputs and the outputs of the activities should be explained, including the needed resources.
  • Appendices may be included, if needed.

4) Work instructions. Work instructions can be part of a procedure, or they can be referenced in a procedure. Generally, work instructions have a similar structure to the procedures and cover the same elements; however, the work instructions include details of activities that need to be realized, focusing on the sequencing of the steps, tools, and methods to be used and required accuracy.

Training of personnel and use of competent personnel can decrease the need for highly detailed work instructions. More detail on this topic can be found in Using Competence, Training and Awareness to Replace Documentation in your QMS.

Good QMS documentation is essential for an effective quality management system

Dimensioning the QMS documentation based on your organizational needs is essential for a functional QMS. Moreover, properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble.

List of mandatory documents required by ISO 9001:2015


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Since the publication of the new revision of ISO 9001 last month, many people have been wondering what documents are mandatory in this new 2015 revision. How many documents are required?

So, here is the list – below you will see not only mandatory documents, but also the most commonly used documents for ISO 9001 implementation.

Mandatory documents and records required by ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.):

  • Scope of the QMS (clause 4.3)
  • Quality policy (clause 5.2)
  • Quality objectives (clause 6.2)
  • Criteria for evaluation and selection of suppliers (clause 8.4.1)

And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):

  • Monitoring and measuring equipment calibration records* (clause
  • Records of training, skills, experience and qualifications (clause 7.2)
  • Product/service requirements review records (clause
  • Record about design and development outputs review* (clause 8.3.2)
  • Records about design and development inputs* (clause 8.3.3)
  • Records of design and development controls* (clause 8.3.4)
  • Records of design and development outputs *(clause 8.3.5)
  • Design and development changes records* (clause 8.3.6)
  • Characteristics of product to be produced and service to be provided (clause 8.5.1)
  • Records about customer property (clause 8.5.3)
  • Production/service provision change control records (clause 8.5.6)
  • Record of conformity of product/service with acceptance criteria (clause 8.6)
  • Record of nonconforming outputs (clause 8.7.2)
  • Monitoring and measurement results (clause 9.1.1)
  • Internal audit program (clause 9.2)
  • Results of internal audits (clause 9.2)
  • Results of the management review (clause 9.3)
  • Results of corrective actions (clause 10.1)

Non-mandatory documents

There are numerous non-mandatory documents that can be used for ISO 9001 implementation. However, I find these non-mandatory documents to be most commonly used:

  • Procedure for determining context of the organization and interested parties (clauses 4.1 and 4.2)
  • Procedure for addressing risks and opportunities (clause 6.1)
  • Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
  • Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
  • Procedure for document and record control (clause 7.5)
  • Sales procedure (clause 8.2)
  • Procedure for design and development (clause 8.3)
  • Procedure for production and service provision (clause 8.5)
  • Warehousing procedure (clause 8.5.4)
  • Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
  • Procedure for monitoring customer satisfaction (clause 9.1.2)
  • Procedure for internal audit (clause 9.2)
  • Procedure for management review (clause 9.3)

So, this is it – what do you think? Is this too much to write? Do these documents cover all aspects of quality management?

ISO 9002 & ISO 9003 are History


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Author: Mark Hammar

ISO 9002 and ISO 9003 were separate documents that were part of a series of standards for Quality Management Systems, and were first introduced by the ISO organization ( in 1987. The standards gave requirements for creating a Quality Management System, often called a QMS, based on documented procedures that defined separate areas of quality management. When they were first introduced, a company would decide which of the standards they should be certified to: ISO 9001 for design and production, ISO 9002 for production or ISO 9003 for inspection and testing, depending on which type of industry the company was in or what the company did. Below is an explanation of what the ISO 9002 & ISO 9003 standards were for, and what they included, but it is important to know that a company can no longer be registered to either of these standards as of the year 2000.

ISO 9002:1987

ISO 9002, first published in 1987, described how to implement a Quality Management System for the manufacture and delivery of products. There were 18 sections for which a documented procedure needed to be written, and the mantra of the standard was “Document what you do, then do what you document.”

The standard was focused on industries that produced products rather than service-based industries.

Note: In 1987, ISO 9001 was identical to ISO 9002 with the addition of requirements for design control and product service.

ISO 9003:1987

ISO 9003, also released in 1987, provided requirements for a Quality Management System exclusively for inspections and testing, and basically stripped away any requirements that dealt with the manufacture or servicing of products. This standard was used almost exclusively by warehouse and resale industries where the company itself did not manufacture the parts, but only stocked and sold the product. These industries would be focused on ensuring that product they purchased was properly inspected in order to meet the needs of customers they re-sold the product to.

ISO 9002 & ISO 9003 Timeline

All three of the standards: ISO 9001, ISO 9002 & ISO 9003, were updated in 1994 with minor changes, but the requirements were still focused on production-based industries. In 2000, ISO 9001 was updated from a “document everything” approach to a more process-based approach for Quality Management Systems. This also made the standard more applicable to service-based industries and added the ability of a company to exclude certain sections of the requirements, such as design for companies that only build to customer design. By allowing the exclusions from some requirements, the need for separate documents (ISO 9001, ISO 9002 & ISO 9003) was removed and the ISO 9002 & ISO 9003 standards were rendered obsolete. From 2000 onward, companies could not have their Quality Management System certified to ISO 9002 or ISO 9003, and a company could only certify an ISO 9001 Quality Management System.

ISO 9001 vs Six Sigma: How they compare and how they are different


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Author: Mark Hammar

Have you considered adding Six Sigma methodologies as a way of focusing the improvement activities in your quality management system? If so, yours is one of several companies that see the benefits of process improvement as a way of saving time and money. Although continual improvement is a key principle of the ISO 9001 standard, the standard does not explain how to implement or maintain this improvement. The Six Sigma method provides this how-to information. Six Sigma is a collection of process improvement techniques and tools which can be used to improve the processes, and can be applied to processes within the quality management system that is defined by the ISO 9001 standard.


There are several requirements that are common to the ISO 9001 standard and the Six Sigma methodologies; as such, these can be done together to meet the requirements of both within the processes defined in the QMS:

Process Approach. Both ISO 9001 and Six Sigma use a process approach in applying their methodologies. ISO 9001 involves looking at an overall system as smaller, interrelated processes to focus efforts toward more consistent and predictable results on the individual processes of the system. This is done because controlling and improving the individual processes can be a much easier and more effective way to control and improve the entire system. Six Sigma is used on an individual process in order to control and improve it using a SIPOC diagram (an abbreviation for Supplier, Inputs, Process, Output, and Customers). SIPOC is a way of representing the process in order to better understand how it works, and how improvements are effective on the process.

Cycle of Improvement. Both systems have an underlying methodology of using a cycle for improvement. ISO 9001 is based on a Plan-Do-Check-Act cycle that is used to focus efforts on improvement in the system. This allows for an ongoing cycle where changes are made to improve an aspect of the system, then checked and acted upon to either correct for problems or cement improvements that are realized. I have explained this further in another post on Plan-Do-Check-Act in the ISO 9001 Standard. The core tool used in Six Sigma for process improvement projects is the DMAIC project methodology (an abbreviation for Define, Measure, Analyze, Improve and Control), which is an improvement cycle based on data that is used to improve, optimize and stabilize business processes. With both systems, all phases of the cycle must be followed for the cycle to work; skipping steps can cause failure.

With these common elements it would seem logical that Six Sigma can be used as one of the main methodologies for attaining process improvement within the ISO 9001 quality management system.

Differences between Six Sigma and ISO 9001

The main difference between ISO 9001 and Six Sigma is in the scope. The ISO 9001 standard is an internationally recognized set of requirements to use as the basis to develop an entire quality management system, including all aspects of the business such as management responsibilities, resource management and all aspects of providing the product or service. Additionally, the implemented QMS can be certified against the ISO 9001 requirements (See ISO 9001 Certification). Meanwhile, Six Sigma is solely a set of tools and methods used to improve business processes, and which are not meant as a means of developing an entire quality management system. In addition, there is no standardized set of requirements that are recognized worldwide, as this is primarily implemented in North America. This limited scope can make the Six Sigma methodologies very useful as the tool used within the quality management system, designed to the ISO 9001 requirements, for process improvement.

Additionally, Six Sigma has a subset project methodology used for design, which is referred to as Design for Six Sigma (DFSS). This project replaces the DMAIC cycle used above and replaces it with a cycle more focused on the design, which is the DMADV project methodology. These five stages stand for Define design goals, Measure and identify critical characteristics, Analyze to develop and design alternatives, Design an improved alternative, and then Verify the design. This methodology is not equivalent to the design process defined in ISO 9001 (see The ISO 9001 Design Process Explained), but could be used as a method of design improvement, which would then feed into the design change requirements of the ISO 9001 quality management system.

Some elements of Six Sigma will require new processes not already implemented in a quality management system, but the addition of the processes should complement the process improvement requirements of the system already in place. There are no fundamental conflicts between the requirements, only additions to what would already be present.

Using system synergies to save time and money

It is not an either/or choice between ISO 9001 and Six Sigma; both can be used. ISO 9001 will provide the QMS framework, and Six Sigma can help provide the process improvements required by the quality management system. Integrating Six Sigma into your ISO 9001 quality management system can help to focus the resources used for improvement by using a set of tried and trusted tools and techniques, saving both time and money for a company. Improvement for cost and time savings is one of the main reasons for implementing a quality management system in the first place, and having a set of tools to guide you in this endeavor can mean the difference between success and failure.

ISO 9011: Don’t confuse it with ISO 9001 or ISO 19011


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Author: Mark Hammar

ISO 9011 is often confused with ISO 9001 just because of the numbering used for the standard. In fact, the ISO 9011 standard has nothing to do with management systems (which the ISO 9001 document defines), but instead is one of many sets of requirements published by the International Organization for Standardization (ISO) that defines the necessary quality requirements for producing a product. In the case of ISO 9011, the product is synchronous belt drives for automotive pulleys. If you need to know what the automotive industry requires for these belt drives, then this is the standard you should get.

ISO 9001 includes requirements for developing and implementing a quality management system based on improving customer satisfaction. For information on the ISO 9001 quality management system standard, see What is ISO 9001.

ISO 19011 is also a standard published by the international organization for standardization, and is confused with ISO 9011. The ISO 19011 standard includes the requirements for auditing a management system, and is used to train the people who certify that companies have met the requirements of standards such as ISO 9001, ISO 14001 and the like. For more information on this process, see ISO 9001 Certification.


A layman’s guide to mobile phone jargon


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mobile phone jargon

With fresh innovations seemingly arriving every week, it can be hard to keep up with smartphone technology and new words that are coined to label them.

To make things a bit easier, we’ve compiled a list of common and not-so-common jargon along with simple explanations in layman’s terms. So if you’re muddled about megapixels or baffled by Bluetooth, we’ll get you up to speed.

First-generation mobiles or mobile systems – these were the first-ever mobiles and provide the basis for all of today’s smartphones.

Second-generation mobiles or mobile systems – 2G mobiles supported data, fax and SMS mobile services. 2G handsets also offer limited data communications.

2.5G or “second-and-a-half generation” – this was the next step from 2G and provided enhanced data communications services, including Multimedia Messaging Service (MMS) as well as Wireless Application Protocol (WAP) access for emails and web browsing.

Introduced in the UK in 1998, 3G is network technology that allowed users could access the internet at higher speeds than before and download music and video smoothly and quickly.


4g vs 3g

This is the current standard in mobile phone technology and is capable of super-fast mobile internet speeds of up to 300Mbps.


Still in development and unavailable at the time of writing, 5G is the next standard of mobile internet.

It offers speeds hundreds of times faster than 4G. But its greatest impact will perhaps be in the area of the so-called ‘internet of things’ that will see household goods such as fridges connected to the web.

Experts also forecast it could be vital in paving the way for driverless cars becoming mainstream.


A-GPS is technology used by mapping software that speeds up the process of determining your location, so you can get directions faster.

Air time
Air time refers to the monthly allowance of talk minutes you’re entitled to with your mobile phone contract.


This refers to Active Matrix Organic Light Emitting Diode (AMOLED) display technology. AMOLED screens are sharper than standard LCD screens and are battery-efficient.


android army

This is software developed by Google that powers smartphones manufactured by the likes of Samsung, HTC and Sony. Rather than ‘software’ Android is more usually referred to as an ‘operating system’, which is a term you’ll find explained below.

Audio jack

This is the aperture in your smartphone where you plug in your headphones or a portable speaker.


Auto-focus is a feature of cameraphones that intelligently and automatically focuses on the subject of your photo without any input required from the photographer.


samsung galaxy s7 edge gold angled

Bezel refers to the outside frame around the phone screen. Some smartphones, such as the Samsung Galazy Edge range have smaller bezels to make room for an edge-to-edge display.

Bluetooth is technology that creates a ‘local’ wireless connection. It allows smartphone-owners to exchange data over short distances.

Caller display
The screen of your mobile that shows the name and number, and sometimes a picture of the caller on a call.

Camera phone

iPhone 7 camera detail

This is a mobile phone with a built-in camera so you can take pictures and record videos.

Cloud storage

Cloud storage is a way of storing your music, photos and other files in a secure location online. It means you’re not limited by your phone’s built-in storage and can access your files from other devices if you need to.

This is the area in which you get mobile phone signal from your network. If you have coverage then you can make and receive calls on your mobile phone, send and receive messages and access the Internet.

Desktop charger
An accessory – also referred to as a charging dock or cradle – that holds the handset upright on a surface on your desk while it is charging so you can easily view the caller display.

Dual band
This term refers to mobiles that can switch between two frequencies. All new UK mobiles are dual band.

Dual lens

A dual lens camera uses two lenses rather than one to take more detailed photos.


A dual-SIM phone has two SIM slots and enables you to have two active SIMs at the same time. This means you will have two phone numbers and can receive calls and texts on both lines.

Fast charging

iphone 6 battery charging

Fast charging, sometimes known as quick charge, allows you to charge your battery by using higher-than-normal voltage. For this to work, both your phone and your wall charger need to support fast charging.

Fingerprint scanner

A fingerprint scanner adds another layer of security by only allowing you to unlock your smartphone with your unique fingerprint.

General Packet Radio Service – This was a way to enhance 2G phones’ capabilities so they can send and receive data at a much faster rate. A GPRS connection means the phone is “always on” and can transfer data immediately.

This is a safety feature that allows you to talk without holding the handset to your head and often involves using an extra hands-free accessory such as a Bluetooth earpiece. This is particularly popular with drivers because holding a handset while driving is illegal in the UK.

Instant messaging
This term refers to services that let you chat to your friends with text messages in real time. Examples of instant messaging apps or services are WhatsApp and BlackBerry Messenger.

Iris scanner

Samsung Galaxy Note 7 launch iris scanner

An iris scanner adds another layer of security by scanning your eye to unlock your phone. It is thought to be more secure than fingerprint scanners.

LCD screen

Liquid Crystal Display (LCD) is made up of an array of liquid crystals that get illuminated by a back-light. They are widely used on smartphones because they perform well, even in direct sunlight, and they don’t use up too much battery power.


Mbps stands for megabytes per second and is a measure of the speed of your internet connection.


Megapixels are a way of measuring the quality of a camera. In general, the more megapixels the better the camera. But it’s not the only thing that determines how good the camera is. The amount of light a lens lets in is also important, for instance. So megapixels aren’t the be-all and end-all.

MP3 Player
This can be a hardware or software built into a mobile phone that allows you to listen to music and podcasts.

Multimedia messaging
This term refers to sending messages between mobile phones that include images and video clips.

microSD card

transcend sd card

A microSD card is a tiny storage accessory that you insert in your phone to massively boost capacity.

Modular phone

A modular smartphone can be upgraded by attaching or replacing components, such as a new battery or a better camera. This means that customers only pay for the features they use and can upgrade components as their needs and technologies change. If their phone breaks, they can replace the broken component without having to replace the entire handset.

This refers to the period of time after business hours have ended and during which mobile networks tend to offer reduced rates for calls.


An Organic Light Emitting Diode (OLED) refers to display technology. Similar to AMOLED, OLED screens are sharper than standard LCD screens and are designed to be energy-efficient.

Operating system

An operating system is the software that powers smartphones, as well as other devices such as tablets and PCs. As well as managing your phone’s resources so you can do lots of things at once, an operating system is the platform on which your phone runs apps.

Examples of operating systems are iOS (iPhone), Android and Windows.

Optical image stabilisation technology

Optical image stabilisation technology keeps your smartphone camera steady, so it’s to take good photos in low-light conditions.

Pay As You Go (PAYG)

Pay as you go means you’re not tied to a contract and only pay for minutes and data when you top up.

The time of day when the phone network is busiest. This usually occurs during normal business hours.

Refurbished phone

A refurbished phone is a handset that has been returned to the seller because of some manufacturing and functioning defect. The phone is then repaired, undergoing full quality checks with best industrial standards and sold again.


This is sometimes referred to as International Roaming and means using your phone in another country and on an another nework.

Your network and talk plan will determine how many countries you can roam in and what charges you may incur from using this service.

Virtual reality headset

Oculus Rift VR headset virtual reality

Virtual Reality or VR headsets create a convincing replacement of an environment using virtual reality content, such as a movie, a game or prerecorded content from a 360-degree camera. Once wearing the headset, the user will be able to look around and sometime interact with the virtual reality on the screen.

Secondary camera

This is the front-facing camera that’s most often used for ‘selfies’.

SIM cards
This stands for Subscriber Identity Module. It is the chip that identifies the mobile number and mobile account to the network. It stores essential data and is required to make or receive calls on your network.

There are three types of SIM cards: standard SIMs, microSIMs and nano SIMs. The sole difference between them is size.

SIM only

A SIM-only deal or SIM only contract is that solely includes a SIM card and an amount of monthly usage. Unlike conventional contracts, SIM-only deals don’t include a phone.

They’re especially popular with cost-conscious consumers and customers who have come to the end of their standard contract and feel they don’t want or need to upgrade to a newer phone.


SIM-free means you buy the phone of your choice without a SIM card in the package, so you will be free from any contract or commitment to a specific network. SIM-free phones come completely unlocked, letting you decide what SIM card to use in them.


woman using smartphone

‘Smartphones’ refers to high-end handsets that carry out a whole range of functions. More than just phones, smartphones can surf the web, send and receive emails, record video, take pictures and be used for video games and viewing movies and much, much more.

This is an acornym for Short Message Service. It’s the technology that allows traditional text messages to be sent and received on all mobile phone networks.


WA splash resistant phone should repel splashes and light water on the device but isn’t water resistant. Simply put, it should be ok if you take it out in the rain, but probably wouldn’t survive being dropped in a puddle.

Standby time
This refers to the number of hours that a mobile phone battery will last without receiving or making any calls. If you use the phone to make calls or send messages then the standby time will be diminished.

Streaming video and music

Streaming is a way to enjoy music and video on your phone without having to download the content first. Instead you watch or listen in ‘real time’. Music services Spotify and Deezer use streaming, as so video on-demand services such as NowTV.


Samsung Galaxy Note 7 angled stylus

A stylus is a type of ‘pen’ that’s used for writing or drawing on your smartphone’s or tablet’s screen. Examples are Samsung’s S-Pen and the Apple Pencil for the iPad Pro.

Talk time
This is the same as air time and refers to the actual amount of time spent talking on the phone, or in some cases the allowance of time available on your talk plan.

Tri band or Triple band phones can operate across three GSM bands, which means they can be used in more than 100 countries.

USB cable

USB cables are used to connect smartphones to PCs and laptops and for charging your phone from the mains with a plug attachment or directly from your computer.

You’ll use a USB when you’re transfering music, video and photos.

USB-C cable

USB-C is a newer type of USB cable that enables users to transfer data faster and charge their smartphones more efficiently.

Voice commands
This is a way of using your mobile with your voice. You speak a command and, assuming it understands, your smartphone will carry out the instruction. Voice commands are especially handy when you’re driving or in situations where your hands are in use elsewhere.

Voicemail is a service provided by your network. Voicemail records audio messages from callers when you are unable to answer the phone.

This stands for Wireless Application Protocol and was the means through which older-generation phones could access the internet.


iPhone 7 jug of water

Water resistant phones can withstand a lot of water without becoming damaged. Their precise imperviousness to liquid veries from phone to phone, but most should survive being submerged in three feet of water for up to half an hour. Water-resistant phones aren’t fully waterproof though, so you probably shouldn’t take them swimming.

Windows Phone

Windows Phone is the term for Microsoft’s Lumia range of handsets, which are powered by the Windows operating system.