Specsavers Case Study

Specsavers

Case Study

A standards solution for a global network

of locally run businesses

A standards solution

for a global network of

locally run businesses

Martin Lockton, Regulatory Affairs Manager at Specsavers looks

at the challenges of certiﬁcation and compliance for a major high

street retailer and manufacturer.

pecsavers is a partnership of nearly 2,000 locally run

businesses. Founded over 30 years ago by Doug and Dame

Mary Perkins, our business pioneered the optical joint venture

partnership model and we now provide product, support and

marketing to over 2,300 partners and 30,000 people working across

stores, ofﬁces, laboratories and factories worldwide.

We are growing globally, and at the latest count we were serving 30

million customers in the UK, Ireland, Denmark, Sweden, Norway,

Finland, Holland, Spain, Australia and New Zealand. All of our frames

and lenses are classiﬁed as medical devices and this makes it a

legislative requirement for us to be registered with a notiﬁed body.

Every partner operating in each country needs to have complete trust

in the products they are supplying, which means we need to be able to

demonstrate legislative compliance in every market we are operating

in. Unfortunately, there is no one size ﬁts all solution and each of these

markets has its own individual requirements and idiosyncrasies. Also,

to further complicate matters, our manufacturing takes place across

multiple sites, with some stores also creating products in their own

laboratories.

Our driving ethos is, and always has been, to make eye-care (and our

other services) affordable to everyone. We are constantly interrogating

every possible opportunity to improve and reﬁne how we operate. This

includes ensuring that we can provide and access standards in the most

efﬁcient way possible throughout our supply chain.

Working with BSI is essential to achieve these efﬁciencies. Over the past

year we have been able to consolidate nearly all of our certiﬁcation and

compliance with BSI. Moving from two, to using just one notiﬁcation

body has meant we are no longer duplicating processes such as audits

in multiple sites. BSI visits our premises and analyses our technical ﬁles,

delivering full surveillance audits to ensure we are always compliant.

By subscribing to British Standards Online (BSOL), we are able to

provide all of our staff and partners with access to a full suite of

standards (without having to buy individual standards for each site,

which is a huge saving). We currently subscribe to BSOL where we can

add up 50 different standards to our package.

We have 42 standards, having added three in the last year, it being

very easy to add new standards when the need arises. BSOL also

updates automatically, alerting us to any changes to the standards in

our collection. Knowing that we are being proactively kept up to speed

with any changes gives ultimate reassurance that we are always fully

compliant and operating in the best possible way.

Everyone should use standards. From the person working from their

shed at the bottom of the garden to a worldwide company like ours,

standards provide a baseline for quality control – a strong and secure

foundation on which the business can grow.

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a

practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a

commitment to the safety and quality of medical devices. It helps to establish and maintain the effectiveness of a manufacturer’s processes

to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services.

About the new ISO 13485 2016

SPECSAVERS CASE STUDY

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We use standards to inform all aspects of our business, from the

medical standards, which are a legislative requirement, to those

covering environmental and quality management systems and health

and safety. We are able to deﬁne the quality we expect of our products,

wherever they are being manufactured, right down to the tiniest

scratch, ensuring consistency right across our production lines.

We signed up to our BSOL subscription in February 2015 and, as of

May 2016, 250 standards have been downloaded by 23 users across 14

sites. Very soon, BSI will be our sole notiﬁcation body.

We have chosen to work with BSI for all of the reasons I have outlined

above. But more than that, we have chosen them [BSI] because they

are not a scary regulatory authority but an advisory service with their

customer’s best interests at heart.

Whether in terms of testing, submitting products or interpreting the

standards themselves, there is always someone at the end of the line at

BSI to provide help and advice, and for me, it’s that human touch that

seals the deal.

Everyone should use standards...

standards provide a baseline for

quality control – a strong and

secure foundation on which the

business can grow.

British Standards Online (BSOL) is the online standards database that makes using

standards easier and more cost effective. You can access a comprehensive library of over

90,000 internationally recognized standards.

Specsavers’ BSOL subscription includes:

9 A custom collection of up to 50 standards

9 42 standards in their collection currently

9 23 users across 14 sites

SPECSAVERS CASE STUDY

Relevant industry standards commonly used by Specsavers

ISO 13485

QMS (Quality Medical Standard) for medical device industry.

ISO 14971

Application of risk management to medical devices.

ISO 15223

Packaging and labeling standards:

symbols to be used with medical device labels.

BS EN 166:2002

Personal eye protection. Speciﬁcations.

BS EN ISO 8980-1:2004

Ophthalmic optics. Uncut ﬁnished spectacle lenses.

Speciﬁcations for single-vision and multi-focal lenses.

BS EN ISO 12312-1:2013

Eye and face protection. Sunglasses and related eyewear.

Sunglasses for general use.

BS EN ISO 21987:2009

Ophthalmic optics. Mounted spectacle lenses.

BS EN ISO 12870:2014

Ophthalmic optics. Spectacle frames.

Requirements and test methods.

BS EN ISO 12311:2013

Personal protective equipment.

Test methods for sunglasses and related eyewear.

BS EN 168:2002

Personal eye protection. Non-optical test methods.

BS EN ISO 14001:2015

Environmental Management systems.

Requirements with guidance for use.

BS EN ISO 9001:2015

Quality management systems. Requirements.

BS OHSAS 18001:2007

Occupational health and safety management systems.

SPECSAVERS CASE STUDY

BSIGROUP.COM

At a glance:

SPECSAVERS AND STANDARDS

SPECSAVERS HAS:

Sold 374 million

contact lenses

2,300 partners worldwide

More than 30,000 people working across its stores,

support ofﬁces and supply chain

Sold

221,000

hearing

aids

1,767 optical stores and

hearing centers

Raised more than £2.2 million across the world

supporting local communities

31 million customers

Sold 17.3 million

frames (glasses)

SPECSAVERS CASE STUDY

+44 (0)20 8996 7029

If you would like to ﬁnd out more about

creating your own digital standards collection

via BSOL please get in touch:

BSI Group

389 Chiswick High Road, London W4 4AL UK

Tel +44 (0)20 8996 7029

Fax +44 (0)20 8996 7001