Author: Sam Kinch

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What is the ‘Scope’ referred to in ISO 9001?

scope

The Quality Management System (QMS) scope, sets boundaries and applicability of your QMS and it is also included in the ISO 9001 certificate, so it’s very important to identify and must be documented.

 

Try not to jump ahead with finalising your scope. Before defining your scope, you must take into consideration the following factors:

 

  • The external and internal issues that are relevant to the purpose of your organisation;
  • Your organisations strategic direction, and your ability to achieve intended results;
  • The requirements of relevant interested parties (internal and external);
  • The products and services of your organisation.
 

As the QMS scope will available for all to see, in and outside of your organisation, you will likely want to keep it simple, short and easy to understand. It will help an auditor have a clear picture of your organisations purpose and activities, it will show you have considered your interested parties expressed needs and expectations, and it will ensure your organisation is aware of their involvement in the QMS.

 

How has the scope changed since the revision of the standard?

 

The 2008 standard referred to ‘exclusions’, unfortunately this was used in some cases as an excuse not to meet the standard in certain areas. Now however, the Appendix A5, specifically mentions that ‘exclusions’ are no longer referred to in the 2015 standard. 

 

The revised standard focuses on ‘Applicability’. What’s applicable to your organisation depends on the organisation size, complexity, your practiced management model, range of organisational activities and nature of risk and opportunities it encounters. So your organisation can decide if a requirement from the ISO 9001:2015 Standard is applicable to the processes and activities in your organisation.

 

Remember that if you do decide a requirement isn’t applicable, you are responsible to ensure this doesn’t negatively impact your products and services!

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ISO 9001 Annex A & B – What is it used for?

With the changes to the ISO 9001:2015 standard comes new terminology and requirements. Annex A and B are included in the ISO 9001 standard to explain structure, terminology, and concepts used in the standard. In this article, we will briefly review Annex A and B.


Annex A


Annex A includes an overview of:

  • Structure and terminology (A.1) 
  • Products and Services (A.2)
  • Understanding the needs and expectations of interested parties (A.3)
  • Risk based thinking (A.4)
  • Applicability (A.5)
  • Documented information (A.6)
  • Organisational Knowledge (A.7)
  • Control of externally provided processes, products and services (A.8)


A.1 Structure and terminology 

This section explains the clause sequencing of the 2015 version of the standard and compares terminology differences between the new and previous version. 


ISO 9001:2008 ISO 9001:2015
Products Products and services
Exclusions  Not used (See A.5 Applicability)
Management representative Not used (Similar responsibilities and authorities are assigned but no requirement for a single management representative)
Documentation, quality manual, documented procedures, records Documented information
Work environment Environment for the operation of processes 
Monitoring and measuring equipment Monitoring and measuring resources
Purchased product Externally provided products and services
Supplier  External provider


Products and Services (A.2)


The standard explains the terms ‘products’ and ‘services’ and how they are different to the terms used in the 2008 version. 


Even though the term ‘product’ included all categories of businesses, the previous 2008 version was a little more difficult for service industries e.g. postal service, to apply the whole standard to. By including the term ‘service’ to the 2015 version, it has allowed businesses greater scope of applying the standard because it highlights the differences between products and services with specific requirements. 


Understanding the needs and expectations of interested parties (A.3)


With reference to clause 4.2, annex A.3 explains there is no mandatory requirement in the standard to consider interested parties when defining your organisations context if they are not relevant to the QMS. 


Risk based thinking (A.4)


Annex A.4 explains risk based thinking as a continuation of clause 0.3.3. The key areas of the standard where risk based thinking applies, the purpose of risk based thinking and applicability. 


It highlights an important note that could be very time consuming if unnoticed by the implementation team, referring to clause 6.1…


Although 6.1 specifies that the organisation shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Organisations can decide whether or not to develop a more extensive risk management methodology than is required by this International Standard, e.g. through the application of other guidance or standards.”

ISO 9001:2015 Annex A.4


Applicability (A.5)


The 2008 version allowed for ‘exclusions’ when identifying the scope of the QMS, the new standard does not. Now the standard specifies that you must consider the applicability of the requirements for your business. You must consider the size and complexity of your organisation, management model, activities and the nature of the risks and opportunities.  Once the applicability has been considered and identified, then you can declare in the scope that the requirements of clause XYZ do not apply to your QMS. This decision must not negatively affect the QMS.


Documented information (A.6)


Annex A.6 explains what the differences are in terminology. Documented information is a new term in the 2015 version, previously known as ‘Documentation, quality manual, documented procedures, records’. Clause 7.5 is dedicated to documented information.


Organisational Knowledge (A.7)


Clause 7.1.6 is dedicated to organisational knowledge. Annex A.7 describes the reason for introducing the clause requirements:

a) safeguarding the organisation from loss of knowledge, e.g. through staff turnover; failure to capture and share information;
b) encouraging the organisation to acquire knowledge, e.g. learning from experience; mentoring; benchmarking.”
ISO 9001:2015 Annex A.7

Control of externally provided processes, products and services (A.8)


Clause 8.4 refers to externally provided processes, products and services and controls over them. These include purchasing from a supplier; associate company associations and outsourcing processes externally. The standard recognises that using external resources is a common practice especially in the case of service industries, so the organisations doing this need to apply the key concepts of the standard. When planning how to control those external companies, your organisation must practice risk-based thinking.


Annex B


Annex B provides details of other International Standards for quality management and quality management systems that have been developed by ISO/TC 176. It compares them on table B.1 and the relationships between them.

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A Guide to Plastic Bag Suffocation Warning

You may be familiar with a plastic bag suffocation warning appearing on internal packaging, even the wording that usually goes with it, but do you know how to specify this to your supply chain? 

This guide gives you the recommendations to send to your supply chain (or use yourself).

The hazard the label tries to minimise the suffocation of children. Suffocation of babies, young children or even pets is more common than we would like, so it’s very important you put in place effective preventative measures.

Suffocation mostly occurs when a child places a bag over their head. The plastic bag could form an airtight seal around their nose and/or mouth. At first this may seem unlikely to the average adult however, children or babies come into contact with plastic bags in situations such as cot mattresses that have been left wrapped in thin plastic bags and other similar situations, especially when the product the bag contains is a toy or child appealing product.

Factors to consider when risk assessing the packaging that could cause a hazard to children would be the bag dimensions, the circumference of the opening, its closure type, the material specification and any air holes or perforations.

First things first

First thing to consider is the size of the bag and opening circumference. If the bag’s greatest dimension is less than 100mm or the opening circumference is less than 200mm, you don’t need to add the warning notice. 

With no legal requirement for child suffocation warnings in the UK / Europe, it can be a little daunting to make a final decision on what to print. Most large organisations supplying products now require the suffocation warning and bag specifications. This will likely be specified in the supplier manual they provide their supply chain with.

If the bag is larger than the above criteria, it would helpful to refer to the standards listed here for more detailed guidance:

Suffocation Warning Text

BS 1133-21 provides a recommendation for the specification and wording for a warning notice on bags and provides a criteria for the conditions under which it should be applied. However, this doesn’t provide a complete specification, so we have given you with recommendations to follow: 

  • Text should be red or black, or a solid colour to contrast with the bag material
  • Text should be in centre of bag or repeated on 0.5m grid for bags greater than 0.8m in any dimension
  • Text is ITC Helvetica or similar sans serif font
  • Font size for WARNING is 18pt minimum. Remainder of text is 14pt minimum
  • A label border can be used for dimensional purposes or not printed at all

WARNING

This bag is not a toy. To avoid danger of suffocation, 

keep out of reach of babies and children.

Bag

The Toy Safety Directive, BS EN 71-1, raises attention to plastic bags and plastic sheets. It specifies bags larger than 380mm opening circumference and having a drawstring closure must be made of a material which is permeable to air. Flexible plastic sheeting must be thicker than 0.038 mm if over a certain size.

Remember, children most at risk of suffocation, will likely be unable to read what a warning says! So it’s very important you make the bag specification as safe as possible, and to the recommended guidelines below…

Air holes and bag specifications:

  • Except where application requires airtight sealing, all bags are to be perforated with holes of 4mm diameter minimum, spaced on 30mm grid
  • Bags for child appealing products and toys must have a minimum of four holes; other bags to have a minimum of two holes
  • Unperforated bags for child appealing products and toys must be manufactured from material with a minimum thickness of 40µm
  • Bags for child appealing products and toys not to have draw-string closures

If in doubt, the majority of packaging suppliers would be able to provide you with pre-printed labels or custom bags that meet these specifications.

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Donate Towards Eliminating Modern Day Slavery ​

slavery

Quality Inspired sponsor Unseen as their chosen charity. We aim to encourage businesses worldwide to look at their supply chain and assess what they can do to support the efforts to reduce and eventually eliminate slavery. 


Donate to Unseen

Awareness Resources


Posters, Checklists, Leaflets & Videos


Stronger2Gether Resources:


https://www.youtube.com/watch?v=U–GL11iU0Q

Are you looking for ways to get your corporation involved?


Download the Unseen guide to arranging a corporate event here.


How can you help?


Your donations can aid with helping survivors of slavery recover and build a new life for themselves. 


Click here to see what difference your donations can do…

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Furniture Stability – Protection for Children

chest drawers

We all want our homes to be a safest place for our children. However, despite every parents best efforts, accidents do happen. 

The type of accident we will discuss is falling furniture.


The Tipping Facts.


Most accidents happen when a child is alone in a room and climbs up drawers or shelves. At 2 years old and walking, a child may start exploring the home without constant observation. Certain rooms may hold their interest more, specifically ones with their toys or games in. They may try to reach for their toys kept in drawers or in shelves, turn the TV on, or just do what kids do by being curious.


The U.S. Consumer Product Safety Commission (CPSC) reports that in the U.S., a child is sent to the emergency room every 30 minutes as a result of falling furniture.


Data from a 2018 CPSC report demonstrates the scope of the problem:

  • A child dies every two weeks as a result of falling televisions, furniture, or appliances
  • 83% of tip-over deaths involve children between 1 month and 14 years old
  • 2 year olds are the age group most affected by tip-overs, and are most likely to be killed
  • 92% of tip-over fatalities occur in a residential setting
  • 46% of fatalities occur in bedrooms and 19% in living/family rooms
  • Crushing by the product (55%) were the most common category of death


See previous reports of the 2016 CPSC report and the Kids in Danger Stability Report for further research. 


Why have so many accidents occurred?


It’s awful to see the above figures of accidents and deaths that have happened in just the past year, highlighted again by a recent series released from Netflix, “Broken”.


Bearing in mind the severity of the injuries and the exposure of the results, why is the number still so high?


There are many reasons but one key issue is, consumers are completely unaware of the risks and how to mitigate them. This is highly unlikely to be their fault as there is not much information out there highlighting the precautions a parent can take to safeguard their children from these risks. There is far more information about how the retailers are incompetent or supply poor quality products.


The most common mitigating action is to attach a suitable anchor to the product. This must also be in the ideal location to suitably support the weight of the product and pressure in key areas. Usually this is provided with the product and explained in the instruction manual.

Granted, the instruction manuals highlight the wall strap, when it’s provided, however there could be more exposure given to it with in-depth instructions online or videos.


Another factor could be, the product may be supplied with a wall strap but they are poor quality fittings that are not universal to all wall types. There are many different types of anchors available and not all are created equal. With products such as cheap wardrobes that require wall straps, they can be near impossible to fit properly!


The good news is…the risk of tipping CAN be reduced!


Stability Standards.


Currently, there is no mandatory safety and stability test standard for children’s cabinetry furniture. Manufacturers and Retailers are governed by the General Product Safety Directive that puts the onus on them to ensure their products are fit for purpose and safe for the intended users.


But don’t panic! Most UK retailers will ensure children’s furniture is tested for safety and stability to FRQG test standards, EN71 or an approved equivalent alternative (where relevant), prior to selling the products to the consumers.


FRQG standards have been designed by FIRA and agreed with a panel of furniture industry experts for best practice. ASTM F2057 is the voluntary standard used in the USA.


What expect.


Due to the increasing demand to make products cheaper and quicker production lead times, manufacturers often provide insufficient quality fixings. You have most likely experienced this yourself, you buy a cabinet but find the fixings are useless so you have to take a trip to the local DIY store! Well this is no different for the wall straps usually provided.


You may wonder what precautions Retailers take prior to putting the product on sale?


Retailers have a sign-off procedure they follow before every launch of new products. Along with a long list of check points, their Quality teams should retrieve the test reports for the product being supplied and, in most cases, conduct a test build of the items (to imitate the customers experience).


If problems are found or insufficient materials are being provided, and the retailers think it needs improvement, the manufacturer has the duty to make those changes prior to shipping.


Tipping Preventions.


So what can we do to put more stringent measures in place?


Consumer recommendations (KID):


  • Buy furniture with a wider base, heavier back panel, and/or interlocking drawers
  • Buy furniture that meets a voluntary standard regarding furniture stability
  • Anchor or permanently secure the furniture to the wall using suitable wall restraints
  • Do not place a TV on furniture unnecessarily and keep TV cables and cords out of reach
  • Reduce climbing temptations by keeping objects such as toys and remote controls off of furniture

What can Retailers do?


  • Increase consumer awareness of the danger of furniture tip-overs and knowledge of the actions needed to keep children safe
  • Ensure all children’s furniture is tested to the appropriate standards, making those standards mandatory and enforceable, promoting changes in children’s furniture safety standards
  • Include in the instruction manual a wall anchoring guide suitable for wall types and floor surfaces e.g. a screw and stud for drywall 
  • Provide free fixings where missing from the packaging or insufficient quality is provided
  • Add appropriate labelling to the items and packaging 
  • Demonstrate the suitable location of the wall strap with bradawl marks or predrilled holes for the attachment
  • Train the sales teams and customer services to understand and advise consumers on the relevant anchor methods 
  • Provide incentives or triggers for consumers


As a large proportion of consumers don’t read or follow the instruction manuals provided (we all know that person!), FIRA suggested minimum label information for manufacturers permanently attach inside the chest drawer to remind the consumer to take safety precautions.


Further measures.


As a result of the findings, CPSC created the Anchor It! campaign. The campaign’s purpose is to educate caretakers about the danger of falling furniture through videos, explanations of dangers and what extra precautions can be added to your products. 


Baby Proofing


Have you considered baby proofing your drawers! There are numerous ways to do this, my top three are:

  • Anchors 
  • Magnetic locks/keys
  • Tension rods

IKEA


After receiving a lot of negative exposure, Ikea has issued a short guide on their website to help customers understand how to secure their products safely here.


Final note.


Supply chains always focus on customer satisfaction, however, It’s important to keep in mind what really matters – the safety of consumers comes first.


So before you finalise that new product design, or agree on material costs, think about the safety and quality of your products. Are they suitable to provide adequate preventative measures? Are you making it clear to the consumer what the risks are and how to mitigate them?


I look forward to hearing your feedback and any updates you may have.


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Changes to SMETA Audit in 2019

In May 2019 Sedex introduced significant changes to the organisation of SMETA audits. The Sedex Stakeholder Forum (SSF) implemented these changes in June 2019. From 1st June 2019, all SMETA full scope audits must now be conducted with the new methodology of version 6.1, with the 6.0 audits being phased out. 


Sedex is a recognised global organisation, whose services include a broad scope of industries. This includes retailers, manufacturers, institutions, and construction businesses. You can find out more about Sedex here.


Updates Effective June 2019


In this article we will look at the changes to;

  1. The SMETA audit and the report
  2. The best practice guide 
  3. The measurement criteria
  4. The noncompliance guidance


We will also review the general improvements and the feedback from Sedex customers considered during the changes. 


The improvements and introductions to new topics have been no small effort. A great amount of work has gone into making the reporting clearer, easier to digest and implemented good suggestions from customers. 


Let’s look at those changes and general improvements…


1.   Changes to the SMETA Audit 


An example of the Sedex SMETA report can be found here. The download also includes guidance to complete the audit.Template SMETA Report

Audit Type – Terminology


SMETA audits are conducted as either 2 Pillar or 4 Pillar audits, depending which criteria the business scope fits into. There is specific terminology that is used for both types due to the intensity of analysis. These changes help clarify if environmental questions are part of 2 or 4 pillar audits. 


  • 2 Pillar audit change: The ‘Health & Safety ‘section has now been renamed ‘Health & Safety plus Environmental 2 pillar’. 
  • 4 Pillar change: ‘Environment’ is now renamed to ‘Environment 4 pillar’ 

SMETA declaration – Auditor credentials 


The lead auditor, team auditor and interview auditors, can now provide details of their credentials on the audit report.  This is in the form of the ‘Association of Professional Social Compliance Auditors’ (APSCA) number and status.

Site Details – Site location


GPS location and ‘Latitude/Longitude’ options have now been added to the report site details page.


Changes to Sections – ‘0A: Universal Rights covering UNGP’


This section looks at whether the site grievance mechanism meets the UNGP expectations. This was previously covered in section 9: No harsh or inhumane treatment is allowed. This is an introduction but not a replacement for a full Human rights assessment. 


The audit will check for:

  • Checks for awareness / commitment 
  • Starting to take responsibility 
  • Access to a grievance 
  • Relevant section of SAQ completed 

The auditor will also look for good examples to measure the effectiveness of practices;

  • Broader awareness of their Human Rights impacts 
  • Giving access to remedy 
  • Engagement of wider community 
  • Grievance methods include salient issues, and that a developed level of response is in place 
  • Demonstrate and implement data privacy procedures for workers’ information 

*UNGP is the acronym for ‘United Nations Guiding Principles of Business and Human Rights’. You can find out more here.


Additional elements – Responsible Recruitment (Regular Employment) 


Recruitment practices are now more transparent – including migrant, agency and other recruitment practices. Additional factors are being reviewed during the audit in responsible recruitment: 

  • Businesses have full understanding of the entire recruitment process including all labour recruiters and intermediaries in terms of required legal and/or ethical requirements. 
  • There are effective management systems in place to identify and monitor the hiring and management of all migrant workers, contract, agency, temporary or casual labour. 
  • Employment agencies must only supply workers registered with them. 
  • All workers pay no recruitment fee at any stage of the recruitment process. 
  • Worker contracts accurately reflect the agreed payment and terms in the recruitment process and are understood and signed by workers. 


Additional elements – Land rights & land grabs management systems


This addition isrelated to legal land tenure and free, informed, prior consent. Additional factors are being reviewed during the audit;

  • Checks on all applicable / required land rights, licences and permission. 
  • Check on management systems in place to conduct legal due diligence relating to land title 


Additional elements – Land rights & Conservation (4 Pillar)


Additional factors are being reviewed during a 4 pillar audit, section 10.B.4 Environment;

  • Checks site management systems and capacity to cover land use 
  • Change to recognize and apply relating to nature conservation and deforestation 
  • Site measures and avoid damage to land which has any biological, ecological, social or cultural values which are considered outstandingly significant or critically important, at the national, regional or global level. 


Additional elements – Workplace Impact assessment indicators 


A set of common industry indicators to measure improvements in the workplace has been added. Where the annual worker turnover is considered, the auditor will also review; 

  • Absenteeism / lost day work cases
  • # work related accidents
  • % workers on high hours 


Definition – ‘Migrant worker’


The definition of migrant worker has been reviewed and amended for version 6.1. 

  • New definition: “The term “migrant worker” refers to a person who is engaged or has been engaged in a remunerated activity in a country of which they are not a national or permanent resident or has purposely migrated on a temporary basis to another in-country region to seek and engage in a remunerated activity”. 
  • Previous definition: “The term “migrant worker” refers to a person who is engaged or has been engaged in a remunerated activity in a country of which they are not a national and where they do not intend to remain permanently or has purposely migrated on a temporary basis to another in-country region to seek and engage in a remunerated activity.” 


New Question – Worker nationality


A new audit question is now included: “B: Please list the nationalities of all workers, with the three most common nationalities listed first.”

2. Changes to the Best Practice Guide


You can download the latest Best Practice Guide here. Best Practice Guide 6.1


Audit Frequency


Sedex have clarified their guidance to buyers how often they recommend supplier sites conduct their social/ethical audits. They encourage audit cycles in relation to the site risk rating. The audit frequency recommended is;

  • High risk – annual audit 
  • Medium risk – 2-yearly audit 
  • Low risk – at customer’s discretion 


Audit duration, sample size and timetable


Interviewing and sampling can take varying time for an auditor to completed dependant on the size of the site and quantity of employees. Guidance to calculate the sample sizes and time taken for over 2000 workers has been released.  


Data Protection 


Processes have been changed to be in line with the newest GDPR requirements.


Audit Report – Observations


The requirement to reference a Code or Law in in relation to Observations has been removed. 


3. Changes to the Measurement Criteria

 

You can download the Measurement Criteria PDF here. Measurement Criteria


Health & Safety Section 3.9


The criteria has been updated to clarify, exit routes in multi-story or multi-business premises that go through other businesses’ premises should be included in the audit checks. 


Other Issues Section 10A.6


Auditors will now check nationalities of workers within UN sanctioned countries for ‘entitlement to work’. Evidence gathered by the auditor will be recorded and reference these nations.


Sedex worker wellbeing assessment


The SMETA methodology now includes a wellbeing assessment of workers. This covers worker satisfaction and job conditions. 


4. Changes to the Noncompliance Guidance


You can download an example of a Corrective Action Plan Report (CAPR) here.  CAPR


0B: Management Systems


The ‘Incomplete Sedex SAQ’ is now not included in nonconformities. 


Final thought – Preparation


Sedex issue a lot of guides available to refer to prior to the audit being conducted. It’s worth taking a thorough look at these guides prior to applying for an audit. They will help you understand exactly what type of audit you need and how to prepare for one. 


Preparation is key! It’s much better to spend 2 days with an auditor well prepared, rather than go into it blindly and potentially be faced with a list of nonconformities so long that you have to employ an additional person to manage them for the next 6 months. 


If you are looking for further advice or guidance in this area, please feel free to reach out to us. 

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Too many modern slaves left in limbo, warns new UK anti-slavery chief

Tackling slavery

Dame Sara Thornton speaks to Thomson Reuters Foundation on the need for sound and timely decision-making for slavery survivors


Dame Sara Thornton raises concerns over what Britain is doing to combat Modern Slavery. You can read the full article here.


“INTERVIEW-Too many modern slaves left in limbo, warns new UK anti-slavery chief” (Thomson Reuters Foundation, 08/08/19)


The full picture of how Britain handles people freed from modern slavery is unclear as authorities do not publish data on how many survivors have applied for asylum or how many are allowed to remain or sent home.


A Home Office spokesman said Britain was ensuring that victims of trafficking and slavery “get the support they need”.


Britain has called itself a world leader in the anti-slavery drive, but is considering the findings of a government-ordered review of a landmark 2015 Modern Slavery Act amid criticism it has not been used fully to tackle the crime and help survivors.