ISO QMS Guide for Recyclers
ISO QMS Guide for Recyclers
Quality
Management
For an ISO compliant Quality
Management System that includes
“End-of-Waste” procedures
Preface
With these Tools for Quality Management the Bureau of International Recycling aims to assist recyclers,
whether members of BIR or customers of BIR members, to demonstrate their Quality Management. BIR
stands for free and fair trade in recyclables and recycled materials and maintains that any company that is
properly licensed, permitted or otherwise authorised by its local, state or national authority to carry out its
business should not be hindered in accessing its required material infeed whether from national or foreign
suppliers. However, regarding international trade in materials classified as waste and scrap or product, the
Competent Authorities of certain importing countries require proof that the exporting company maintains
a certified Quality Management System. Customers may also require their suppliers to have an applicable
Quality Management System.
Here the BIR provides via the internet for all, and in hard copy for its members, the necessary information for
companies in the waste management sector, the recovery and recycling sector of scrap collectors, sorters,
processors and metal-works and foundries to implement an ISO Quality Management System. Furthermore,
this guide is the first Quality Management System to incorporate end-of-waste procedures complementary
to the Council of the European Union’s Regulation (EU) No 333/2011, such elements are colour coded dark
blue. Besides these quality criteria for End-of-Waste, to benefit from the intended regulatory relief of “End-
of-Waste” Recovery and Recycling sector operators under EU jurisdiction must comply with the Regulations’
associated specifications and standards and other legal requirements. Recyclers not under the jurisdiction
of the EU may choose whether or not to use these End-of-Waste quality elements dependent on their own
assessment of their added value to their company’s Quality Management System.
Therefore the tools in this guide should be useful to those companies that import or export materials classified
as waste and scrap or product, and also those companies under the jurisdiction of the EU that assure they
recycle materials from end-of-life goods and scrap that are classified as waste into quality assured materials
that are classified as product.
Companies may then show, after implementation, verification and certification that they have an applicable
Quality Management System.
This implementation guide with the basic elements of ISO 9001 is complementary to any tailored sectoral
Quality Management System, and to any already developed national ISO based system, enabling the End-
of-Waste quality criteria to be incorporated into those tailored or national systems taking into account the
size of the enterprise, especially the situation of Small and Medium sized Enterprises (SMEs), the type and
amount of wastes, the nature of the operation and their domestic legislation.
The intention of the BIR is to follow up this initiative with further workshops at its biannual Conventions and
to gather experience from companies and national associations.
BIR thanks Mr. Frans Bijlhouwer MBA BSc, Quality Consultants (www.qualityconsultants.nl) for compiling
these Tools for Quality Management.
Ross Bartley
Environmental & Technical Director
Bureau of International Recycling
The easy implementation of an ISO compliant Quality Management System for the recycling industry 1
Contents
1 Preface ............................................................................................................................ 1
2 Contents; No warranty and disclaimer of liability..................................................................... 3
3 Why a Quality Management System for the Waste Management, Recovery and
Recycling Industry?................................................................................................................ 4
4 What is needed and what is already available?........................................................................ 10
5 End-of-Waste quality criteria and it’s implications for the Recycling Industry............................ 13
6 To determine the Quality Policy and the Objectives................................................................. 16
7 Identify and define the key processes in your company.......................................................... 17
8 Determine the gaps between what you have and what you need............................................. 18
9 Writing the Quality Manual..................................................................................................... 31
10 Modify existing Procedures and Job Instructions and write new ones...................................... 46
11 Preparing the Required Quality Procedures............................................................................ 48
12 Continual Improvement.......................................................................................................... 61
13 The Implementation of the QMS............................................................................................. 63
14 References............................................................................................................................ 68
15 Annexes
Annex 1 Monitoring for presence of unwanted radioactive contamination............................ 69
Annex 2 Example certificate of shipment monitoring........................................................... 73
Annex 3 Example of EU Statement of Conformity with the end-of-waste criteria................... 74
These tools are provided on an “as is” basis, without warranties or conditions of any kind, either
expressed or implied including, without limitation, any warranties or conditions of title, non-infringement,
merchantability or fitness for purpose.
Each recipient is solely responsible for determining the appropriateness of using and distributing these
tools and assumes all risks including but not limited to the risks and costs of errors, compliance with
applicable laws, and interruption of operations.
Neither recipient nor any contributors shall have any liability for any direct, indirect, incidental, special,
exemplary, or consequential damages (including without limitation lost profits), however caused and on
any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising
in any way out of the use or distribution of these tools even if advised of the possibility of such damages.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 3
Why a Quality Management System for the Waste Management, Recovery
and Recycling Industry?
To have a Quality Management System (QMS) according to ISO-9001:2008 in place in your company is
always a good idea, simply because it will give you many advantages such as complying with an increasing
number of customers’ requirements for a QMS, besides improving your company’s business management
system, your organizational performance and increasing the global recognition of your company so to be
able to compete in both domestic and world markets.
As an example of customer requirements, the 2009 Chinese Regulations Governing the Inspection,
Quarantine and Supervision of Imported Solid Scrap Usable as Raw Materials require its new registrants to
have a certified QMS such as ISO 9001.
Furthermore the Council of the European Union’s Regulation (EU) No 333/2011 establishing criteria when
ferrous and aluminium scrap metal cease to be waste requires that EU waste management, recovery and
recycling companies that wish to gain relief through end-of-waste for their products have a certified QMS with
documented procedures concerning particular aspects.
This Implementation Guide is dedicated to the small and medium size enterprises in the global Waste
Management, Recovery and Recycling industry. It provides all the tools to do the implementation individually
or with a small team with minimal effort, minimal time and minimal cost to get a result that is certifiable and
acceptable to competent authorities and business partners, whether suppliers or customers.
In most small and medium size companies, focus is on getting things done, hands-on to satisfy the customer,
realizing profits and growing the business. Often less focus is given to the Business Management System
also because these SME’s usually started out as micro - companies and have been growing fast over time.
The QMS is offering an excellent business structure about how things should be done, how registration
should take place, what the requirements are for your documentation and records, and how to realize
continual improvement.
Adopting such a QMS in your company will streamline the management processes and will eventually pay
back the time and effort you have put in it to get it started.
Nowadays many customers frequently audit their suppliers. When you have a valid ISO-9001 certification,
such repetitive auditing will also be minimized by similar and different customers.
At a later stage, it will be easier to implement an Environmental Management System (EMS) according to
ISO 14000:2004 with the QMS as a basis, because it uses the same framework.
Likewise the implementation of OHSAS 18001, the standard for Occupational Health and Safety Assessment
Series follows the same structure so that you and your company are also prepared for the implementation
of this management system.
ISO 9001:2008 includes five primary sections that contain the most important clauses.
4 The easy implementation of an ISO compliant Quality Management System for the recycling industry
• Clause 7: Product realization
Why a Quality Management System for the Waste Management, Recovery and Recycling Industry?
• Clause 8: Measurement analysis and improvement
The model of a process-based quality management system shown below illustrates the process linkages
presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining
requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information
relating to customer perception as to whether the company has met the customer requirements. The
model shown below covers all the requirements of the ISO standard, but does not show processes at
a detailed level.
Continual Improvement of
The Quality Management System
Management
responsibility
Customers
Management,
Resource
Customers analysis and Satisfaction
Management
improvement
Product Material /
Requirements
realisation Product
Input Output
The QMS promotes the improvement of the different processes by continually evolving control systems
and optimizing all phases of production and services with a focus on customer requirements and
satisfaction. The following figure demonstrates the organisational interrelationships between Core
and Support processes, quality procedures, and functional position titles of the Quality Management
System.
Continual
Improvement
Quality
Policy
Management
Review
Planning
Checking
and Implementation
corrective and operation
action
ISO 9001:2008 is based on 8 management principles. These are described in ISO 9001:2008 and
are regarded as key for the achievement of a company’s quality objectives. These key principles will
be discussed later in this guide. A QMS refers to the activities you carry out within your company to
satisfy the customer requirements and the customer’s expectations. To ensure that you have a QMS
in place, customers may insist that your company demonstrate that your QMS conforms to the ISO
9001:2008 model.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 5
Complying with the ISO 9001:2008 standard does not indicate that every material / product or service
Why a Quality Management System for the Waste Management, Recovery and Recycling Industry?
you deliver to your customer meets the customers’ requirements, only that the QMS use is capable
of meeting them. Your company must continually assess how satisfied they are and demonstrate
constant improvement measured against their feedback. And if you do not get any feedback, you are
obliged to solicit for that feedback because that helps your company to move forward on the path of
continual improvement. Evidence of your compliance with the ISO standard is first gathered by your
own internal auditors.
This requires you to select, train, evaluate and prove and continually re-evaluate your internal auditors.
At times a customer will check your compliance with the standard. You may choose to do second party
auditing by your own suppliers.
When a registrar body sends, on your request, an auditor to confirm your compliance with the standard
and this registrar finds that your company fulfils the requirements of ISO 9001:2008, your company
becomes officially registered and the certificate that proves it will be issued by them. This certificate
shows your customers, and other officials who require ISO 9001 compliance, that your company
can meet these demands. Other recycling companies not concerned with becoming registered may
nevertheless, want to comply with ISO 9001 because it is a continual improvement business model.
ISO 9001:2008 contains a large number of requirements and methods, but the numbers of principles
are small. These principles form the base for your QMS. It makes sense to get familiar with these
principles and communicate them with your employees.
Companies depend on their customers and therefore should understand current and future customer
needs, and should meet customer requirements and strive to exceed customer expectations.
6 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Principle 2: Leadership
Why a Quality Management System for the Waste Management, Recovery and Recycling Industry?
Leaders establish unity of purpose and direction of the company. They should create and maintain the
internal environment in which people can become fully involved in achieving the company’s objectives.
People at all levels are the essence of a company and their full involvement enables their abilities to
be used for the company’s benefit.
A desired result is achieved more efficiently when activities and related resources are managed as a
process.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 7
Key benefits are:
Why a Quality Management System for the Waste Management, Recovery and Recycling Industry?
• Lower costs and shorter cycle times through effective use of resources.
• Improved, consistent and predictable results.
• Focused and prioritized improvement opportunities.
Continual improvement of the company’s overall performance should be a permanent objective of the
company.
8 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Applying the principle of continual improvement typically leads to:
Why a Quality Management System for the Waste Management, Recovery and Recycling Industry?
• Employing a consistent company-wide approach to continual improvement of the
company’s performance.
• Providing people with training in the methods and tools of continual improvement.
• Making continual improvement of material / products, processes and systems an
objective for every individual in the company.
• Establishing goals to guide, and measures to track, continual improvement.
• Recognizing and acknowledging improvements.
Applying the principle of factual approach to decision making typically leads to:
• Ensuring that data and information are sufficiently accurate and reliable.
• Making data accessible to those who need it.
• Analysing data and information using valid methods.
• Making decisions and taking action based on factual analysis, balanced with
experience and intuition.
A company and its suppliers are interdependent and a mutually beneficial relationship enhances the
ability of both to create value
Applying the principles of mutually beneficial supplier relationships typically leads to:
• Establishing relationships that balance short-term gains with long-term
considerations.
• Pooling of expertise and resources with partners.
• Identifying and selecting key suppliers.
• Clear and open communications.
• Sharing information and future plans.
• Establishing joint development and improvement activities.
• Inspiring, encouraging and recognizing improvements and achievements by suppliers.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 9
What is needed and what is already available?
Quality
Manual
Procedures and
Job Instructions
Records
The Quality Manual is the core of the QMS. It should address each area of the ISO 9001:2008 standard with
a basic statement claiming compliance and how the company maintains compliance. It often also contains
the Company’s Quality Policy.
The Quality Policy is a statement from Management and describes the overall intentions and direction of a
company related to quality as formally expressed by top management. The quality Policy must also address
the quality objectives of the company.
Usually this policy is part of the Quality Manual.
A Procedure is a documented practice, defining the who, what and when of activities. Procedures are
typically used at department levels and may involve more than one department.
See what is available in your company on procedures. Usually you find already procedures with regards to
Document Control or other Quality Assurance activities.
A Job Instruction is a document that describes how the work is accomplished in your recycling company.
Also job instructions from how to do things or how to operate equipment are an important part of the QMS.
These instructions can be for example about how to check purchased scrap, how to assure that it is not
radioactive, how to measure the weight and how to check the chemical content of the scrap.
You will probably find that you already have job instructions for many of your key operations. Many of them
will fit the QMS or can be easily made to fit.
Maybe these instructions are not yet written down. In that case the best way to get a work or job instruction
is to interview the operator and write down exactly how he or she will check a container load of scrap or
check the chemical content, in other words, how the job is accomplished.
Keep such a description simple, use a standardized format and avoid any jargon.
Such a written down reflection of the reality is the start point for collecting up-to-date work instructions.
10 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Over time these documents can develop into a system of job instructions that cover all activities in a
Records must be maintained to show compliance of the QMS, for feed back into the QMS and for
historical reasons. These records must be determined by the company to be necessary to ensure the
effective planning, operation and control of the processes.
Each company that is established for a while makes use of documents or systems on computers to
register all kinds of processes and activities. This is what is meant by records.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 11
Procedure Control of non-conforming material / product
What is needed and what is already available?
The company shall ensure that material / product which does not conform to material / product
requirements is identified and controlled to prevent its unintended use or delivery. A documented
procedure shall be established to define the controls and related responsibilities and authorities for
dealing with non-conforming material / product.
Where applicable, the company shall deal with non-conforming material / product by one or more of
the following ways:
• by taking action to eliminate the detected non-conformity;
• by authorizing its use, release or acceptance under concession by a relevant authority
and, where applicable, by the customer;
• by taking action to preclude its original intended use or application;
• by taking action appropriate to the effects, or potential effects, of the non-conformity
when non-conforming material / product is detected after delivery or use has started.
• reviewing non-conformities
• determining the causes of non-conformities,
• evaluating the need for action to ensure that non-conformities do not recur,
• determining and implementing action needed,
• records of the results of action taken
• reviewing the effectiveness of the corrective action taken.
12 The easy implementation of an ISO compliant Quality Management System for the recycling industry
End-of-Waste quality criteria and its implications for the Recycling Industry
For the Recycling Industry legislation is changing. Governments require more assurances with regards
to the quality of metals, materials and scrap that is transferred between countries.
The acceptance of input materials, all treatment steps and material / product quality checks (including
any sampling and testing or visual inspections) according to the end-of-waste quality criteria must
have been carried out under a fully implemented and externally verified quality management system.
The quality management system must at least include the following elements:
The quality management system must be auditable and ready for inspection by the competent
authority under waste law to satisfy itself that the system is suitable for the purpose of demonstrating
compliance with end-of-waste quality criteria.
It must include a set of documented procedures addressing each key process relevant to compliance
with the technical end-of-waste criteria, including:
Specific requirements regarding monitoring material / product quality for iron, steel and aluminium
scap, including aluminium alloy scrap.
It must be assured that each consignment shall at least be:
• Monitored for radioactivity
• Inspected visually regarding all other material / product quality requirements
■ Testing of compliance with the limit value regarding the metal content or the metal
yield.
The appropriate frequencies of sampling shall be established by consideration of the following factors:
The easy implementation of an ISO compliant Quality Management System for the recycling industry 13
•
End-of-Waste quality criteria and its implications for the Recycling Industry
The process of determining monitoring frequencies should be documented as part of the overall quality
assurance scheme and as such should be available for auditing.
Conclusion:
Although the ISO QMS is a complete system, the End-of-Waste quality criteria is specifically asking for
some documented procedures, while in the ISO QMS a job instruction was sufficient. Therefore new
procedures are added to the QMS to satisfy these requirements. Based on these new regulations we
can conclude that the QMS for EU recycling companies wishing to benefit from end-of-waste should
include the following:
Possess detection equipment for radioactivity Install and operate Detection Equipment per
(metal recyclers) procedure
14 The easy implementation of an ISO compliant Quality Management System for the recycling industry
This means that a Waste Management, Recovery or Recycling Company that wants to comply
End-of-Waste quality criteria and its implications for the Recycling Industry
according to ISO 9001:2008 and the EU requirements with regards to End-of-Waste, needs the
following procedures:
A Waste Management, Recovery or Recycling company that wants to comply according to ISO
9001:2008 and does not wish to comply with EU End-of-Waste Regulations needs only the procedures
1 to 6 listed above.
End-of-Waste
Procedure
End-of-Waste Feedback
from
Procedure
customer End-of-Waste
Procedure
Radiation
General
Art.6(2)(e) Feedback
End-of-Waste
from
Procedure
Monitoring customer
Procedures General
Radiation Art.6(2)(e)
Art.6(2)(d)
Monitoring
Art.6(2)(d) Procedures
ISO ISO
Procedure
Procedure Control of
End-of-Waste
Documents
Procedure
Control of
4.2.3
Training
Documents End-of-Waste of
staff
ProcedureEnd-of-Waste
Procedure
Art.6(2)(h)
4.2.3
End-of-Waste
Procedure
Training
Review and
Improvement
ISO
Acceptance of of QMS
Procedure
of input
staff
Art.6(2)(g)
Procedure action
Procedure
processes
Improvement
of QMS ISO
Art.6(2)(b)
of input Art.6(2)(g)
ISO End-of-Waste End-of-Waste ISO
Procedure Procedure
ISO
Procedure Procedure
material Control of non- Preventive
Monitoring
conforming Record Internal
action quality Procedure OK?
Product
4.2.4
Art.6(2)(a)
product keeping audit
OK?
8.3 Art.6(2)(c) Art.6(2)(f) 8.2.2
End-of-Waste Corrective
8.5.3
Procedure action
8.5.2
Monitoring
processes
Art.6(2)(b)
ISO Procedure
Control of Records
The easy implementation of an ISO compliant Quality Management System for the recycling industry 15
To determine the Quality Policy and the Objectives
To ensure that top management in your company takes a direct leadership role in defining, implementing
and improving the QMS, with the goal of meeting all customer requirements and expectations, it is important
that they take part in defining the Quality Policy.
Therefore it must be ensured that there is a continuous commitment from the management.
The intentions of the management are laid down in a policy statement as is required by the standard.
The most effective way is to design the policy by a group of people from different levels and present the
policy to top management for their commitment.
Make sure that the Quality Policy is understandable for everybody in the company. Make it ambitious, yet
achievable.
Measurable quality objectives are set by top management to be used as a leadership tool that provides a
focused direction that fits with the framework of the quality policy. The intention of setting objectives is to
show and measure results from a continually improving company.
Company name
It is the policy of our Company to operate its business in a manner that consistently meets or exceeds
the quality standards set by affected stakeholders – being customers, industry regulators and the
communities within which our operations are conducted. We are committed to continuously improving
the quality of our operations and the services we provide.
Material / product / Service quality is a customer determination and as such we are dedicated to:
• identify and anticipate the changing needs and expectations of our customers;
• maintain processes and procedures which ensure that these changes are
accommodated and in compliance with customers requirements and expectations
• provide material / product / services on time
• provide an employment environment where continual improvement is an objective
• train all staff and contractors to act in accordance with the requirements of this policy.
We support the adoption of the Quality Management System in order that all stakeholders benefit from
this quality commitment.
16 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Identify and define the key processes in your company.
What are key processes? Key processes are those processes that have maximum impact on the
success of a company. Key processes deliver results that are directed towards specific and measurable
business goals. Key processes are those that ensure that your company remains competitive. Key
processes are the real value creating processes in the company that customers and shareholders are
concerned with.
The purpose of identifying the key processes in your company in this context is to make sure that they
are covered within the system of procedures and job instructions to assure optimal performance and
continual improvement.
The identification of key processes in your company needs to be done through a brain-storming
among the senior level executives of the company. This will ensure greater understanding of what
processes and activities are important for fulfilling the company goals. The results are different for
each company because of not only the different material / products, services or markets, but mainly
because of the different objectives
Step 1: Identify critical success factors to achieve the company’s objectives. These are performance
drivers which have major contribution towards accomplishment of company’s objectives.
Step 2: Identify metrics for measuring the critical success factors – this amounts to establishing
company key performance indicators (KPIs).
Step 3: Identify the processes that deliver the above drivers for performance or KPIs.
Step 4: Group or un-group related or un-related processes and give them names which convey the
activity or operation that gets done. These are the key business processes of a company.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 17
Determine the gaps between what you have and what you need
This gap analysis provides you with the gaps between what is already in place and functioning well
versus what is missing and has to be implemented in the QMS. It follows the numbering of the elements
as mentioned in the ISO standard.
Going through this gap analysis form teaches you the weak points of your existing system and
determines exactly where and how you can improve it. Do not skip any step in this analysis because it
provides useful information about the completeness and correctness of your QMS.
Status/
ISO 9001:2008 Requirements remarks Action
c) Have the criteria and methods needed to ensure both the operation and
control of these processes been determined?
d) Are the resources available and information needed to support the operation
and monitoring of these processes ensured?
Does the scope of the manual include details of and justification for any exclusion?
Does the manual include procedures for the QMS or references to them?
Does the manual contain a description of the interaction between the processes of the
QMS?
18 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Determine the gaps between what you have and what you need
Is a Documented Procedure established to define the controls needed to:
- ensure that changes and the current revision status of documents are
identified?
- ensure that relevant versions of applicable documents are available at
points of use?
5. Management responsibility
5.1 Management commitment
Does top management provide evidence for their commitment to develop and implement
a QMS and continually improve its effectiveness by:
- communicating to the company the importance of meeting customer as
well as statutory and regulatory requirements?
Does the policy include a commitment to comply with requirements and continually
improve the effectiveness of the QMS
The easy implementation of an ISO compliant Quality Management System for the recycling industry 19
Determine the gaps between what you have and what you need
Does the policy provide a framework for establishing and reviewing quality objectives?
5.4 Planning
5.4.1 Quality objectives
Are the quality objectives, incl. those needed to meet requirements for material / product,
established at relevant functions and levels within the company?
Are the quality objectives measurable and consistent with the quality policy?
Is the QMS planning carried out in order to meet the requirements given in 4.1, as well as
the quality objectives?
Is the integrity of the QMS maintained when changes to the QMS are planned and
implemented?
Are responsibilities and authorities defined and communicated within the company?
Does top management ensure that appropriate communication processes are established
within the company and that communication takes place regarding the effectiveness of
the QMS?
Does top management review the QMS at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness?
20 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Determine the gaps between what you have and what you need
Does the review include assessing opportunities for improvement and the need for
changes to the QMS, including the quality policy and quality objectives?
- customer feedback?
- resources needed?
6. Resource management
6.1 Provision of resources
Has the company identified and provided the resources needed to implement and
maintain the QMS and continually improve its effectiveness?
Has the company identified and provided the resources needed to enhance customer
satisfaction by meeting customer requirements?
Are personnel performing work affecting material / product conformity competent on the
basis of appropriate education, training, skills and experience?
The easy implementation of an ISO compliant Quality Management System for the recycling industry 21
Determine the gaps between what you have and what you need
Are the necessary competences for personnel to perform work affecting material / product
conformity determined?
Has training been provided or other actions taken to achieve needed competence?
Are personnel aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives?
6.3 Infrastructure
Has the company identified, provided and maintained the infrastructure needed to
achieve conformity to material / product requirements?
This includes, as applicable, buildings, workspace, utilities, process equipment and
supporting services, such as transportation, communication or information systems.
Is the output of this planning in a form suitable for the company’s method of operation?
Are the requirements specified by the customer, including the requirements for delivery
and post-delivery activities identified?
22 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Determine the gaps between what you have and what you need
Are the requirements not stated by the customer but needed for specified or intended
use, where known identified?
Are the statutory and regulatory requirements applicable to the material / product known
to the company?
Are records of the results of the review and actions arising from the review maintained?
Does the company plan and control the design and development of material / product?
Does, during the design and development planning, the company determine the:
- review, verification and validation that are appropriate to each design and
development stage?
The easy implementation of an ISO compliant Quality Management System for the recycling industry 23
Determine the gaps between what you have and what you need
Does the company manage the interfaces between different groups involved in
design and development to ensure effective communication and clear assignment of
responsibility?
Are requirements complete, unambiguous and not in conflict with each other?
Are the outputs of design and development provided in a form that enables verification
against the design and development input and approved prior to release?
- specify the characteristics of the material / product that are essential for its
safe and proper use?
Do participants in such reviews include representatives concerned with the design and
development stages being reviewed?
Are records of the results of the reviews and any needed actions maintained?
24 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Determine the gaps between what you have and what you need
7.3.5 Design and development verification
Are records of the results of the verification and any needed actions maintained?
Are the records of the results of the validation and necessary actions maintained?
Are design and development changes identified and are records maintained?
Are the changes reviewed, verified and validated, as appropriate, and approved before
implementation?
Is the review of design and development changes included in the effect of changes on
constituent parts and material / product already delivered?
Are records of the results of the review of changes and any needed actions maintained?
7.4 Purchasing
7.4.1 Purchasing process
Does the company ensure that the purchased material / product conforms to specified
purchase requirements?
Does the type and extent of control applied to the supplier and the purchased material
/ product depend upon the effect of the purchased material / product on subsequent
product realization or the final material / product?
Does the company evaluate and select suppliers based on their ability to supply material /
product in accordance with the company’s requirements?
Are criteria for the selection, evaluation and re-evaluation of suppliers established?
Are records of the results of evaluations and any needed actions arising from the
evaluation maintained?
The easy implementation of an ISO compliant Quality Management System for the recycling industry 25
Determine the gaps between what you have and what you need
- QMS requirements?
Does the company ensure the adequacy of specified purchase requirements prior to their
communication to the supplier?
Has the company established and implemented the inspection, or other activities, needed
for ensuring that purchased material / product meets specified purchase requirements?
When the company or its customer intends to perform verification at the supplier’s
premises, does the company state the intended verification arrangements and method of
material / product release in the purchasing information?
Does the company plan and carry out production and service provision under controlled
conditions?
Does the company validate any processes for production and service provision where the
resulting output cannot be verified by subsequent monitoring or measurement?
Does validation demonstrate the ability of these processes to achieve planned results?
Has the company established arrangements for these processes including, as applicable:
- requirements of records?
- revalidation?
26 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Determine the gaps between what you have and what you need
7.5.3 Identification and traceability
Where appropriate, has the company identified the material / product by suitable means
throughout product realization?
Does the company identify the material / product status with respect to monitoring and
measurement requirements throughout product realization?
Where traceability is a requirement, does the company control and record the unique
identification of the material / product and maintain the records?
Does the company exercise care with customer property while it is under the company’s
control or being used by the company?
Does the company identify, verify, protect and safeguard customer property provided for
use or incorporation into the material / product?
If any customer property is lost, damaged or otherwise found to be unsuitable for use, is
this reported to the customer and are records maintained?
Does the company preserve the material / product during internal processing and delivery
to the intended destination in order to maintain conformity to requirements?
Does this preservation include identification, handling, packaging, storage and protection?
Has the company established processes to ensure that monitoring and measurement can
be carried out and are carried out in a manner that is consistent with the monitoring and
measurement requirements?
The easy implementation of an ISO compliant Quality Management System for the recycling industry 27
Determine the gaps between what you have and what you need
When used in the monitoring and measurement of specified requirements, is the ability of
computer software to satisfy the intended application confirmed. Is this undertaken prior
to initial use and reconfirmed as needed?
Does the company plan and implement the monitoring, measurement, analysis and
improvement processes needed to:
Has the method for obtaining and using this information been determined?
Is the audit program planned, taking into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits?
Does the selection of auditors and the conduct of audits ensure objectivity and impartiality
of the audit process?
Are the responsibilities and requirements for planning and conducting audits, and for
reporting results and maintaining records defined in a Documented Procedure?
Is it ensured that actions are taken to reduce delay to eliminate detected non-conformities
and their causes?
Are follow-up activities included in the verification of the actions taken and the reporting
of verification results?
28 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Determine the gaps between what you have and what you need
8.2.3 Monitoring and measurement process
Does the company apply suitable methods for monitoring and where applicable,
measurement of the QMS processes?
Are these methods demonstrating the ability of the processes to achieve planned results?
When planned results are not achieved, is correction and corrective action taken, as
appropriate?
Does the company monitor and measure the characteristics of the material / product to
verify that material / product requirements have been met?
Is this carried out at appropriate stages of the product realization process in accordance
with the planned arrangements?
Do records indicate the person(s) authorizing material / product release to the customer?
Do material / product release and service delivery not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a
relevant authority and, where applicable, by the customer?
Are the controls and related responsibilities and authorities for dealing with non-
conforming material / product defined in a Documented Procedure?
Does the company deal with non-conforming material / product by one or more of the
following ways:
The easy implementation of an ISO compliant Quality Management System for the recycling industry 29
Determine the gaps between what you have and what you need
- customer satisfaction?
- suppliers?
8.5 Improvement
8.5.1 Continual improvement
Does the company continually improve the effectiveness of the QMS through the use
of the quality policy, quality objectives, audit results, analysis of data, corrective and
preventive action and management review?
Has the company taken action to eliminate the cause of non-conformities in order to
prevent recurrence?
- evaluating the need for action to ensure that non-conformities do not recur?
Does the company determine action to eliminate the causes of potential non-conformities
in order to prevent their occurrence?
30 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Writing the Quality Manual
Writing the Quality Manuals is usually a hard task. Therefore we have included in this guide an example
of a dedicated Quality Manual for the Recycling Industry, that contains not only the ISO 9001:2008 but
also the requirements with regards to the EU End-of Waste. The term “The Company“ can be replaced
with your company name. The red text and blue should be adjusted to your own situation, or read as
instructions.
The QMS of The Company meets the requirements of the international standard ISO 9001:2008
with the additional EU End-of-Waste quality criteria. The manual is divided into eight sections that
correlate to the QMS sections of ISO 9001:2008. Each section begins with a policy statement
expressing The Company’s obligation to implement the basic requirements of the referenced QMS
section. Each policy statement is followed by specific information pertaining to the procedures that
describe the methods used to implement the necessary requirements.
This manual describes the QMS, delineates authorities, inter-relationships and responsibilities of the
personnel responsible for performing within the system. The manual also provides procedures or
references for all activities comprising the QMS to ensure compliance to the necessary requirements
of the standard.
This manual is used internally to guide the company’s employees through the various requirements
of the ISO standard and End-of-Waste quality criteria that must be met and maintained in order to
ensure customer satisfaction, continual improvement and provide the necessary instructions that
create an empowered work force.
This manual is used externally to introduce our QMS to our customers and other external companies
or individuals. The manual is used to familiarize them with the controls that have been implemented
and to assure them that the integrity of the QMS is maintained and focused on customer satisfaction
and continual improvement.
Section 1: Scope
1.1 General
The quality manual outlines the policies, procedures and requirements of the QMS. The system is
structured to comply with the conditions set forth in the International Standard ISO 9001:2008 and the
EU requirements with regards to End-of-Waste quality criteria.
1.2 Application
The Company has determined that the following requirements are not applicable to the operations at
this site and are documented as exclusions:
The easy implementation of an ISO compliant Quality Management System for the recycling industry 31
Section 2: Normative Reference
Writing the Quality Manual
Section 3: Definitions
3.0 Quality Management System Definitions
This section is for definitions unique to The Company.
• Identified the processes needed for the QMS and their application throughout the
company and documented them on the Process Flow Diagram at the end of this
section of the Quality Manual
• Determined the sequence and interaction of these processes, and illustrated them on
the Process Flow Diagram
• Determined criteria and methods needed to ensure that the operation and control of
the processes are effective, and documented them in job instructions
• Ensured the continuing availability of resources and information necessary to achieve
planned results and continual improvement of these processes
• Established systems to monitor, measure and analyze these processes, and
• Established processes to identify and implement actions necessary to achieve
planned results and continual improvement of these processes
• The Company manages these processes in accordance with the requirements of ISO
9001:2008 and the EU End-of-Waste quality criteria.
• Where The Company chooses to outsource any process that affects material / product
conformity, The Company ensures control over such processes. Control of such
processes is identified with the QMS.
32 The easy implementation of an ISO compliant Quality Management System for the recycling industry
4.2 Documentation Requirements
The required document procedure Record Keeping of Quality Control Parameters, as required by the
EU End-of-Waste quality criteria is completely covered by the ISO 9001:2008 Procedure Control of
Records.
Related Documents
• Procedure Control of Documents (4.2.3)
• Procedure Control of Records (4.2.4)
The easy implementation of an ISO compliant Quality Management System for the recycling industry 33
Insert your process flow diagram here:
Writing the Quality Manual
Key process
reception of See Annex 1
goods Part 2
Key process
storing on LAN
sorting
Key process
shredder
Key process
magnetic
separation
Key process
eddy current
separation
Manual
correction
Document According to
Quality control Quality check
specification
report (2)
Not according to
Shipping advice specification
Packaging Packaging
Document
radioactivity Negative Radioactivity Positive
check
test certificate (1)
with statement
of conformity
Key process
shipping
Footnote:
Finish (1) Quality check by visual inspection and or
monitoring: see Annex 1
(2) Quality check by visual inspection and at
intervals by sampling and analysis.
34 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Section 5: Management Responsibility
5.4 Planning
5.4.1 Quality objectives
Quality objectives are established to support our company’s efforts in achieving our quality policy and
reviewed annually for suitability. Objectives have been established for the following: (describe the levels
at which objectives have been established. For example, quality objectives have been established for
each division, department, and team. Make sure that objectives to meet material / product requirements
are included). Quality objectives are measurable, and reviewed against performance goals at each
management review meeting.
(State where quality objectives have been documented. This can be stated in the Quality Policy).
The easy implementation of an ISO compliant Quality Management System for the recycling industry 35
5.5 Responsibility, authority and communication
Writing the Quality Manual
General Manager
Management
Representative
Shift 1
Shift 2
Shift 3
• ensure that processes needed for the QMS are established and implemented.
• report to top management on the performance of the QMS, and note needed
improvements.
• promote awareness of customer requirements throughout the company.
• act as a liaison with external parties such as customers or auditors on matters
relating to the QMS.
5.5.3 Internal communication
Processes are established for communication within the company. Methods of communicating the
effectiveness of the QMS include department and management meetings, management review,
circulation of minutes of management review meetings, Internal Audit closing meetings, and other
routine business communication.
36 The easy implementation of an ISO compliant Quality Management System for the recycling industry
5.6 Management review
Management Review is laid down in a documented procedure according to the End-of-Waste quality
criteria.
• Results of audits
• Customer feedback
• Process performance and material / product conformity
• Company level quality data
• Status of preventive and corrective actions
• Follow-up actions from previous management reviews
• Planned changes that could affect the Quality Management System
• Recommendations for improvement
Responsibilities for required actions are assigned to members of the management review team. Any
decisions made during the meeting, assigned actions, and their due dates are recorded in the minutes
of management review.
Related Documents
• Management Responsibility (5.5.1)
• Planning of Product realization Processes (5.3)
• Quality Policy and Quality Objectives (5.3) (5.4.1)
• Management Review meeting report (5.6.2)
• Organogram (5.5.1)
• Procedure Management review (5.6)
The easy implementation of an ISO compliant Quality Management System for the recycling industry 37
6.2 Human resources
Writing the Quality Manual
6.2.1 General
To ensure competence of our personnel, job descriptions have been prepared identifying the
qualifications required for each position that affects material / product quality. Qualifications include
requirements for education, skills and experience. Appropriate qualifications, along with required
training, provide the competence required for each position.
All employees are trained on the relevance and importance of their activities and how they contribute
to the achievement of the quality objectives.
6.3 Infrastructure
To meet quality objectives and material / product requirements The Company has determined the
infrastructure needed. The infrastructure has been provided, and includes buildings, workspace,
utilities, process equipment and supporting services. As new infrastructure requirements arise, they
will be documented in quality plans. Existing infrastructure is maintained to ensure material / product
conformity. Maintenance requirements are documented in:
Data from the QMS is evaluated to determine if the work environment is sufficient for achieving material
/ product conformance, or if preventive or corrective action related to the work environment is required.
Related Documents
• Competence, Awareness and Training
• Training Process Instruction
• Infrastructure
• Procedure Training of Staff
38 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Quality planning is required before new material / products or processes are implemented. The quality
The output of quality planning includes documented quality plans, processes, and design outputs.
•
Material / product requirements are defined
•
Contract or order requirements differing from those previously expressed are resolved
•
The Company has the ability to meet the defined requirements
•
Records are maintained showing the results of the review and any actions arising
from the review
• Where a customer does not provide a documented statement of requirement, the
customer requirements are confirmed before acceptance
• When material / product requirements are changed, The Company communicates
changes to relevant personnel and amends relevant documents
The Company has implemented a documented Procedure for soliciting feedback from customers to
adjust processes, improve quality and continually improve the company’s performance
The easy implementation of an ISO compliant Quality Management System for the recycling industry 39
•
Writing the Quality Manual
Verification and validation methods appropriate to each design and development stage
• Responsibilities and authorities for design and development
• Identification of the technical interfaces required for the project
• Updating of the design plan as the project progresses
• Evaluate the results of design and development activities and determine if they fulfill
requirements
• Identify any problems and propose necessary actions
• Include representatives of functions concerned with the design and development
stage being reviewed
40 The easy implementation of an ISO compliant Quality Management System for the recycling industry
validating and approving design changes. The review of design and development changes includes an
7.4 Purchasing
7.4.1 Purchasing process
A documented Procedure Acceptance of Input Materials is followed to ensure that purchased material
/ product conforms to the specified purchase requirements. The job instruction outlines the extent of
control required for suppliers. Suppliers are evaluated and selected based on their ability to supply
material / product in accordance with requirements as outlined in the procedure. Criteria for selection,
evaluation and re-evaluation are documented in the job instruction. Records of the evaluation and any
necessary actions are maintained as quality records according to the Procedure control of records.
The purchasing documents are reviewed to ensure the adequacy of requirements before orders are
placed with the supplier.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 41
•
Writing the Quality Manual
A documented instruction outlines the process used to ensure that monitoring and measurement to
be carried out are carried out in a manner that is consistent with the monitoring and measurement
requirements.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application is confirmed. This shall be undertaken prior to initial use
and reconfirmed as necessary.
If recycling metal in addition, The Company maintains a documented Procedure Effectiveness of
Radiation Monitoring to ensure that the radiation detection equipment is functioning, calibrated and
42 The easy implementation of an ISO compliant Quality Management System for the recycling industry
maintained according to the set intervals and requirements advised by the manufacturer in absence
Related Documents
• Planning of Product Realization (7.1)
• Instruction Communication with Customers (7.2.3)
• Procedure Soliciting Feedback from Customers (7.2.3)
• Procedure Monitoring of Processes (7.1)
• Customer Related Processes (7.2)
• Design and Development (7.3)
• Purchasing (7.4)
• Procedure Acceptance of Input Materials (7.4.1)
• Control of Production and Service Provision (7.5)
• Identification and Traceability (7.5.3)
• Customer Property (7.5.4)
• Preservation of Material / product (7.5.5)
• Control of Monitoring and Measuring Equipment (7.6)
• Procedure Effectiveness of Radiation Monitoring (7.6)
• Procedure Control of Records (4.1) (7.6)
An audit program has been designed and implemented and identifies an audit schedule based on
the importance of the areas to be audited, as well as the results of previous audits. The audit criteria,
scope, frequency, methods, responsibilities and requirements for planning and conducting audits, and
The easy implementation of an ISO compliant Quality Management System for the recycling industry 43
for reporting and maintaining results, are defined and documented in the Procedure Internal Audit.
Writing the Quality Manual
The management responsible for the area being audited is responsible for ensuring that any necessary
corrections and corrective actions are taken without undue delay to eliminate detected non-conformities
and their causes. Follow-up activities include the verification of the actions taken and the reporting of
verification results.
The required document Procedure Measures for Review of the QMS, as required by the EU End-of-
Waste quality criteria is completely covered by the ISO 9001:2008 Procedure Internal Audit.
Evidence of conformity with the acceptance criteria is maintained. Records indicate the person
authorizing release of material / product. Material / product release and service delivery does not
proceed until all the planned arrangements have been satisfactorily completed, unless otherwise
approved by a relevant authority, and where applicable by the customer.
• Customer satisfaction
• Conformance to material / product requirements
• Characteristics and trends of processes and material / products including
opportunities for preventive action
• Suppliers
44 The easy implementation of an ISO compliant Quality Management System for the recycling industry
8.5 Improvement
Related Documents
• Management Responsibility (8.2.1)
• Customer Related Processes (8.2.1)
• Procedure Internal Audit (8.2.2)
• Monitoring of Processes (8.2.4)
• Procedure Monitoring Material / product Quality (8.2.4)
• Procedure Control of Non-conforming Material / product (8.3)
• Procedure Control of Data (8.4)
• Procedure Corrective Action (8.5.2)
• Procedure Preventive Action (8.5.3)
The easy implementation of an ISO compliant Quality Management System for the recycling industry 45
Modify existing Procedures and Job Instructions and write new ones
Procedures are the documents defining who, what, when and where policies are carried out. Normally
procedures are written by the process owners. They describe the activities that accomplish the output of
the identified process and their relationship to the company’s operations as a whole. In your company,
implementing the QMS, you will more than likely, participate in the preparation of the procedures and/
or job instructions.
To obtain a suitable set of procedures, it makes sense to identify in the first place the current procedures
that exist in your company. Be aware that many times documents are called procedures, but are just
job instructions or other documents.
Form a team of people around each process that has to be documented in a procedure and discuss
the applicable clauses from ISO 9001:2008 and/or the EU End-of-Waste quality criteria.
The most logical step is to document the process under investigation in a flowchart. By doing this and
having the experts around the table, critical questions may be asked in order to improve or simplify the
process. If it can be improved, the responsible people should implement the changes and document
it in the procedure and flowchart.
After agreeing on the time table for the implementation of the new or revised procedure, the procedure
can be written in its final form. Nowadays the written procedures are often replaced by flowcharts,
because they visualize far better the actions, decision moments and the responsibilities for a process.
In the example procedures in this implementation guide, we have provided the flowcharts. The
following information must be added to be complete:
Work or job instructions are documentation that describes how work is accomplished and are usually
written by the operators and documentation facilitators. You will most likely find that you already have
job instructions for many of your operations.
Use the following list of points when you are documenting work from yourself or others.
46 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Document the process:
Modify existing Procedures and Job Instructions and write new ones
• Keep it short and simple, do not over-document
• Flowchart the process
• Make extensive use of charts and tables
• Use a standardized format so that everybody recognizes it as a procedure or job
instruction
• Keep the audience in mind
• Don’t use jargon
• Use perfect grammar
• Make the meaning clear
• Write the tasks, do not describe an individual’s way of working
• Test the procedure by reading it to someone else
To assure that the procedure or job instruction is the latest issue, these documents are usually marked
with a revision number (paper versions) as pre-described by the Procedure Control of Documents.
Check always that you have the latest revision.
Nowadays most companies use computer monitors or digital displays where the procedures and job
instructions can be displayed. This guarantees that the latest or current version is always available.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 47
Preparing the Required Quality Procedures
The following documents were used as reference during the preparation of the Quality Management
System:
Start
Management
Representative
maintains all
documents
Retain master
documents
Affected departments
Submission of final
Final version Review or
version to Managing
Revision
Director
Approval by
OK signing and Not OK
dating
Electronic
document Storing
control documents
systems LAN
convert to PDF
Revision
Annually review number and
EDCS document
index
Document retention
determined
By retainment,
Annually review reassign new
Document retention for destruction retention date
list (1)
Finish
Footnote:
References: (1) Minimum 1 year retention of statement
ISO 9001:2008 of conformity for EU End-of-Waste
48 The easy implementation of an ISO compliant Quality Management System for the recycling industry
4.2.4 Procedure Control of Records (as required by ISO 9001:2008)
Start
Identify records
subject to this
procedure
Identify other
records subject to Other records
this procedure
ISO Required Records
Destruct
records
Finish
References: Footnote:
ISO 9001:2008 (1) Minimum 1 year retention of statement of
Defined records conformity for EU End-of-Waste
The easy implementation of an ISO compliant Quality Management System for the recycling industry 49
8.2.2 Procedure Internal Audit (as required by ISO 9001:2008)
Preparing the Required Quality Procedures
Start
Communicate with
all departments
Inform auditors
Provide
information to
Appointment auditor and
according to announce audit
planning
Conduct audit
Non-conformance
report
Completion of
audit
Corrective and
preventive action
Process review
audit results
OK
Not OK
Communicate OK?
Plan re-audit
result
Provide
information to the
Audit report form
Management
Representative
and management
Finish
References:
ISO 9001:2008
Audit reports
50 The easy implementation of an ISO compliant Quality Management System for the recycling industry
8.3 Procedure Control of Non-conforming Material / product (as required by ISO
Procedure
Identify non -
monitoring
conforming material /
processes
Quality report product
Procedure
monitoring
Non-conforming material / product
product is identified quality
Customer and segregated from
complaint conforming material /
product
Quality Manager or
Supplier authorized personnel
information will be notified of non-
confirming material /
product
Quality rejection
report Non-conforming
material / product is
placed under Quality
Material review Control Department
board (MRB)
Non-conforming
material / product will be
used as is
Material / product
release report Preventive action
response
Non-conformance
condition is addressed
(repaired) and only
conforming material / Corrective action
product remains response
Only conforming
material / product will be
shipped to customer
Non-conformance
documentation
All non-conformance
documentation and
records are processed Data storing
to completion, LAN
Quality and
re-verified and the non- process data
conformancy is closed
Finish
References:
ISO 9001:2008 Procedure control of records
Procedure monitoring processes
Procedure monitoring material / product quality
The easy implementation of an ISO compliant Quality Management System for the recycling industry 51
8.5.2 Procedure Corrective Action (as required by ISO 9001:2008)
Preparing the Required Quality Procedures
Start
Customer
complaints Identified need
for corrective
action
Internal audit
report
Define corrective
action
Management
review report
Implement
corrective action
Does it
Yes No
perform?
Correct process
Yes Evaluate No
Finish
References:
ISO 9001:2008
Procedure monitoring processes
Procedure monitoring material / product quality
52 The easy implementation of an ISO compliant Quality Management System for the recycling industry
8.5.3 Procedure Preventive Action (as required by ISO 9001:2008)
Procedure
monitoring
Process data processes
Review potential
and
problems
objectives
Procedure
Customer monitoring
Identify need for
complaints material /
preventive action
product quality
Internal audit
Define preventive
Report
action
Management Implement
review report preventive action
Does it
Yes No
perform?
Correct process
Yes Evaluate No
References: Finish
ISO 9001:2008
Procedure monitoring processes
Procedure monitoring material / product quality
The easy implementation of an ISO compliant Quality Management System for the recycling industry 53
7.4.1 Procedure Acceptance of Input Materials (as required by EU End-of-Waste quality
Preparing the Required Quality Procedures
criteria)
Description: Number of the Procedure:
Prepared by: Date of first issue: Issued by:
Revision number: Date of revision: Approved by:
Purpose:
This procedure sets out the requirements for acceptance of raw materials.
Scope:
This procedure is concerned with the requirements for accepting supplied goods and raw materials,
owned by the company or third parties, to be checked on conformance against standards and quality
requirements.
Responsibility:
The execution and maintenance of the procedure is the responsibility of the production management
and the Management Representative.
Start
Radiation monitoring
per supplied
consignment
(1)
Measure weight
Purchase order Job instruction
Weight bill of supplied input
materials
Check
conformity of Material
input materials specification
Stored data according to
LAN Job instruction purchase
Visual inspection
and at set specifications
intervals
sampling
and analysis
Quality
acceptance
report
Yes Accepted No Hold goods
Release material
to process
Inform Supplier
Finish
References:
ISO 9001:2008
Procedure effectiveness of radiation monitoring
Procedure monitoring of processes
Procedure control of records
(1)
metal specific and for other materials where there is a risk of radioactive contamination.
54 The easy implementation of an ISO compliant Quality Management System for the recycling industry
8.2.3 Procedure Monitoring of Processes (as required by EU End-of-Waste quality
Implement monitoring
equipment for key
processes Store process
data LAN
Not OK,
Evaluate
OK redefine key
measures
processes
Monitoring key
processes at set
intervals
Exceeding set
parameters or other Not OK Monitoring OK
observations
Deviation report
Finish
References:
ISO 9001:2008
Procedure internal audit
Procedure monitoring of material / product quality
Procedure control of records
The easy implementation of an ISO compliant Quality Management System for the recycling industry 55
8.2.4 Procedure Monitoring of Material / product Quality (as required by EU End-of-
Preparing the Required Quality Procedures
Procedure internal
audit
Process capability
Define quality
parameters for each Procedure
material / product monitoring
Material / product processes
requirements
Define inspection
Intervals by use of
Input material
Stastistical Process
specifications
Control (SPC) Quality reports
Key process
parameters
and process Design measuring
data Procedure protocols for each History
detection and material / product at
monitoring each stage of the
radiation process
Customer
complaints
Measuring
protocol
Implement inspection
Stored
responsibilities for
process data
operators
LAN
Job instruction
Not OK,
Evaluate
OK Redefine quality
measures
parameters
Monitoring material /
Deviation report product quality at set Acceptance report
intervals
Radiation monitoring
References:
per supplied ISO 9001:2008
consignment
(1) Procedure internal audit
Procedure monitoring of processes
Finish
metal specific and for other materials where
(1)
Procedure
monitoring
processes
Procedure
Job instruction Radiation monitoring
monitoring material / product
quality
Visual inspection
Job instruction
See Annex 1
Part 1
Radiation
No OK? Yes acceptance
report
Accepted for
processing
Finish
References:
ISO 9001:2008
Procedure monitoring processes
Procedure monitoring of material / product quality
Procedure control of records
The easy implementation of an ISO compliant Quality Management System for the recycling industry 57
7.2.3 Procedure Soliciting Feedback from Customers (as required by EU End-of-Waste
Preparing the Required Quality Procedures
quality criteria)
Description: Number of the Procedure:
Prepared by: Date of first issue: Issued by:
Revision number: Date of revision: Approved by:
Purpose:
To continually improve, the Company will monitor the effectiveness of the customer service, the material
/ product quality and the overall performance.
Scope:
By soliciting feedback from customers, information is gathered allowing for possibilities for improvement
of performance. Together with information of internal audits, customer complaints and management
reviews this information will be used to continually improve the Company’s performance.
Responsibility:
The execution and maintenance of the procedure is the responsibility of the sales management and
the Management Representative.
Start
Shipping
information Quality data
Collect order
data
Certificate(s)
Financial data
Contact
customer
Report for
Management
Review
Procedure
Inform customer
corrective action
about corrective
and preventive
action
Finish
References:
ISO 9001:2008
Procedure control of non-conforming material / product
Procedure monitoring of material / product quality
Procedure preventive action
Procedure corrective action
58 The easy implementation of an ISO compliant Quality Management System for the recycling industry
6.2.2 Procedure Training of Staff (as required by EU End-of-Waste quality criteria)
Requirements
Customer Identify training
EoW
complaints needs
Personal
development
Internal audits Plan training needs
program
Personnel
Planning data
Develop training
Training course
Review training
and correct
where needed
Implement
training program
Issue training
certificates
Carry out
training
Document
training in Results are Evaluate Results are not
personnel files sufficient training sufficient
Finish
References:
ISO 9001:2008
Training records
Procedure control of records
The easy implementation of an ISO compliant Quality Management System for the recycling industry 59
5.6 Procedure Management Review (as required by EU End-of-Waste quality criteria)
Preparing the Required Quality Procedures
Start
Planning by
Annual planning
Management
management
Representative
reviews
Management
Customer Assessing
Representative
complaints and previous actions
to collect input
feedback
Conduct
Internal audit management Assessing needed
reports review resources
Other
Conclude on Assessing
recommendations
actions and opportunities for
for improvement
report continual
improvement
Corrective and
Initiate actions
preventive action
on findings
and changes Assessing
effectiveness QMS
Previous
Finish
management
Assessing
review reports
adequateness
quality policy and
quality objectives
References:
ISO 9001:2008
Internal Audit reports
Customer complaints
60 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Continual Improvement
PLAN
ACT DO
CHECK
Other widely used methods of continuous improvement, such as Six Sigma, Lean, and Total Quality
Management, emphasize employee involvement and teamwork; measuring and systematizing
processes; and reducing variation, defects and cycle times.
Continuous or Continual?
The terms continuous improvement and continual improvement are frequently used interchangeably.
But some quality practitioners make the following distinction:
Continual improvement: a broader term preferred by W. Edwards Deming to refer to general
processes of improvement and encompassing “discontinuous” improvements, that is, many
different approaches, covering different areas.
Continuous improvement: a subset of continual improvement, with a more specific focus on linear,
incremental improvement within an existing process. Some practitioners also associate continuous
improvement more closely with techniques of statistical process control.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 61
Typical drivers for continual improvement are the internal audit reports, customers complaints and the
Continual Improvement
results of the management review. But it is important to listen also to improvements that are suggested
by the operators. They are the experts in their processes and know usually very well what is failing,
why and what can be improved. Unfortunately many companies do not recognize this and let valuable
knowledge go unused.
To make certain that there is an active plan for continual QMS improvements, and that causes of non-
conforming material / product are investigated, specifically to eliminate these non-conformance.
Also attempts should be made to detect and eliminate potential causes of non-conforming material
/ product before they occur. These actions contribute to the continually improvement of the system.
Continual Improvement is a constant search for ways to improve the functioning of the QMS by
investigation and elimination of causes of non-conforming material / product, at any point in the
process, distribution and storing. Also, it is the procedure in use to prevent occurrence of non-
conforming material / product in the first place.
62 The easy implementation of an ISO compliant Quality Management System for the recycling industry
The Implementation of the QMS
Before implementing the QMS, make sure that the company is ready for it, that there is top management
commitment and clear communication about the objectives. The ten most common mistakes made
when implementing a QMS are:
1. Undertaking the process for the wrong reason. Occasionally business owners have
visions of grandeur derived from potentially displaying the certificate or attending the
awards ceremony rather than focusing on the long term benefits to their business.
4. Failing to accept the change is an on-going process not a project with an end date
6. Failing to implement the QMS throughout the company, instead believing it is only applicable
to the operational functions such as processing. A QMS is influencing the whole company.
8. Documenting the QMS before it has been properly designed. Design the organization first
and document after.
10. Implementing the QMS before robust checks and updates, if required, have been carried out.
Make sure that you purchase an original document of the ISO 9001:2008 standard from your
national standards office or from www.iso.org; and if your company is within EU jurisdiction,
that you have a relevant copy of the European Regulation regarding End-of-Waste quality criteria
for the material you intend to be classified as a product.
The QMS Implementation Planner consists of the Planning Calendar below and the dedicated flow
chart.
The Planning Calendar below identifies a typical sequence of steps that Recycling Companies should
take when implementing a Quality Management System according to ISO 9001:2008 and the relevant
European Regulation regarding End-of-Waste quality criteria.
It provides an illustration indicating a number of important steps, but is not an exhaustive list of
activities necessary to develop an effective Quality Management System.
Since this Implementation Planner is a guide line, it is very important to follow the implementation
very closely. React immediately to unexpected situations and unexpected reactions of personnel. If
personnel do not understand certain measures, take the time to explain it and get them involved.
Make sure that every step is completed.
The easy implementation of an ISO compliant Quality Management System for the recycling industry 63
The QMS Implementation Planner
The Implementation of the QMS
64 The easy implementation of an ISO compliant Quality Management System for the recycling industry
The Implementation of the QMS
Step 2 • Flow charts
Define the system based • Value stream maps
on the results from step 1 • Existing procedures
• Job Instructions
Say what you do and how • Check what is already available in
you do it. your company
• Determine the gaps between
what you have and what you need
• Select internal auditors and train
them
• Modify existing procedures and
Job Instructions
• Write new procedures and Job
Instructions
The easy implementation of an ISO compliant Quality Management System for the recycling industry 65
The Implementation of the QMS
• Demonstrate assurance,
Follow-up Stage organizational efficiency,
effectiveness and continual
Continually improve. improvement from the QMS.
• Continually enhance top
management support and
commitment to provide the
needed resources such
as competent people and a
capable infrastructure.
• Evaluate changes resulting from
continual improvement efforts.
• Repeat comprehensive analysis
of all activities periodically to
continue improvement in output
quality and productivity.
• Identify requirements that your
material / product or services
are to meet, as established by
your Recycling Company,
Customers, and statutory and
regulatory requirements.
• Monitor and measure, as
appropriate, the processes to
ensure that they are
under control.
• Keep people involved and
informed
Please find on the next page the flow diagram that supports the QMS implementation planner.
66 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Flow Chart for the QMS Implementation Planner
Understand
Identify your
Your
Customers
Customer
Needs and
Improve if
Necessary
Perform Gap
Are your processes No Analysis and
well documented? begin
documentation
Yes
Say
What Rework into your
You Standard Format
Do
No
Do Follow your
What procedures and
You documentation
Say
Conduct
Perform
Registration Pass?
Corrective action
Audit No
Yes
Prove
It
Conduct
Perform
Surveillance Pass?
Corrective action
Audits No
Yes
Continually
Improve
Continue to follow
and improve
The easy implementation of an ISO compliant Quality Management System for the recycling industry 67
References
ISO 9000:2005 ISO International Organization for Standardization - Fundamentals and vocabulary
ISO 9001:2008 ISO International Organization for Standardization - Requirements
ISO 9004:2000 ISO International Organization for Standardization - Guidelines for performance
improvements
ISO 10005:2005 ISO International Organization for Standardization - QMS, Guidelines for quality Plans
ISO 14001:2004 ISO International Organization for Standardization – Environmental Management
Systems – Requirements and Guidance for use
ISO 19011:2002 ISO International Organization for Standardization – Guidelines for Quality and/or
environmental management systems auditing
Quality Control Handbook, J.M. Juran, McGraw-Hill Publishing Co. New York 1999
Guide to Quality Control, Kaoru Ishikawa, Asian Productivity Organisation, Tokyo 1982
IAEA Safety Standards. Safety Guide DS411. Orphan Sources and Other Radioactive Material in the
Metal Recycling and Production Industries
UN-ECE Recommendations on Monitoring and Response Procedures for Radioactive Scrap Metal
agreed at the UNECE Group of Experts Meeting (Geneva, 12-14 June 2006) [http://www.unece.org/
trans/radiation/docs/recommendations_e.pdf]
Council of the European Union’s Regulation (EU) No 333/2011 establishing criteria when ferrous and
aluminium scrap metal cease to be waste
68 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Annex - 1 - Part 1
Monitoring for presence of unwanted radioactive contamination
Cs137 Medical/health uses U238 (depleted uranium) Am241 & Be Geological Co60 Filling level
Ra226 Smoke detector Aircraft wing prospection measurement
Cs137 Geological Ra226 & Be Density Radioactive source out of Radioactive source out of
prospection measurement Am241 Lightening rod its shield its shield
IMPORTANT
IF YOU SEE A LABEL OR DEVICE SIMILAR TO THOSE ILLUSTRATED, OR YOU
SEE SUSPECTED OR ACTUAL PRESENCE OF RADIOACTIVE MATERIAL IN SCRAP
METAL, METAL PRODUCTS OR WASTES: CALL
Company to add internal contact details of manager who may contact the appropriate regulatory body and/or
competent authority in emergencies
The easy implementation of an ISO compliant Quality Management System for the recycling industry 69
Annex - 1 - Part 2
Monitoring for presence of unwanted radioactive contamination
Gate Monitoring
RADIATION
ACCEPTANCE
REPORT
70 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Get qualified Inspect the consigment (driver,
FOUND passengers and truck) until the
personnel to use SUSPICIOUS
a portable detector PART(S) radioactive item(s) are found.
If necessary scan the truck again
Park the truck in
a predesignated
safe area
— DOES
Cordon off work RADIATION DOES
area around the EXCEED 50 µSv/h Unload the RADIATION
IN CONTACT WITH suspicious part(s) EXCEED
truck 50 µSv/h
THE TRUCK
Get qualified
personnel to
use a portable
detector
INFORM Segregate
Cordon off
COMPETENT INFORM Radioactive
the 1 µSv/h zone
— AUTHORITY ON SUPPLIER item(s)
EMERGENCIES —
Forbid access
— Store item(s) in a
Call in a suitable container
specialised —
INFORM REGULATORY BODY
company Secure the
FOR RADIATION SAFETY
container
The easy implementation of an ISO compliant Quality Management System for the recycling industry 71
Annex - 1 - Part 3
Monitoring for presence of unwanted radioactive contamination
DISTANCE: Keep your distance from radioactive materials. The intensity of radiation and its effects drop of
sharply with distance from the source, so always maximize your distance.
SHIELDING: Shielding reduces radiation exposure. Shielding materials, like cement blocks, lead, steel, and
other metals, will block the radiation produced by radioactive materials. Properly-trained personnel use
shielding to reduce the amount of radiation to which they are exposed
BASIC ADVICE
Isolate the suspicious car, van, truck, container(s) or equipment. If considered necessary, stop further
processing and dispatching of any metal products or wastes.
Identify people who may have been exposed to radiation. Record their contact details.
Inform the managing director /operator of the incident, they may seek the assistance of an on-site radiation
safety person or external qualified experts.
Learn about basic radiological protection; if the company has a gate monitor or portable detector, ask how
it works.
DON’T
DON’T touch or pick up packages or containers with a radio activity symbol and stay as far
away from them as possible
DON’T open or destroy any suspicious container under any circumstances. Opening a
container may be dangerous for you, your fellow workers and the public. Note that heavy
metal containers or shielding blocks may be constructed of depleted uranium rather than
of lead
DON’T touch suspect or actual radioactive material with your bare hands
Recyclers do not want radioactive contamination entering their metal scrap but face such a threat because
governments either lost control, or never had control, over radioactive material designated in national law
or by a regulatory body as being subject to regulatory control. By identifying such unwanted radioactivity,
recyclers protect human health and the environment and help restore government control, thereby
preventing further dispersion of, or contamination by, such radioactive material
This advice from the Bureau of International Recycling (also online at www.bir.org) takes into account IAEA
and UN-ECE guidance publications (available online at www.iaea.organd www.unece.org).
72 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Annex - 2
Example certificate of shipment monitoring
MONITORING STATION
Location of monitoring station
Name of organization/company and person conducting the monitoring
Address
Telephone
Fax
E-mail
DETAILS OF LOAD
Country of origin
Origin of load - supplier of merchandise
(address, contact person and telephone)
Destination of load (contact details of recipient)
Identification of load (reference to transit documents
being carried with the load)
Means of transport (identity truck, ship, container, etc.)
Details of carrier (contact details)
MEASUREMENTS
Details of the monitoring equipment used
Average values measured at 1 metre from the
surface of the load ( µSv/h)
Maximum dose rate value in contact with the outer surface of
the container, truck or wagon, in µSv/h (identify position)
Background radiation value in the area, in µSv/h
CERTIFICATION STATEMENT
(by person responsible for monitoring) Certifying that the
above values are a true record of the measurements made
at the date of monitoring stated below.
Official stamp of monitoring organization/company
Date of monitoring of shipment
N.B. No certification document should be provided for a load showing radiation levels significantly in excess of natural radi-
N.B. No certification document should be provided for a load showing radiation levels
ation background in the local area.
significantly in excess
Extract from Annex of natural
I to the UN-ECE radiation on
Recommendations background
Monitoring andinResponse
the local area. for Radioactive Scrap
Procedures
Metal. 2006
The easy implementation of an ISO compliant Quality Management System for the recycling industry 73
Annex - 3
Example of EU Statement of Conformity with the end-of-waste criteria
At date of printing this example is current for iron, steel and aluminium scrap, including aluminium
alloy scrap that ceases to be waste, for other end-of-waste material types, check against the relevant
EU Regulation.
Statement of Conformity with the end-of-waste criteria referred to in Article 5(1)
3. The scrap metal consignment complies with the specification or standard referred
to in point 2:
6. The producer of scrap metal applies a quality management system complying with
Article 6 of Regulation (EU) No 333/2011 (1), which has been verified by an accredited
verifier or, where scrap metal which has ceased to be waste is imported into the
customs territory of the Union, by an independent verifier:
7.The scrap metal consignment meets the criteria referred to in points (a) to (c) of
Articles 3 and 4 of Regulation (EU) No 333/2011 (1):
8. Declaration of the producer/importer of scrap metal: I certify that the above information
is complete and correct to my best knowledge.
Name: Date:
Signature:
when certain types of scrap metal cease to be waste under Directive 2008/98/EC of the
European Parliament and of the Council (OJ L 94, 8.4.2011, p.2).
74 The easy implementation of an ISO compliant Quality Management System for the recycling industry
Notes
The easy implementation of an ISO compliant Quality Management System for the recycling industry 75
Notes
76 The easy implementation of an ISO compliant Quality Management System for the recycling industry
The Bureau of International Recycling (BIR) was created in 1948 as the international trade federation
representing the world’s recycling industries. BIR members’ interests cover in particular ferrous and
non-ferrous metals, paper and textiles, represented by the four commodity divisions. BIR committees
deal with amongst other topics: stainless steel and special alloys; plastics; and tyres which are also
studied and traded by some BIR members. About 800 companies and national federations from
over 70 countries are affiliated to BIR. BIR’s primary goals are to promote materials recycling and
recyclability, thereby conserving natural resources, protecting the environment, and facilitating free
trade of recyclables in an environmentally sound manner.
bir@bir.org
www.bir.org