ISO Management Systems Solutions Ireland

Integrated Management Systems

Quality Management Systems ISO 9001:2015

ISO 9001 is the international standard that specifies requirements for quality management systems. An organisation may use the ISO 9001 standard to demonstrate its ability to consistently meet and exceed both its customers and stakeholder requirements to ensure ongoing satisfaction. Adapting ISO 9001 allows an organisation to enhancement reputation in the marketplace. At its core is an ongoing commitment from the organisation to achieving continual improvements in its performance based on a never-ending cycle of ‘plan-do-check-act’. 

PDCA Work Plan Infographic
The PDCA CYCLE

The ISO 9001 standard is known as a generic management system standard. ‘Generic’ implies that it can be applied to any organisation, large or small, no matter its product or service. It also has relevance to business enterprises, public administration and government departments. No matter what the organisation’s scope of activity is, the ISO 9001 standard provides the requirements for several essential features you need to establish in your quality management system for any sector. The standard was developed based on seven quality management principles.

So what are the benefits of having your organisation compliant with ISO 9001?

  • Greater customer satisfaction.
  • Much greater controls on risk to the business
  • Clear responsibility guidelines.
  • Better communication.
  • Decision making based on facts.
  • Better controls.
  • Better utilisation of resources and waste reduction.
  • Resource optimisation.
  • Transparency of process
  • More efficient validation and documentation of techniques, methods and procedures.
  • Improves documentation.
  • More sustainable business model with increased growth potential.
  • Increased potential for innovation and development.
  • Control focused on what is necessary.
  • Organises and targets communication among stakeholders.
  • Better planning, less post-process verification.

An organisation may employ many business and analytical enhancement tools within its ISO 9001 Quality Management system to assist its application such as: Risk registers, Stakeholders registers, needs and opportunity analysis, SWOT, PESTEL, Turtle, 5 why, 5S, 6S, Statistical Process Controls (SPC), process mapping, communications matrix,     

For further information on ISO 9001:2015 Quality Management: 

Link to ISO – the International Standards Body

ISO Guide for small business

Link to NSAI

Link to CEN, the European Standards Body

General information on ISO 9001 see American Society of Quality (ASQ)

To buy a copy of the standard

ISO 14001:2015 Environmental Management 

ISO 14001 is a globally recognized standard for an environmental management system (EMS). This standard defines the requirements for controlling and improving the organization’s environmental impact. The ISO 14001 standard recommends controls for those processes that have an environmental impact. E.g. Use of environment resources, environmental waste management & energy consumption. At its core is an ongoing commitment from the organisation to achieving continual improvements in its environmental performance based on a never-ending cycle of ‘plan-do-check-act’. 

Purpose of ISO 14001
The main purpose of ISO 14001 is to define the requirements for the EMS and provides guidance for its implementation. The standard gives a structured activity for making environmental improvements in the organization.

Key Elements of ISO 14001
The ISO 14001 environmental management systems standard contains the following key elements:

  1. Environmental policy.
  2. Planning.
  3. Implementation and Operation.
  4. Checking and Corrective Action
  5. Management review.

Benefits of implementing ISO 14001

  • Enhanced reputation in the marketplace
  • Systematic way for controlling their environmental impact.
  • Productivity and efficiency are increased so there is more cost savings in the organisation. 
  • Environment system gives the structure for an organisation to attain an extremely high level of environmental performance that shows commitment of an organisation at every level in controlling negative impact on the environment, such as: waste, pollution and energy consumption. 
  • Cost savings due to increased environmental efficiency
  • Cutback of environmental responsibilities
  • Risk mitigation of negative environmental impacts
  • Increased organisational ability to battle to fight climate change.

 

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For further information on ISO 14001:2015 Environmental Management: Click on the Below Links

Link to ISO – the International Standards Body

ISO a practical Guide to environmental management

European Union Eco Label ‘EcoFlower’ scheme:

EPA Ireland: 

EPA USA:

SEAI:

Link to NSAI

Irish Law listing

Link to CEN, the European Standards Body

General information on ISO 14001 see American Society of Quality (ASQ)

To buy a copy of the standard

Occupational Health and Safety Management Systems ISO 45001:2018

ISO 45001 is an international standard for workplace occupational health and safety that provides a framework to improve employee safety and welfare, reduce work-related injury, control risks, and prevent ill health and death. The standard provides a platform for safer working conditions. The standard helps organisations provide a safe and healthy work environment for workers and visitors by continually improving their Occupational Health & Safety performance.

At its core is an ongoing commitment from the organisation to achieving continual occupational health & safety improvements in its performance based on a never-ending cycle of ‘plan-do-check-act’. 

The basic requirement of ISO 45001 is for organizations to provide a safe and healthy place for all personnel to work. This is done by preventing work-related injury or ill-health. The standard requires active involvement of top management, and to ensure that all employees are aware of the Occupational Health & Safety management system.

ISO 45001 Key Features

  • Top management commitment
  • Context of the organization
  • Risk-based thinking
  • Process approach
  • Consultation and worker participation
  • Prevention of ill-health and injury
  • Supplier and sub-contractor management 

ISO 45001 Benefits

  • More efficient use of resources and improved financial performance,
  • Improved risk management and protection of people and the environment
  • Increased capability to deliver consistent and improved services and products, thereby increasing value to customers and all other stakeholders.
  • Provides evidence of ‘core competency’ for SSIP (UK) construction supply chain compliance. 

For further information on ISO 45001:2018 Occupational Health & Safety Management: Click on the Below Links

Link to ISO – the International Standards Body

HSA Guidance

Irish Statute (law) Listings

Link to NSAI

General information on ISO 45001 see American Society of Quality (ASQ)

To buy a copy of the standard

Construction Products Regulation (CPR) and ‘CE’ marking 

All construction product manufactured in or imported into European Economic Area (EU 27* + EFTA) must comply with the EU Construction Products Regulation (CPR). The CPR states that all products traded or sold in Europe must bear a ‘CE’ mark when a harmonised standard exists for this product.  A ‘CE’ mark indicates that a product complies with the regulation. It does not necessarily mean that a product will be suitable for all end uses, but it does indicate that the product is consistent with its Declaration of Performance (DoP), as made by the manufacturer.

A construction product with ‘CE’ marking can be traded throughout the EEA*. European States may not prevent this or impose additional requirements.

*UK has left the EU on January 31st, 2020 and is not an EFTA area member but is required to obey the single market rules until the end of 2020.

WHAT DOES THE EU CPR MEAN FOR IMPORTERS, DISTRIBUTORS AND MANUFACTURERS?

The manufacturer of a product that requires ‘CE’ marking, is ultimately responsible for ensuring that the product meets all requirements. The manufacturer needs to ensure that all evidence is available and presented in the correct way. This includes the application of a ‘CE’ label on the product if possible or associated labels or packaging if the products is loose together with the distribution of the DoP.

Importers and/or distributors must ensure that construction products, where required, bear the ‘CE’ mark, and are accompanied by the correct documentation, instructions and safety information. Distributors must also ensure that the manufacturer and the importer have complied with their requirements under the Construction Products Directive. Achieving compliance can be a complex process.

FACTORY PRODUCTION CONTROL (FPC) CERTIFICATION

An important document for many ‘CE’ marked products is a factory production control (FPC) Certificate.  FPC certification, which covers quality control of procedures and inspections of a product. Following a successful audit by a Notified Body, the manufacturer will receive an FPC certificate which indicates compliance with the European standard for the procedures and inspections from the Notified body.

The CPR distinguishes five different levels of control regarding ‘CE’ marking. The level of control is indicated per standard and is given in the Annex ZA at the back of the harmonised EN standard normally in the below table. 

An FPC Certificate is only required for the three highest levels. In many standards one level of control is prescribed. In others, a level may be selected by the manufacturer or is dependent on a specific end use or application.

EU/EFTA area ‘CE’ mark.

You as a manufacturer or distributor of a construction product which falls under the CPR will have to ensure that you have a factory production control manual in place with supporting testing schedules, calibration and maintenance inspection records, test data supporting by an inspection regime. A current copy of the FPC from your Notified Body – if applicable, must be available to support your legal claim of conformance in your signed DoP for the product or products which you have placed on the market. 

So, what are Attestation of Conformity Systems (level), called the verification of constancy of performance in the CPR?

The EU Commission has set out the product families in the legal text of the CPR. For ease of access the levels are repeated in the Annex ZA of the applicable EN harmonised standard, sometimes referred to as a hEN. There are five systems (AVCP levels). For all systems of Attestation of Conformity, the manufacturer must have factory production control (FPC) system the type and extent of which is determined by the relevant product standard and initial type-testing (ITT).

Attestation of Conformity systems depend on the level of safety of a product in installation and use (e.g.: structural products tend to be safety critical therefore it will be likely to be system 1, whereas decorative products are usually not). For safety critical products, these usually involve testing, inspection and certification by a notified body. For less safety critical products, the CE marking will usually involve a manufacturer’s declaration only, with no third-party involvement. It is not optional however, if your products fall under level 2 for example you must involve an EU notified body, whereas if your product falls under system 4 you cannot involve an EU Notified body. 

The processes involved in attaining that system and who is responsible for those tasks are shown in the Table below.

(I)         For all construction products which fall under the CPR, a system of Factory Production Control (FPC) is required. The FPC is largely similar to a quality management system and the requirements are covered in the applicable product standard.  If your organisation already holds an ISO 9001 2015 registration these requirements may be fulfilled therein.

(II) For Attestation Systems 1+ and 1 you need to obtain an EC Certificate of Constancy of Performance issued by a Notified Body

(III) For Attestation Systems 2+ and you need to obtain an EC Certificate of Factory Production Control issued by a Notified Body 

(IV) For systems 2+ and 4 you must complete Initial Type Testing and draw up a Declaration of Performance based on the product properties required by the applicable standard 

(V) For systems 1+ and 1 you will need to apply to a Notified body to enable samples to be taken and initial type testing to be conducted by the Notified body

(VI) For system 3 you will need an Initial Type test report from a Notified testing laboratory

(VII) For system 4 Declaration of performance can be drawn up by the producer with no involvement of a notified body (a self-declaration).

EU Commission Guidance:

Download PDF Here

Harmonised standards (hEN’s)

EU Notified Bodies:

Link to Department of Housing – building standards:

Link to NSAI:

Link to CEN, the European Standards Body

To buy a copy of the standard

‘UKCA mark’ – proposed by the UK

As noted earlier, the UK has left the EU and is not a member of EFTA. Under the terms of the withdrawal agreement between the EU 27 and the UK, the single market rules continue to apply to the UK until the end of 2020. At that point anew new trade agreement may be in place between the EU and the UK with would cover matters currently addressed by the EU single market with regard to the free movement of goods, services capital and labour – often referred to as the ‘four freedoms’. However, the UK have already signalled their intention to replace the EU ‘CE’ mark by a new UK wide ‘UKCA’ mark for goods manufactured in the UK and goods traded into the UK. The UK have stated that for a period of time the existing EU ‘CE’ mark will continue to be recognised. 

Irish construction products manufacturers who supply into the UK must now plan to achieve the ‘UKCA’ mark in time to ensure business continuity of their sales.

  Mark will in time replace the EU ‘CE’ mark in the UK.

See links to UK Dept. for Business, Energy & Industrial Strategy: