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| Overview of ISO 9001 & ISO 14001

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| Overview of ISO 9001 & ISO 14001

Mike Morgan QA Manager

BREIF HISTORY OF ISO

The organization which today is known as ISO started out as ISA in

1926

ISO was launched in 1946

UK Manufactures used British Standard .e.g. BS5750 created in 1979

ISO was being used by UK Manufactures from 1987.

Most UK manufactures moved from BS 5750 to ISO in 1994.

New standard in 2008 (BS EN ISO 9001-2008).

New standard this year (BS EN ISO 9001-2015).

Slide No. 1

Mike Morgan QA Manager

ISO 9001 & ISO14001 IN BRIEF

ISO 9001 and ISO 14001 are among ISO’s most well known standards

ever.

They are implemented by more than a million organisations in some 175

countries.

ISO 9001 helps organisations to implement quality management.

ISO 14001 helps organisations to implement environmental

management.

Slide No. 2

Mike Morgan QA Manager

QUALITY MANAGEMENT

ISO 9001 is for quality management.

Quality refers to all those features of a product (or service) which are required by the customer.

Quality management means what the organisation does to:

ensure that its products or services satisfy the customer’s quality requirements and

comply with any regulations applicable to those products or services.That means that all regulations from ISO 9001-14001,we must have procedure or a statement within a procedure that will satisfy the ISO requirements. Auditors will look for this.

Slide No. 3

Mike Morgan QA Manager

QUALITY MANAGEMENT (continued)

Quality management also means what the organisation does to:

enhance customer satisfaction, and

achieve continual improvement of its performance. Updating procedure's and documents to keep pace with change, either within our organisation (ESG) or with customer requirements.

Only use controlled Documents or Procedures which we can monitor and update. Uncontrolled Documents or Procedures will cause non-conformities and cost our company money and may damage it’s reputation.

Slide No. 4

Mike Morgan QA Manager

ENVIRONMENTAL MANAGEMENT

ISO 14001 is for environmental management. This means what the organisation does to:

minimise harmful effects on the environment caused by its activities,

to conform to applicable regulatory requirements, and to

achieve continual improvement of its environmental performance.

Slide No. 5

Mike Morgan QA Manager

GENERIC STANDARDS

ISO 9001 and ISO 14001 are generic standards. Generic means that the same standards can be applied:

to any organisation, large or small, whatever its product or service,

in any sector of activity, and

whether it is a business enterprise, a public administration, or a government department.

Slide No. 6

Mike Morgan QA Manager

GENERIC STANDARDS (continued)

Generic also signifies that:

no matter what the organisation’s scope of activity

if it wants to establish a quality management system, ISO 9001 gives the essential features,

or if wants to establish an environmental management system, ISO 14001 gives the essential features.

Slide No. 7

Mike Morgan QA Manager

MANAGEMENT SYSTEMS

Management system means what the organisation does to manage its processes, or activities in order that:

its products or services meet the organisation’s objectives, such as

satisfying the customer’s quality requirements

complying to regulations, or

meeting environmental objectives

Slide No. 8

Mike Morgan QA Manager

MANAGEMENT SYSTEMS

To be really efficient and effective, the organisation can manage its way of doing things by systemizing it.

Nothing important is left out.

Everyone is clear about who is responsible for doing what, when, how, why and where.

Management system standards provide the organisation with an international, state-of-the-art model to follow.

Slide No. 9

Mike Morgan QA Manager

MANAGEMENT SYSTEMS (continued)

Large organisations, or ones with complicated processes, could not function well without management systems.

Companies in such fields as aerospace, automobiles, defence or health care devices have been operating management systems for years.

The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organisations.

Slide No. 10

Mike Morgan QA Manager

PROCESSES, NOT PRODUCTS

Both ISO 9001 and ISO 14001 concern the way an organisation goes

about its work.

They are not product standards.

They are not service standards.

They are process standards.

They can be used by product manufacturers and service providers.

Slide No. 11

Mike Morgan QA Manager

PROCESSES, NOT PRODUCTS (continued)

Processes affect final products or services.

ISO 9001 gives the requirements for what the organisation must do to manage processes affecting quality of its products and services.

ISO 14001 gives the requirements for what the organisation must to manage processes affecting the impact of its activities on the environment.

Slide No. 12

Mike Morgan QA Manager

CERTIFICATION & REGISTRATION

Certification is known in some countries as registration.

It means that an independent, external body has audited an organisation’s management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001) .

ISO does not carry out certification and does not issue or approve certificates.

Slide No. 13

Mike Morgan QA Manager

ACCREDITATION

Accreditation is like certification of the certification body.

It means the formal approval by a specialised body – an accreditation body – that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors. In ESG case, NQA carry this out on yearly basis over 6 days.

Certificates issued by accredited certification bodies – and known as accredited certificates – may be perceived on the market as having increased credibility.

ISO does not carry out of approve accreditations.

Slide No. 14

Mike Morgan QA Manager

CERTIFICATION NOT A REQUIREMENT

Certification is not a requirement of ISO 9001 or ISO 14001.

The organisation can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified.

The organisation can implement them for the internal benefits without spending money on a certification programme.

Slide No. 15

Mike Morgan QA Manager

CERTIFICATION IS A BUSINESS DECISION

Certification is a decision to be taken for business reasons:

if it is a contractual, regulatory, or market requirement,

if it meets customers preferences

it is part of a risk management programme, or

if it will motivate staff by setting a clear goal.

Slide No. 16

Mike Morgan QA Manager

ISO DOES NOT CERTIFY

ISO does not carry out ISO 9001 or ISO 14001 certification.

ISO does not issue certificates.

ISO does not accredit, approve or control the certification bodies.

ISO develops standards and guides to encourage good practice in accreditation and certification.

Slide No. 17

Mike Morgan QA Manager

THE ISO 9000 FAMILY

ISO 9001 is the standard that gives the requirements for a quality management system.

ISO 9001:2008 is the latest, improved version.

It is the only standard in the ISO 9000 family that can be used for

certification.

There are 16 other standards in the family that can help an organisation on specific aspects such as performance improvement, auditing, training…

Slide No. 18

Mike Morgan QA Manager

THE ISO 14000 FAMILY

ISO 14001 is the standard that gives the requirements for an environmental management system.

ISO 14001:2004 is the latest, improved version.

It is the only standard in the ISO 14000 family that can be used for

certification.

The ISO 14000 family includes 21 other standards that can help an organisation specific aspects such as auditing, environmental labelling, life cycle analysis…

Slide No. 19

Mike Morgan QA Manager

BENEFITS OF ISO 9001 & ISO 14001

International, expert consensus on state-of-the-art practices for quality and environmental management.

Common language for dealing with customers and suppliers

worldwide in B2B.Business to Business (B2B) refers to a situation one business makes a commercial transaction with another. This typically occurs when:

A business is sourcing materials for their production process, e.g. a food manufacturer purchasing salt.

A business needs the services of another for operational reasons, e.g. a food manufacturer employing an accountancy firm to audit their finances.

A business re-sells goods and services produced by others, e.g. a retailer buying the end product from the food manufacturer.Slide No.

20

Mike Morgan QA Manager

BENEFITS OF ISO 9001 & ISO 14001 (continued)

Increase efficiency and effectiveness.

Model for continual improvement.

Model for satisfying customers and stakeholders.

Build quality into products and services from design onwards

Unifying base for industry sectors

Quality suppliers for global supply chains

Technical support for regulations

Slide No. 21

Mike Morgan QA Manager

BENEFITS OF ISO 9001 & ISO 14001 (continued)

Address environmental concerns of customers and public, and comply with government regulations.

Integrate with global economy

Sustainable business

Transfer of good practice to developing countries

Tools for new economic players

Regional integration

Facilitate rise of services

Slide No. 22

Mike Morgan QA Manager

NON-CONFORMANCE GUIDE

What is Non-Conformance?ISO 9001 requires that we document a non-conformance procedure (requirement 8.3) and keep a record of non-conformance issue we identify and actions take. This also needs to be completed on ISO 14001(4.4.7) & OHSAS (4.4.7) Emergency Preparedness & response.

A non-conformance means that something went wrong-a problem has occurred and needs to be addressed. Non-conformance are addressed with corrective action. You may find a non-conformance in a service, a product, a process, from a supplier or may be a fault in the system.

The non-conformance procedure needs to do the following:

Identify the non-conformance(quarantine & identify as rejected, e.g. reject or quarantine label)

Decide what actions you are going to carry out

Contact relevant people or organizations(purchasing or Customer etc.)

Document the non-conformance, stating what will happen, scrap/rework or return to supplier. (Non-conformance report(reject Note completed)

Keep a record of the non-conformance-Spread-sheet. Key Performance Indicator.

????? have Four main areas that non-conformance could occur, QMS, Audits, Supplier defects & jobs incorrectly done or parts damaged during installation. One of the most frequent is suppliers that have a poor time delivery record, e.g. states 10.00am delivery and delivers 2 hours late.

New Non-compliance form QA10019, will replace GO1029,and is available in the QA 10000 section of the DC library. All Non-conformances & audit corrective actions will be logged on QA 10017 spreadsheet ByQA Manager.

Slide No. 23

Mike Morgan QA Manager

NON-CONFORMANCE FORM

Completed by:

Department or site:

Date completed:

Issue Action Completed     

     

     

     

Please complete and return to QA Manager or SHE Manager depending on the issue.Please mark one of the following:

Quality Issue (9001) Health & Safety Issue (18001) Environment Issue (14001)

Slide No. 24

Mike Morgan QA Manager

CUSTOMER COMPLAINTS

Snagging Document No PME 3004

ESG can and do subject to the project terms and conditions issue self-snagging sheets throughout the Projects they can be self-signed off or signed off by the Client whatever the terms and conditions of that Project require. The Clients snagging list can follow the same route, but they would/ can issue, then inspect and sign off when ESG have confirmed that the snags have been signed off. At the end of the project the Client or Clients Agent will/can issue a final snagging sheet for addressing, confirming when complete by ???? followed by the Client/Clients Agent inspection and sign off.

Project Close out Meetings Document No COM 7013

Project close out meeting are called at the end of a project and will discuss all complaint raised during the project. This meeting is document and all complaints/issues raised are discussed and actioned by the project team?

New Complaints Form QA 10018

The new complaints form will cover existing projects and any other complaints from completed projects. The responsibility for raising the complaint form rest with the person taking the complaint, either via telephone call or via email. Copy of the email can be used as proof of compliance. The decision to formulise/action the complaint will be taken by Project Team or Director responsible. All complaint forms raised will be emailed to QA Manager (Mike Morgan) and these will be added to complaints spreadsheet. This form could be used by Contract Services if the customer has not used their own paperwork and it’s outside 12/24 month warranty period.

Slide No. 25

Mike Morgan QA Manager

CUSTOMER COMPLAINT FORM

Name of person making complaint:

Telephone number:

Address:

Nature of complaint:

Results of investigation:

Action taken:

Date complainant contacted with the results of the investigation and action taken:

Initials of person investigating complaint:

Initials of person taking complaint:

Slide No. 26

Mike Morgan QA Manager

CUSTOMER COMPLAINT CHART 1

Slide No. 27

Complaint receivedContract Services

This received via email orcustomer document

Complaint Investigated

Management review meeting

Relevant project team ADor sub-contractor informed

Job completed and documented Customer informed

Not ESG or out of warranty period

Customer not satisfied

*MD or OP’s Directorwill communicate with customer

Document complaint via defect tracker spreadsheet

Within warranty period 12/24 months

Documentcomplaint via

QA 10018

* Only in exceptional circumstances

Mike Morgan QA Manager

CUSTOMER COMPLAINT CHART 2

Slide No. 28

Complaint documented on QA10018

Relevant project team notified of complaint

Not ESG Issue

Complaint investigated

ESG Issue

Report raised

If appropriate add to snagging listPME 3004

All complaints discussed at project close out meeting com 7013 document

Complaint active by relevant team

Customer not satisfied

MD or OP Director willcommunicate with customer

Management review meeting

Customer informed

Complaint receivedAD, OP, Director

OP’s Directoronly in exceptional

circumstances

Mike Morgan QA Manager

CUSTOMER COMPLAINT CHART 3

Slide No. 29

Complaint received on site

Either raise customer complaint form (QA 10018) or snagging document PME

3004

Investigation

Not ESG Issue

All complaints discussed at project close out meeting com 7013 document

Issue resolved and outcome, documented on either QA 10018 or

snagging list

Management review meeting

Inform customer

Customer not satisfied

*MD or OP’s Directorwill communicate with customer

ESG Issue

* Only in exceptional circumstances