SMALL BUSINESS QMS Self Appraisal ISO 9001:2015

Similar documents
DNV GL Assessment Checklist ISO 9001:2015

ISO 9001:2015 Internal Audit Checklist

QUALITY MANUAL ISO 9001:2015

Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization

ISO 9001:2000 AUDIT CHECKLIST

ISO 9001:2000 Gap Analysis Checklist

ISO-9001:2000 Quality Management Systems

ISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION

ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR

ISO 9001:2008 Quality Management System Requirements (Third Revision)

ISO 9001:2008 Audit Checklist

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents

SMALL BUSINESS OH&S SELF APPRAISAL

QUALITY MANAGEMENT SYSTEM Corporate

Row Manufacturing Inc. Quality Manual ISO 9001:2008

Rev: Issue 4 Rev 4 Quality Manual AOP0101 Date: 10/07/13. Quality Manual. CBT Technology, Inc. 358 North Street Randolph, MA 02368

FINE LOGISTICS. Quality Manual. Document No.: Revision: A

CENTRIS CONSULTING. Quality Control Manual

QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA FAX

ISO 9001 Quality Systems Manual

ISO 9001:2015 Overview of the Revised International Standard

Quality Manual. UK Wide Security Solutions Ltd. 1 QM-001 Quality Manual Issue 1. January 1, 2011

NORTH AMERICA OPERATIONS. (Fairmont and Montreal Facilities) QUALITY MANUAL. Prepared to comply with the requirements of ISO 9001:2008

ED FAGAN INC. QUALITY SYSTEM MANUAL

Quality Manual Printed copy valid for 24 hours from time of printing unless stamped CONTROLLED COPY in red. Page

Micro Plastics, Inc. Quality Manual

Quality Management System Manual

Revision Date Author Description of change Jun13 Mark Benton Removed Admin. Manager from approval

Quality Management System Manual

Disclosure to Promote the Right To Information

QUALITY MANAGEMENT SYSTEM (QMS) MANUAL

GENERIC STANDARDS CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE CUSTOMISED SOLUTIONS INDUSTRY STANDARDS TRAINING SERVICES THE ROUTE TO

Vigilant Security Services UK Ltd Quality Manual

QUALITY MANUAL ISO Quality Management System

ONTIC UK SUPPLIER QUALITY SURVEY

Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002)

ISO 9001: 2008 Boosting quality to differentiate yourself from the competition. xxxx November 2008

Eagle Machining, Inc. Quality Management System

ISO 9001:2008 QUALITY MANUAL. Revision B

The President of Inductors Inc. is the senior executive responsible for operations.

This Business Management System Manual is based on ISO 9001:2008 requirements

Quality Systems Manual

CCD MARINE LTD QUALITY MANUAL PROCEDURE Q Date: Title. Revision: QUALITY MANUAL PROCEDURE Q September 2014

How To Manage A Quality Management System

Cartel Electronics. AS 9100 Quality Systems Manual

Contents. Management Policy Manual SEM USA Page 2 of 12

14620 Henry Road Houston, Texas PH: FX: WEB: QUALITY MANUAL

Control No: QQM-02 Title: Quality Management Systems Manual Revision 10 07/08/2010 ISO 9001:2008 Page: 1 of 22

The Prophotonix (UK) Ltd Quality manual

Appendix 3 (normative) High level structure, identical core text, common terms and core definitions

Surgi Manufacturing Quality Manual

QUALITY OPERATING PROCEDURE QOP QUALITY ASSURANCE SYSTEM MANUAL

Free Download ISO/TS 16949:2009. Requirements Checklist. 29 of 57 pages (PDF) For additional information see

Quality Management System Manual

Quality Management System Manual

Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702

G & R Labs. Quality Assurance Manual. G&R Labs Scott Boulevard Santa Clara CA Light Meters and Calibration

Quality Management System

ABC COMPANY INC ISO 9001:2000 QUALITY MANUAL

ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL

CORPORATE QUALITY MANUAL

PUBLICATIONS. Introduction

Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702

Quality Management System Policy Manual

BLOOM AND WAKE (ELECTRICAL CONTRACTORS) LIMITED QUALITY ASSURANCE MANUAL

Karas Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL

Company Quality Manual Document No. QM Rev 0. 0 John Rickey Initial Release. Controlled Copy Stamp. authorized signature

QUALITY MANAGEMENT SYSTEM (QMS) ASSESSMENT CHECKLIST

Quality Management System General

Uncontrolled Document

Quality & Safety Manual

AS9100 Quality Manual

Quality Manual ISO 9001:2015 Quality Management System

FMC Technologies Measurement Solutions Inc.

SUPPLIER QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE

QUALITY MANUAL REVISION RECORD

ISO/IEC QUALITY MANUAL

Checklist. Standard for Medical Laboratory

Camar Aircraft Products Co. QUALITY MANUAL Revision D

Client information note Assessment process Management systems service outline

Document subject to ISO Requirements

TÜV UK Ltd Guidance & Self Evaluation Checklist

COMPANY NAME. Environmental Management System Manual

Implementation of a Quality Management System for Aeronautical Information Services -1-

AEROSPACE STANDARD. Quality Management Systems - Requirements for Aviation, Space and Defense Organizations RATIONALE

ISO 9001:2008 Clause PR018 Internal Audit Procedure

QW Enterprises, LLP. Quality Manual

Quality Assurance System Manual

Quality Manual TABLE OF CONTENTS APPROVAL SIGNATURE PAGE AMENDMENT RECORD SCOPE EXCLUSIONS 2.1 3

Quality Management System Manual ISO9001:2008

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC.

MEAT GRADING AND CERTIFICATION BRANCH QUALITY MANUAL

OH&S MANAGEMENT SYSTEM CHECKLIST - AS 4801:2001 (STATUS A = Acceptable; N = Not Acceptable; N/A = Not Applicable)

DEC STD ISO Quality Systems - Model for Quality Assurance in Production and Installation

QUALITY MANAGEMENT SYSTEM MANUAL

23. The quality management system

Specialties Manufacturing. Talladega Castings & Machine Co., Inc. ISO 9001:2008. Quality Manual

Transcription:

SMALL BUSINESS QMS Self Appraisal ISO 9001:2015 Please complete and return with the signed proposal documents This questionnaire is designed to help you judge whether your Quality Management System (QMS) is ready for assessment by LRQA. If you are unsure about any of the questions, please do not hesitate to contact us. Small Business Advisors: 0800 783 2179 Guidance Note The following questionnaire should be completed in all sections by answering Yes, No or Not Applicable in the appropriate column. Not Applicable should only be recorded if you do not undertake the process described as part of your operational processes. This only applies to section 8. Please explain any NO answers in the space given at the end of this questionnaire. Where there is a specific reference in your system that addresses this requirement in your quality management system, please record this. A reference MUST be recorded where the ISO 9001:2015 standard indicates a need for a documented procedure. This document is numbered in accordance with the ISO 9001:2015 standard. 4 Context of the organisation 4.1 Understanding the organisation and its context Do you know how your organisation determines external and internal issues that are relevant to its purpose and strategic direction? Does your organisation determine the external and internal issues that could affect its ability to achieve the results that your QMS is trying to achieve? Does your organisation monitor and review information about these external and internal issues? 4.2 Understanding the needs and expectations of interested parties Can you list the interested parties that are relevant to your organisation s quality management system? Have the requirements of these interested parties been determined and defined? Is information relating to your organisation s interested parties and their relevant requirements monitored and reviewed? Improving performance, reducing risk

4.3 Determining the scope of the quality management system When determining the scope of your QMS, were the following issues considered: a) The boundaries and applicability of the quality management system? b) The relevant external and internal issues? c) The relevant requirements of interested parties? d) The products and services provided? Is the scope of your management system documented and available throughout the organisation? Does your scope clearly state the following: a) The types of products and services provided? b) Any requirement of ISO 9001:2015 that your organisation determines is not applicable to the scope of your QMS? 4.4 Quality management system and its processes Does your organisation s QMS fully establish, implement, maintain and improved on a continual basis? Has your organisation identified the processes required in your QMS? Have the following requirements for the processes within your QMS been determined: a) The required inputs and outputs? b) Their sequence and interaction? c) The criteria and methods needed to ensure the effective operation and control of these processes? d) The resources needed for these processes? e) Responsibilities and authorities for these processes? f) The relevant risks and opportunities? Are the processes measured or monitored and evaluated? When required are process changes implemented to ensure that they achieve their intended results? Does your organisation seek opportunities to improve its processes? Where required, does your organisation provide documentation to support the operation of its processes? Does your organisation retain documentation to give and prove that the processes are being carried out as planned?

5. Leadership 5.1 Leadership and commitment 5.1.1 General In relation to your QMS, can top management clearly demonstrate their leadership and commitment with respect to the following: a) Accountability for the effectiveness of your QMS? b) Ensuring that your quality policy and objectives are established for your QMS and are compatible with the context and strategic direction of the organisation? c) Ensuring the quality policy is communicated, understood and applied? d) Ensuring the QMS requirements are integrated into the organisation s business processes? e) Promoting the use of the process approach and risk-based thinking? f) Ensuring that the sufficient resources are provided for the application of your QMS? g) Communicating the importance of effective quality management and of conforming to the requirements of your QMS? h) Ensuring that your QMS achieves its intended results and targets? i) Engaging, directing and supporting persons to contribute to the effectiveness of your QMS? j) Promoting continual improvement? k) Supporting other relevant management to enable them to demonstrate their leadership in their areas of responsibility? 5.1.2 Customer focus Can top management demonstrate their leadership and commitment with respect to customer focus by ensuring that the following aspects are completed: a) Customer and applicable statutory and regulatory requirements are determined, understood and consistently met? b) Risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed? c) That products and services provided consistently meet the requirements of customers and applicable statutory and regulatory requirements? d) The focus on enhancing customer satisfaction is maintained? 5.2 Policy 5.2.1 Developing the quality policy Have your top management established, implemented and maintained a quality policy that: a) Reflects the purpose and context of your organisation and supports its strategic direction? b) Provides the basis for setting quality objectives to support the achievement of the quality policy? c) Gives a clear commitment to satisfy applicable requirements? d) Gives a clear commitment to continual improvement of your QMS?

5.2.2 Communicating the quality policy Is the quality policy: a) Documented and maintained? b) Communicated, understood and applied within the organisation? c) Available to relevant interested parties? 5.3 Organisational roles, responsibilities and authorities Have top management ensured that the responsibilities and authorities for relevant roles have been assigned, communicated and understood with the organisation? Have top management assigned the responsibility and authority for the following: a) That the QMS conforms to the requirements of ISO 9001:2015? b) That the processes are delivering their required outputs? c) Reporting to top management and other interested parties on the performance of your QMS, improvement opportunities and need for change? d) Promoting customer focus throughout the organisation? e) That the integrity of your QMS is maintained when changes to your QMS are planned and implemented? 6. Planning 6.1 Actions to address risks and opportunities When planning for your QMS, has your organisation considered the following: a) External and internal issues that are relevant to its purpose and strategic direction? b) The needs and expectations of interested parties? When the QMS was planned, did your organisation determine the risks and opportunities that needed to be addressed to achieve the following: 6.1.2 a) To give assurance that your QMS can achieve its intended result? b) To prevent, or reduce, undesired effects? c) To achieve continual improvement? Does your organisation plan, implement and evaluate actions to deal with relevant risks and opportunities? Are the actions taken to address risks and opportunities determined and prioritised based upon their potential impact on product and service conformity?

6.2 Quality objectives and planning to achieve them Has your organisation established quality objectives at relevant functions, levels and processes within your QMS? Are your quality objectives: a) Consistent with the requirements of your quality policy? b) Measurable? c) Address applicable requirements within your QMS? d) Relevant to conformity of your products and services and the enhancement of customer satisfaction? e) Monitored? f) Communicated? g) Updated when required? Are your quality objectives documented? Were the following factors determined when you were planning the achievement of your quality objectives: a) What needs to be done? b) What resources will be required? c) Who will be responsible? d) When it will be completed? e) How the results will be evaluated? 6.3 Planning of changes When changes are required within your QMS, are these changes carried out in a planned and systematic manner? When changes are required, does your organisation consider the following: a) The purpose of the changes and their potential consequences? b) The integrity of your QMS? c) The availability of resources? d) The allocation or reallocation of responsibilities and authorities? 7. Support 7.1 Resources 7.1.1 General Does your organisation determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of your QMS? When resource planning, does your organisation consider the following: a) The capabilities of, and constraints on, existing internal resources? b) What needs to be obtained from external providers?

7.1.2 People Does the organisation determine and provide persons necessary for the effective implementation of your QMS and for the operation and control of its processes? 7.1.3 Infrastructure Does your organisation determine, provide and maintain the infrastructure necessary for the implementation of its processes and the achievement of product and service conformity, i.e., buildings and associated utilities, equipment, including hardware and software, transportation resources, information and communication technology, etc.? 7.1.4 Environment for the operation processes Does your organisation determine, provide and maintain the environment necessary for the operation of its processes and the achievement of products and service conformity? 7.1.5 Monitoring and measuring resources Does your organisation determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements? Does your organisation ensure that your resources for monitoring and measurement are suitable and maintained? Does your organisation retain appropriate documentation to prove the fitness for purpose of the monitoring and measurement resources? When measurement traceability is a requirement, or is considered by your organisation to be an essential part of providing confidence in the validity of measurement results, is your measuring equipment: a) Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? b) If no such standard exists, is the basis for collaboration or verification recorded in a documented format? c) Identified in order to determine their status? d) Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results? When measuring equipment is found to be unfit for its intended purpose, does your organisation determine the previous measurement results and take appropriate action as necessary? 7.1.6 Organisational knowledge Does your organisation determine, maintain and ensure the availability of the knowledge necessary for the operation of its processes and to achieve conformity of your products and services? Is current knowledge and the need for new knowledge considered when addressing changing needs and trends within your organisation? 7.2 Competence In respect of competence, does your organisation complete the following: a) Determine the necessary competence of persons doing work that affects the performance and effectiveness of you QMS? b) Ensure that these persons are competent on the basis of appropriate education, training or experience? c) Where applicable, take actions to acquire the necessary competence and evaluate the effectiveness of the actions taken? d) Retain appropriate records as evidence of competence?

7.3 Awareness Does your organisation ensure that persons doing work under your organisation s control are aware of the following: a) The quality policy? b) Relevant quality objectives? c) Their contribution to the effectiveness of your QMS, including benefits of improved performance? d) The implications of not conforming the requirements of the QMS? 7.4 Communication Does your organisation determine the internal and external communications relevant to your QMS, including the following: a) On what it will communicate? b) When to communicate? c) With whom to communicate? d) How to communicate? 7.5 Documented information 7.5.1 General Does your organisation s QMS include: a) The Documentation required by ISO 9001:2015? b) The Documentation determined by your organisation as being necessary for the effectiveness of your QMS? 7.5.2 Creating and updating When creating and updating documentation, does your organisation ensure appropriately: a) Identified and described? b) Formatted? c) Reviewed and approved for suitability and adequacy? 7.5.3 Control of documented information Is documented information required by your QMS and by ISO 9001:2015 controlled to ensure: a) That it is available and suitable for use, where and when it is needed? b) That it is adequately protected? In respect of documentation, does your organisation address and control the following practices: a) Distribution, access, retrieval and use? b) Storage and preservation, including preservation of legibility? c) Control of changes? d) Retention and disposition?

Do you have methods in place to ensure that documentation of external origin determined by your organisation necessary for the planning operation of your QMS is identified as appropriate, and is controlled? Does your organisation retain documentation as evidence of conformity and is it protected from unintended alterations? 8 Operation 8.1 Operational planning and control Does your organisation plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions determined when planning and completing the following: a) Determining the requirements for the products and services? b) Establishing criteria for the processes and the acceptance or products and services? c) Determining the resources needed to achieve product and service conformity? d) Implementing control of the processes in accordance with the criteria? e) Determining and keeping documentation to the extent necessary to give confidence that processes have been completed out as planned and to demonstrate products and services? Is the output of operational planning suitable for your organisation s operations? Does your organisation control planned changes and review the consequences of unintended changes and when required take action to mitigate any adverse effects? Does your organisation ensure that the outsourced processes are controlled? 8.2 Requirements for products and services 8.2.1 Customer communication Do you have suitable processes in place to communicate with customers in respect of the following: a) Provision of information relating to products and services? b) Handling of enquiries, contracts or orders, including changes? c) Obtaining customer feedback relating to products and services, including customer complaints? d) Handling or controlling customer property? e) Establishing specific requirements for contingency actions, when relevant? 8.2.2 Determining the requirements related to products and services When selecting the products and services to be offered to customers, do you ensure that: a) Requirements for the products and services are defined, including those considered necessary by your organisation and any applicable statutory and regulatory requirements? b) Your organisation can meet the claims for the products and services it offers?

8.2.3 Review of requirements related to products and services Does your organisation ensure that it has the ability to meet the requirements for products and services that are offered to customers? Does your organisation conduct a review before committing to supply products and services to customers that includes: a) Requirements specified by the customer, including the requirements for delivery and post-delivery activities? b) Requirements not stated by the customer, but necessary for the specified or intended use, when known? c) Requirements specified by the organisation? d) Statutory and regulatory requirements applicable to the products and services? e) Contract or order requirements differing from those previously expressed? Does your organisation ensure that contract or order requirements differ from those previously defined, are resolved? Are your customer requirement s confirmed by your organisation before acceptance, when the customer does not provide documented statement of their requirements? Does your organisation retain documented information on: a) the results of the review? b) any new requirements of the products and services? 8.2.4 Changes to requirements for products and services Does your organisation ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements when the requirements for products and services are changed? 8.3 Design and development of products and services 8.3.1 General Does your organisation establish, implement and maintain design and development process that is appropriate to ensure the subsequent provision of products and services? 8.3.2 Design and development planning In determining the stages and controls for design and development, does your organisation consider: a) The nature, duration and complexity of the design and development activities? b) The required process stages, including applicable design and development reviews? c) The required design and development verification and validation activities? d) The responsibilities and authorities involved in the design and development process? e) The internal and external resource needs for the design and development of products and services? f) The need to control interfaces between persons involved in the design and development process? g) The need for involvement of customers and users in the design development process? h) The requirements for subsequent provision of products and services? i) The level of control expected for the design and development process by customers and other relevant interested parties? j) The documented information needed to demonstrate that design and development requirements have been met?

8.3.3 Design and development inputs Does your organisation determine the requirements essential for the specific types of products and services to be designed and developed? Does your organisation consider: a) Functional and performance requirements? b) Information derived from previous similar design and development activities? c) Statutory and regulatory requirements? d) Standards or codes of practice that the organisation has committed to implement? e) Potential consequences of failure due to the nature of the products and services? Are your organisation s inputs adequate for design and development purposes and are they complete and unambiguous? Does your organisation resolve your conflicting design and development issues? Does your organisation retain documented information on design and development inputs? 8.3.4 Design and development controls Does your organisation apply controls to the design and development process to ensure that: a) The results to be achieved are defined? b) Reviews are conducted to evaluate the ability of the results of design and development to meet requirements? c) Verification activities are conducted to ensure that the design and development outputs meet the input requirements? d) Validation activities are conducted to ensure the resulting products and services meet the requirements for the specified application or intended use? e) Any necessary actions are taken on problems determined during the reviews, or verification and validation activities? f) Documented information of these activities is retained? 8.3.5 Design and development outputs Does your organisation ensure that design and development outputs: a) Meet the input requirements? b) Are adequate for the subsequent processes for the provision of products and services? c) Include or reference monitoring and measuring requirements, as appropriate and acceptance criteria? d) Specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision? Does your organisation retain documented information on design and development outputs? 8.3.6 Design and development changes Does your organisation identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there are no adverse impact on the conformity to requirements? Does your organisation retain documented information on: a) Design and development changes? b) The results of reviews? c) The authorisation of the changes? d) The actions taken to prevent adverse impacts?

8.4 Control of externally provided processes, products and services 8.4.1 General Does your organisation ensure that externally provided processes, products and services conform to requirements? Does your organisation determine the controls to be applied to externally provided processes, products and services when: a) Products and services from external providers are intended for incorporation into your organisation s own products and services? b) Products and services are provided directly to the customer by external providers on behalf of your organisation? c) A process, or part of a process, is provided by an external provider as a result of a decision by your organisation? Does your organisation determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements? Does your organisation retain documented information of these activities and any necessary actions arising from the evaluations? 8.4.2 Type and extent of control Does your organisation ensure that externally provided processes, products and services do not adversely affect the organisation s ability to consistently deliver conforming products and service to its customers? Does your organisation: a) Ensure that externally provided processes remain within the control of your QMS? b) Define both the controls that it intends to apply to an external provider and those it intends to apply to resulting output? c) Take into consideration: 1) The potential impact of the externally provided processes, products and services on your organisation s ability to consistently meet customer and applicable statutory and regulatory requirements? 2) The effectiveness of the controls applied by the external provider? d) Determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements? 8.4.3 Information for external providers Does your organisation ensure the adequacy of requirements prior to their communication to the external provider? Does your organisation communicate to external providers its requirements for: a) The processes, products and services to be provided? b) The approval of: 1) Products and services? 2) Methods, processes and equipment? 3) The release of products and services? c) Competence, including any required qualification of persons? d) The external providers interactions with your organisation? e) Control and monitoring of the external providers performance to be applied by the organisation? f) Verification or validation activities that the organisation, opt its customers, intends to perform at the external providers premises?

8.5 Production and service provision 8.5.1 Control of production and service provision Does your organisation implement production and service provision under controlled conditions? Does your organisation s controlled conditions include: a) The availability of documented information that defines: 1) The characteristics of the products to be produced, the services to be provided, or the activities to be performed? 2) The results to be achieved? b) The availability and use of suitable monitoring and measuring resources? c) The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met? d) The use of suitable infrastructure and environment for the operation of processes? e) The appointment of competent persons, including any required qualification? f) The validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurements? g) The implementation of actions to prevent human error? h) The implementation of release, delivery and post-delivery activities? 8.5.2 Identification and traceability Does your organisation use suitable means to identify outputs when it is necessary to ensure the conformity of products and services? Does your organisation identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision? Does your organisation control the unique identification of the outputs when traceability is a requirement and does your organisation retain the documented information necessary to enable traceability? 8.5.3 Property belonging to customers or external providers Does your organisation exercise care with property belonging to customers or external providers while it is under your organisation s control or being used by your organisation? Does your organisation identify, verify, protect, and safeguard customers or external providers property provided for use or incorporated into the products or services? When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, does you organisation report this to your customer or external provider and retain documented information on what has occurred? 8.5.4 Preservation Does your organisation preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements? 8.5.5 Post-delivery activities Does your organisation meet requirements for post-delivery activities associated with the products and services? In determining the extent of post-delivery activities that are required, does you consider: a) Statutory and regulatory requirements? b) The potential undesired consequences associated with its products and services? c) The nature, use and intended lifetime of its products and services? d) Customer requirements? e) Customer feedback?

8.5.6 Control of changes Does your organisation review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements? Does your organisation implement planned arrangements, at appropriate stages to verify that the product and service requirements have been met? Does your organisation make sure the release of products and services to the customer are not proceeded until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer? Does your organisation retain documented information on the release of products and services? Does your organisations documented information include: a) Evidence of conformity with the acceptance criteria? b) Traceability to the person(s) authorising the release? 8.7 Control of nonconforming outputs 8.7.1 Does your organisation ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery? Does your organisation take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services? Does this also apply to nonconforming products and services detected after delivery of products, during or after the provision of services? Does your organisation deal with nonconforming outputs in one or more of the following ways: a) Correction? b) Segregation, containment, return or suspension of provision of products and services? c) Informing the customer? d) Obtaining authorisation? Does your organisation ensure conformity to the requirements are verified when nonconforming outputs are corrected? 8.7.2 Does your organisation retain documented information that: a) Describes the nonconformity? b) Describes the actions taken? c) Describes any concessions obtained? d) Identifies the authority deciding the action in respect of the nonconformity?

9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General Does your organisation determine: a) What needs to be monitored and measured? b) The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results? c) When the monitoring and measuring shall be performed? d) When the results from monitoring and measurement are analysed and evaluated? Does your organisation evaluate the performance and the effectiveness of your QMS? Does your organisation retain appropriate documented information as evidence of the results? 9.1.2 Customer satisfaction Does your organisation monitor customers perceptions of the degree to which their needs and expectations have been fulfilled? Does your organisation determine the methods for obtaining, monitoring and reviewing this information? 9.1.3 Analysis and evaluation Does your organisation analyse and evaluate appropriate data and information arising from monitoring and measurement? Are the results of your analysis used to evaluate: a) Conformity of products and services? b) The degree of customer satisfaction? c) The performance and effectiveness of your QMS? d) If planning had been implemented effectively? e) The effectiveness of actions taken to address risks and opportunities? f) The performance of external providers? g) The need for improvements to your QMS? 9.2 Internal audit 9.2.1 Does your organisation conduct internal audits at planned intervals to provide information on whether your QMS: a) conforms to: 1) your organisation s own requirements for your QMS? 2) the requirements of ISO 9001:2015? b) is effectively implemented and maintained?

9.2.2 Does your organisation: a) plan, establish, implement and maintain an audit programme including the frequency, methods, responsibilities, planning requirements and reporting, which take into consideration the importance of the processes concerned, changes affecting the organisation and the results of previous audits? b) Define the audit criteria and scope for each audit? c) Select auditors and conduct audits to ensure objectivity and the impartiality of the audit process? d) Ensure that the results of the audits are reported to relevant management? e) Take appropriate correction and corrective actions without undue delay? f) Retain documented information as evidence of the implementation of the audit programme and the audit results? 9.3 Management review 9.3.1 General Do top management review your organisation s QMS, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organisation? 9.3.2 Management review inputs Is the management review planned and carried out taking into consideration: a) The status of actions from previous management reviews? b) Changes in external and internal issues that are relevant to your QMS? c) Information on the performance and effectiveness of your QMS, including trends in: 1) Customer satisfaction and feedback from relevant interested parties? 2) The extent to which quality objectives have been met? 3) Process performance and conformity of products and services? 4) Nonconformities and corrective actions? 5) Monitoring and measurement results? 6) Audit results? 7) The performance of external providers? d) The adequacy of resources? e) The effectiveness of actions taken to address risks and opportunities? f) Opportunities for improvement? 9.3.3 Management review outputs Do the outputs of your management review include decisions and actions related to: a) Opportunities for improvement? b) Any need for changes to your QMS? c) Resource needs? Does your organisation retain documented information as evidence of the results of your management reviews?

10 Improvement 10.1 General Does your organisation determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction? Do these include: a) Improving products and services to meet requirements as well as to address future needs and expectations? b) Correcting, preventing or reducing undesired effects? c) Improving the performance and effectiveness of your QMS? 10.2 Nonconformity and corrective action 10.2.1 When a nonconformity occurs, including any arising from complaints, does your organisation: a) React to the nonconformity and, as applicable: 1) Take action to control and correct it? 2) Deal with the consequences? b) Evaluate the need for action to eliminate the cause of the nonconformity, so that it does not recur or occur elsewhere, by: 1) reviewing and analysing the nonconformity? 2) determining the causes of the nonconformity? 3) determining if similar nonconformities exist, or could potentially occur? c) implement any action needed? d) review the effectiveness of any corrective action taken? e) update risks and opportunities determined during planning, if necessary? f) make changes to the quality management system, if necessary? Do you ensure corrective actions are appropriate to the effects of the nonconformities encountered? 10.2.2 Does your organisation retain documented information as evidence of: a) the nature of the nonconformities and any subsequent actions taken? b) the results of any corrective action? 10.3 Continual improvement Does your organisation continually improve the suitability, adequacy and effectiveness of your QMS? Does your organisation consider the results of your analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that are addressed as part of continual improvement?

Do you believe you are now ready for assessment? Yes or No (as applicable) If No, please advise when you feel that you will be ready months please complete Please advise how long your system has been issued and in use months please complete If you are ready for assessment or believe you will be ready within the next six months, then you should complete and return this questionnaire to us as soon as possible, either by post to LRQA Small Business Advisors (see address at the bottom of this page) or by e-mail to your LRQA contact or enquiries@lrqa.co.uk Our technical staff will then review it and, if we need to clarify any points, we will contact you before we visit. If you have any questions at all, please call our dedicated Small Business Advisors on 0800 783 2179. Finally, please also complete the following section about your organisation: Mr, Mrs, Ms, Dr? First name: Last name: Job title: Organisation: Post Code: E-mail: Telephone (Mobile:) Telephone (Office): Signature: Date: LRQA 1 Trinity Park, Bickenhill Lane, Birmingham, West Midlands, B37 7ES, UK Sales and Marketing T 0330 414 1342 E enquiries@lrqa.co.uk LRQA Training T 0330 414 1340 E lrqatraining@lrqa.com Improving performance, reducing risk Care is taken to ensure that all information provided is accurate and up to date. However, LRQA accepts no responsibility for inaccuracies in, or changes to, information. Lloyd s Register and variants of it are trading names of Lloyd s Register Group Limited, its subsidiaries and affiliates. Lloyd s Register Quality Assurance Limited 2016. A member of the Lloyd s Register group. Rev. April 2016

For LRQA office use only: Office review Client Support Technical 1) Has client confirmed their readiness for assessment? Yes or No (as applicable) 2) Have No responses been qualified? Yes or No (as applicable) 3) Has the questionnaire been reviewed and deemed satisfactory? Yes or No (as applicable) Client Support Name: Signature: Date: Technical Name: Signature: Date: Improving performance, reducing risk