National Security Inspectorate Sentinel House, 5 Reform Road Maidenhead SL6 8BY Website: nsi.org.uk Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner Head of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC ( RESTRICTED) Page 1 of 32 © NSI 2020 Quality Schedule NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval EASQS207 Issue 1 Aug 2020 NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 2 of 32 © NSI 2020 NSI Evacuation Alert Systems (EAS) Gold is an approval scheme combining Quality Management System (QMS) Certification and Product Certification (PC). The QMS element of the Evacuation Alert Systems Gold sche me calls for compliance with BS EN ISO 9001:2015, the British, European and International Standard for QMS. The ISO 9001 Standard can be applied to any organization, whether they are manufacturing a product or supplying a service, and is mandatory for any UKAS Accredited Certification of QMS. The BAFE SP207 document a nd the NSI Evacuation Alert Systems Gold scheme require that e vacuation a lert s ystems are des igned, installed, commissioned and maintained by competent , and , w here required, security screened personnel to the appropriate manufacturer ’ s requirements and scr eening standards, such as BS 7858. Compliance with BS EN ISO 9001:2015, this Quality Schedule, and BAFE SP207 is a condition of any NSI Evacuation Alert Systems Gold approval . NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 3 of 32 © NSI 2020 1 Introduction 1.1. Quality Schedules are designed for particular sectors of industr y and are used to amplify the requirements of the QMS Standard (BS EN ISO 9001) and provide an agreed basis for audit. 1.2. The 2015 standard is based on the quality management principles described in ISO 9000, which are customer focus, leadership, engagement o f people, process approach, improvement, evidence – based decision making and relationshi p management. There is a strong focus on leadership and co mmitment to the quality management system (see BS EN ISO 9001:2015 Clause 5). The concept of risk – based thinkin g enable s greater flexibility to be applied to the requirements for processes, documented information and organizational responsibilities. 1.3. BS EN ISO 9001:2015 includes a requirement to maintain documented information required by the Standard and documented information determined to be necessary to ensure the effectiveness of the quality management system (see BS EN ISO 9001:2015 Clause 7.5). Documented information required includes: (1) the scope of the of the quality management system, (2) information nece ssary to support the operation of processes, which will probably require maintained information (documented procedures) and retained information (records), (3) the quality policy and (4) where appropriate organisational knowledge. More detailed information on the structure, terminology and concepts introduced by the new standard can be found in BS EN ISO 9001:2015 Annex A. 1.4. Use of a n NSI Evacuation Alert Systems Gold approved company (called “you” or “organization” in this Quality Schedule) provides a high le vel of assurance that: a) Evacuation Alert Systems are designed , installed , commissioned and handed over, verified and maintained by technically competent and , where required, security screene d personnel, to the appropriate Product S tandard s (such as BS 8629) and contractual service agreements are fulfilled; b) there is a commitment to customer satisfaction and continual business improvement derived from the implementation of a QMS designed specifically to meet the needs of the Evacuation Alert Systems industry, such needs having been agreed in consultation with insurers, fire and rescue services, building control, installers, trade associations and professional institutions. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 4 of 32 © NSI 2020 1.5. The scope of the organization’s approval is detailed on the NSI Certificate of Approval, and is referenced to the Quality Schedule. 2 Scope 2.1 Compliance with this Quality Schedule is a condition of NSI Gold approval for Evacuation Alert Systems . 2.2 This Quality Schedule sets out the criteria for auditing the QMS of organizations engaged in the design , installation, commissioning and maintenance of Evacuation Alert Systems and does not in any way diminish the NSI Regulations or the defined scheme criteria. 2.3 The full requirements of BS EN ISO 9001:20 15 apply and, additionally, you must adhere to the requ irements of this Quality Schedule. 2.4 T his Schedule retains the alignment with the main clause numbers of BS EN ISO 9001:2015 . Certain requirements are included from the Standard for emphasis and they do not detract from the need for you to comply with all of the requirements of the Standard. Where there are no additional requirements this is stated. 2.5 Requirements of this Quality Schedule you must satisfy are shown in normal text and are further emphasised by the use of “shall” or “must”. Where additional guida nce is given it is reproduced in italics and often further emphasised by the use of “may” or “can” within the text. 3 Definitions In addition to t he definitions in BS EN ISO 9000 the following definitions also apply: 3.1 C omplaint means an expression of dissatis faction made to an organization, related to its product or service, or the complaints – handling process itself, where a response or resolution is explicitly or implicitly expected . 3.2 S ecurity screened means having been adjudged suitable for working in the Eva cuation Alert Systems industry, following completion of security screening . See BS 7858 regarding completion of limited security screening, pending completion of full security screening. 3.3 S ub – contractor means an individual or company external to the organi zation that enters into an agreement or contract with the organization to supply processes, products and/or services . NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 5 of 32 © NSI 2020 This definition applies, irrespective of the contractual arrangements or parties involved, to all individuals performing work for your or ganization who are not staff personnel. BS EN ISO 9001 (see clause 8.4) uses the term “external provider” and this includes “sub – contractors ”. 3.4 S taff personnel means the managing partners of the organization, the sole – proprietor of the organization, or (in the case of a limited company) the directors of the organization and employees from whose remuneration the organization deducts Income Tax and National Insurance contributions. 4 Context of the organisation 4.1 Understanding the organization and its contex t No additional requirements apply to this clause of BS EN ISO 9001:2015. 4 . 2 Understanding the needs and expectations of interested parties No additional requirements apply to this clause of BS EN ISO 9001:2015. 4.3 Determining the scope of the quality ma nagement system Whilst there is no requirement in BS EN ISO 9001:2015 to hold a quality manual there is a requirement to maintain documented information that describes the scope of the QMS . When determining the scope the following must be considered : a) the i nternal and external issues affecting the QMS (clause 4.1); Issues to consider are f or example, chan ges in technology, the introduction or changes to standards, new legislation and personnel changes . b) the requirements of any relevant interested parties affe cting the QMS (clause 4.2); I nterested parties may include shareholders, trade bodies, certification bodies, fire & rescue services and insurers. and c) the organization ’ s products a nd services affected by the QMS. plus d) any justifications where the organiz ation has determined that requirements of the standard are not applicable to the scope of the QMS (clause 4.3). NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 6 of 32 © NSI 2020 When determining the scope of the QMS to meet the requirements of BS EN ISO 9001:2015 organizations may omit ANY requirement, which is not appli cable to the determined scope of the quality management system and does not affect the organisation’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction . Where an organization determ ines that a specific requirement does not apply to the scope of their QMS the justification is to be included within the scope of the QMS. NSI will continue to permit organizations to omit requirements relating to the development aspects of BS EN ISO 9001: 2015 Clause 8.3 Design and development of products and services provided the organization does not undertake these development activities” after the word “services . Where other requirements are not determined to be applicable these are to be justified wit hin the scope of the QMS. 4.4 Quality management system and its processes No additional requirements apply to this clause of BS EN ISO 9001:2015. 5 Leadership 5.1 Leadership and commitment 5.1.1 General No additional requirements apply to this clause of BS EN ISO 9001:2015. 5.1.2 Customer focus No additional requirements apply to this clause of BS EN ISO 9001:2015. 5.2 Policy 5.2.1 Establishing the quality policy In addition to the requirements of this clause of BS EN ISO 9001:2015, the Quality Policy must include a commitment to comply with this Quality Schedule, with industry agreed Codes of Practice and applicable legal and/or statutory requirements. Accredited Certification Bodies (CBs) for any management systems certification must comply with UKAS requ irements to withhold or withdraw approval from companies if any breaches of applicable legislation are found. This is reflected in BS EN ISO 9001:2015 where an organization is required to identify and comply with all relevant statutory requirements applica ble to product(s) and/or service(s) provided (also expressed as legal requirements). NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 7 of 32 © NSI 2020 NSI, as a United Kingdom Accreditation Service (UKAS) accredited CB, does not recommend approval (or continued approval) to BS EN ISO 9001 if there are known breaches of l egal requirements that relate directly to the product or service provided. You must include a commitment in your Quality Policy that it is your intention to comply with applicable legal requirements and periodically to evaluate compliance with the same as an input to management review. Appropriate management must also demonstrate they are generally aware of the prime legislation that impinges on their area of responsibility and authority. For example if an operations manager deploying installation engineer s was unaware of the health & safety legislation relating to working at height then it could hardly be argued they are competent to perform their duties. This would not only be an issue in terms of the potential for legal nonconformity, but also in terms o f compliance with clause 7.2 Competence. 5.2.2 Communicating the quality policy No additional requirements apply to this clause of BS EN ISO 9001:2015. 5.3 Organisational roles, responsibilities and authorities As detailed within the ISO 9001 Standard, you must define and communicate responsibilities and authorities within your organization. The size and complexity of an organization has a bearing on how such responsibilities and authorities are defined. In a large organization with various departmental in terfaces, responsibilities and authorities can be defined through documented job descriptions, a schedule of key personal responsibilities in the quality manual and/or inclusion within the documented procedures. In a very small family run organization, pro vided management and staff can demonstrate on interview a common understanding of everyone’s prime responsibilities and authorities, it may not be necessary to have them fully documented. Notwithstanding the above, Evacuation Alert Systems Gold specificall y requires certain responsibilities are clearly assigned: a) for the ‘Nominated Designer(s)’ see clause 8.3 Design . The Nominated Designer(s) is ( are) responsible for authorising all evacuation alert system designs . NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 8 of 32 © NSI 2020 There is no requirement to appointment a n i ndividual to act as a Quality Management Representative but there remains a need for top management to assign the responsibility and authority for mai ntaining the quality management system. Whilst this does not forbid the organisation from appointing a su b – contract ed quality consultant into this role, top management within the organisation should consider the risks associated with managing the appointment in this way and identify the means to mitigate the potential impact. 6 Planning 6.1 Actions to addr ess risks and opportunities No additional requirements apply to this clause of BS EN ISO 9001:2015. 6.2 Quality objectives and planning to achieve them No additional requirements apply to this clause of BS EN ISO 9001:2015. 6.3 Planning of changes No addit ional requirements apply to this clause of BS EN ISO 9001:2015. However the following are e xamples of situations where changes to the quality management system should be considered: acquisitions and joint ventures introduction of new technologies organisat ional restructuring use of sub – contractors 7 Support 7.1 Resources 7.1.1 General Whilst you must maintain adequate and competent resources, you may not always be able to provide a complete service using your staff personnel and you may have to use sub – cont ractors. C lause 8 .4 .1 of BS EN ISO 9001 :2015 requires you to be able to demonstrate you have established criteria for selection, evaluation and re – evaluation of suppliers of both product and services including sub – contractors. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 9 of 32 © NSI 2020 7.1.2 People You must adopt a documented policy statement in relation to the security screening of personnel who visit customers ’ premises for the purpose of selling, design ing, installing, commissioning and maintaining Evacuation Alert Systems or who have access to confidential info rmation regarding such systems or the premises in which such systems are installed or are to be installed. The documented po licy statement must cover staff personnel and sub – contract personnel. A copy must be available to customers and prospective customer s on request. Evacuation Alert Systems Gold is not prescriptive as to the content of the policy statement. However, it must be clear to a reader of the policy statement whether or not you ensure all personnel visiting customer’s premises , or having access to confidential information , are security screened in accordance with BS 7858 or to another security screening standard as may be required under contractual obligations. Your internal procedures and practices must ensure that any contractual obligations re garding use of security screened personnel are met. Identity cards All staff coming into contact with customer s and their representatives must carry an identity card or other equivalent means of identification. Such identity cards must , as a minimum , inclu de a current photograph of the individual, the name of the organization represented and a contact telephone number for verification purposes. You must have evidence of control in respect of issue, co ntrol and withdrawal of identity cards. Dependent upon t he client base and the type of sites visited the organization may also need to consider incorporating additional information on their identity cards, for example issue and expiry dates, signature and so on and have clearly defined procedures to recover ide ntity cards from leavers. If you permit another company to issue identity cards for the sub – contractors they are supplying, you must ensure (for example through written agreement with the other company and subsequent audit) that identity cards are properly issued, controlled and withdrawn. 7.1.3 Infrastructure You must ensure the premises you operate from meet the requirements of the Evacuation Alert Systems Gold approval criteria and the BAFE SP207 scheme document. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 10 of 32 © NSI 2020 7.1.4 Environment for the operation of pr ocesses No additional requirements apply to this clause of BS EN ISO 9001:2015. However, we draw your attention to the following note in the standard: The e nvironment for the operation of processes can include physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics and cleanliness). S pecific aspects of legislation may apply in some cases and NSI a pproval will not normally be granted if there are any areas of nonconformity with re gard to applicable legislat ion . 7.1.5 Monitoring and measuring resource You must maintain a register of all instruments and equipment used for measurement, inspection and testing purposes and where relevant you must retain up – to – date records of calibration. Where you engage sub – c ontractors (whether they are directly or indirectly engaged) you must seek assurance that all measuring devices are and remain appropriately calibrated and retain sufficient documented information to evidence this. 7.1.6 Organisational knowledge No additio nal requirements apply to this clause of BS EN ISO 9001:2015. 7.2 Competence In accordance with clause 7.2 of BS EN ISO 9001:2015, you must determine the necessary competence of persons doing work under your control that affects the performance and effecti veness of the QMS and you must ensure these persons are competent on the basis of appropriate education, training and experience. Where applicable, you must take actions to enable people to acquire the necessary competence and you must evaluate the effecti veness of the actions taken. You must retain appropriate documented information as evidence of competence. The fact that someone receives training does not guarantee they will be competent in carrying out their duties and therefore there has to be a syste m for confirming competency. W e suggest you should consider a probation ary period for all new people and review their competency formally before granting confirmed employment. The objective here is to identify and address any areas where competency is not immediately indicated and which could indicate a need for further training/development. Thereaft er, you should have a NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 11 of 32 © NSI 2020 process for verifying on – going competency which could include feedback from internal and external audit, formal staff appraisal/evaluation and so on. You must define and document your processes for determining both initial and on – going competency and ensure that such processes are subject to periodic internal audit. In determining and being able to demonstrate the availability of the necessa ry competence within your organization a training programme must be established that includes, where relevant: surveying skills design skills installation skills inspection and test skills (commissioning and handover) maintenance and service skills quality procedures and/or documentation appropriate to business processes company standards for quality and in particular control over requirements internal auditing skills product specific training Training records must be available for review and you must be ab le to demonstrate the effective operation of the above training programme and provide assurance as to who attended the training. Training records must include evidence to substantiate that staff have the technical capability to work upon the equipment or s ystems used. It is not mandatory for personnel to attend external training courses. However, we recommend that selected personnel should attend such courses if the organization does not possess the necessary skills in a given area. Sub – contractors You must use sub – contractors only as permitted by the BAFE SP207 scheme document and only where the individuals involved are adequately skilled, experienced, tra ined, briefed, organised, supervised and monitored. If you engage one or more sub – contractors directly , or you engage an individual or other company to supply sub – contractors, you must ensure there are suitable and adequate procedures and controls in place within the QMS to ensure adequate skill, experience, t raining and so on. You must have written agreem ents with the sub – contractors covering confidentiality of information, training and assignment to agreed tasks. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 12 of 32 © NSI 2020 You must retain sufficient in – house expertise to verify an acceptable service has been provided and have evidence to show the adequacy of sub – co ntractors’ work is validated periodically. By adequacy we mean compliance with all the relevant Product Standards and with all your organization’s procedures and requirements. 7.3 Awareness No additional requirements apply to this clause of BS EN ISO 9001 :2015. 7.4 Communication No additional requirements apply to this clause of BS EN ISO 9001:2015. 7.5 Documented information 7.5.1 General You must ensure your QMS includes the documented information required by BS EN ISO 9001:2015 and the doc umented pro cesses/procedures required by the BAFE SP207 scheme document. 7.5.2 Creating and updating No additional requirements apply to this clause of BS EN ISO 9001:2015. 7.5.3 Control of documented information Within the general practices of controlling document ed information : a) you must make provision to list the issue status of external documents including those called up in the NSI Regulations and Scheme Criteria, and other applicable standards and regulations. b) you must make provision to list the issue status of i nternal documents pertinent to your QMS, including procedures, process maps and so on. c) if documented information is held electronically, you must observe the following safeguards and protocols: (1) Where a document includes a customer signature, the document m ust be held electronically as a facsimile copy, including a facsimile copy of the signature. Alternatively, traceability from a customer signature on a hard copy to an electronically held document will be acceptable. Where documents held electronically req uire authorisation (say customer specification) then issue NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 13 of 32 © NSI 2020 status must be allocated and access rights controlled by password entry at appropriate levels of authorisation. If you introduce other arrangements, you must demonstrate that the above principles o f authorisation and agreement are upheld. It is your responsibility to determine whether specific contractual documents are required legally to be originals. (2) You must have robust and secure backup arrangements and you must keep to these arrangements. (3) You m ust hold backup s of retained information securely (preferably in a fire – resistant container or at a secure off – site location). We draw your attention to the General Data Protection Regulation (GDPR) and the Data Protection Act (DPA). For companies consider ing the use of cloud computing services we draw your attention to the Information Commissioner’s Office (ICO) guidance on the use of cloud computing in relation to compliance with the DPA. (4) You must have ready access to all documentation and records for th e purposes of our Evacuation Alert Systems Gold inspections/audits/surveillance visits and so on . Control of retained documents You must include information security policies for the protection of retained information held on portable electronic devices ( s uch as laptops, tablets, memory sticks) and you must ensure your personnel, including any sub – contractors, keep to these policies. For example, devices should be password protected and have their hard drives encrypted. In addition, there should be restrict ions on leaving devices unattended in vehicles and/or in premises that are not alarmed. Contract information R ecords in respect of contracts (including survey, design, quotations, amendments, installation, commissioning, verification, handover, modificatio n and ‘as fitted drawings’) shall be maintained and made readily accessible for a minimum of 7 years, or the minimum legal requirement whichever is the greater, from the date of handover of the project or until some other organization, e.g. the owner of th e installation formally takes responsibility for their ongoing storage and maintenance. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 14 of 32 © NSI 2020 You shall keep comprehensive records of maintenance work for each project for a minimum of 7 years or the legal minimum requirement whichever is the greater, from the d ate of completion of the work. Complaint information You must hold records of complaints for the life of the contract plus a minimum of two (2) years and you must ensure these records are readily available to our auditors. Training information See BS EN IS O 9001:2015 clause 7.2 for training information. Security screening information For security screening information see clause 7.1.2 of this schedule. 8 Operation 8.1 Operational planning and control You must develop processes for the design, installation, commissioning and maintenance of Evacuation Alert Systems to take account of the need for the QMS to incorporate all the product and regulatory requirements of the Evacuation Alert System industry. The extent and form of documented information required mu st take account of the need to provide evidence: a) that contractual obligations are agreed and understood by all relevant parties ; b) that system design specifications reflect the level of life safety protection required ; c) of the of the competency of staff person nel and sub – contractors ; d) that components used on installations meet the technical requirements of the industry and relevant standards and/or codes of practice (e.g. BS 8629) ; e) of the process es for design, installation, commissioning and handover and maintena nce documentation ; f) of adequate planning and monitoring of installation work and commissioning work including project management techniques where appropriate ; g) of adequate administrative and technical support to installation personnel on site ; and NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 15 of 32 © NSI 2020 h) of the appropriat e level of on – site supervision, particularly on long running contracts . Activities for process control must be consistent with the specified requirements for Evacuation Alert Systems defined in BS 8629 and any other applicable standards or codes of practice . 8.2 R equirements for products and services 8.2.1 Customer communications The following requirements apply in addition to the requirements of this clause of BS EN ISO 9001:2015: System Design Proposal (Specification) Prior to an order being placed a syste m design proposal shall be provided to the client that shall include the following information as a minimum: a) Client’s name . b) Address where system is to be installed . c) British Standard/Specification to which the Evacuation Alert System will be provided . d) Scop e of work (e.g. design, installation, commissioning) . e) Identification of design responsibility for the system (e.g. the company or the client) . f) Overview of equipment to be provided (e.g. make/model of control equipment, types of evacuation alert devices to be provided etc.) . g) The grade of cable to be used (e.g. standard or enhanced) . h) The minimum battery standby and alarm period. i) Reference to design drawings . Management of complaints You must deal promptly with all complaints and in an appropriate manner i ncluding sending the complainant an acknowledgment the matter is receiving timely attention. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 16 of 32 © NSI 2020 You must have a suitable register of complaints, which must include the date of receipt, complainant details, summary of the complaint, and a complaint reference n umber or code. You must register all complaints promptly and then investigate and action them at an appropriate level of seniority. You must find the root causes of complaints so that corrective actions are effective in preventing further occurrences. The decision on the appropriate course of action (or actions) must be documented. When all reasonable steps have been taken to restore confidence, complaints must be closed down by entering a date of closure in the complaint register. T he complainant must be formally notified of the outcome of the complaint investigation. Complaints must be included in the review of nonconformities (see 9.3.2) and consequently clauses 10.1 and 10.2 of BS EN ISO 9001:2015. We draw your attention to the guidelines in BS ISO 100 02:2018 – Quality management – Customer satisfaction – Guidelines for complaints handling in organizations, including guidance for s mall businesses given in Annex B of BS ISO 10002:2018 . BS ISO 10002 defines “complaint” as an “ expression of dissatisfacti on made to an organization , related to its product or service, or the complaints – handling process itself, where a response or resolution is explicitly or implicitly expected ”. Such expr essions of dissatisfaction can be made in a number of different ways for example in writing, including email, or orally on the telephone. We draw your attention to the guiding principles given in clause 4 of BS ISO 10002:2018 , which are recommended for effective handling of complaints: Commitment (committed to defining and impl ementing a complaints – handling process) Capacity (sufficient resource to deal with complaints effectively and efficiently) transparency (well publicised information about where , and how, to complain) accessibility (easily accessible to all complainants) re sponsiveness (immediate acknowledgement and addressed promptly) objectivity (equitable, objective and unbiased) NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 17 of 32 © NSI 2020 charges (free of charge) Information integrity (handling of complaints and data collection) confidentiality (protected from disclosure except wh ere consented) customer – focused approach (open to feedback and commitment to resolve) accountability (for and reporting on the organisation’s actions and decisions) improvement (permanent objective of the organization) competence (personnel have the necess ary competence to handle complaints) timeliness (complaints resolved in a timely manner) 8.2.2 Determining the requirements related to products and services No additional requirements apply to this clause of BS EN ISO 9001:2015. 8.2.3 Review of requirement s related to products and services The formal contract review process is set out below. We remind you that associated practices in respect of the agreement for the system design specification are set out in clause 8.3. a) General The identity of the person ( s ) allocated responsibility and authority to carry out contract reviews must be clearly defined and communicated within the organization (clause 5. 3 of BS EN ISO 9001: 2015 refers). b) Review Reviews must be undertaken: (1) Before submission of any tender or quota tion, to confirm the requirements are adequately defined and documented and your organization has the capability and resou rces to meet the requirements including any statutory and regulatory requirements. (2) After receipt of the customer’s reply to any tender or quotation, or on receipt of purchase order; to ensure any changes requested by the customer are resolved. There must be evidence, by means such as stamp, signature or electronic authorisation, of all reviews. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 18 of 32 © NSI 2020 You must make clear in appropriate document ation whether or not your organization accepts oral confirmation of orders and, if so, your policy must require you to send a written statement to the customer stating your understanding of the agreement and confirming that this will be taken as the agreem ent unless the customer notifies otherwise in writing. c) Amendment to contract On completion of the installation (or the relevant areas of the work), your procedures must ensure all amendments are agreed, recorded and authorized and the requirements of the c ontract are completed. d) Documented information You must retain documented evidence of contract reviews fo r a minimum of seven (7) years or the minimum legal requirement whichever is the greater, from the date of handover of the project . Certain contract i nformation may need to be held for a longer period to satisfy HM Revenue and Customs and VAT requirements and so on. e) Customer liaison You must maintain effective customer liaison through the life of the contract. Clause 8.2.2 of BS EN ISO 9001:20 15 makes it clear that statutory and regulatory requirements shall be determined and a NOTE in the Standard references that supplementary services such as recyc ling or final disposal are post – delivery activities and must also be considered. With any accredited man agement system certification there is increasing recognition that certification ought to give a level of assurance that the approved organization is aware of relevant legislation and is essentially compliant. The reference to recycling or final disposal is a useful pointer to the increasing raft of environmental legislation that applies to organizations whether or not they choose to implement an Environmental Management System. For example electronic and electrical equipment can no longer be sent to landfil l (the WEEE Regulations apply) and manufacturers of certain types of equipment are obliged to have or participate in a take back scheme for the old equipment. We recommend you should maintain a consolidated list of the legislation you believe is relevant t o your organization (see also clause 7.5.1). NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 19 of 32 © NSI 2020 8.2.4 Changes to requirements for products and services No additional requirements apply to this clause of BS EN ISO 9001:2015 . 8.3 Design and development of products and services 8.3.1 General We consider the d etailed selection, placement and configuration of products and the interconnection to meet the specified requirements for a particular installation is application desig n rather than development (such as conceptual design of new products). For this reason, the word ‘development’ is excluded from the sub – headings of this section on design (and therefore differs in this respect from the corresponding clauses in BS EN ISO 9001). If you sub – contract design work you must retain sufficient in – house expertise to ve rify that all designs, and all subsequent installations, meet the relevant Product Standards. 8.3.2 Design planning We will consider Design Planning arrangements differing from those set out in 8.3.2 below (for any organization wishing to adopt differing a rrangements) provided there is evidence the arrangements adopted ensure the provisions of BS EN ISO 9001:2015, this Quality Schedule and the relevant technical and other Standards, Codes of Practice, manufacturers documentation regulatory requirements and so on are met. Any organization wishing to adopt alternative arrangements should write to us giving details. a) You must adopt control s to ensure: (1) The appropriate stages of system design specification development (viz. design planning, design inputs, design outputs, design review, design verification, design validation, and control of design changes; see 8 .3 of BS EN ISO 9001:20 15 ) are f ollowed. (2) The customer is made aware of and agrees to the limitation (if any) of the demands of the appropriate technical S tandard and regulatory requirements of other interested parties (for example local authority building control, fire & rescue services, insurers). (3) T he customer is made aware of, and agrees to , any other limitations to the design (or to the proposed design) in terms of adequacy of control and warning/evacuation capability. (4) The requirements of the customer are translated into a system design specification that is appropriate to the premises (or site) where the Evacuation Alert System is to be installed and t hat lists the equipment and components to be supplied, detailing their proposed locations and containing a general indication of their coverage and purpose. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 20 of 32 © NSI 2020 (5) T he system design specification contains within it a Design Statement, which includes information on any limitations to the design in terms of adequacy of control and warning/evacuation capability. (Alternatively, the Design Statement may be a separate document, provided it is clearly referenced within the system design specification). (6) There is consid eration of any variations and amendments in the customer requirements as installation proceeds (or arising from practicalities coming to notice as installation proceeds), and recorded agreement of such variations or amendments between customer and the orga nization, in the system design specification, or in properly issued amendments to the system design specification, or in an “as – fitted” system record. (7) The “as fitted” system record shall include “as fitted” drawings and, where appropriate, to scale. (8) Agr eed variations (agreed by you with the customer) to the requirements of the r elevant standard (i.e. BS 8629) shall be documented. b) In discha rging your responsibility (see 8.3.2 of BS EN ISO 9001:2015 ) to define the responsibilities and authorities for desi gn and to manage the interfaces between different groups involved in design: (1) You must designate one or more suitably competent individual(s) as “Nominated Designer(s)”. (2) Each individual designated by you as a “Nominated Designer” must be competent to undert ake tasks including: i. acting as the focal point for matters of design of the Evacuation Alert System . ii. assessing the risk factors (for example re lating to adequacy of the control and w arning/evacuation capability influencing the design). iii. being conversant wi th the products and systems specified, and with any significant limitations inherent in such products and systems. iv. ensuring that the content of quotations and system design specifications is compatible with the requirements of th e applicable Product Standa rds and reg ulatory standards. v. “Signing Off” designs on behalf of the organization. vi. being conversant with and up – to – date in respect of new technologies, technical amendments , regulatory standards, and NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 21 of 32 © NSI 2020 national implementation of EU Directives and so on rele vant to the design process. vii. being conversant with installation requirements such that system design specifications are professionally compiled and finalised in a manner which gives clear and unambiguous information to the customer and to the technicians wh o install and commission. c) There should be evidence that “Nominated Designers” are willing to seek advice and guidance as required from other companies (such as equipment manufacturers) and organisations, and to develop and to keep up – to – date their skills b y such means as reading relevant professional magazines and journals, attending conferences and workshops. d) In all cases, a site survey (preferably at initial enquiry stage, or at some other stage prior to issue of a quotation and system design proposal, bu t always at a stage prior to actual commencement of installation) must be undertaken by a “Nominate d Designer” . Final “sign off” of a system design proposal on behalf of the organization must not occur until such a site survey has been completed. Clause ( d) does not apply to new builds on green or brown field sites. It does apply to retrofit to existing buildings. 8.3.3 Desig n inputs No additional requirements apply to this clause of BS EN ISO 9001:2015 . 8.3.4 Design controls No additional requirements app ly to this clause of BS EN ISO 9001:2015 . 8.3.5 Design outputs Throughout the installation, commissioning and handover process the original design and any subsequent changes to that original design must be verified in order that the completed Evacuation Al ert system is confirmed “fit for purpose”. This must be an ongoing process for systems contrac ted to one c ompany or for syste ms contracted to more than one c ompany . In the latter scenario the organisation responsible for verification should be identified p rior to the commencement of the installation work. In – process inspection and testing (for example during commissioning), and final inspection and testing (for example at handover), must be consistent with the requirements of the appropriate Standards (for example BS 8629 ) and with specific contract requirements. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 22 of 32 © NSI 2020 The following processes are also applicable to the “commissioning and handover modul e” (as outlined in BAFE SP207 scheme document). a) Commissioning engineers must have a good working knowledge of the des ign of Evacuation Alert Systems in order that design verification can be carried out during the commissioning process. b) Particular attention must be given to the issue of NSI/BAFE Certificates of Compliance, Modular Certificates and Modification Certific ates. The criteria for issuing Certificates can be found in t he BAFE SP 207 scheme document and on the certificate itself. c) Documentation related to the in spection and test status of Evacuation Alert S ystems shall include and provide information as follows: (1) The “as fitted drawings” preferably to scale. (2) Loop resistance and cable insulation resistance readings. (3) Theoretical standby battery capacity calculations together with the verified current readings taken at commissioning. (4) Sounder audibility readings. (5) Caus e and effect verification checks – to include confirmation that all manual controls and indicators operate correctly and are adequately labelled or identified; this includes confirmation that each evacuation alert zone control triggers operation of sounder s in the correct evacuation alert zone and only that zone. (6) Customer log books. (7) Operation & Maintenance manual(s) . (8) Evacuation alert z one diagrams (where required) . Commissioning, testing and handover in accordance with BS 8629 will normally fulfil va lidation requirements. 8.3.6 Design changes No additional requirements apply to this clause of BS EN ISO 9001:2015 . NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 23 of 32 © NSI 2020 8.4 Control of externally provided processes, products and services 8.4.1 General In accordance with clause 8 .4.1 of BS EN ISO 9001 :2015 , yo u must evaluate and select suppliers (including sub – contractors and companies who provide sub – contractors) based on their ability to supply product or service in accordance with your requirements and the requirements of this Quality Schedule, which include s the requirements of the relevant Product Standards. You must establish criteria for selection, evaluation and re – evaluation of suppliers and keep records of the results including any necessary actions arising from evaluation and re – evaluation. 8.4.2 Type and extent of control You may use sub – contractors on ly as permitted by the BAFE SP207 scheme document . You must: a) Maintain a register of all sub – contractors, which must clearly show the services they can supply; b) Record clearly the basis of selection of all sub – contractors; c) Conclude formal agreements that adequately cover the services to be provided and make it clear services can only be delivered by named individual sub – contractors who have been security screened (where required) and whose competency is demo nstrated; d) Audit and monitor sub – contractors on the same basis as staff personnel; e) Brief sub – contractors on the organization’s policies, procedures, work instructions and records to be completed to verify completion of assigned tasks or service delivery; f) Re tain overall responsibility for all sub – contracted services even if extensive use is made of sub – contractors; g) Allow us to have the right to audit the work carried out by sub – contractors and interview such sub – contractors to confirm their competence; and h) Retain sufficient in – house expertise, if system design is sub – contracted, to enable you to verify the designs are compliant with the relevant Product Standards. If you carry out component and equipment repairs, you must carry out these repairs in accordance with UK Regulations and then only if you are the component manufacturer, NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 24 of 32 © NSI 2020 the manufacturer’s appointed repair agent, or you have a facility that has been assessed satisfactorily against BS EN ISO 9001 (or an equivalent specification) by a recognised, third – part y certification body. 8.4.3 Information for external providers No additional requirements apply to this clause of BS EN ISO 9001:2015. 8.5 Production and service provision 8.5.1 Control of production and service provision Use of sub – contractors You must r e quire your sub – contractors to allow our auditors to examine and inspect vehicles, office premises, workshops and so on used in the course of sub – contract work, and to co – operate in and facilitate such examinations and inspections. You must ensure the tool kits used by sub – contractors are adequate for purpose and are consistent with your requirements. 8.5.2 Identification and traceability Unless customers impose special contractual conditions, your procedures must reflect the extent of traceability of equipm ent and/or components, required for your own purposes, such as for reasons of a warranty. Where applicable, each business process must contain provision for identifying specific traceability requirements, that is, installation hist orical log , security scre ening in progress and so on. 8.5.3 Property belonging to customers or external providers Procedures for the takeover of EAS installations must be consistent with the requirements of NSI Regulations and Codes of Practice. BS EN ISO 9001 includes a useful no te to remind organizations that “customer property can include intellectual property and personal data”. 8.5.4 Preservation No additional requirements apply to this clause of BS EN ISO 9001:20 15 . The “first in, first out” system of stock control is recom mended for items with a limited shelf life. NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 25 of 32 © NSI 2020 8.5.5 Post – delivery activities M aintenance must be carried out in accordance with the recommendations of BS 8629, clause 21. You must provide adequate administrative and technical support to service personnel inc luding any sub – contractors eng aged in maintenance and service . For compone nt and equipment repairs see 8.4.2 of this Quality Schedule. The following specific requirements apply to servicing (maintenance) of Evacuation Alert Systems. The following processe s are also applicabl e to the Maintenance Module of the BAFE SP207 scheme . a) Corrective maintenance (1) There must be a record of the date and time of receipt of every emergency call, together with the date and time of the engineer’s arrival on site and of any ne cessary corrective action. There shall be comprehensive records of maintenance work for each project, which shall be kept for a minimum of 7 years or the legal minimum requirement whichever is the greater, from the date of completion of the work. C ustom er s shall be provided with a report detailing the work that has been carried out . (2) Authorisation from the customer for temporary disconnection must be kept for at least three (3) months after reconnection. (3) There must be adequate access to spares at all time s. (4) You must audit all technicians’ holdings of spares to ensure continued adequate provision (see also 8.2.2 of this Quality Schedule). b) Preventive maintenance You must have a documented process for the planning, scheduling and implementation of preventive maintenance and for the review of preventive maintenance performance. We draw your attention to the requirements of NSI Technical Bulletin TB 0046 “ Information Concerning the Level of Performance in Relation to the Carrying Out of Routine (preventive) Maintenance V isits ”. The principles here are a pplicable to maintena nce of Evacuation Alert Systems . NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 26 of 32 © NSI 2020 8.5.6 Control of changes No additional requirements apply to this clause of BS EN ISO 9001:2015. 8.6 Release of products and services No additional requirements apply to this clause of BS EN ISO 9001:2015. 8.7 Control of no nconforming outputs Your retained documentation for control of nonconforming product must provide for the identification of: Evacuation Alert Systems giving repeated problems (troublesome systems) inadequate periodic servicing (preventive maintenance) perf ormance temporary disconnections defective components complaints from any parties any other type of nonconforming product as determined by the organization . Means for identifying nonconforming product may be found in other parts of the QMS, for example thro ugh technical auditing of systems and through investigation of customer complaints. Non – conformance may be identified by a contractor with work carried out by an earlier contractor. This may arise through the verification process. The nonconformity should be documented and resolved through a process of consultation. Corrective action forms under a corrective action procedure may be used as a means for recording the existence of nonconforming product and ensuring appropriate corrective action is taken. 9 Per formance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General You must have a process for the management of complaints (see clause 8.2.1) . This process must cover all complaints whether they are from directly contracted customers o r from stakeholders including the fire and rescue services and the insurers. This process NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 27 of 32 © NSI 2020 (or a separate one) must also cover situations where we contact you about a complaint made to us about your organization. The process for management of complaints can be included in the process(es) for the control of nonconforming product (see 8.7) or can be a stand – alone process. 9.1.2 Customer satisfaction You must monitor customer perceptions of the degree to which requirements have been met. Sources of information on customer perception could include: the outcome of customer satisfaction surveys the number of sales arising from recommendations the number of installations taken over by competitors the number of installations deemed as “troublesome” for reasons attrib utable to your organization (including shortcomings in sub – contracting arrangements) complaints against your organization letters of commendation received from satisfied customers other sources as determined by you warranty claims The maintenance of good relationships with customers is a significant factor affecting the success and growth of any business. Concern for the customer should be part of the overall business strategy. You should set out to avoid complaints. When complaints do occur, the objective should be to come out of each situation with a strengthened relationship with whoever is complaining. 9.1.3 Analysis and evaluation Your analysis of data must include provision of information relating to: customer satisfaction (see clause 8.2.1) suppliers of products (including services) (see clause 8.4) core business processes NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 28 of 32 © NSI 2020 In relation to customer satisfaction, you must analyse the causes of complaints. The analysis must form part of the input to management review (see clause 9.3.2). The main purpose o f the analysis is to assist you in deciding on appropriate corrective action with a view to improving customer satisfaction and reducing future incidence of complaints. The following analysis of rectified complaints by cause code is suggested: a) unsatisfacto ry work (relating to fixing and finishing) b) unsatisfactory installation (relating to performance or safety) c) disputed service charge d) failure to meet service contract (including corrective maintenance) e) lack of timely response to enquiries and complaints f) di spute over rental/maintenance charge g) behaviour of organization’s personnel h) behaviour of sub – contractors (if used) i) accounts dispute (not emanating from one of the items listed above) j) other (use text) You must examine causes of complaints at appropriate in tervals and make (and record) suitable decisions or recommendations regarding corrective action (for example in relation to common causes of complaint). For the maintenance of Evacuation Alert Systems : The level of achievement for preventive (routine) mai ntenance performance must be recorded and the information must form part of Management Review (as well as providing the information necessary to deliver any corrective actions that may arise). The level of achievement in respect of eight (8) hour response to requests for corrective (emergency) maintenance must be recorded and the information must form part of Management Review (as well as providing the information necessary to deliver any corrective actions that may arise). NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 29 of 32 © NSI 2020 9.2 Internal audit The requiremen ts are as specified within BS EN ISO 9001:20 15 , with the clarification that the audit programme must include: a) Technical auditing of the work of each installing technician (including any sub – contractors) using appropriate installation checklists encompassin g the specific requirements of the standards , codes of practice and manufacturers documentation for the systems installed. b) T echnical auditing of each commissioning technician (if such technicians are used solely for commissioning work) using appropriate commissioning checklists encompassing the specific requirements of the standards , codes of practice and manufacturers documentation for systems installed. c) Technical auditing of the work of each maintenance technician using appropriate maintenance checklist s encompassing the specific requirements of the standards , codes of practice and manufacturers documentation for the systems maintained. d) You must plan, establish, implement and maintain an internal audit programme, which must include a statement (or statem ents) of the frequency at which audits shall be undertaken (the frequency of audits shall be that as defined with in the BAFE SP207 S cheme document ) and the person(s) nominated by the organization to undertake the audits. You must also define the steps to b e taken if the systems selected fail to meet the specified criteria and you must include a reference to possible training needs and/or an increase in the frequency and number of audits. Your capability to monitor standards of design, installation, commissi oning and maintenance is an auditable element of Evacuation Alert Systems Gold and you must be able to demonstrate you are capable of identifying all your own nonconformities. Selection, auditing and review of sub – contractors In accordance with BS EN I SO 9001, thorough and effective procedures must exist for the selection, auditing and periodic review of sub – contractors. The level of auditing of sub – contracted work must not be less than the level of auditing that is applied to work undertaken by the org anization’s own staff personnel. Where the auditing of the work of sub – contractors is undertaken by a sub – contractor company through or under which the sub – contractor is engaged, you must inspect the audit records and carry out audits of installations to v erify the standard of the sub – NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 3 0 of 32 © NSI 2020 contracted audits and periodically you must accompany the sub – contractor’s auditor on witnessed audits. You must maintain records of the audits and checks you carry out. 9.3 Management review 9.3.1 General The general requirem ents set out in clause 9.3.1 of BS EN ISO 9001:2015 apply. We recognise there are different views as to who are the top management personnel who should carry out the management review. Each case has to be considered on its own merit, particularly in large multi – layered organizations such as PLC’s. For example it may not be practical or necessary for all Directors to be present at the management review meetings, if when interviewed on actual audit, they can demonstrate awareness of all significant issues rai sed at the meetings. 9.3.2 Management review inputs Top management must review the organisation’s quality management system, which must include, but not be limited to, the following areas as appropriate : the status of actions from previous management revi ews changes in internal and external issues that are relevant to the quality management system (including changes in legislation) information on the performance and effectiveness of the quality management system, including trends in: customer satisfaction and feedback from relevant interested parties (includ ing the analysis of complaints) the extent to which q uality objectives have been met process performance and conformity of products and services (including performance and trend analysis for routine main tenance, response to emergency call outs and false alarms(where applicable) non – conformities and corr ective actions mon itoring and measurement results audit results the performance of external providers (including suppliers, sub – contracto rs and alarm recei ving centres) NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 31 of 32 © NSI 2020 effectiveness of continual improvement initiatives adequacy of resources (including human, equipment and facilities) the effectiveness of actions taken to address risks and opportunities opportunities for improvement (including assessmen t of new software and hardware) review adequacy of Quality Policy and Quality Objectives training needs and requirements infrastructure (when appropriate) evaluation of legal compliance . 9.3.3 Management review outputs No additional requirements apply to this cl ause of BS EN ISO 9001:2015. 10 Improvement 10.1 General No additional requirements apply to this clause of BS EN ISO 9001:2015. 10.2 Nonconformity and corrective action You must have effective process(es) for the development and implementation of appropri ate corrective actions where a nonconforming process output, product or service is identified, including systems failing to operate as expected , substandard installations, poor service performance and customer complaints to prevent the recurrence of the no n – conformity. Clause 10.2 of BS EN ISO 9001 makes it clear the organization must take action to eliminate the causes of nonconformities in order to prevent recurrence and that nonconformities include customer complaints. You must carry out root cause analy sis to find the causes of nonconformities in order to support the corrective actions taken in response to nonconformities. You must retain sufficient documentation to provide evidence of the nature of any nonconformities identified and subsequent correctiv e actions and you must retain evidence of the results of this corrective action. As a minimum this retained information NSI Quality Schedule for the application of BS EN ISO 9001:2015 to Evacuation Alert Systems Gold Approval Document no. EASQS207 Document issue no. 1 Document issue date August 2020 Document owner He ad of Field Operations (Systems) Last review date August 2020 Document classification PUBLIC (RESTRICTED) Page 32 of 32 © NSI 2020 must include evidence of the review of audit result s, service reports, false activation statistics, and customer complaints. 10.3 Contin ual improvement No additional requirements apply to this clause of BS EN ISO 9001:2015. Measures in 10.2 and 10.3 are not exhaustive. Corrective actions and opportunities for continual improvement may apply to other areas of the q uality m anagement s ystem.