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Is 9001 annex sl


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ISO 9001-2015 Annex SL

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Is 9001 annex sl

  1. 1. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 1 of 9 May 31, 2016 IS 9001-2015 Annex SL (replaces ISO guide) Quality System 1 An organisation adopts a management system to take care of comfortably achieving its set objectives 2 Management system comprises various sets of procedures for charting out & implementing various operations or activities, so as to successfully reach its intended objectives, which leads to enhanced use of resources, improvement on risk management & increased customer satisfaction by meeting product or services expectations 3 Organizations do work on various management systems say Quality Management, Environment Management, Safety Management etc. 4 These various systems in line to ISO 9001-2008 used to work on varying management structures, causing inconvenience to interface with each other 5 Annex SL being a high level Management System has produced a common platform, so as all systems that organization adopts can be drawn, based on Annex SL designs or format 6 Such arrangement provides many commonalities in designing system, implementation, monitoring, evaluation & improvement, by trying to eliminate conflicts that existed within ISO 9001-2008 system 7 All management systems shall have single high level identical core text, with common terms & definitions. 8 High level structure cannot be changed, but discipline specific sub clauses can be both added or changed 9 Annex SL applies to all Management System standards, publically available specifications & technical specifications. 10 Revised ISO 9001, 14001 & 45001 shall all be based on Annex SL high level structure Annex SL structure is indicated below Clause Format title Description & intended actions, related to PDCA (Plan-Do-Check-Act) Clause 1 Scope Includes Intended outcome of management system, which are industry specific & should be aligned with Clause 4 Context of Organisation Clause 2 Normative references Includes Details of reference standards or publications, relevant to particular
  2. 2. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 2 of 9 May 31, 2016 standard Clause 3 Terms & definitions Includes Detailed terms & definitions applicable to particular / specific standard in addition to format related terms & conditions Clause 4 Context of organization Includes 1 Understanding organization & its context 2 Understanding needs & expectation of parties 3 Determining scope of Management System 4 Management System Points for Considerations 1 Why organization is here? 2 Identify internal & external issue that impact intended outcome 3 Interested parties & their requirements 4 Define scope & set boundaries of management system 5 Raise employees awareness & involvement Clause 5 Leadership Includes 1 Leadership & commitment 2 Policy 3 Organisational roles, responsibilities & authorities Points for Considerations 1 Emphasis on leadership, Not just top management, but leadership is responsible & accountable 2 Top management has greater accountability & involvement in organizational management system 3 Integrate requirement of management system into organizations core business process 4 Ensure that management system allocates necessary resources
  3. 3. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 3 of 9 May 31, 2016 5 Ensure management system achieves business intended outcome 6 Top management responsible to communicate importance of management system & ensure employees awareness & involvement Clause 6 Planning Includes 1 Actions to address risks & opportunities 2 Management system objectives & planning to achieve these objectives Points for Considerations 1 Being risk based thinking to front 2 Ones organization pin points risks & opportunities, it has to work out how to resolve / address through planning 3 What, who, how & when these risks be addressed 4 This approach replaces preventive action 5 Reduces risk for corrective action later 6 Objectives of management system should be measurable, communicated, aligned to management system policy & updated as & when required Clause 7 Support Includes 1 Resources 2 Competence 3 Awareness 4 Communication 5 Documented information Points for Considerations 1 Material, equipment & human resources 2 Capacity potential of organization & individual
  4. 4. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 4 of 9 May 31, 2016 3 Qualification of personnel 4 Awareness among all pertinent system & its functioning 5 Written job description, work procedures, safety procedures, quality control procedures, administration methods etc. 6 Documented information is different than documentations 7 Whatever information about management & procedures or process in whatever form, such as written text, maps, charts, designs, successful implementation, evidence of compliance of requirements etc. 8 No system of documents but evidentiary available documents for reference & future use (documented information) Clause 8 Operation Includes Operational planning & control Points for Considerations 1 In-house processes 2 Outsourced processes 3 Overall process management includes adequate criteria to control these processes 4 Manage planned & unintended changes Clause 9 Performance evaluation Includes 1 Monitoring, measurement, analysis & evaluation 2 Internal audit 3 Management review Points for Considerations 1 Management requires to decide about internal audit to ensure compliance of management system 2 Final review by management to ensure its compliance & whether or
  5. 5. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 5 of 9 May 31, 2016 not, system works suitable, adequately & effectively Clause 10 Improvement Includes 1 Non conformity & corrective action 2 Continual improvement Points for Considerations 1 In changing business environment, processes & objectives vary, to meet which requirements, continual monitoring, evaluation & improvements are a must Two most important objectives in revision of ISO 9000 series of standards have been: 1 To develop a simplified set of standards that shall be equally applicable to small as well as medium and large organizations 2 For amount and detail of documentation required to be more relevant to desired results of organization’s process activities. Notes 1 ISO 9001:2015 Quality management systems – Requirements has achieved these objectives and purpose of this writing is to explain intent of new standard with specific regard to documented information. 2 ISO 9001:2015 allows an organization flexibility in way it chooses to document its quality management system (QMS). This enables each individual organization to determine correct amount of documented information needed in order to demonstrate effective planning, operation and control of its processes with implementation and continual improvement of effectiveness of its QMS. 3 It is stressed that ISO 9001 requires “Documented quality management system”, and not a “system of documents”. What is documented information? Definitions and references 1 Term Documented information was introduced as part of common High Level Structure (HLS) and common terms for Management System Standards (MSS). 2 Definition of documented information can be found in ISO 9000 clause 3.8.
  6. 6. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 6 of 9 May 31, 2016 3 Documented information can be used to communicate a message, provide evidence of what was planned has actually been done or knowledge sharing. Following are some main objectives of an organization’s documented information independent of whether or not, it has implemented a formal QMS; Documented information a Communication of Information As a tool for information transmission and communication Type and extent of documented information shall depend on nature of organization’s products and processes, degree of formality of communication systems and level of communication skills, within organization and organizational culture. b Evidence of conformity Provision of evidence that what was planned has actually been done. c Knowledge sharing d To disseminate and preserve organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product or service. A list of commonly used terms and definitions, relating to documented information is presented in ISO 9001:2015 Annex A. It must be stressed that, according to ISO 9001:2015 clause 7.5.3 Control of documented information requirements, documents may be in any form or type of medium and definition of “document” in ISO 9000:2015 clause 3.8.5 gives the following examples: 1 paper 2 magnetic 3 electronic or optical computer disc 4 photograph 5 master sample ISO 9001:2015 Documentation Requirements ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to an extent necessary to support operation of processes and retain documented information to an extent necessary to have confidence that the processes are being carried out as planned.” Clause 7.5.1 General explains that quality management system documentation shall include:
  7. 7. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 7 of 9 May 31, 2016 1 documented information required by this International standard; 2 documented information determined by an organization as being necessary for effectiveness of quality management system Note after this Clause make it clear that extent of QMS documented information can differ from one organization to another due to: 1 Size of organization and its type of activities, processes, products and services; 2 Complexity of processes and their interactions, 3 Competence of persons. All documented information that forms part of the QMS has to be controlled in accordance with clause 7.5 Documented information. Documented information needed be maintained by organization for purposes of establishing a QMS (high level transversal documents). These include: 1 Scope of quality management system (clause 4.3). 2 Documented information necessary to support operation of processes(clause 4.4). 3 Quality policy (clause 5.). 4 Quality objectives (clause 6.2). 5 This documented information is subject to requirements of clause 7.5. Documented information maintained by organization for purpose of communicating information necessary for organization to operate (low level, specific documents). See 4.4. Although ISO 9001:2015 does not specifically requires any of them, examples of documents that can add value to a QMS may include 1 Organization charts (Top management to line management) 2 Process maps, process flow charts and/or process descriptions (Engineering) 3 Procedures (Technical & administrative) 4 Work and/or test instructions (IFCs etc) 5 Specifications (Project, General & Particular) 6 Documents containing internal communications (Memos, mails, methods) 7 Production schedules (Descriptive schedules) 8 Approved supplier lists (List of all vendors) 9 Test and inspection plans (Check List & ITPs) 10 Quality plans (Site or project based documents) 11 Quality manuals (Organisation based documents) 12 Strategic plans 13 Forms
  8. 8. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 8 of 9 May 31, 2016 Where it exists, all such documented information, is also subject to the requirements clause 7.5. Documented information needed to be retained by organization for purpose of providing evidence of result achieved (records). These include: 1 Documented information to an extent necessary to have confidence that processes are being carried out as planned (clause 4.4). 2 Evidence of fitness for purpose of monitoring and measuring resources (clause 3 Evidence of basis used for calibration of monitoring and measurement resources (when no international or national standards exist) (clause 4 Evidence of competence of persons doing work under control of organization that affects performance and effectiveness of QMS (clause 7.2). 5 Results of review and new requirements for products and services (clause 8.2.3). 6 Records needed to demonstrate that design and development requirements have been met (clause 8.3.2) 7 Records on design and development inputs (clause 8.3.3). 8 Records of activities of design and development controls (clause 8.3.4). 9 Records of design and development outputs (clause 8.3.5). 10 Design and development changes, including results of review and authorization of changes and necessary actions (clause 8.3.6). 11 Records of evaluation, selection, monitoring of performance and re- evaluation of external providers and any other actions arising from these activities (clause 8.4.1) 12 Evidence of unique identification of outputs, when traceability is a requirement (clause 8.5.2). 13 Records ofproperty of customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to owner (clause 8.5.3). 14 Results of review of changes for production or service provision, persons authorizing change, and necessary actions taken (clause 8.5.6). 15 Records of authorized release of products and services for delivery to customer, including acceptance criteria and traceability to authorizing person(s) (clause 8.6). 16 Records of nonconformities, actions taken, concessions obtained and identification of authority deciding action in respect of nonconformity (clause 8.7). 17 Results of evaluation of performance and effectiveness of QMS (clause 911)
  9. 9. Annex SL ISO 9001-2015 QMS IntPE(India) Suraj Singh Page 9 of 9 May 31, 2016 18 Evidence of implementation of audit programme and audit results (clause 9.2.2). 19 Evidence of results of management reviews (clause 9.3.3). 20 Evidence of nature of nonconformities and any subsequent actions taken (clause 10.2.2). 21 Results of any corrective action (clause 10.2.2). Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products, services and quality management system. Where they exist, all such records are also, subject to requirements clause 7.5. To Continue