Yes, they are required. I shall explain this from the perspective of both ISO 9001 - 2022. the old standard and ISO 9001-2015, the new standard since the ISO 9001-2022 still has co-existence with ISO 9001-2022 till the dead line of transition to new standard which is 15 September, 2018.ISO 9001u20132008ISO 9001 - 2022 under clause 4.2.1 expects organization to have :a) documented statements of a quality policy and quality objectivesb) a quality manualc) documents and records, required by the international standardd) documents including records, determined by the organization to be necessary to ensure effective planning, operation and control of processes.There are six mandatory procedures required by international standard against following clauses, namely, :4.2.3 Control of Documents4.2.4 Control of Records8.2.2 Internal Audits8.3 Control of Non Conforming Product8.5.1 Corrective Action &8.5.2 Preventive ActionAgainst the above clauses, the statement of requirement u201c A documented procedure shall be maintained u201d can be seen.The mandatory records required by the international standard can be identified by the statement u201c records ofu2026.. Shall be maintained u2022 under respective clauses. Also in the brackets, 4.2.4 will be indicated which is the clause number for Control of Records.ISO 9001- 2015In ISO 9001- 2022 both documents and records are integrated together and bought under clause 7.5 documented information, which has sub clauses as follows, namely :7.5.1 General7.5.2 Creating and Updating7.5.3 Control of documented Information.Clause 7.5.1 of ISO 9001-2022 states that u201c The organization u2018s quality management system shall include :a) documented information required by the international standardb) documented information determined by the organization as being necessary for the effectiveness of quality management system.The relevant clauses in the standard, where required, also indicate regarding maintaining the documented information.The question also refers to specifications, which, I believe, is pertinent to design and development specifications. Hence please note the following :The mandatory records required under clause 7.3 Design and Development of ISO 9001- 2022 are :Design & Development Input recordsDesign & Development Review recordsDesign & Development Verification recordsDesign & Development Validation records &Record of review of design changes & actionsThe documented information required by the clause 8.3, Design and Development of products and services of ISO 9001- 2022 are those relevant to :Design & Development PlanningDesign & Development InputsDesign & Development ControlsDesign & Development Outputs &Design & Development changes & its reviewsRef. ISO 9001-2022 & ISO 9001-2022 Standards